ГОСТ Р ИСО 13408-5—2011
Библиография
(1] ИСО 9000
Quality management systems — Fundamentals and vocabulary
(2] ИСО/ТC 11139:2006
Sterilization of health care products — Vocabulary
(3] ИCO 22442 (все части)
Medical devices utilizing animal Ussues and their derivatives
(4] 21 CFR — Part 11
Electronic records, electronic signature
(5]
[6)
EEC Guide to Good Manufacturing Practice for Medicinal Products. Annex 11. EEC
Commission Document III/2244/87 Rev
Agalloco J. Steam Sterilization-in-Place Technology. Journal of Parenteral Science and
Technology. 44. No. 5. 1990. pp. 253—256
[7)
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[9]
Berman. D.. Myer, T. and Chrai. S. Factors Involved in Cycle Development of a
Steam-ln-Place System. Journal of Parenteral Science and Technology. 40. No. 4. 1986.
pp. 119— 1121
Haeggstroem. M. New Developments In Aseptic Design Relating to CIP and SIP, Biotech
Forum Europe 3/92, pp. 164—167. Dr. Alfred Hulhig Verlag GmbH. Heidelberg
Marks. D. M., and Kirsten. D. E. An Integration Approach to CIP/SIP Design for Bloprocess
Equipment. Pharmaceutical Engineering. March/April. 1999. pp. 34—45
[10]
[11]
Myer. T. and Chrai. S. Design Considerations for Development of Steam-ln-Place
Sterilization Processes. Journal of Parenteral Science and Technology. 35. No. 1.1981.
pp. 111 — 115
Myer. T. and Chrai. S. Steam-ln-Place Stenlizatlon of Cartridge Filters In-line with a
Receiving Tank, Journal of Parenteral Science and Technology. 36. No. 3.1982.
pp. 108— 112
[12]Pflug, I. J. and Kirsten. D. E. Carrying out biological qualification, the control operation of
moist heat (steam sterilization) processes for producing sterile pharmaceuticals and
medical devices. PDA Journal of Pharmaceutical Science and Technology. 54 (2). 2000
[13]Selberling, D. A. Clean-ln-Place & Stenlise-ln-Place Applications In the Parenteralsolutlons
Process. Pharmaceutical Engineering. Novi’Dec. 6. No. 6.1986. pp. 30—35
[14] Young. J. H.. Ferko. B. L. and Gaber. P. P. Parameters Governing Steam Sterilization of
Dead legs. Journal of Parenteral Science and Technology. 46. No. 4.1992. pp. 117— 123
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