USP（1208）-无菌测试-隔离器系统的验证.pdfVIP

2019/3/21 USP-NF Printed on: Thu Mar 21 2019, 08:47:06 am Printed by: John Schlemmer Currently Ocial as of: 21-Mar-2019 Ocial Prior to 2013 DocId: GUID-AA521856-522E-4CA D-97B0-A2F2FCD61EA 1_2_en-US Printed from: /uspnf/document/GUID-AA521856-522E-4CA D-97B0-A2F2FCD61EA 1_2_en-US?highlight=1208 © 2019 USPC 〈 1208〉 STERILITY TESTING—VALIDATION OF ISOLATOR SYSTEMS This chapter provides guidelines for the validation of isolator systems for use in sterility testing of compendial articles. [NOTE—In the context of this chapter, “decontaminated” refers to an item or surface that has been subjected to a process that eliminates viable bioburden.] Isolators—devices that create controlled environments in which to conduct Pharmacopeial sterility tests—have been used since the mid- 1980s. An isolator is supplied with air through a HEPA or better air lter and is able to be reproducibly decontaminated. Closed isolators, which are systems with no direct opening to the external environment, are normally used for sterility testing, although open isolators which allow the egress of materials through a dened opening that precludes the entry of contamination by means of air overpressure may be used. Closed isolators use only decontaminated interfaces or a rapid-transfer port for the transfer of materials. Isolators are constructed of exible plastics (such as polyvinyl chloride), rigid plastics, glass, or stainless steel. Isolator systems protect the test article and supplies from contamination during handling by essentially eliminating direct contact between the analyst and the test articles. All transfers of material into and out of the isolator are accomplished in an aseptic fashion while m