Month: March 2021

Supporting Clean Areas & Clean Areas Separation in Aseptic Product Manufacturing – USFDA

Supporting Clean Areas Supporting clean areas can have various classifications and functions.  Many support areas function as zones in which nonsterile components, formulated products, in-process materials, equipment, and container/closures are prepared, held, or transferred.  These environments are soundly designed when they minimize the level of particle contaminants in the final product and control the microbiological …

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Sterile Product Building, Facility and Clean Area Classification Guideline By USFDA

Sterile Product Building, Facility and  Clean Area Classification Guideline By USFDA has clearly mentioned what conditions to be followed to maintain the Sterile Conditions in Sterile Product Manufacturing site. 21 CFR 211.42(b) states, in part, that “The flow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building or buildings …

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TEST FOR SPECIFIED MICRO-ORGANISMS (Ph. Eur. method 2.6.13.)

TEST FOR SPECIFIED MICRO-ORGANISMS (Ph. Eur. method 2.6.13.) INTRODUCTION The tests described hereafter will allow determination of the absence or limited occurrence of specified micro-organisms that may be detected under the conditions described. The tests are designed primarily to determine whether a substance or preparation complies with an established specification for microbiological quality. When used …

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