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4.3 .............................................................................................................................................3
4.4 ........................................................................................................... 3
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5.2 ........................................................................................................................................... 3
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8.3 ................................................................................................ 8
8.4 ..........................................................................................................9
8.5 ...........................................................................................................................9
8.6 ..........................................................................10
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 13408-62009

(I) ISO 9001:2000 Quality management systems Requirements

[2} ISO 10648-1 Containment enclosures Part 1: Design principles
(3) ISO 10648-2 Containment enclosures Part 2: Classification according to leak tightness and associated
checking methods
(4) iSOtfS 11139 Sterilization of health care products Vocabulary
[5] ISO 14644-1 Cleanroomsand associated controlled environments Part 1: Classification of air cleanliness
[6] ISO 14971:2000 Medical devices Application of risk management to medical devices
[7 J ISO 17665 Sterilization of health care products Moist heat Development, validation and routine
control of a sterilization process for medical devices

[8) Wegner. . M. and Akers. J. E. isolator technology: applications In the pharmaceutical and
biotechnology industries. Interpharm Press. 1995

PI Biotechnology industries, interpharm Press. 1995

(10] USP 27 <1116>. Microbiological evaluation of clean rooms and other controlled environments21

[II] IEST-RP-CC006.2. Testing cleanrooms'"

[12 ] PlC/S. Draft recommendations on the inspection of isolator technology, www.olcscheme.oro

[13] POA Technical Report 34. Design and validation of isolator systems for manufactunng and
testing of health care products, www.oda.oro

[14] ISPE Pharmaceutical Engineering Guide. Volume 3: Sterile Manufacturing Facllues.

www.isoe.org
[15] Meeting the Goals in increased Sterility Confidence for Advanced Aseptic
Processing Implementation of a Restricted Access Barrier. Davenport. S.M.. Presented at
the 1994 ISPE earner Isolator Technology Conference. Philadelphia. Pa. www.oicscheme.oro
[16] Is isolation Technology the only Acceptable Answer to improving your Aseptic Processing?
Davenport. S.M.. Presented at the 2001 PDA Annual Conference. Philadelphia. Pa.
www.pda.oro

[1 USP 27. <1208> Sterility testing Validation of Isolator Systems"

[18] PlC/S. Pi 014-1. isolator used for aseptic processing and sterility teeing. www.picscheme.oro

11 .
2)United Stales Pharmacopeial Convention Inc.. 12601 Twmbrook Parkway. Rockvile.MD 20582. USA.
31 Institute of Environmental Science end Technology. 940 East Nothwest Highway. Mount Prospect. Illinois 60056.

USA.

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