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Cleaning validation manual: a comprehensive guide for the pharmaceutical and biotechnology industries

"With over 20 easy-to-use template protocols for cleaning validation of extensively used equipments, this book provides technical solutions to assist in fulfilling the training needs of finished pharmaceutical manufacturers. Drawing on the authors more than two decades of experience, the text o...

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Hauptverfasser:	Haider, Syed Imtiaz (VerfasserIn), Asif, Erfan Syed (VerfasserIn)
Format:	Buch
Sprache:	English
Veröffentlicht:	Boca Raton [u.a.] CRC Press 2010
Schlagworte:	Drug Contamination > prevention & control Drug Industry > methods Drug factories > Cleaning > Handbooks, manuals, etc Equipment Contamination > prevention & control Pharmaceutical industry > Equipment and supplies > Sterilization > Handbooks, manuals, etc Biotechnologie Reinigung Pharmazie
Online-Zugang:	Inhaltsverzeichnis Klappentext
Zusammenfassung:	"With over 20 easy-to-use template protocols for cleaning validation of extensively used equipments, this book provides technical solutions to assist in fulfilling the training needs of finished pharmaceutical manufacturers. Drawing on the authors more than two decades of experience, the text offers hands-on training based on current approaches and techniques. The manual is organized as a database to train those involved in the development, manufacturing, auditing, and validation of bio-pharmaceuticals on a pilot scale, leading to scaled-up production. It also provides exclusive training guidelines in a CD-ROM to enable the users to amend or adopt them as necessary."--Provided by publisher.
Beschreibung:	XXXIX, 568 S. Ill. 1 CD-ROM (12 cm)
ISBN:	9781439826607 1439826609

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245	1	0	\|a Cleaning validation manual \|b a comprehensive guide for the pharmaceutical and biotechnology industries \|c Syed Imtiaz Haider ; Erfan Syed Asif
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650		4	\|a Drug Industry \|x methods
650		4	\|a Drug factories \|x Cleaning \|v Handbooks, manuals, etc
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Datensatz im Suchindex

_version_	1804140991329861632
adam_text	Contents List of Figures ..............................................................................................................................xxi List of Tables ...............................................................................................................................xxv About the Book .........................................................................................................................xxvii Preface .........................................................................................................................................xxxi Acknowledgments ..................................................................................................................xxxiii Authors ......................................................................................................................................xxxv Introduction ............................................................................................................................xxxvii Disclaimer ................................................................................................................................xxxix CLV-l How to Establish a Cleaning Validation Program .....................................................1 1.1 Cleaning in Finished, Biopharmaceuticals, and Bulk Chemicals ............................1 1.1.1 Cleaning Program Norms ..................................................................................1 1.1.1.1 Cleaning Methods ...................................................................................2 1.1.1.2 Equipment ................................................................................................2 1.1.1.3 Product ......................................................................................................4 1.1.1.4 Facility .......................................................................................................4 1.1.2 Cleaning Validation .............................................................................................5 1.1.2.1 Cleaning Validation Program ................................................................5 1.1.2.2 Residues and Residue Removal .............................................................5 1.1.2.3 Cleaning of Equipment ...........................................................................6 1.1.2.4 Cycle Development .................................................................................6 1.1.2.5 Sampling Techniques and Analytical Methods ..................................7 1.1.2.6 Limits and Acceptance Criteria .............................................................7 1.1.2.7 Ongoing Monitoring of Cleaning .........................................................8 1.1.2.8 Change Control ........................................................................................8 CLV-2 Introduction .......................................................................................................................9 2.1 Cleaning Validation ........................................................................................................9 2.1.1 US. FDA Guidelines ..........................................................................................10 2.1.2 Health Canada Guidelines ...............................................................................10 2.1.3 EU-GMP Guidelines ..........................................................................................10 2.2 Validation Master Plan .................................................................................................11 CLV-3 Scope and Approach ......................................................................................................13 CLV-4 Cleaning Validation Team Members and Responsibilities ..................................15 4.1 Specific Responsibilities ...............................................................................................15 4.1.1 Validation Department .....................................................................................15 4.1.2 Production ...........................................................................................................15 4.1.3 Packaging ............................................................................................................16 4.1.4 Utílitíes/Calibration/HVAC .............................................................................16 Contents A.1.5 Quality Control ..................................................................................................16 4.1.6 Quality Assurance .............................................................................................16 4.1.7 Product Development Laboratory ...................................................................16 CLV-5 Cleaning Validation Philosophy, Strategies, and Methodology ...........................................................................................................17 5.1 Cleaning Validation Philosophy .................................................................................17 5.2 Cleaning Validation Strategies ....................................................................................17 5.2.1 General ................................................................................................................17 5.2.2 Specific .................................................................................................................17 5.3 New Products, Equipment, and Processes ................................................................18 5.4 Cleaning Validation Methodology .............................................................................19 CLV-6 Planning Phase ...............................................................................................................21 6.1 Prevalidation Requirements ........................................................................................21 6.1.1 Equipment ...........................................................................................................21 6.1.2 Cleaning Procedures .........................................................................................21 6.1.3 Personnel Training .............................................................................................21 6.2 Worst-Case Product Selection Matrix ........................................................................21 6.3 Analytical Development ..............................................................................................22 6.4 Recovery .........................................................................................................................22 6.5 Protocol Development ..................................................................................................23 CLV-7 Execution Phase ..............................................................................................................25 7.1 Visual Examination ......................................................................................................25 Zl.l Sampling .............................................................................................................25 7.1.2 Swab Sampling ...................................................................................................25 7.1.3 Rinse Sampling ..................................................................................................26 CLV-8 Analytical Testing and Reporting Phase ...................................................................27 8.1 Acceptance Criteria .......................................................................................................27 8.1.1 Limits Determination ........................................................................................27 8.1.2 Microbial Burden ...............................................................................................28 8.1.3 Analytical Results Reporting ...........................................................................28 8.1.4 Incident Investigation ........................................................................................28 8.1.5 Reports .................................................................................................................29 8.1.6 Monitoring ..........................................................................................................29 8.1.7 Change Control/Revalidation ..........................................................................29 CLV-9 Equipment Description .................................................................................................31 9.1 Solid Dosage Manufacturing ......................................................................................31 9.1.1 Equipment Description .....................................................................................31 9.2 Sterile ..............................................................................................................................33 9.2.1 Equipment Description (Injectables) ...............................................................33 9.3 Liquid Manufacturing ..................................................................................................34 9.3.1 Equipment Description (Soft Product) ............................................................34 9.4 Filling Lines ...................................................................................................................35 9.4.1 Equipment Description (Soft Product) ............................................................35 Contents ix CLV-IO Facility Description...................................................................................................... 37 10.1 Solid Dosage Manufacturing ......................................................................................37 10.1.1 Facility Description ...........................................................................................37 CLV-ll Utilities Description: DIW, WFI, Steam, and Compressed Air ..........................39 11.1 Utilities Description ......................................................................................................39 11.1.1 Water System ......................................................................................................39 11.1.2 WFI System .........................................................................................................39 11.1.3 Purified Water System .......................................................................................39 11.1.4 Process Chilled Water System ..........................................................................40 11.1.5 Steam System ......................................................................................................40 11.1.6 Compressed Air .................................................................................................40 11.1.7 Compressed Air (Solid and Liquid Products) ...............................................41 11.1.8 Nitrogen System .................................................................................................41 CÌN-H Utilities Monitoring and Microbiological Control ................................................43 CLV-13 Equipment Cleaning Materials/Detergent Description .......................................45 13.1 Solid Dosage Plant ........................................................................................................45 13.2 Sterile Plant ....................................................................................................................45 13.3 Antibiotic Plant ..............................................................................................................46 13.4 Liquid Dosage Plant .....................................................................................................46 CLV-14 Microbiological Cleaning of Equipment Surface ..................................................47 CLV-W Solubility of Active Materials in Water ...................................................................49 CLV-16 Toxicity of Active Materials .......................................................................................55 CLV-iy Cleaning Validation Products Grouping Matrix (Tablets, Capsules, and PPS) ......................................................................................61 17.1 Product Grouping Matrix (Solid Dosage) ..................................................................61 17.1.1 Tablets ..................................................................................................................61 17.2 Product Grouping Matrix (Capsules) .........................................................................76 17.3 Product Grouping Matrix (Granules) .........................................................................78 CLV-18 Product/Equipment Train Matrix (Tab-Cap-PPS) ................................................79 18.1 Products/Equipment Train (Tablets, Capsules, and PPS) .......................................79 18.1.1 Wet Granulation Uncoated Tablets ..................................................................79 18.1.2 Wet Granulation Coated Tablets ......................................................................80 18.1.3 Dry Granulation Uncoated Tablets ..................................................................80 18.1.4 Dry Granulation Coated Tablets ......................................................................81 18.1.5 Sugar-Coated Tablets .........................................................................................81 18.2 Product/Equipment Train (Capsules) ........................................................................81 18.3 Product/Equipment Train (Granules) ........................................................................82 CLV-19 Worst-Case Products (Tablets, Capsules, and PPS) Matrix ..................................83 19.1 Worst-Case Products (Tablets) .....................................................................................83 19.1.1 For Coating Machines Only .............................................................................84 Contents 19.1.2 Sugar-Coated Products (for Conventional Coating Pans) ............................84 19.2 Worst-Case Products (Capsules) .................................................................................84 19.2.1 For Encapsulator A ............................................................................................84 19.2.2 For Encapsulator В .............................................................................................85 19.3 Worst-Case Products (Granules) .................................................................................85 Validation with Corresponding Cleaning Procedures .........................................87 20.1 Protocols for Tablets Manufacturing Equipment .....................................................87 .l Cleaning Validation Protocol for Fluid Bed Dryer ............................................89 20.1.1 Objective ....................................................................................................................90 20.1.2 Scope ...........................................................................................................................90 20.1.3 Responsibility ............................................................................................................90 20.1.4 Description of the Cleaning Process ......................................................................91 20.1.4.1 Difficult-to-Clean Parts ............................................................................92 20.1.5 Description of the Sampling Process .....................................................................92 20.1.5.1 Sampling Technique .................................................................................92 20.1.5.2 Sampling Precautions ..............................................................................92 20.1.5.3 Procedure for Sampling ...........................................................................92 20.1.5.3.1 Surface Swabs ...........................................................................92 20.1.5.4 Handling of Samples ................................................................................96 20.1.6 Test Functions ...........................................................................................................96 20.1.7 Verification of Documents .......................................................................................97 20.1.8 Documentation ..........................................................................................................97 20.1.9 Acceptance Criteria ..................................................................................................97 20.1.10 List of Attachments ..................................................................................................99 CLV-20.2 Cleaning Validation Protocol for Mixer .............................................................107 20.2.1 Objective ..................................................................................................................108 20.2.2 Scope .........................................................................................................................108 20.2.3 Responsibility ..........................................................................................................108 20.2.4 Description of the Cleaning Process ....................................................................109 20.2.4.1 Difficult-to-Clean Parts ..........................................................................109 20.2.5 Description of the Sampling Process ...................................................................109 20.2.5.1 Sampling Technique ...............................................................................109 20.2.5.2 Sampling Precautions ............................................................................110 20.2.5.3 Procedure for Sampling .........................................................................110 20.2.5.4 Handling of Samples .............................................................................. HI 20.2.6 Test Functions ......................................................................................................... HI 