Standard Operating Procedure for Using Autotitrator

1) Purpose

The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the autotitrator in the pharmaceutical manufacturing of otic dosage forms to ensure accurate and reliable titration results.

2) Scope

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

3) Responsibilities

Operators: Responsible for correctly operating the autotitrator as per this SOP.
Quality Control (QC) Personnel: Responsible for verifying the accuracy of the titration results and ensuring compliance with regulatory standards.
Maintenance Personnel: Responsible for maintaining the autotitrator in proper working condition.

4) Procedure

4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the autotitrator for cleanliness and integrity before use.
4.1.1.2 Ensure that the electrodes and control panel are functional and calibrated.
4.1.1.3 Check that the titration vessel is clean and free of any residue.

4.1.2 Preparation
4.1.2.1 Clean the titration vessel and electrodes with a suitable disinfectant.
4.1.2.2 Prepare the titration reagents and samples according to the specified protocol.
4.1.2.3 Load the samples and reagents into the autotitrator and secure the vessel.

4.2 Operation
4.2.1 Setting the Controls
4.2.1.1 Turn on the autotitrator and set the desired titration parameters according to the procedure.
4.2.1.2 Start the titration process and monitor the titration curve to ensure proper titration.
4.2.1.3 Adjust the titration parameters if necessary to achieve the desired results.

4.2.2 Safety Precautions
4.2.2.1 Wear appropriate personal protective equipment (PPE) when handling the autotitrator and samples.
4.2.2.2 Avoid opening the titration vessel while the titration process is in progress to prevent contamination.
4.2.2.3 Follow all safety protocols to prevent contamination or accidents.

4.3 Post-operation
4.3.1 Shutting Down
4.3.1.1 Turn off the autotitrator and remove the samples and reagents from the vessel.
4.3.1.2 Clean the titration vessel and electrodes with a suitable disinfectant.
4.3.1.3 Document any deviations in titration parameters or process conditions.

4.3.2 Cleaning and Maintenance
4.3.2.1 Regularly clean the titration vessel, electrodes, and control panel with a suitable disinfectant.
4.3.2.2 Inspect the electrodes for any signs of wear or damage and replace them as necessary.
4.3.2.3 Calibrate the titration parameters periodically to ensure accuracy.
4.3.2.4 Document all cleaning and maintenance activities in the autotitrator log.

5) Abbreviations, if any

QC: Quality Control
SOP: Standard Operating Procedure
PPE: Personal Protective Equipment

6) Documents, if any

Autotitrator log
Titration parameter records

7) Reference, if any

Manufacturer’s manual for the autotitrator
Pharmacopeial guidelines for titration in pharmaceutical manufacturing

8) SOP Version

Version 1.0