Sterile processing of pharmaceutical products : engineering practice, validation, and compliance in regulated environments

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Bibliographic Details
Main Author: Hout, Sam, (Author)
Format: eBook
Language: English
Published: Hoboken, NJ : Wiley, 2022.
Subjects:
Drugs > Sterilization.
Drug factories.
Pharmaceutical industry.
elektronické knihy
electronic books
ISBN: 9781119802358
1119802350
9781119802334
1119802334
9781119802341
1119802342
9781119802327
1119802326
Physical Description: 1 online resource.

Cover

Table of contents

LEADER 02694cam a2200445 i 4500
001 kn-on1292745389
003 OCoLC
005 20240717213016.0
006 m o d
007 cr cn|||||||||
008 220120s2022 nju ob 001 0 eng d
040 |a DG1  |b eng  |e rda  |e pn  |c DG1  |d YDX  |d OCLCO  |d UKAHL  |d OCLCF  |d OCLCO  |d OCLCQ  |d UPM  |d N$T  |d OCLCQ  |d UKMGB  |d OCLCO  |d OCLCL  |d OCLCQ 
020 |a 9781119802358  |q (electronic bk. : oBook) 
020 |a 1119802350  |q (electronic bk. : oBook) 
020 |a 9781119802334  |q (electronic bk.) 
020 |a 1119802334  |q (electronic bk.) 
020 |a 9781119802341  |q (electronic bk.) 
020 |a 1119802342  |q (electronic bk.) 
020 |z 9781119802327  |q (print) 
020 |z 1119802326 
024 7 |a 10.1002/9781119802358  |2 doi 
035 |a (OCoLC)1292745389  |z (OCoLC)1290814051  |z (OCoLC)1290840015 
100 1 |a Hout, Sam,  |e author. 
245 1 0 |a Sterile processing of pharmaceutical products :  |b engineering practice, validation, and compliance in regulated environments /  |c Sam Hout. 
264 1 |a Hoboken, NJ :  |b Wiley,  |c 2022. 
300 |a 1 online resource. 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
505 0 |a Sterilization -- Sterile Manufacturing Facilities -- Sanitary Process Piping and Equipment -- Passivation -- Chilled Water System -- Clean-In-Place (CIP) Systems -- Computerized Automated Systems -- Personal Protective Equipment (PPE) and Process Flow -- Sterile Aseptic Processing -- Integrated Facility Design -- Barriers and Isolators -- Guidelines for Statistical Procedure -- Calibration -- Cleaning Validation -- Validation of Filling Equipment -- Manufacturing Process Validation -- Appendix A: Installation Test Plans -- Appendix B: Operational Tests Plans -- Appendix C: WFI Turbulence Flow Requirements -- Appendix D: Water For Injection (WFI) - Design Requirements -- Appendix E: Solution Transfer System (STS) - Design Requirements -- Glossary -- Nomenclature. 
504 |a Includes bibliographical references and index. 
506 |a Plný text je dostupný pouze z IP adres počítačů Univerzity Tomáše Bati ve Zlíně nebo vzdáleným přístupem pro zaměstnance a studenty 
590 |a Knovel  |b Knovel (All titles) 
650 0 |a Drugs  |x Sterilization. 
650 0 |a Drug factories. 
650 0 |a Pharmaceutical industry. 
655 7 |a elektronické knihy  |7 fd186907  |2 czenas 
655 9 |a electronic books  |2 eczenas 
776 0 8 |i Print version:  |z 1119802326  |z 9781119802327  |w (OCoLC)1252702414 
856 4 0 |u https://proxy.k.utb.cz/login?url=https://app.knovel.com/hotlink/toc/id:kpSPPPEPV2/sterile-processing-of?kpromoter=marc  |y Full text 

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