20.2.7 Verification of Documents ..................................................................................... Ill 20.2.8 Documentation ........................................................................................................ Ill 20.2.9 Acceptance Criteria ................................................................................................112 20.2.10 List of Attachments ................................................................................................113 Q-S Cleaning Validation Protocol for Granulation Machines (Type A) .............121 20.3.1 Objective ..................................................................................................................122 20.3.2 Scope .........................................................................................................................122 20.3.3 Responsibility ..........................................................................................................122 20.3.4 Description of the Cleaning Process ....................................................................123 20.3.4.1 Difficult-to-Clean Parts ..........................................................................123 Contents Xl 20.3.5 Description of the Sampling Process ...................................................................123 20.3.5.1 Sampling Technique ...............................................................................123 20.3.5.2 Sampling Precautions ............................................................................124 20.3.5.3 Procedure for Sampling .........................................................................124 20.3.5.4 Handling of Samples ..............................................................................124 20.3.6 Test Functions .........................................................................................................124 20.3.7 Verification of Documents .....................................................................................126 20.3.8 Documentation ........................................................................................................127 20.3.9 Acceptance Criteria ................................................................................................127 20.3.10 List of Attachments ................................................................................................128 O^ Cleaning Validation Protocol for Powder Bins .................................................137 20.4.1 Objective ..................................................................................................................138 20.4.2 Scope .........................................................................................................................138 20.4.3 Responsibility ..........................................................................................................138 20.4.4 Description of the Cleaning Process ....................................................................140 20.4.4.1 Difficult-to-Clean Parts ..........................................................................140 20.4.5 Description of the Sampling Process ...................................................................140 20.4.5.1 Sampling Technique ...............................................................................140 20.4.5.2 Sampling Precautions ............................................................................140 20.4.5.3 Procedure for Sampling .........................................................................140 20.4.5.4 Handling of Samples ..............................................................................140 20.4.6 Test Functions .........................................................................................................141 20.4.7 Verification of Documents .....................................................................................142 20.4.8 Documentation ........................................................................................................143 20.4.9 Acceptance Criteria ................................................................................................143 20.4.10 List of Attachments ................................................................................................144 CLV-IOS Cleaning Validation Protocol for Tablet Press ..................................................153 20.5.1 Cleaning Validation Protocol for Tablet Press Type A ............................................................................................................154 20.5.1.1 Objective ..................................................................................................154 20.5.1.2 Scope .........................................................................................................154 20.5.1.3 Responsibility ..........................................................................................154 20.5.1.4 Description of the Cleaning Process ....................................................154 20.5.1.5 Difficult-to-Clean Parts ..........................................................................156 20.5.1.6 Description of the Sampling Process ...................................................156 20.5.1.6.1 Sampling Technique .............................................................156 20.5.1.6.2 Sampling Precautions ...........................................................157 20.5.1.6.3 Surface Swabs .........................................................................157 20.5.1.7 Test Functions .........................................................................................157 20.5.1.8 Verification of Documents .....................................................................161 20.5.1.9 Documentation ........................................................................................161 20.5.1.10 Acceptance Criteria ................................................................................161 20.5.1.11 List of Attachments ................................................................................162 20.5.2 Cleaning Validation Protocol for Tablet Press Type В (Figure 20.5.2.1)............170 20.5.3 Cleaning Validation Protocol for Tablet Press Type С (Figure 20.5.3.1) ..........180 20.5.3.1 List of Attachments ................................................................................180 Xli Contents .e Cleaning Validation Protocol for Sieve ..............................................................193 20.6.1 Objective ..................................................................................................................194 20.6.2 Scope .........................................................................................................................194 20.6.3 Responsibility ..........................................................................................................194 20.6.4 Description of the Cleaning Process ....................................................................194 20.6.4.1 Difficult-to-Clean Parts ..........................................................................196 20.6.5 Description of the Sampling Process ...................................................................196 20.6.5.1 Sampling Technique ...............................................................................196 20.6.5.2 Sampling Precautions ............................................................................196 20.6.5.3 Procedure for Sampling .........................................................................196 20.6.5.4 Handling of Samples ..............................................................................196 20.6.6 Test Functions .........................................................................................................197 20.6.7 Verification of Documents .....................................................................................198 20.6.8 Documentation ........................................................................................................198 20.6.9 Acceptance Criteria ................................................................................................198 20.6.10 List of Attachments ................................................................................................199 .? Cleaning Validation Protocol for Powder-Filling Machine ...........................207 20.7.1 Objective ..................................................................................................................208 20.72 Scope .........................................................................................................................208 20.7.3 Responsibility ..........................................................................................................208 20.7.4 Description of the Cleaning Process ....................................................................209 20.7.4.1 Difficult-to-Clean Parts ..........................................................................209 20.7.5 Description of the Sampling Process ...................................................................210 20.7.5.1 Sampling Technique ...............................................................................210 20.7.5.2 Procedure for Sampling .........................................................................210 20.7.5.3 Sampling Precautions ............................................................................210 20.7.5.4 Handling of Samples ..............................................................................210 20.7.6 Test Functions .........................................................................................................210 20.7.7 Verification of Documents .....................................................................................213 20.7.8 Documentation ........................................................................................................213 20.7.9 Acceptance Criteria ................................................................................................213 20.7.10 List of Attachments ................................................................................................214 О.