In the pharmaceutical industry, the production of sterile products is critical to ensuring the safety and efficacy of medications. Sterile products are those that are free from living organisms and are not contaminated with harmful microorganisms. The process of producing sterile products is called aseptic manufacturing. Aseptic manufacturing involves the use of sterile equipment, sterile […]
Production of sterile pharmaceutical products Read More »
The SOP for testing container closure integrity by microbial ingression appears to be well-structured and organized. It includes the purpose, scope, responsibility, accountability, and detailed procedure for testing. The procedure mentions the use of a biosafety cabinet, sterile hand gloves, fresh sterile pipettes, and disinfectant for handling cultures, which is necessary to maintain the sterility
SOP For for Testing Container Closure Integrity by Microbial Ingression Read More »
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
Supporting Clean Areas & Clean Areas Separation in Aseptic Product Manufacturing – USFDA Read More »
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
Sterile Product Building, Facility and Clean Area Classification Guideline By USFDA Read More »
