In this post Standard Operating Procedure of Particulate Matter count Monitoring in Pharmaceuticals is describe.
1.0 Revision History
The Objective of this SOP is:
2.1 To describe the objective for checking of air particulate matter counts in the clean room or Under Laminar Air Flow unit (LAF).
3.0 SCOPE:
3.1 This SOP is applicable for the checking of air particulate matter count in the clean room or Under Laminar Air Flow unit (LAF).
4.0 RESPONSIBILITY:
4.1 The Maintenance Engineer shall be responsible:
4.1.1 Responsible for procedure for checking of air particulate matter count in the clean Room or under Laminar Air Flow unit (LAF).
5.0 ACCOUNTABILITY:
Head –Engineering Services
6.0 PROCEDURE:
6.1 Particle counting in the clean room or LAF to be carried out by the external party by (supplier) Using the calibrated Particle counter, during the performance qualification of new facility or Equipment.
6.2 Inform the concerned department in-charge, where particle counting to be done.
6.3 Switch on the AHU/LAF and let it run for 10-15 minutes.
6.4 Switch `On’ the particle counter and set the sampling rate as 1.0 cfm (Cubic Feet Per Minute) Approximately 28.0 liters/ minute. Person carrying flow pattern checking activity should wear following apparel.
6.5 Hold the particle sampler to the working height at different positions and take the print out of the particle count.
6.6 Limit of the particle count in the control area is as mentioned below.
6.8 Switch ‘Off’ the particle counter.
6.9 Get report of the particle count by the external party (Supplier).
6.10 The Engineering department should preserve such reports.
6.11 Particle of all AHU’s and LAF to be carried out once in six months or earlier immediately After any major change in AHU/LAF/Facility.
7.0 ANNEXURES:
Nil
8.0 References (S)
Nil
9.0 Glossary
SOP : Standard Operating procedure
No : Number
cfm : Cubic Feet Per Minute
LAF : Laminar Air Flow
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