Ѕ Cleaning Validation Protocol for Encapsulation Machine .............................223 20.8.1 Cleaning Validation Protocol for Encapsulation Machine (Type A) ...............223 20.8.1.1 Objective ..................................................................................................223 20.8.1.2 Scope .........................................................................................................223 20.8.1.3 Responsibility ..........................................................................................224 20.8.1.4 Description of the Cleaning Process ....................................................225 20.8.1.5 Description of the Sampling Process ...................................................225 20.8.1.5.1 Sampling Technique .............................................................225 20.8.1.5.2 Sampling Precautions ...........................................................226 20.8.1.5.3 Procedure for Sampling ........................................................226 20.8.1.5.4 Handling of Samples ............................................................226 20.8.1.6 Test Functions .........................................................................................229 20.8.1.7 Verification of Documents .....................................................................229 20.8.1.8 Documentation ........................................................................................229 20.8.1.9 Acceptance Criteria ................................................................................229 Contents Xlii 20.8.1.10 List of Attachments ................................................................................231 20.8.2 Cleaning Validation Protocol for Encapsulation Machine (Type B) ................239 20.8.2.1 Objective ..................................................................................................239 20.8.2.2 Scope .........................................................................................................239 20.8.2.3 Responsibility ..........................................................................................240 20.8.2.4 Description of the Cleaning Process ....................................................240 20.8.2.4.1 Cleaning Agent/Disinfectant ..............................................240 20.8.2.5 Description of the Sampling Process ...................................................240 20.8.2.5.1 Sampling Technique .............................................................240 20.8.2.5.2 Sampling Precautions ...........................................................241 20.8.2.5.3 Surface Swab ..........................................................................241 20.8.2.5.4 Handling of Samples ............................................................242 20.8.2.6 Test Functions .........................................................................................242 20.8.2.7 Verification of Documents .....................................................................242 20.8.2.8 Documentation ........................................................................................242 20.8.2.9 Acceptance Criteria ................................................................................243 20.8.2.10 List of Attachments ................................................................................243 CLV-20.9 Cleaning Validation Protocol for Film-Coating Pan ........................................259 20.9.1 Objective ..................................................................................................................259 20.9.2 Scope .........................................................................................................................259 20.9.3 Responsibility ..........................................................................................................261 20.9.4 Description of the Cleaning Process ....................................................................261 20.9.4.1 Difficult-to-Clean Parts ..........................................................................261 20.9.5 Description of the Sampling Process ...................................................................262 20.9.5.1 Sampling Technique ...............................................................................262 20.9.5.2 Sampling Precautions ............................................................................262 20.9.5.3 Handling of Samples ..............................................................................262 20.9.5.4 Surface Swabs ..........................................................................................262 20.9.5.4.1 Procedure for Sampling ........................................................262 20.9.6 Test Functions .........................................................................................................264 20.9.7 Verification of Documents .....................................................................................264 20.9.8 Documentation ........................................................................................................264 20.9.9 Acceptance Criteria ................................................................................................264 20.9.10 List of Attachments ................................................................................................266 CLV^O.IO Cleaning Validation Protocol for Sugar-Coating Pan ...................................275 20.10.1 Objective ..................................................................................................................275 20.10.2 Scope .........................................................................................................................275 20.10.3 Responsibility ..........................................................................................................276 20.10.4 Description of the Cleaning Process ....................................................................276 20.10.4.1 Difficult-to-Clean Parts ..........................................................................277 20.10.5 Description of the Sampling Process ...................................................................277 20.10.5.1 Sampling Technique ...............................................................................277 20.10.5.2 Handling of Samples ..............................................................................277 20.10.5.3 Surface Swabs ..........................................................................................278 20.10.5.3.1 Procedure for Sampling ......................................................278 20.10.6 Test Functions .......................................................................................................280 20.10.7 Verification of Documents ...................................................................................280 xiv Contents 20.10.8 Documentation .....................................................................................................280 20.10.9 Acceptance Criteria ..............................................................................................281 20.10.10 List of Attachments ..............................................................................................282 CIW-ll Cleaning Validation Product Grouping Matrix (Syrup) ....................................291 CLV-22 Cleaning Validation Product/Equipment Train (Syrup) ....................................293 CLV-23 Worst-Case Products (Syrup) ...................................................................................295 CLV-24 Cleaning Validation Product Grouping Matrix (Suspension) ..........................297 CLV-25 Product Grouping/Equipment Train Matrix (Suspension) ...............................299 CLV-26 Worst-Case Products (Suspension) .........................................................................301 CLV-27 Product Grouping Matrix (Drops) ..........................................................................303 CLV-28 Product/Equipment Train (Drops) ..........................................................................305 CLV-29 Worst-Case Products (Drops) ...................................................................................307 0 Cleaning Validation Product Grouping Matrix (Cream/Ointment) ................309 30.1 Ointments .....................................................................................................................310 1 Product/Equipment Train (Cream and Ointment) ..............................................311 31.1 Cream Products ...........................................................................................................312 CLV-32 Worst-Case Products (Ointment and Cream) .......................................................313 32.1 Ointments .....................................................................................................................313 32.1 Creams ..........................................................................................................................313 СІУ-ЗЗ Product Grouping Matrix (Suppositories) ............................................................315 CLV-34 Cleaning Validation Product/Equipment Train (Suppositories) ......................317 CLV-SS Worst-Case Products (Suppositories) .....................................................................319 CLV-36 Cleaning Validation Protocols Products (Suppositories) ...................................321 -Sö.l Protocol for Manufacturing Vessel ......................................................................323 36.1.1 Objective ..................................................................................................................324 36X2 Scope .........................................................................................................................324 36.1.3 Responsibilities .......................................................................................................326 36.1.4 Description of the Cleaning Process ....................................................................327 36.1.5 Identification of Critical Parameters ....................................................................327 36.1.6 Description of the Sampling Process ...................................................................328 36.1.6.1 Sampling Technique ...............................................................................328 36.1.6.1.1 Surface Swabs .........................................................................328 Contents xv 36.1.7 Test Functions .........................................................................................................331 36.1.7.1 Visual Inspection ....................................................................................331 36.1.8 Verification of Documents .....................................................................................331 36.1.9 Documentation ........................................................................................................331 36.1.10 Acceptance Criteria ................................................................................................332 36.1.11 List of Attachments ................................................................................................333 б.