Sterilization of Different Components and Items SOPs

Sterilization of Different Components And Items SOPs performed in Microbiology Lab of Pharmaceuticals Unit.

1.Purpose:-

1.1.      This procedure is developed to Sterilize different components & items.

2.Scope:-

2.1.      This method applies for Sterilization of Ampoules, Vials, Rubber Stopper, Machine parts, Silicon Tubing, Vessels, Filters, Uniforms and Different Products etc.

3. HSE Statement:-                                 

3.1. Follow the following instructions to perform the subjected job in safe manner.

• Only persons trained and knowledgeable in the use of a specific piece of equipment.
• Recommended machinery maintenance or pre planned maintenance must be conducted.
• Standard operating procedures are in place for machinery and equipment use.
• Report any job related injuries or illnesses, questions on health and safety, or any unsafe or unhealthy working conditions to their supervisor.
• Personal protective equipment necessary for safe use of the equipment.

4. Responsibilities:-             

• Lab Assistant. is responsible to conduct assigned tasks in safe manners and report to supervisor in case of any problem.
• Microbiologist is responsible to carry out the complete process.

5.Materials:-                          

i.  Autoclave

ii. SS Trays

6.     Definition:-                      

6.1.   Sterilization:

• Sterilization is the process of killing the entire viable microorganism.

7.Flow Chart:-                    

• N/A

8.Description:-

8.1.      Select the sterilizer (i.e. Autoclave) according to the type of component or items to be sterilized. Tools having Rubber or Teflon parts and finished product should be sterilized in steam sterilizer (Autoclave) & other parts made up of SS Material in Dry Heat Sterilizer (Oven).

8.2.               Machine parts, fitted over each other should be sterilized in same sterilizer to avoid any size variation due to different temperature treatment, may result in difficulty during assembling parts.

8.3.      Select sterilization Temperature / time cycle as per guidelines below:

8.4.      For Autoclave, washed items should be wrapped in Aluminum Foil, butter paper in perforated S.S. Trays with covers.

8.5.      For oven, washed components / items should be arranged in S.S. Trays with covers for sterilization.

Note:   Sterilized Items should be used within 12 hrs after sterilization.

9. Record:-

• Sterilization Cycle log 
• Sterilization Load Verification Checklist (Ampoule Autoclave)     
• Sterilization Load Verification Checklist (PVS)                              

10.Reference:-

• Standard Manufacturing Procedure

11.            Distribution:-    

           

Sr. #	Distributed to	Received (Current)	Returned (Obsolete)
01	Quality Control Department
02	Quality Assurance Department
03	Quality Management Department