SOP for Environmental Monitoring by Non Viable Air Particle Count

1.0 Objective

To ensure the control over non-viable count in solid dosage form area at rest condition.

2.0 Scope

To measure non-viable count of air in solid dosage form area at rest condition.

3.0 Responsibility

3.1 Doing: Technical Assistant./Executive
3.2 Checking: Executive/Manager

4.0 Accountability

Head of Department

5.0 Procedure

5.1 Frequency of the test
Cover all operational area (“O” area) of solid dosage form once in a three month. ( 3 Months + 7 days )
5.2 Location chart for non-viable particle count of air in solid dosage area is attached.
5.3 Instrument Used:- Laser particle counter
5.4 Take air sample from a location near the concerned operation at its working height. Repeat and take two (2) such reading.
5.5 Sample the air at the rate of 1 ft3 for 1 min.
5.6 Operate the instrument as per S.O.P.
5.7 Record the results in the Annexure-I.
5.8 Acceptance criteria /ft3

Limits

Class	Air particle count	Alert level	Action level
100	> 0.5µ	76 – 100	>100
	> 5.0µ	Nil	Nil
100,000	> 0.5µ	80,000 – 100,000	>100,000
	> 5.0µ	400 - 560	>560

6.0 Abbreviations

6.1 µm = Micro meter
6.2 ft3 = Feet cube

ANNEXURE – I

MICROBIOLOGY DEPT 

NON VIABLE PARTICLE COUNT OF SOLID DOSAGE AREA 

S.O.P.NO.-_________________

Test :- Non  Viable Air Particle Count
Location:-
Sampling Point No.:-	Date of sampling:-
Instrument Id.No:-	Date of Report:-
Sampled area:- 1 ft3	Sample run time:- 1 minute

RESULT:-

SR.No	No. of readings	(Particle/ft 3)
		0.5 µ	5.0 µ
1	First reading
2	Second reading
Mean Value

LIMIT: -

Class	Air particle count	Alert level	Action level
100	> 0.5 µ	76 – 100	> 100
	> 5.0 µ	Nil	Nil
100,000	> 0.5 µ	80,000 - 100,000	> 100,000
	> 5.0 µ	400 - 560	> 560

REMARKS: -

MICROBIOLOGIST	CHECKED BY
DATE	DATE

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