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
