Operation and Maintenance of Gel Manufacturing Unit

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the gel manufacturing unit to ensure the production of high-quality gel products.

2) Scope

This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the gel manufacturing unit in the manufacturing facility.

3) Responsibilities

It is the responsibility of production operators, maintenance staff, and quality control personnel to follow this SOP to ensure proper operation and maintenance of the gel manufacturing unit.

4) Procedure

4.1 Preparation

1. Ensure the work area and equipment are clean and sanitized before starting the gel manufacturing process.
2. Verify the availability and integrity of raw materials and ingredients required for the gel formulation.
3. Inspect the gel manufacturing unit, including mixing tanks and filling equipment, to ensure they are clean and operational.

4.2 Gel Formulation

1. Weigh and measure each ingredient according to the formulation specifications.
2. Transfer the ingredients into the mixing tank and begin the mixing process under controlled conditions.
3. Mix the ingredients thoroughly to achieve a homogenous gel mixture.

4.3 Heating and Cooling

1. Heat the gel mixture to the specified temperature for processing, if required.
2. Cool the gel mixture to the appropriate temperature before filling into containers.

4.4 Filling and Packaging

1. Transfer the cooled gel mixture into clean and sanitized containers using filling equipment.
2. Ensure proper sealing and labeling of gel containers according to regulatory requirements.

4.5 Cleaning and Maintenance

1. Stop the gel manufacturing unit after completing the batch.
2. Disassemble and clean all equipment parts, including mixing tanks and filling machines.
3. Sanitize the equipment and work surfaces thoroughly to prevent cross-contamination.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Formulation record

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for gel manufacturing unit

8) SOP Version

Version 1.0