г Protocol for Bin-Washing Station ........................................................................339 36.2.1 Objective ..................................................................................................................340 36.2.2 Scope .........................................................................................................................340 36.2.3 Responsibilities .......................................................................................................340 36.2.4 Description of the Process .....................................................................................341 36.2.5 Identification of Critical Parameters ....................................................................341 36.2.6 Description of the Sampling Process ...................................................................341 36.2.6.1 Sampling Technique ...............................................................................341 36.2.6.1.1 Surface Swabs (Sterile Cotton Swabs Wetted with WFI) ..................................................................342 36.2.7 Test Functions .........................................................................................................342 36.2.8 Verification of Documents .....................................................................................343 36.2.9 Documentation ........................................................................................................343 36.2.10 Acceptance Criteria ................................................................................................343 36.2.11 List of Attachments ................................................................................................344 СГУ-Зб.З Cleaning Validation Protocol for Syrup-Holding Tank .................................355 36.3.1 Objective ..................................................................................................................356 36.3.2 Scope .........................................................................................................................356 36.3.3 Validation Approach ..............................................................................................356 36.3.4 Responsibility ..........................................................................................................356 36.3.5 Procedure .................................................................................................................356 36.3.6 Description of the Cleaning Process ....................................................................357 36.3.6.1 Procedure .................................................................................................357 36.3.7 Identification of Critical Parameters ....................................................................358 36.3.8 Description of the Sampling Process ...................................................................358 36.3.8.1 Sampling Technique ...............................................................................358 36.3.8.2 Sampling Precautions ............................................................................358 36.3.8.3 Rinse Sample ...........................................................................................358 36.3.8.4 Handling of Sample ...............................................................................358 36.3.9 Test Functions .........................................................................................................359 36.3.9.1 Visual Inspection ....................................................................................359 36.3.10 Verification of Documents .....................................................................................360 36.3.11 Documentation ........................................................................................................360 36.3.12 Acceptance Criteria ................................................................................................360 36.3.13 List of Attachments ................................................................................................361 CLV-36A Protocol for Filling Station and Filter Assembly ..............................................367 36.4.1 Protocol for Filling Machine (Type A) .................................................................368 36.4.1.1 Objective ..................................................................................................368 36.4.1.2 Scope .........................................................................................................368 36.4.1.3 Cleaning Validation Approach .............................................................368 XVI Contents 36.4.1.4 Responsibilities .......................................................................................368 36.4.1.5 Description of the Cleaning Process ....................................................368 36.4.1.6 Identification of Critical Parameters ....................................................369 36.4.1.7 Description of the Sampling Process ...................................................370 36.4.1.7.1 Sampling Technique .............................................................370 36.4.1.7.2 Surface Swabs .........................................................................372 36.4.1.8 Test Functions .........................................................................................373 36.4.1.8.1 Visual Inspection ...................................................................373 36.4.1.9 Verification of Documents .....................................................................373 36.4.1.10 Documentation ........................................................................................373 36.4.1.11 Acceptance Criteria ................................................................................374 36.4.1.12 List of Attachments ................................................................................374 36.4.2 Protocol for Filling Station (Type B) .....................................................................380 36.4.2.1 Objective ..................................................................................................380 36.4.2.2 Scope .........................................................................................................380 36.4.2.3 Validation Approach ..............................................................................380 36.4.2.4 Responsibilities .......................................................................................381 36.4.2.5 Description of the Cleaning Process ....................................................381 36.4.2.6 Identification of Critical Parameters ....................................................382 36.4.2.7 Description of the Sampling Process ...................................................382 36.4.2.7.1 Surface Swabs .........................................................................383 36.4.2.8 Test Functions .........................................................................................384 36.4.2.8.1 Visual Inspection ...................................................................384 36.4.2.9 Verification of Documents .....................................................................384 36.4.2.10 Documentation ........................................................................................384 36.4.2.11 Acceptance Criteria ................................................................................385 36.4.1.12 List of Attachments ................................................................................385 36.4.3 Protocol for Filling Station (Type C) ....................................................................391 36.4.3.1 Test Functions .........................................................................................392 36.4.3.1.1 Visual Inspection ...................................................................392 36.4.3.1.2 Verification of Documents ....................................................394 36.4.3.2 Documentation ........................................................................................394 36.4.3.3 Acceptance Criteria ................................................................................394 36.4.3.4 List of Attachments ................................................................................395 CLV-37 Cleaning Validation Product Grouping Matrix (Sterile) ....................................401 CLV-38 Cleaning Validation Product/Equipment Train Matrix (Sterile) ......................403 CLV-39 Validation Protocols Biological and Sterile Products ..........................................405 Cleaning Validation Protocol for Freeze Dryer .................................................407 39.1.1 Objective ..................................................................................................................408 39.1.2 Scope .........................................................................................................................408 39.1.2.1 Cleaning Validation Program ...............................................................408 39.1.3 Responsibility ..........................................................................................................410 39.1.4 Description of the Cleaning Process ....................................................................410 