Transfer Of Materials In Microbiological Laboratory




Transfer Of Materials In Microbiological Laboratory

1.     Purpose:-

This procedure is developed to ensure the sterility of Area.

2.     Scope:-

This method is used for transfer of bulk materials, machine parts / tools, which cannot with stand the Temperature of Autoclave or Oven.

3.     HSE Statement:-                                  

3.1.      Follow the following instructions to perform the subjected job in safe manners.
3.1.1.      Only trained and knowledgeable persons perform subjected job.
3.1.2.      All work is performed in accordance with applicable regulatory requirements.
3.1.3.      Report any job related injuries or illnesses, questions on health and safety, or any unsafe or unhealthy working conditions to supervisor.
3.1.4.      Personal protective equipment necessary to perform subjected job in safe manners.

4.     Responsibilities:-               

4.1.      Lab. Assistant is responsible to conduct assigned tasks in a safe manner and report to supervisor in case of any problem.
4.2.      Microbiologist is responsible to monitor the subjected process.
4.3.      Microbiologist is responsible to manage all activities include operator training, record keeping, proper use of personal protective equipment & other related tasks.

5.     Materials:-                         

Lint Free Duster
Water for Injection
IPA 70%

6.     Definition:-

6.1.      Aseptic Area

An area which is clear from microbial & particle contamination.




getintopharma

1.     Description:-

1.1.      Cleaning of Material Transfer Hatch

1.1.1.      Clean outer body of Material Transfer Hatch with lint free duster and water for injection.
1.1.2.      Open the outer door of Material Transfer Hatch & clean chamber with lint free duster and WFI.
1.1.3.      Now the Material Transfer Hatch is ready for Routine operation.
1.1.4.      Maintain Machine Cleaning Record on.

1.2.      Transfer of Material
1.2.1.      Mop the outer side of Media Tubes with 70% IPA and keep in material transfer hatch.
1.2.2.      Take the media tubes into the aseptic area mop again with 70% IPA.

1.3.      Transfer of SS Tray Having Media Plates

1.3.1.      Mop the outer side of SS trays having media plates with 70% IPA and keep in pass through.
1.3.2.      Take the SS trays having media plates into the aseptic area mop again with 70% IPA.
1.3.3.      Then take the SS trays having media plates into the aseptic area mop again with 70% IPA.


1.4.      Transfer of Routine Maintenance Tools / Parts

1.4.1.      Mop tool / parts with 70% IPA.
1.4.2.      Keep the tool / parts in pass through under UV Light for irradiation for 30 minutes.
1.4.3.      Then take the tool / parts into the aseptic area mop again with 70% IPA.

Note:   Record operational process of Material Transfer Hatch.


2.     Reference:-

2.1.      NA

3.     Distribution:-          

Sr. #
Distributed to
Received (Current)
Returned (Obsolete)
01
Quality Control Department



02
Quality Assurance Department 



03
Quality Management Department




4.     Revision History:-                      

Date                                        Changes


No comments:

Post a Comment