SOP for Resuming Aseptic Area after Maintenance Activities

1.0 OBJECTIVE

To lay down a procedure for resuming aseptic area after maintenance activities.

2.0 SCOPE

This procedure applies to sterile manufacturing facilities.

3.0 RESPONSIBILITY

Chemist/ Executive

4.0 ACCOUNTABILITY

Asst. Manager

5.0 PROCEDURE

The maintenance activities include:

5.1 Preventive maintenance

5.1.1 Schedule the planned preventive maintenance preferably for the last working shift of the week or a holiday.
5.1.2 Issue a maintenance requisition elaborating the availability of the machine.
5.1.3 During the planned preventive maintenance do not keep components in or near the area where the preventive maintenance will be carried out.
5.1.4 Ensure that the trained maintenance personnel is aware of the aseptic operations and requirements.
5.1.5 The maintenance personnel going into the aseptic area will follow the SOP of the sterile area.
5.1.6 Take care to prevent the spillage of oil, grease or any other material from falling onto the ground. (This can be prevented by placing a sanitized polythene sheet at the area of work.)
5.1.7 After the completion of the job remove the poly sheet and discard the same out of the sterile area across a hatch.
5.1.8 After removal of the sheet from the pass box, disinfect the pass box area with the solution prepared for the day.
5.1.9 Cleaning and disinfection of the area which had been under maintenance will be carried out.

5.2 Breakdown maintenance

5.2.1 With well planned preventive maintenance, the breakdown maintenance usually involves minor adjustments or alterations to ensure that process and quality parameters are within limits. However, if the breakdown is of significant nature, case the aseptic operations and follow the below-mentioned procedures.
5.2.2 Ensure the removal of product and sterilized containers from the workplace.
5.2.3 Carry out the required maintenance activities.
5.2.4 Follow steps 5.1.5 to 5.1.9
5.2.5 Take dummy trials and ensure that the product parameters of the equipment are met.
5.2.6 After taking the dummy trial, the whole related area must be clean and disinfected with scheduled disinfectant solution.
5.2.7 Spray 70% filtered (sterilized) IPA solution in area.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 IPA: Isopropyl Alcohol

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