SOP FOR MONITORING (Air microbial count) AND PROCEDURE OF ALL STERILE AREAS THROUGH AIR SAMPLER.

 

SOP FOR MONITORING (Air microbial count) AND PROCEDURE OF ALL STERILE AREAS THROUGH AIR SAMPLER.

AIR SAMPLER

Department: Quality Assurance
Originated by:
		(Senior Microbiologist)		Date
Reviewed by:
		(Incharge Microbiology Lab)		Date
Reviewed by:
		(Quality Assurance Manager)		Date
Approved by:
		(Head Quality Assurance)		Date
Next Review Date:

 

Distribution List:

Ø  Head Quality Assurance

Ø  Incharge Microbiology Lab

1.0.      Purpose

To describe the microbiological monitoring (Air microbial count) and procedure of all sterile production areas through Air sampling.

 

2.0.      Scope

This procedure is applicable to area monitoring of all sterile areas

 

3.0.      Responsibilities

Action	Responsibility
To follow this procedure	Microbiologist
To implement this procedure	Incharge Microbiology Lab

 

4.0.     Requirements

·         Air Sampler

·         Tryptic Soy agar

·         Sterilized Petri plates 90mm

·         70% IPA

·         S.S sealed containers

·         Incubator 

5.0.      Procedure

5.1       Preparation and Pre-incubation of media plates

S. No	Action	Responsibility
5.1.1	Aseptically pour the sterilized Tryptic Soy agar to the sterilized Petri plates.	Microbiologist
5.1.2	Leave the media plates to solidify at room temperature.
5.1.3	Incubate these plates at 30 to 35°C for a minimum of 3 days for pre incubation to eliminate any chance of contamination during preparation.
5.1.4	These pre-validated plates are used for area monitoring of all sterile areas.

     

      5.2       Air Sampling

S. No	Action	Responsibility
6.2.1	Follow the procedure as per Doc No: for air sampling.	Microbiologist
6.2.2	After sampling, carefully remove the plates and incubate these plates at 30 to 35°c for 48 hrs.
6.2.3	After incubation take out the plates and count Microbial colonies. Make a report in the attached Annexures for each sterile area and send it to the concerned area supervisor. In case of results exceed to Acceptable limit advice for cleaning and sanitization.
4.3.4	Acceptable limit: As per ISO-14644-2

 

      5.3.      Frequency

      The weekly basis or as per requirement

6.0       Definition

Term/word/statement	Meaning/Description
TSA	Tryptic Soy Agar
IPA	Isopropyl Alcohol

 

7.0       References Used:

 

S. No	Description
I.	ISO standards for cleanrooms & associated controlled environment ISO-14644-2, FDA Guidance.

 

8.0.      List of Records Generated

 

S. No	Description of Record
1	Area monitoring report of Parenteral Liquid section through Air Sampler
2	Area monitoring report of Cephalosporin vial section through Air Sampler
3	Area monitoring report of Ear & Eye drop section through Air Sampler

 

9.0.        Referred Document(s)

 

Document No	Description
N/A	N/A

 

10.0.   Annexure:

 

S. No	Description of Annexure
1	Area monitoring report of Parenteral Liquid section through Air Sampler
2	Layout of Area monitoring of Parenteral Liquid section ( Air sampling positions)
3	Area monitoring report of Cephalosporin vial section through Air Sampler
4	Lay out of Area monitoring of Cephalosporin vial section (Air sampling positions)
5	Area monitoring report of Ear & Eye drop section through Air Sampler
6	Lay out of Area monitoring of Ear & Eye drop section (Air sampling positions)