sop for transfer of material for testing and sampling in sterile area

 

 

sop for transfer of material for testing and sampling in sterile area

 

 

1.0 OBJECTIVE:

The objective of this SOP is:
1.1 To lay down a procedure for transfer of material for testing and sampling in sterile area

2.0 RESPONSIBILITY:
Executive / Microbiologist

3.0 ACCOUNTABILITY:

Head – Quality Control

4.0 PROCEDURE:

4.1 For transferring materials in sterile area of microbiology laboratory ( for testing ):-

4.1.1 Equipments and tools used for testing are unloaded from the door at the sterile side, after completion of sterilization process.
4.1.2 Keep the media required for testing & monitoring in the pass-box under U.V light for 10 minutes. In case when the samples / materials are

enclosed in S-S containers, spray the containers with 70 % I.P.A before transferring it to hatch..
4.1.3 The samples (vials or bottles) for sterility testing should be kept in poly bag, spray inner and outer portion with 70% I.P.A solution and

carry the samples through the hatch taking care that the UV lamp is off.

4.2 For transferring materials in sterile area of (for sampling):-

4.2.1 Transfer containers containing sterile sampling accessories from quarantine area of block to interim R.M room.
4.2.2 Spray the containers for monitoring, with 70% I.P.A solution followed by moping with lint free cloth followed again with 70% I.P.A solution

and then keep the containers and depyrogenated accessories in dynamic pass-box under U.V light for 10 mm.
4.2.3 Then transfer the materials under L.A.F of blending room.
4.2.4 After completion of sampling cover the container with lid tightly and transfer them to dynamic pass-box. In case , when there are

chances of exposure of collected sample to U.V light, ensure that the U.V lamp is turned off when the sample is kept in the pass box and

turned on after collecting the material from the pass box.

5.0 REASON FOR REVISION :

Change in procedure

6.0 TRAINING :
Trainer — Executive – Quality Assurance
Trainees — Microbiologist and QA officer

7.0 DISTRIBUTION:
Certified Copy : Head of Department – Quality Control
Certified Copy : Microbiology Department .
Original Copy : Head – quality assurance.

 

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sop for transfer of material for testing and sampling in sterile area

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sop for Monitoring of Compressed Air/gases for microbiological analysis

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sop for receipt storage and Determining the population of Biological indicators

sop for qualification of analyst microbiologist

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gowning procedure for microbiological testing area

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sop for endotoxin challenge test

Hold time study protocol for sterilized media

sop for personnel Qualification protocol for aseptic area

sop for sampling and testing of drain water

Sop for Operation of Airborne Particle Counter

sop for Inoculum Preparation

sop for Validation protocol of steam sterilizer autoclave

sop for pathogen detection from drain point

Sop for Analysis of Raw water Purified water water for injection and pure steam water

sop for preservatives efficacy test

sop for collection and preservation of in house isolated microorganisms

sop for Operation Calibration and Maintenance of Micropipette

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sop for gram staining

Sop for swab testing

sop for microbiological testing of water

PROCEDURE FOR FUMIGATION

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sop for monitoring of personnel in aseptic area

sop for maintenance of cultures

sop for Operation and cleaning of laminar bench

preparation of settle plates

sop for monitoring of pure steam

sop for entry and exit procedure to m.l.t and b.e.t room

sop for storage of and use of media

sop for disposal of microbiological media and cleaning of microbiological glassware

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