Standard Operating Procedure for Using Autoclave Tape Dispenser
1) Purpose
The purpose of this SOP is to describe the procedure for using the autoclave tape dispenser in the pharmaceutical manufacturing of otic dosage forms to ensure proper sealing and identification of sterilized items.
2) Scope
This SOP applies to all personnel involved in the use of autoclave tape dispensers in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly using the autoclave tape dispenser as per this SOP.
Quality Control (QC) Personnel: Responsible for verifying the integrity of autoclave tape seals.
Maintenance Personnel: Responsible for maintaining the autoclave tape dispenser in proper working condition.
4) Procedure
4.1 Preparation
4.1.1 Inspection
4.1.1.1 Inspect the autoclave tape dispenser for cleanliness and functionality.
4.1.1.2 Ensure that autoclave tape rolls are loaded correctly and securely in the dispenser.
4.2 Application of Autoclave Tape
4.2.1 Dispensing Tape
4.2.1.1 Pull out the desired length of autoclave tape from the dispenser.
4.2.1.2 Cut the tape to the required length using the built-in cutter or scissors.
4.2.2 Sealing
4.2.2.1 Apply the autoclave tape firmly to the package or item to be sterilized.
4.2.2.2 Ensure that the tape adheres securely and completely around the package.
4.3 Verification
4.3.1 Visual Inspection
4.3.1.1 Inspect the applied autoclave tape for proper adhesion and color change (if applicable) after autoclaving.
4.3.1.2 Verify that the tape indicates successful sterilization by appropriate color change or marking.
4.4 Post-sterilization
4.4.1 Documentation
4.4.1.1 Record the use of autoclave tape, including batch numbers and sterilization details.
4.4.1.2 File the documentation in accordance with facility protocols.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
6) Documents, if any
Sterilization log
Autoclave tape usage records
7) Reference, if any
Manufacturer’s manual for the autoclave tape dispenser
Pharmacopeial guidelines for sterilization processes in pharmaceutical manufacturing
8) SOP Version
Version 1.0
