Standard Operating Procedure for Maintaining Sterility in Granules Production

1) Purpose

The purpose of this SOP is to establish procedures for maintaining sterility throughout the granules production process in the pharmaceutical industry to prevent contamination and ensure product quality.

2) Scope

This SOP applies to all personnel involved in granules production processes where maintaining sterility is critical within the pharmaceutical manufacturing facility.

3) Responsibilities

Production Supervisors: Responsible for ensuring adherence to sterility procedures during production.
Quality Assurance (QA) Department: Responsible for monitoring sterility practices and conducting audits.
Operators and Technicians: Responsible for implementing sterility measures during operations.

4) Procedure

1. Personnel Hygiene:
   1. Ensure personnel adhere to proper gowning and hygiene practices before entering production areas.
   2. Regularly train personnel on aseptic techniques and procedures.
2. Environmental Monitoring:
   1. Conduct routine monitoring of air quality, particulate levels, and microbial contamination in production areas.
   2. Take corrective actions if deviations are detected.
3. Equipment Sterilization:
   1. Validate and maintain sterilization procedures for equipment and tools used in granules production.
   2. Perform routine checks and calibrations of sterilization equipment.
4. Material Handling:
   1. Ensure all raw materials and components are sterilized or sanitized before use.
   2. Implement procedures to prevent cross-contamination during material transfer.
5. Process Control:
   1. Monitor critical process parameters that affect sterility during production.
   2. Implement controls to minimize exposure of sterile products to the environment.
6. Cleaning and Disinfection:
   1. Develop and follow procedures for cleaning and disinfecting production areas and equipment.
   2. Use approved disinfectants and follow contact times for effective disinfection.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance

6) Documents, if any

Sterilization Validation Reports, Environmental Monitoring Records, Cleaning and Disinfection Procedures

7) Reference, if any

Good Manufacturing Practice (GMP) guidelines for sterile pharmaceutical manufacturing.

8) SOP Version

Version 1.0