Pharma forum 2018

AIR VELOCITY MEASUREMENT Purpose: To provide a procedure to measure for airflow velocity and uniformity of velocity and supply airflow rate in clean room and clean zone. Scope: Applicable to all Air Handling Units system, Forced Air Ventilation system, Laminar Air Flow system(Unidirectional airflow system), Dynamic pass boxes, Garment Cubicles, Air showers, Air duct, Non unidirectional airflow installation(Diffuser, Grills, Risers). Responsibility: All HVAC Engineers. Definition: Uniformity of air flow: Unidirectional air flow pattern in which the point-to-point readings of velocities are within the defined percentage of the average airflow velocity. Unidirectional airflow: Controlled air flow through entire cross section of clean zone with steady velocity and approximately parallel streamlines. Non-Unidirectional airflow: Air distribution where the supply air entering the clean zone mixes with the internal air by means of induction. Laminar A...

MONITORING OF MICROBIAL LOAD Objective: This test is undertaken to verify that the system can provide the required microbiological cleanliness defined in the USP, Microbiological evaluation of clean rooms and other controlled environment(1116) and EU guidance on Good Manufacturing Practice. Acceptance Criteria: Less than 100 CFU per cubic meter of air. (By using sampler method). Less than 80 CFU per 90mm dia settle plate for 4 hours of exposure. By using air settle plate method). Method: Microbiological monitoring shall be carried out as per the organization SOP “Microbial Environmental Monitoring”. Number of sample locations: Each 10 m²(Approx) of area should have one sampling location. The number of locations may be seen in the table provided whilst the count locations within each room should be shown on a drawing as an appendix. Number of sampling locations: Room No. Room Description Floor Area(m²) No. of...

PARTICLE COUNT TESTS(AT REST) Objective: This test is undertaken to verify that the system can provide the required airborne particulate cleanliness classification as defined in the design specification in the “at rest” condition. Acceptance Criteria: The particle counts should not exceed the airborne particulate cleanliness classification identified within EN ISO 14644, clean rooms & Associated Controlled Environments, part 1, Classification of Air Cleanliness.(Class 8). Class limits in particles of size equal to, or greater than, 0.5 µ m and 5.0 µ m are shown below:- Classification ISO 14644 Allowable number of “At Rest” particles per cubic meter at 0.5 µ m Allowable number of “At Rest” particles per cubic meter at 5.0 µ m ISO Class 8 (At Rest) 3,520,000 29,300 Test Equipment: Calibrated light scattering particle counter. These tests can only be carried out after a complete clean o...