Standard Operating Procedure for Vial Washing Machine

1) Purpose

The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Vial Washing Machine used in the pharmaceutical manufacturing of otic dosage forms to ensure clean and sterile vials for product filling.

2) Scope

This SOP applies to all personnel involved in the operation and maintenance of the Vial Washing Machine in the pharmaceutical manufacturing facility.

3) Responsibilities

Operators: Responsible for correctly operating the Vial Washing Machine as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the quality of vial washing processes.
Maintenance Personnel: Responsible for maintaining the Vial Washing Machine in proper working condition.

4) Procedure

4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Vial Washing Machine for cleanliness and integrity before use.
4.1.1.2 Ensure all vial holders, spray nozzles, and washing chambers are clean and free of residues.
4.1.1.3 Verify that all safety devices and interlocks are functioning properly.

4.1.2 Preparation
4.1.2.1 Clean and sanitize the Vial Washing Machine and surrounding area.
4.1.2.2 Prepare the washing solution and ensure adequate supply of purified water.
4.1.2.3 Set up the vials in the washing holders according to batch size and type.

4.2 Operation
4.2.1 Washing Process
4.2.1.1 Start the Vial Washing Machine and initiate the washing cycle.
4.2.1.2 Monitor the washing process parameters (temperature, pressure, cycle time).
4.2.1.3 Inspect washed vials for cleanliness and visual defects.

4.2.2 Sterilization
4.2.2.1 Perform sterilization of vials using hot air or steam sterilization methods.
4.2.2.2 Ensure vials are dried completely after sterilization.
4.2.2.3 Conduct integrity tests on vials post-sterilization.

4.3 Post-operation
4.3.1 Shutdown
4.3.1.1 Complete the washing and sterilization cycles as per batch requirements.
4.3.1.2 Clean and sanitize the Vial Washing Machine thoroughly.
4.3.1.3 Perform post-operation checks to ensure no residual vials in the Vial Washing Machine.

4.3.2 Maintenance
4.3.2.1 Clean washing chambers, spray nozzles, and filters after each batch.
4.3.2.2 Perform preventive maintenance on pumps, filters, and heating elements.
4.3.2.3 Document all maintenance activities and update maintenance records accordingly.

5) Abbreviations, if any

QC: Quality Control
SOP: Standard Operating Procedure

6) Documents, if any

Batch records for each vial washing and sterilization batch
Maintenance records
Calibration records for temperature and pressure sensors

7) Reference, if any

Manufacturer’s manual for the Vial Washing Machine
Pharmacopeial guidelines for pharmaceutical vial washing and sterilization

8) SOP Version

Version 1.0