Standard Operating Procedure for Vial Sterilizing Machine

1) Purpose

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

2) Scope

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

3) Responsibilities

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

4) Procedure

4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Vial Sterilizing Machine for cleanliness and integrity before use.
4.1.1.2 Ensure all vial racks, heating elements, and sterilization 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 Sterilizing Machine and surrounding area.
4.1.2.2 Load vials into sterilization racks according to batch size and type.
4.1.2.3 Set sterilization parameters (temperature, time, pressure) as per product requirements.

4.2 Operation
4.2.1 Sterilization Process
4.2.1.1 Start the Vial Sterilizing Machine and initiate the sterilization cycle.
4.2.1.2 Monitor sterilization parameters throughout the cycle.
4.2.1.3 Ensure vials remain undisturbed during the sterilization process.

4.2.2 Cooling
4.2.2.1 Allow vials to cool naturally within the sterilization chamber.
4.2.2.2 Monitor cooling conditions to prevent thermal shock to vials.
4.2.2.3 Ensure vials are cooled to room temperature before removal.

4.3 Post-operation
4.3.1 Shutdown
4.3.1.1 Complete the sterilization cycle and ensure all vials are properly sterilized.
4.3.1.2 Clean and sanitize the sterilization chamber and racks.
4.3.1.3 Perform post-operation checks to ensure no residual vials in the Vial Sterilizing Machine.

4.3.2 Maintenance
4.3.2.1 Clean and inspect sterilization chambers and heating elements after each cycle.
4.3.2.2 Perform preventive maintenance on temperature and pressure sensors.
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 sterilization batch
Maintenance records
Calibration records for temperature and pressure sensors

7) Reference, if any

Manufacturer’s manual for the Vial Sterilizing Machine
Pharmacopeial guidelines for pharmaceutical vial sterilization processes

8) SOP Version

Version 1.0