SOP for Environmental Monitoring by Non Viable Air Particle Count : Pharmaceutical Guidelines

SOP for Environmental Monitoring by Non Viable Air Particle Count

Standard operating procedure to measure non viable count of air in solid dosage form area at rest condition in class 100 and 10000.

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





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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