Standard Operating Procedure for Using Centrifuge

1) Purpose

The purpose of this SOP is to describe the procedure for the safe and effective operation of the centrifuge in the pharmaceutical manufacturing of otic dosage forms to separate substances based on density using high-speed rotation.

2) Scope

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

3) Responsibilities

Operators: Responsible for correctly operating the centrifuge as per this SOP.
Quality Control (QC) Personnel: Responsible for verifying centrifugation results.
Maintenance Personnel: Responsible for maintaining the centrifuge in proper working condition.

4) Procedure

4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the centrifuge for cleanliness, balance, and any visible damage.
4.1.1.2 Ensure that rotor and buckets are securely attached and properly balanced.
4.1.1.3 Verify that the centrifuge is free from any obstructions inside.

4.1.2 Load Samples
4.1.2.1 Load sample tubes or containers into the centrifuge rotor, ensuring even distribution.
4.1.2.2 Close the centrifuge lid securely and ensure it is locked in place.

4.2 Operation
4.2.1 Setting Parameters
4.2.1.1 Set the centrifuge parameters such as speed, time, and temperature (if applicable) according to the protocol.
4.2.1.2 Start the centrifuge and monitor the operation to ensure smooth rotation without vibrations or unusual noises.
4.2.1.3 Observe the centrifugation process through the transparent lid or monitoring system.

4.2.2 Safety Precautions
4.2.2.1 Do not open the centrifuge lid during operation unless it has come to a complete stop.
4.2.2.2 Handle biohazardous or hazardous materials with appropriate safety measures as per facility protocols.
4.2.2.3 Wear appropriate personal protective equipment (PPE) when handling samples or operating the centrifuge.

4.3 Post-operation
4.3.1 Unloading Samples
4.3.1.1 Wait for the centrifuge rotor to come to a complete stop before opening the lid.
4.3.1.2 Remove sample tubes carefully from the rotor to avoid spills or contamination.
4.3.1.3 Transfer samples to designated areas for further processing or analysis.

4.3.2 Cleaning and Maintenance
4.3.2.1 Clean the centrifuge rotor and interior surfaces after each use to remove any residues.
4.3.2.2 Inspect and clean the rotor seals, lid gasket, and centrifuge chamber as per manufacturer recommendations.
4.3.2.3 Schedule regular maintenance checks and lubrication of moving parts.

5) Abbreviations, if any

QC: Quality Control
SOP: Standard Operating Procedure

6) Documents, if any

Centrifuge log
Maintenance log

7) Reference, if any

Manufacturer’s manual for the centrifuge
Safety guidelines for centrifugation in pharmaceutical manufacturing

8) SOP Version

Version 1.0