CLEANING AND OPERATION OF DRY HEAT STERILIZER (DHS)

1. OBJECTIVE

To lay down the procedure for Cleaning and Operation of Dry Heat Sterilizer.

• SCOPE

This SOP is applicable for Cleaning and Operation of Dry Heat Sterilizer in production areas.

3.0       RESPONSIBILITY

            Production Chemist & operator      : To follow the procedure

4.0      ACCOUNTABILTY:

     QA & Head Production                  : For system compliance

       5.0      OPERATION:

• Check the cleanliness of the Dry Heat Sterilizer. Assemble the cleaned of inside before operation.
• Switch ‘ON’ the power supply of the dry heat sterilizer.
  • Load the raw material in the SS container according to their capacities and labeled each SS container.

• Set the temperature of the dry heat sterilizer for timing 1.30 hrs. according to BPCR and stander

Limit of temperature (180^oC ± 5^oC).

• When the sterilization time complete then stop the DHS and hold for cooling material up to 60^oC or as per requirement.
  • Remove the sterilized of SS container from DHS with proper status label.
  • Record the activity in equipment log book.

• Cleaning: Affix “TO BE CLEAN” labels in DHS

                       [At the Time of Product Change Over]

• Switch ‘OFF’ the power supply of DHS.
  • Open the lid of the dry heat sterilizer.
  • Take out the SS container from dry heat sterilizer.
  • Prepare teepol 2% solution in potable water and clean the inner & outer side of DHS with this solution with the help of nylon brush.
  • Wipe the DHS with 70% IPA using lint free cloth.
  • Affix “CLEANED” label on DHS.
  • Record the activity in equipment log book.
  •  Cleaning: [At the Time of Batch Change Over]
  • Ensure that the machine is labeled as “TO BE CLEAN”.
    • Ensure that the machine is switched ‘OFF’
    • Open the lid of the dry heat sterilizer.
    • Clean the inner and outer surface of tray dryer with dry lint free cloth.
    • Ensure visually that the inside surface and DHS are free from any oily Substance.
    • Close the lid of the dry heat sterilizer.
    • Affix “CLEANED” label in dry heat sterilizer.
    • Record the activity in equipment log book.

    6.0   TRAINING

Trainer   : Head – Production Department

  Trainees : Staff and machine operator of production and QA chemist.

         7.0       DISTRIBUTION

   Master Copy                  :           QA Department

   Controlled Copy            :           Production Department  

   Display Copy                 :           Production Department (If Required)

  8.0   ATTACHMENTS

                Nil .

•    REFERENCES     

In-house

   10.0    ABBREVIATION

Abbreviation	Extended Form
EG	Engineering
SOP	Standard Operating Procedure
QA	Quality Assurance
WH	Warehouse
NA	Not Applicable
MB	Microbiology

      11.0 REVISION HISTORY OF CHANGE

Sr. No.	Date	Revision Details	Revision No.