FEROZSONS LABORATORIES LIMITED Appendix 4

QUALITY ASSURANCE DEPARTMENT

Doc. № PQ/PDB-01/02

Non – Viable Particle Count of PDB – 01

(Reverse Laminar Airflow Dispensing Booth)

1. PURPOSE
Determine non – viable particulate count in following condition inside the Dispening
Booth:
At Rest Condition.

2. METHODOLOGY
The methodology is described in an internal standard operational procedure in
accordance with ISO – 14644-3, Annex – B.

The equipment used in this test is an air particle counter.

The particle count carried out in condition as “at rest”.

3. ACCEPTANCE CRITERIA
The average non – viable particle count must comply with ISO 14644-1 for 0.5 µm and
5.0 µm sized particles/m3 under at rest condition to demonstrate the “Cleanroom Class”
specified.

Maximum Number of Permitted Particles / m3

ISO EU GGMP
At Rest (Static) Condition
14644-1 Grades
0.5 µm 5.0 µm
ISO 5 Grade A 3,520 29

ISO 6 Grade B 35,200 293

ISO 7 Grade C 352,000 2,930

ISO 8 Grade D 3,520,000 29,300

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 FEROZSONS LABORATORIES LIMITED Appendix 4
QUALITY ASSURANCE DEPARTMENT
Doc. № PQ/PDB-01/02

Non – Viable Particle Count of PDB – 01

(Reverse Laminar Airflow Dispensing Booth)

4. DATA TABLE FOR CLEAN ROOMS:

NON – VIABLE PARTICLE COUNT

Observed Class
Room Name Design Class Notes
Class Achieved
WC-10
Dispensing Booth ISO 5 Yes / No
HM
Remarks:

Filled by: Signature: Date:

5. CONCLUSIONS:

Final result of the

PASS FAIL
test
Remarks:

Prepared by: Signature: Date:

Checked by: Signature: Date:

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 FEROZSONS LABORATORIES LIMITED Appendix 4
QUALITY ASSURANCE DEPARTMENT
Doc. № PQ/PDB-01/02

Non – Viable Particle Count of PDB – 01

(Reverse Laminar Airflow Dispensing Booth)

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