Standard Operating Procedure of Sterilization Of Personnel Grab in Pharmaceuticals is describe in this post.
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1.0 PURPOSE
1.1 It is established to ensure the personnel garb free from any sort of organism.
2.0 SCOPE
2.1 It is applicable to Sterile Mfg. Section.
3.0 RESPONSIBILITIES / AUTHORITIES
3.1 Officer Production
3.2 Supervisor
3.3 Operator
4.0 REFERENCES
4.1 Quality Management Manual
5.0 DEFINITIONS
5.1 List of Technical Definition
6.0 PROCEDURE
6.1 Wash personnel garb properly to remove any sort of stain present in the clothing.
6.2 Iron (press) the garb.
6.3 15 numbers of sets of garbs are required for each process.
6.4 Each set of garb to be warped with butter paper.
6.5 Place all the 15 sets of garbs in a tray and put in the internal Tray of autoclave for sterilization.
6.6 Fill the steam generation tank with steam up to the required level.
6.7 Close the steam outlet valve tightly.
6.8 Make sure the second door of Autoclave inside the sterile area is tightly closed and fastened with hooks.
6.9 After loading the Autoclave, close the door in non-sterile area and fasten with hooks.
6.10 Open both inter link valves slowly.
6.11 On attaining the required steam pressure of 15psi (121°C) in the internal chamber, close the steam supply valve and sterilize the set of garb for 15 minutes.
6.12 STOP OVER
6.12.1 Open the steam release valve of steam generating tank and de-pressurize it to zero.
6.12.2 Close the steam valve.
6.12.3 Open the internal outlet valve to de-pressurize the chamber to zero.
6.12.4 Open the autoclave door in sterile area and take out the sets of garb.
6.12.5 Close the door of autoclave in sterile area tightly.
6.12.6 Take the sets of personnel garb in buffer zone II and keep under UV light.
6.13 PRECAUTION
6.13.1 Never open the door of Autoclave when it is pressurized.
6.13.2 Always wear protective gear while operating the Autoclave.
7.0 DOCUMENTS / RECORDS
7.1 Grab Autoclaving Log
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