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

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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