Category: Clean Room

Clean Room Validation Recovery test

How a recovery test is done during validation of AHU/clean room in pharmaceutical manufacturing? Recovery test in AHU or clean room validation is a test where the ability of the clean room or AHU to maintain the level of cleanliness or the particle count below the rated classification limit. In the process clean room is […]

Clean Room Validation in Pharmaceutical Industry how to do

Clean Room Validation how it’s done different requirements of clean Room Validation from particle Count to Microbial Count Limits methods to do it? Validation is an important activity in Pharmaceutical Industry, it impart trust on the process and inturn the product manufactured. For doing validation of clean room, unless all the installed equipment are validated, […]

Clean Room Validation Microbial Count Limits

Microbial action limits for clean room

Clean Room Validation Microbial Count Limits method settle plate contact plate viable bacterial fungal count limits frequency of validation. Classification of clean rooms in pharmaceutical manufacturing companies is part of validation activity, a clean room is designed to provide the desired level of clean grade environment. but it’s rated only to a particular grade after […]

Modular Clean Room in Pharmaceutical Industry

Clean Room Classification Pharma Industry

Clean room in Pharmaceutical Manufacturing Facility Higher degree of cleanness is required in some places like pharmaceutical manufacturing and in healthcare and Space and computer chip manufacturing places. Particle contaminants are not just particles but they harbor bacterial as well as fungal and viral contaminants, therefore it is important to eliminate the particles from air […]

Clean room classification In Pharmaceutical Industry Guidelines

Clean Room Classification Pharma Industry

Clean Room Classification in pharmaceutical Industry how it is done?. What is a clean room in Pharmaceutical Manufacturing?. Which are the different requirements of clean room class in pharmaceutical manufacturing ? Particle count and Viable Count requirements of different grades of Clean Rooms. Clean rooms in pharmaceutical industry are classified by three Standards. 1. ISO […]

Pharmaceutical Area classification with respect to filters used as per WHO guidelines

EN1822 CLASSIFICATION OF FILTERS

Pharmaceutical Area classification with respect to filters used as per WHO guidelines WHO gmp guidelines describes area in a pharmaceutical Manufacturing facility, as Level 1 level 2 and level 3 areas. Level 1 Area is place where there is no possibility of contamination of product, the product comes here after final packing if at all, […]

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