Follow
1.0 OBJECTIVE : To set up a standardized general procedure for the validation and routine monitoring of Laminar Air Flow workstation this ensures an aseptic microbiological working area.
2.0 SCOPE : This SOP is applicable for the validation and routine monitoring of Laminar Air Flow Workstation.
3.0 RESPONSIBILITY
3.1 Operating personnel is responsible for carrying out the procedure.
3.2 Overall responsibility for training, implementation & follow-up with the QC Manager or his nominee.
4.0 ACCOUNTABILITY
4.1 Head of Quality.
5.0 PRECAUTIONS
5.1 The lid of the plates should be kept in slanting position after opening.
5.2 Pre-filters of the laminar air flow should be cleaned properly.
6.0 PROCEDURE
6.1 Prerequisite
6.1.1 Make the machine ready for operation as per the Operation and cleaning of Laminar Air Flow Workstation SOP (SOP No. QC124).
6.2 Monitoring and Validation
6.2.1 For viable particle count monitoring by active air sampling method, place the air sampler at the two corner of the bench 6 inches away from the HEPA filter grill and from the side polycarbonate panels and on the middle of the bench 6 inches away from the outer edge.
6.2.2 Follow the procedure of Microbiological environmental monitoring SOP (SOP No.: QC104) for viable particle count.
6.2.3 After incubation check the growth and record the observation in the FRM No.: FQC/014.
6.2.4 If no total viable aerobic counts are obtained, then the Laminar Flow is OK.
6.2.5 If any total viable aerobic counts are obtained, repeat the calibration procedure.
6.2.6 If counts are still persistent, stop using the Laminar Flow with immediate effect. Affix UNDER MAINTENANCE label on the instrument and inform the Engineering department for rectification.
6.2.7 Frequency of viable particle count monitoring: Microbiological monitoring shall be performed every six months and after each maintenance job by active air sampling or settle plate method for consecutive 3 days and record the data in FRM No.: FQC/014.
6.2.8 Acceptance criteria of viable particle count monitoring in at rest and in operation conditions.
6.2.8.1 Settle plate: <1cfu/ 4 hrs
6.2.8.2 Air sample: <1 cfu/m3
6.2.9 Air velocity, Non-viable particle count, HEPA filter integrity test shall be performed as per the laminar airflow validation protocol.
6.2.10 Pre-filters of the laminar air flow should be cleaned twice in year by the Engineering Department.
6.2.11 Validate the laminar air flow by checking air velocity twice in a year and record the data in Annexure-I.
6.2.12 Check the non viable particle counts twice in a year and record the data in Annexure-II.
6.2.13 Check the DOP leak test once in a year and record the data in the format no. FEG/032.
6.2.14 Acceptance criteria for following parameter in at rest condition
• For HEPA filter integrity test – Penetration should not be more than 0.03%.
6.2.15 Acceptance criteria for following parameters in at rest and in operation conditions
• Air velocity : 0.45 m/s +/- 20% (0.36 to 0.54 m/sec.)
• Non viable particle count: For 0.5 µ particle -NMT 3520 / m3.
• For 5.0µ particle-NMT 29 / m3.
