Standard Operating Procedure for Inline Mixer

1) Purpose

The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Inline Mixer used in the pharmaceutical manufacturing of otic dosage forms to ensure efficient mixing and blending of materials inline.

2) Scope

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

3) Responsibilities

Operators: Responsible for correctly operating the Inline Mixer as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the quality of mixing and blending.
Maintenance Personnel: Responsible for maintaining the Inline Mixer in proper working condition.

4) Procedure

4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Inline Mixer for cleanliness and integrity before use.
4.1.1.2 Ensure all mixing chambers, seals, and connections are clean and in good condition.
4.1.1.3 Verify that all safety guards and interlocks are functioning properly.

4.1.2 Preparation
4.1.2.1 Clean and sanitize the Inline Mixer and surrounding area.
4.1.2.2 Check and prepare all raw materials and components required for mixing.
4.1.2.3 Ensure utilities (power, water, etc.) are connected and operational.

4.2 Operation
4.2.1 Mixing and Blending Process
4.2.1.1 Power on the Inline Mixer and set parameters as per batch requirements.
4.2.1.2 Initiate material flow through the Inline Mixer.
4.2.1.3 Monitor mixing efficiency and adjust parameters (flow rate, pressure, etc.) as necessary.

4.2.2 Quality Checks
4.2.2.1 Perform periodic checks to ensure uniform mixing and blending.
4.2.2.2 Collect samples for in-process quality control testing.
4.2.2.3 Record all critical parameters and observations during the mixing process.

4.3 Post-operation
4.3.1 Shutdown
4.3.1.1 Complete the mixing process and ensure all product is transferred or collected.
4.3.1.2 Clean and sanitize the Inline Mixer and associated equipment thoroughly.
4.3.1.3 Perform post-operation checks to ensure no residual material in the Inline Mixer.

4.3.2 Maintenance
4.3.2.1 Clean mixing chambers, seals, and connections after each use.
4.3.2.2 Perform routine maintenance on motor, bearings, and seals.
4.3.2.3 Document all maintenance activities and keep maintenance records updated.

5) Abbreviations, if any

QC: Quality Control
SOP: Standard Operating Procedure

6) Documents, if any

Maintenance records
Batch records for each mixing operation
Calibration records for pressure and flow rate controls

7) Reference, if any

Manufacturer’s manual for the Inline Mixer
Pharmacopeial guidelines for pharmaceutical mixing processes

8) SOP Version

Version 1.0