Category: Air handling Unit

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 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 […]

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, […]

Air Lock Types of Airlock Sink Airlock Cascade Bubble Airlock Types of Filters Clean up time

Air lock: Air lock is a system formed in the form of a small room which has entry in and exit doors, entry doors are kept open while exit doors are kept closed. Air flow is controlled in the room so that it prevents contamination of air of inside clean room of higher level of […]

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