SOP on Procedure for Non-Viable Particle Count (Locations, limits, and Frequency)

1.0 Purpose: To lay down a procedure for Locations, limits, and frequency of nonviable particle count.
2.0 Aim: This SOP is applicable to nonviable particle count locations, limits, and their frequency in the Production facility.
3.0 Responsibility:
3.1 Sr. Officer / Officer & line coordinator shall execute this SOP.
3.2 In-charge / Head shall supervise that the process is being followed as per SOP.
3.3 Head-Quality Assurance shall be responsible for ensuring compliance with this SOP.

4.0 Safety Considerations:
Not Applicable

5.0 Equipment:
5.1 Particle counter

6.0 Procedure:
6.1 Operation of Particle counter:
6.1.1 Take the nonviable particle count as per the “Operation of Particle Counter” SOP.

6.2 Limits of Non-viable particle count:
6.2.1 The Limits of non-viable particles according to the respective area are as per Annexure 1.
6.3 Particle Count Locations and Frequency:
6.3.1 The non-viable particle count locations of the production facility and their frequency of measurement are classified as per Annexure 2.

7.0 Abbreviations: PR: Production
SOP: Standard operating procedure
No. : Number
QA: Quality Assurance
ID: Identification
Cf 3: Cubic feet
HEPA: High-efficiency particulate air
M3: Cubic Meter

Annexure-1

Annexure-2