ГОСТ Р ИСО 13408-6—2009
Библиография
12]
ISO 10648-1
[3]
ISO 10648-2
(<]
ISO
H S
11139
[5]
ISO 14644-1
[6]
ISO 14971:2000
P )
ISO 17665"
18]
(9]
[10]
111)
[12]
m
ISO 9001:2000
Qua
l
ity management systems — Requirements
Containment enclosures — Part 1: Design principles
Containment enclosures — Part 2: Classification according to leak tightness and associated
checking methods
Sterilization of health care products — Vocabulary
Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness
Medical devices — Application of nsk management to medical devices
Sterilization of health care products — Moist heat — Development, validation and routine
control of a sterilization process for medical devices
Wagner. С. M. and Akers. J. E. Isolator technology: applications in the pharmaceutical and
biotechnology industries. Interpharm Press. 1995
Biotechnology Industries. Interpharm Press. 1995
USP 27 <1116>. Microbiological evaluation of clean rooms and other controlled environments21
IEST-RP-CC006.2. Testing cleanrooms1"
PlC/S. Draft recommendations on the inspection of isolator technology.
vs4vw.Dlcscheme.0rQ
113]
PDA Technical Report 34. Design and validation of isolator systems for manufactunng and
testing of health care products,
www.oda.org
[14]
ISPE Pharmaceutical Engineering Guide. Volume 3; Sterile Manufacturing Eacllltes.
www.ispe.oro
[15]
Meeting theGoals InInc
r
easedSte
ri
lity Confidence for AdvancedAsept
i
c
Processing — Implementation of a Restricted Access Barrier. Davenport. S.M.. Presented at
the 1994 ISPE Barrier Isolator Technology Conference. Philadelphia. Pa.
www.picscheme.orQ
[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
117
]
USP 27. <1208> Sterility testing — Validation of Isolator Systems"
[18]
PlC/S, Pi 014-1. Isolator used for aseptic processing and sterility testmg.
www.picscheme.org
11 Будет опубпикоаан.
z> United States Pharmacopeial Convention Inc.. 12601 Twmbrook Parkway. Rockviie. MD 20582. USA.
31 Institute of Environmental Science and Technology. 940 East Nothwest Highway. Mount Prospect, Illinois 60056.
USA.
14