LEADER 05848nam 2200757Ia 450 001 9910818795703321 005 20200520144314.0 010 $a0-429-15225-6 010 $a1-4398-2661-7 024 7 $a10.1201/b10506 035 $a(CKB)2670000000028306 035 $a(EBL)544090 035 $a(OCoLC)646788208 035 $a(SSID)ssj0000457804 035 $a(PQKBManifestationID)11282230 035 $a(PQKBTitleCode)TC0000457804 035 $a(PQKBWorkID)10435339 035 $a(PQKB)10565017 035 $a(MiAaPQ)EBC544090 035 $a(MiAaPQ)EBC4010177 035 $a(Au-PeEL)EBL544090 035 $a(CaPaEBR)ebr10393126 035 $a(CaONFJC)MIL693226 035 $a(OCoLC)649911987 035 $a(Au-PeEL)EBL4010177 035 $a(OCoLC)1287179697 035 $a(FINmELB)ELB158204 035 $a(EXLCZ)992670000000028306 100 $a20100408d2010 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aCleaning validation manual $ea comprehensive guide for the pharmaceutical and biotechnology industries /$fSyed Imtiaz Haider, Erfan Syed Asif 205 $a1st ed. 210 $aBoca Raton $cCRC Press/Taylor & Francis Group$dc2010 215 $a1 online resource (610 p.) 300 $aDescription based upon print version of record. 311 $a1-322-61944-1 311 $a1-4398-2660-9 320 $aIncludes bibliographical references and index. 327 $aFront cover; Contents; List of Figures; List of Tables; About the Book; Preface; Acknowledgments; Authors; Introduction; Disclaimer; CLV-1: How to Establish a Cleaning Validation Program; Body; CLV-2: Introduction; CLV-3: Scope and Approach; CLV-4: Cleaning Validation Team Membersand Responsibilities; CLV-5: Cleaning Validation Philosophy, Strategies,and Methodology; CLV-6: Planning Phase; CLV-7: Execution Phase; CLV-8: Analytical Testing and Reporting Phase; CLV-9: Equipment Description; CLV-10: Facility Description; CLV-11: Utilities Description: DIW, WFI, Steam,and Compressed Air 327 $aCLV-12: Utilities Monitoring and Microbiological ControlCLV-13: Equipment Cleaning Materials/DetergentDescription; CLV-14: Microbiological Cleaning of Equipment Surface; CLV-15: Solubility of Active Materials in Water; CLV-16: Toxicity of Active Materials; CLV-17: Cleaning Validation Products Grouping Matrix (Tablets, Capsules, and PPS); CLV-18: Product/Equipment Train Matrix (Tab-Cap-PPS); CLV-19: Worst-Case Products (Tablets, Capsules,and PPS) Matrix; CLV-20: Validation with Corresponding Cleaning Procedures; CLV-20.1: Cleaning Validation Protocol for Fluid Bed Dryer 327 $aCLV-20.2: Cleaning Validation Protocol for MixerCLV-20.3: Cleaning Validation Protocol for Granulation Machines (Type A); CLV-20.4: Cleaning Validation Protocol for Powder Bins; CLV-20.5: Cleaning Validation Protocol for Tablet Press; CLV-20.6: Cleaning Validation Protocol for Sieve; CLV-20.7: Cleaning Validation Protocol for Powder-Filling Machine; CLV-20.8: Cleaning Validation Protocol for Encapsulation Machine; CLV-20.9: Cleaning Validation Protocol for Film-Coating Pan; CLV-20.10: Cleaning Validation Protocol for Sugar-Coating Pan 327 $aCLV-21: Cleaning Validation Product Grouping Matrix (Syrup)CLV-22: Cleaning Validation Product/Equipment Train (Syrup); CLV-23: Worst-Case Products (Syrup; CLV-24: Cleaning Validation Product Grouping Matrix (Suspension); CLV-25: Product Grouping/Equipment Train Matrix (Suspension); CLV-26: Worst-Case Products (Suspension); CLV-27: Product Grouping Matrix (Drops); CLV-28: Product/Equipment Train (Drops); CLV-29: Worst-Case Products (Drops); CLV-30: Cleaning Validation Product Grouping Matrix (Cream/Ointment); CLV-31: Product/Equipment Train (Cream and Ointment) 327 $aCLV-32: Worst-Case Products (Ointment and Cream)CLV-33: Product Grouping Matrix (Suppositories); CLV-34: Cleaning Validation Product/Equipment Train (Suppositories); CLV-35: Worst-Case Products (Suppositories); CLV-36: Cleaning Validation Protocols Products (Suppositories); CLV-36.1 Protocol for Manufacturing Vessel; CLV-36.2 Protocol for Bin-Washing Station; CLV-36.3 Cleaning Validation Protocol for Syrup-Holding Tank; CLV-36.4: Protocol for Filling Station and Filter Assembly; CLV-37: Cleaning Validation Product Grouping Matrix (Sterile) 327 $aCLV-38 Cleaning Validation Product/Equipment Train Matrix (Sterile) 330 $aWith 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. 606 $aPharmaceutical industry$xEquipment and supplies$xSterilization$vHandbooks, manuals, etc 606 $aDrug factories$xCleaning$vHandbooks, manuals, etc 615 0$aPharmaceutical industry$xEquipment and supplies$xSterilization 615 0$aDrug factories$xCleaning 676 $a615/.19 686 $aVN 7000$2rvk 686 $aVN 8900$2rvk 686 $aZM 8360$2rvk 700 $aHaider$b Syed Imtiaz$01703196 701 $aAsif$b Erfan Syed$01703197 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910818795703321 996 $aCleaning validation manual$94088218 997 $aUNINA