Standard Operating Procedure for Using Orbital Shaker

1) Purpose

The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the orbital shaker in the pharmaceutical manufacturing of otic dosage forms to ensure effective and safe shaking and mixing of solutions.

2) Scope

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

3) Responsibilities

Operators: Responsible for correctly operating the orbital shaker as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the shaking speed and duration to ensure they remain within the required range.
Maintenance Personnel: Responsible for maintaining the orbital shaker in proper working condition.

4) Procedure

4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the orbital shaker for cleanliness and integrity before use.
4.1.1.2 Ensure that the speed and timer control devices are functional and calibrated.
4.1.1.3 Check that the platform is clean and free of any residue.

4.1.2 Preparation
4.1.2.1 Clean the platform with a suitable disinfectant.
4.1.2.2 Securely place the containers to be shaken on the platform.
4.1.2.3 Ensure that the containers are evenly distributed to maintain balance.

4.2 Operation
4.2.1 Setting the Controls
4.2.1.1 Turn on the orbital shaker and set the desired shaking speed and duration according to the procedure.
4.2.1.2 Start the shaking process and monitor the operation to ensure uniform mixing.
4.2.1.3 Adjust the speed and duration 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 orbital shaker and materials to be shaken.
4.2.2.2 Avoid opening the shaker lid while it is in operation to prevent spillage.
4.2.2.3 Follow all safety protocols to prevent spills or accidents.

4.3 Post-operation
4.3.1 Shutting Down
4.3.1.1 Turn off the orbital shaker and remove the containers from the platform.
4.3.1.2 Clean the platform and any used containers with a suitable disinfectant.
4.3.1.3 Document any deviations in shaking speed, duration, or process conditions.

4.3.2 Cleaning and Maintenance
4.3.2.1 Regularly clean the platform and control panel with a suitable disinfectant.
4.3.2.2 Inspect the shaker for any signs of wear or damage and repair or replace components as necessary.
4.3.2.3 Calibrate the speed and timer control devices periodically to ensure accuracy.
4.3.2.4 Document all cleaning and maintenance activities in the orbital shaker log.

5) Abbreviations, if any

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

6) Documents, if any

Orbital shaker log
Speed and duration monitoring records

7) Reference, if any

Manufacturer’s manual for the orbital shaker
Pharmacopeial guidelines for shaking and mixing solutions in pharmaceutical manufacturing

8) SOP Version

Version 1.0