Standard Operating Procedure for Maintaining Sterility in Powders Production

1) Purpose

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

2) Scope

This SOP applies to all personnel involved in powders 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 powders 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