QUALIFICATION PROCEDURE OF WEIGHING BALANCES AS PER OFFICIAL MEDICINES CONTROL LABORATORY
Verification:- Verification of the balance is performed by placing a suitable weight (depending on the type of balance) in the centre of the weighing pan…
Category: Pharma Industry Guidelines
FILTER INSTALLATION LEAK TESTS – TOTAL AEROSOL PENETRATION TEST METHOD FOR CLEAN ROOMS
The purpose of the total aerosol penetration test method is to verify filter and installation integrity when downstream access to the filter and installation is…
FILTER INSTALLATION LEAK TESTS – DISCRETE PARTICLE COUNTER TEST METHOD
The particle counter test method employs discrete particle sizing and quantitative analysis. This test is performed by introducing an artificial aerosol challenge upstream of the…
FILTER INSTALLATION LEAK TESTS – AEROSOL PHOTOMETER
TEST METHOD FOR CLEAN ROOMS The photometer test method employs either logarithmic or linear mass concentration detection and does not provide discrete quantitative analysis. This…
AIRFLOW VELOCITY AND UNIFORMITY TEST – FILTER FACE FOR CLEAN ROOMS
AIRFLOW VELOCITY – UNIDIRECTIONAL:- The purpose of the filter face airflow velocity test is to document the average airflow velocity and uniformity of the filter…
GENERAL TEMPERATURE AND HUMIDITY UNIFORMITY TESTS FOR CLEAN ROOMS
INSTRUMENTATION AND EQUIPMENT Temperature measuring devices such as standard thermometers and electronic thermometers. Temperature sensing devices such as thermocouples, thermostats, or other temperature sensors used…
RECOVERY TESTS FOR CLEAN ROOMS
The purpose of the recovery test is to determine the amount of time that is necessary for nonunidirectional cleanrooms or clean spaces and their systems…
CLEANROOM AIRFLOWS IN ASEPTIC FACILITY
UNIDIRECTIONAL AIRFLOW:- In a unidirectional airflow system, air is uniformly introduced through HEPA filters from one entire surface of the room, such as the ceiling…
SOP TO ENSURE TERMINAL HEPA FILTER FOR CLEAN ROOM (HAVING INDIVIDUAL UPSTREAM PORT) ARE INTACT AND SUITABLE FOR OPERATION
1.0 PURPOSE:- To provide a guideline to ensure that HEPA filters are intact and suitable for operation. 2.0 SCOPE:- Applicable to all HEPA filters installed…
BENCH SCAN FILTER LEAK TESTS FOR CLEAN ROOMS
The purpose of this test is to determine the integrity of each filter shipment by spot testing random statistical samples prior to filter installation. INSTRUMENTATION…
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