39.1.5 Description of the Sampling Process ...................................................................410 39.1.5.1 Sampling Technique ...............................................................................410 Contents XVII 39.1.5.2 Surface Swabs ..........................................................................................410 39.1.5.3 Rinse Sampling .......................................................................................410 39.1.5.4 Sampling Precautions ............................................................................411 39.1.6 Test Functions .........................................................................................................411 39.1.7 Verification of Documents .....................................................................................412 39.1.8 Documentation ........................................................................................................412 39.1.9 Acceptance Criteria ................................................................................................412 39.1.10 List of Attachments ................................................................................................413 CLV-39.2 Cleaning Validation Protocol for Glass-Lined Mobile Tank ..........................421 39.2.1 Objective ..................................................................................................................422 39.2.2 Scope .........................................................................................................................422 39.2.2.1 Cleaning Validation Program ...............................................................422 39.2.3 Responsibilities .......................................................................................................422 39.2.4 Description of the Cleaning Process ....................................................................422 39.2.5 Identification of Critical Parameters ....................................................................423 39.2.6 Description of the Sampling Process ...................................................................423 39.2.6.1 Sampling Technique ...............................................................................423 39.2.6.2 Surface Swabs .................................... J .....................................................424 39.2.6.2.1 Procedure for Sampling ........................................................424 39.2.6.3 Water Rinses ............................................................................................424 39.2.6.3.1 Procedure for the Sample .....................................................424 39.2.6.4 Sampling Precautions ............................................................................425 39.2.7 Test Functions .........................................................................................................425 39.2.8 Verification of Documents .....................................................................................426 39.2.9 Documentation ........................................................................................................426 39.2.10 Acceptance Criteria ................................................................................................427 39.2.11 List of Attachments ................................................................................................427 CLV-39.3 Protocol for Preparation and Holding Vessel for Egg Protein .........................................................................................................435 39.3.1 Objective ..................................................................................................................435 39.3.2 Scope .........................................................................................................................435 39.3.3 Cleaning Validation Approach .............................................................................436 39.3.4 Responsibilities .......................................................................................................436 39.3.5 Description of the Cleaning Process ....................................................................436 39.3.6 Description of the Sampling Process ...................................................................436 39.3.6.1 Sampling Technique ...............................................................................436 39.3.6.2 Procedure for Sample .............................................................................437 39.3.6.3 Surface Swabs ..........................................................................................437 39.3.6.4 Sampling Precautions ............................................................................437 39.3.6.5 Sampling and Testing Plan ...................................................................438 39.3.6.6 Preparation Vessel (Swab Sample) .......................................................439 39.3.6.7 Sampling and Testing Plan ...................................................................439 39.3.6.8 Holding Vessel (Swab Sample) ..............................................................440 39.3.7 Test Functions .........................................................................................................440 39.3.7.1 Visual Inspection ....................................................................................440 39.3.8 Verification of Document .......................................................................................440 39.3.9 Documentation ........................................................................................................440 XVIII Contents 39.3.10 Acceptance Criteria ................................................................................................441 39.3.11 List of Attachments ................................................................................................441 ^ Protocol for Filtration Assembly ..........................................................................447 39.4.1 Objective ..................................................................................................................447 39.4.2 Scope .........................................................................................................................447 39.4.3 Responsibility ..........................................................................................................449 39.4.4 Description of the Cleaning Process ....................................................................449 39.4.4.1 Sampling Technique ...............................................................................449 39.4.4.2 Procedure for Sampling .........................................................................450 39.4.4.2.1 Surface Swabs .........................................................................450 39.4.4.2.2 Water Rinses ...........................................................................451 39.4.4.3 Sampling Precautions ............................................................................451 39.4.5 Test Functions .........................................................................................................451 39.4.5.1 VancomycinHCl .....................................................................................452 39.4.5.2 Bacitracin Injection, USP ........................................................................452 39.4.6 Verification of Documents .....................................................................................453 39.4.7 Documentation ........................................................................................................453 39.4.8 Acceptance Criteria ................................................................................................453 39.4.9 List of Attachments ................................................................................................454 ^S Protocol for Preparation and Holding Vessels for Biological Products .......465 39.5.1 Objective ..................................................................................................................465 39.5.2 Scope .........................................................................................................................465 39.5.3 Responsibilities .......................................................................................................466 39.5.4 Description of the Cleaning Process ....................................................................466 39.5.5 Identification of Critical Parameters ....................................................................466 39.5.6 Documentation ........................................................................................................467 39.5.6.1 Documents Required .............................................................................467 39.5.6.2 Documents Attached/Checking ...........................................................467 39.5.7 Verification of Document .......................................................................................467 39.5.8 Test Functions .........................................................................................................467 39.5.9 Acceptance Criteria ................................................................................................468 39.5.10 Description of the Sampling Process ...................................................................469 39.5.10.1 Sampling Technique ...............................................................................469 39.5.10.2 Procedure for Sample .............................................................................469 39.5.10.3 Surface Swabs ..........................................................................................473 39.5.10.4 Sampling Precautions ............................................................................473 CLV-39.6 Protocol for Filtration Assembly and Filling Machine for Biological Products ...........................................................................................489 39.6.1 Objective ..................................................................................................................489 39.6.2 Scope .........................................................................................................................489 39.6.3 Cleaning Verification Approach ...........................................................................490 39.6.4 Responsibilities .......................................................................................................490 39.6.5 Description of the Cleaning Process ....................................................................492 39.6.6 Documentation ........................................................................................................492 39.6.6.1 Documents Required .............................................................................492 39.6.6.2 Documents Attached/Checking ...........................................................492 Contents xix 39.6.7 Verification of Documents .....................................................................................492 39.6.8 Test Functions .........................................................................................................492 39.6.9 Acceptance Criteria ................................................................................................493 39.6.10 Description of the Sampling Process ...................................................................494 39.6.10.1 Sampling Technique ...............................................................................494 39.6.10.2 Procedure for Sample .............................................................................494 39.6.10.3 Sampling Precautions ............................................................................494 CLV-40 Cleaning Validation Tentative Plan (Schedule) ...................................................501 40.1 Tablets Products ........................................................................................................501 40.2 Tablets (Coated) Products ........................................................................................502 40.3 Capsules Products .....................................................................................................503 40.4 PPS Products ..............................................................................................................503 40.5 Syrup Products ..........................................................................................................504 40.6 Suspension Products ................................................................................................505 40.7 Drops Products ..........................................................................................................506 CLV-41 Cleaning Validation Sampling and Testing Status .............................................507 CLV-42 Cleaning Validation Regulatory Guidelines ........................................................511 CLV-42.1 Guide to Inspections Validation of Cleaning Processes .................................513 42.1.1 Introduction .............................................................................................................513 42.1.2 Background .............................................................................................................513 42.1.3 General Requirements ...........................................................................................514 42.1.4 Evaluation of Cleaning Validation .......................................................................515 42.1.4.1 Equipment Design ..................................................................................515 42.1.4.2 Cleaning Process Written ......................................................................516 42.1.4.2.1 Procedure and Documentation ...........................................516 42.1.4.3 Analytical Methods ................................................................................517 42.1.4.4 Sampling ..................................................................................................517 42.1.5 Establishment of Limits .........................................................................................518 42.1.6 Other Issues .............................................................................................................518 42.1.6.1 Placebo Product .......................................................................................518 42.1.6.2 Detergent ..................................................................................................518 42.1.6.3 Test until Clean .......................................................................................519 Bibliography ..........................................................................................................................519 CLV-42.2 WHO Good Manufacturing Guidelines for Cleaning Validation ...............521 42.2.1 Cleaning Program ..................................................................................................521 42.2.1.1 Detailed Cleaning Procedure ...............................................................521 42.2.1.2 Sampling Plan .........................................................................................521 42.2.1.3 Analytical Methods/Cleaning Limits .................................................522 CLV-42.3 Health Products and Food Branch Inspectorate Guidance Document Cleaning Validation Guidelines GUIDE-0028 .............................523 42.3.1 Scope .........................................................................................................................523 42.3.2 Introduction .............................................................................................................523 42.3.3 Principles ..................................................................................................................524 42.3.4 Validation of Cleaning Processes .........................................................................525 xx Contents 42.3.5 Equipment and Personnel .....................................................................................526 42.3.5.1 Equipment ................................................................................................526 42.3.5.2 Personnel ..................................................................................................526 42.3.6 Microbiological Considerations ............................................................................526 42.3.7 Documentation ........................................................................................................526 42.3.8 Analytical Methods ................................................................................................528 42.3.9 Sampling, Rinsing, Rinse Samples, and Detergents .........................................528 42.3.9.1 Sampling ..................................................................................................528 42.3.9.2 Detergents ................................................................................................529 42.3.9.3 Last Rinse .................................................................................................529 42.3.10 Establishment of Limits .........................................................................................530 42.3.11 Change Control/Revalidation ..............................................................................530 Bibliography ..........................................................................................................................531 CLV-42.4 Qualification and Validation ................................................................................533 CLV-43 Sampling Tools ...........................................................................................................545 43.1 Remote Swabbing and Microbiological Sampling Tools .....................................545 43.2 Remote Swabbing and Microbiological Sampling Tools .....................................545 43.3 Teflon Template Tool .................................................................................................546 43.4 Accessories .................................................................................................................546 43.5 Cleaning Validation Coupons .................................................................................550 Acknowledgment .................................................................................................................551 CLV-44 Recommended Readings ..........................................................................................553 Index .............................................................................................................................................555 Cleaning Validation Manual A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its uses have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-use training tools. Until now. Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries elucidates how to train the manpower involved in developing, manufacturing, auditing, and validating of biopharmaceutfcals on a pilot scale, leading to scale-up production. With over 20 easy-to-use template protocols for cleaning validation of extensively used equipment, this book provides technical solutions to assist in fulfilling the training needs of finished product pharmaceutical manufacturers. Drawing on the authors1 more than two decades of experience in the pharmaceutical and biotech industries, the text offers hands-on training based on current approaches and techniques. The book does not merely provide guidelines or thought processes; rather, it gives ready-to-use formulas to develop Master Plans, SOPs., and validation protocols. It includes cleaning procedures for the most commonly used equipment in various manufacturing areas and their sampling points, using a pharmaceutical manufacturing site with both sterile and non-sterile operations as the case facility, It also provides the training guidelines on a CD-ROM to enable users to amend or adopt them as necessary. Grounded in practicality, the book s applicability and accessibility set it apart, ft can be used as a guide for implementing a cleaning validation program on site without the help of external consultants, making it a resource that will not be found collecting dust on a shelf, but rather, referred to again and again.
