| Power Failure and Recovery Test for HVAC System Qualification |
1.0 OBJECTIVE To lay down the procedure for recovery test during the HVAC system qualification. 2.0 SCOPE This procedure is applicable to covers the procedure involved in recovery test during the HVAC system qualification (Initial, requalification and periodic verification) applicable. 3.0 RESPONSIBILITY • Officer or above – QA / Engineering/Concern Department • Executive / Asst. Manager – QA / Engineering 4.0 ACCOUNTABILITY Head Quality / QA 5.0 PROCEDURE 5.1 Power Failure Study (Sweep Test): 5.1.1 Set the particle counter at one-minute interval and start the particle counter in the area to verify the specified grade (as per table No. 5.2.5.1). 5.1.2 Off the air handling unit and note down the off time (T1) as well as measure the particle count at one-minute interval. 5.1.3 Study shall be carried out up to 30 minutes only. If particle count results of the area does not go outside acceptance criteria. 5.1.4 Record that time where clean room grade is contaminated or out of limit of air borne particle (T2). 5.1.5 Calculate the power failure time or sweep time = T2-T1. 5.1.6 Power failure (sweep test) shall be done in one area of each air handling unit. 5.2 Recovery Test: 5.2.1 The recovery test shall be performed to determined whether the clean room installations is capable of returning to a specified cleanliness level within a define time, after being exposed briefly to a source of airborne particulate challenged for personnel. 5.2.2 Recovery performance is evaluated by using the 100:1 recovery time or the cleanliness recovery rate. 5.2.3 The 100:1 recovery time is defined as the time required for decreasing the initial concentration by a factor of 0.01 times. 5.2.4 Prior to testing, verify that all aspects of the clean rooms or clean zones that contributed to its operational integrity are completed and functioning. 5.2.5 Go to the area where the test shall be performed with aerosol generator and air borne particle counter. 5.2.6 Shut down the air handling unit; raise the initial particle concentration to 100 or more times of specified limit of particulate grade by start the generation of aerosol at the pressure of 20 psi. 5.2.7 Measure the particle count at one minute interval till 100 times of specified limit (as per table No. 5.2.5.1) of particular grade is not achieved. When particle count level reaches more than 100 time of specified limit (as per table No. 5.2.5.1) of particulate grades, stop the aerosol generator. 5.2.8 Start the air handling unit and record the AHU ON time (T3) as well as start the particle count at one minute interval. 5.2.9 When clean room specified level (as per table No. 5.2.5.1) is achieved the particular grade of clean room, stop the particle counter and note down the time (T4). 5.2.10 Calculate the recovery time = T4-T3. 5.2.11 If any observations are found outside the acceptance criteria than 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. 5.2.12 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. |
