Standard Operating Procedure for Maintaining Sterility in Gels Production

1) Purpose

The purpose of this SOP is to establish procedures to maintain sterility throughout the manufacturing process of gels to ensure product quality and safety.

2) Scope

This SOP applies to all personnel involved in the manufacturing and handling of gels within the pharmaceutical manufacturing facility.

3) Responsibilities

Quality Assurance (QA) Manager: Oversee compliance with sterility procedures and protocols.
Production Operators: Implement sterility practices during gel production.
Microbiologist: Monitor environmental conditions and conduct sterility testing as required.

4) Procedure

4.1 Facility and Equipment Preparation
4.1.1 Clean and disinfect manufacturing areas and equipment before use.
4.1.2 Validate sterilization processes for critical equipment and components.

4.2 Personnel Hygiene and Garbing
4.2.1 Wear sterile garments (e.g., gowns, gloves, hairnets) and PPE as required.
4.2.2 Perform hand hygiene and gowning procedures according to established protocols.

4.3 Aseptic Techniques
4.3.1 Maintain aseptic conditions during all stages of gel production.
4.3.2 Use sterile materials, tools, and components in the manufacturing process.

4.4 Environmental Monitoring
4.4.1 Conduct routine monitoring of air quality and surface contamination.
4.4.2 Perform viable and non-viable particle monitoring as per schedule.

4.5 Sterility Assurance
4.5.1 Validate sterilization methods and filtration processes for sterile components.
4.5.2 Perform sterility testing on finished products and in-process samples as per regulatory requirements.

4.6 Contamination Control
4.6.1 Implement procedures for containment and remediation of microbial contamination events.
4.6.2 Investigate and document any deviations related to sterility practices.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance
PPE: Personal Protective Equipment

6) Documents, if any

– Environmental Monitoring Reports
– Sterility Test Records
– Validation Reports for Sterilization Processes

7) Reference, if any

– USP <71> Sterility Tests
– EU GMP Annex 1: Manufacture of Sterile Medicinal Products
– Company-specific contamination control procedures

8) SOP Version

Version 1.0