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spelling	Haider, Syed Imtiaz Verfasser aut Cleaning validation manual a comprehensive guide for the pharmaceutical and biotechnology industries Syed Imtiaz Haider ; Erfan Syed Asif Boca Raton [u.a.] CRC Press 2010 XXXIX, 568 S. Ill. 1 CD-ROM (12 cm) txt rdacontent n rdamedia nc rdacarrier "With over 20 easy-to-use template protocols for cleaning validation of extensively used equipments, this book provides technical solutions to assist in fulfilling the training needs of finished pharmaceutical manufacturers. Drawing on the authors more than two decades of experience, the text offers hands-on training based on current approaches and techniques. The manual is organized as a database to train those involved in the development, manufacturing, auditing, and validation of bio-pharmaceuticals on a pilot scale, leading to scaled-up production. It also provides exclusive training guidelines in a CD-ROM to enable the users to amend or adopt them as necessary."--Provided by publisher. Drug Contamination prevention & control Drug Industry methods Drug factories Cleaning Handbooks, manuals, etc Equipment Contamination prevention & control Pharmaceutical industry Equipment and supplies Sterilization Handbooks, manuals, etc Biotechnologie (DE-588)4069491-4 gnd rswk-swf Reinigung (DE-588)4049250-3 gnd rswk-swf Pharmazie (DE-588)4045705-9 gnd rswk-swf Reinigung (DE-588)4049250-3 s Biotechnologie (DE-588)4069491-4 s DE-604 Pharmazie (DE-588)4045705-9 s b DE-604 Asif, Erfan Syed Verfasser aut Digitalisierung UB Regensburg application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=018863437&sequence=000003&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis Digitalisierung UB Regensburg application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=018863437&sequence=000004&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA Klappentext
spellingShingle	Haider, Syed Imtiaz Asif, Erfan Syed Cleaning validation manual a comprehensive guide for the pharmaceutical and biotechnology industries Drug Contamination prevention & control Drug Industry methods Drug factories Cleaning Handbooks, manuals, etc Equipment Contamination prevention & control Pharmaceutical industry Equipment and supplies Sterilization Handbooks, manuals, etc Biotechnologie (DE-588)4069491-4 gnd Reinigung (DE-588)4049250-3 gnd Pharmazie (DE-588)4045705-9 gnd
subject_GND	(DE-588)4069491-4 (DE-588)4049250-3 (DE-588)4045705-9
title	Cleaning validation manual a comprehensive guide for the pharmaceutical and biotechnology industries
title_auth	Cleaning validation manual a comprehensive guide for the pharmaceutical and biotechnology industries
title_exact_search	Cleaning validation manual a comprehensive guide for the pharmaceutical and biotechnology industries
title_full	Cleaning validation manual a comprehensive guide for the pharmaceutical and biotechnology industries Syed Imtiaz Haider ; Erfan Syed Asif
title_fullStr	Cleaning validation manual a comprehensive guide for the pharmaceutical and biotechnology industries Syed Imtiaz Haider ; Erfan Syed Asif
title_full_unstemmed	Cleaning validation manual a comprehensive guide for the pharmaceutical and biotechnology industries Syed Imtiaz Haider ; Erfan Syed Asif
title_short	Cleaning validation manual
title_sort	cleaning validation manual a comprehensive guide for the pharmaceutical and biotechnology industries
title_sub	a comprehensive guide for the pharmaceutical and biotechnology industries
topic	Drug Contamination prevention & control Drug Industry methods Drug factories Cleaning Handbooks, manuals, etc Equipment Contamination prevention & control Pharmaceutical industry Equipment and supplies Sterilization Handbooks, manuals, etc Biotechnologie (DE-588)4069491-4 gnd Reinigung (DE-588)4049250-3 gnd Pharmazie (DE-588)4045705-9 gnd
topic_facet	Drug Contamination prevention & control Drug Industry methods Drug factories Cleaning Handbooks, manuals, etc Equipment Contamination prevention & control Pharmaceutical industry Equipment and supplies Sterilization Handbooks, manuals, etc Biotechnologie Reinigung Pharmazie
url	http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=018863437&sequence=000003&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=018863437&sequence=000004&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA
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