SOP for Environmental Monitoring of Aseptic Area : Non Viable Particle Count of Air : Pharmaceutical Guidelines

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SOP for Environmental Monitoring of Aseptic Area : Non Viable Particle Count of Air

Standard operating procedure to ensure the control over non viable particle count in aseptic area i.e class 100 and class 10000.

1.0 Objective

To ensure the control over non-viable particle count in aseptic area.

2.0 Scope

To measure non-viable particle count of air in the aseptic area.

3.0 Responsibility

3.1 Doing: Tech.Assistant.(Microbiologist)/Executive
3.2 Checking: Executive /Manager

4.0 Accountability

Head of the Department

5.0 Procedure

Sampling room

Room class
Frequency


Insulin filling & Filtration room
Other than insulin area

Under PF module of Filling machine

Under PF module in Sterile Filtration room
100


100

Three times in a week


Three times in a week
Weekly once to coverall area once in a month


Weekly once to cover all area once in a month

Sterile Filtration room Preparation room

10,000

Three times in a week during work

Weekly once to cover room once in a month

Non sterile preparation & wash room

100,000

Weekly once to cover room once in a month

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure
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