Table of Contents
1.0 OBJECTIVE
1.1 To lay down the procedure for testing of containment leakage during the HVAC system qualification.
2.0 SCOPE
2.1 This procedure is applicable to covers the procedure involved in containment leakage test during the HVAC system qualification (Initial, requalification and periodic verification).
3.0 RESPONSIBILITY
3.1 Officer or above – QA / Engineering / Concern Department
3.2 Executive / Asst. Manager – QA / Engineering
4.0 ACCOUNTABILITY
4.1 Head Quality / QA
5.0 PROCEDURE
5.1 Containment Leakage Test:
5.1.1 Containment leakage test is performed to determine if there is intrusion of contaminated air into the clean zones from surrounding non controlled areas at the same or different static pressure level and to check pressurized ceiling system for leaks.
5.1.2 Produce an aerosol outside the clean room or device in accordance with in concentration high enough to cause the photometer to exceed full scale on the 0.1% setting. A reading on the photometer 0.1% setting in excess of 0.01% indicates leak.
5.1.3 To check the leakage through the construction joints, crack or seems can inside the enclosure at distance of not more than 5 cm from the joint, or seal surface to be tested, at a scan rate of approximately 5 cm/s.
5.1.4 To check for intrusion at open doorway, measure the concentration inside the enclosure at a distance of 0.3m to 1m from the open door.
5.1.5 If any observations are found outside the acceptance criteria, then officer/executive- QA shall inform to Head-QA/Validation. Head-QA/Validation shall analyze the criticality of observation, corrective and preventive action shall be taken.
5.1.6 During investigation of failure it shall be assessed that there is no impact on product quality. If any modification or replacement is required, same shall be handled as per SOP on change control & requalification criteria shall be followed.
5.2 Frequency of Test:
The containment leakage test shall be done at the time of commissioning clean rooms, or re-testing,
Frequency(For aseptic area) – Containment leakage test – 24 months