Standard Operating Procedure for Cleanroom Maintenance

1) Purpose

The purpose of this SOP is to establish the procedures for maintaining cleanrooms to ensure they meet the required cleanliness standards and comply with regulatory requirements in the pharmaceutical industry.

2) Scope

This SOP applies to all cleanrooms used in the pharmaceutical manufacturing process.

3) Responsibilities

The Maintenance and Quality Control Departments are responsible for implementing and adhering to this SOP. All relevant personnel must be trained on the procedures outlined in this document.

4) Procedure

1. Cleaning and Disinfection
   1. Develop a cleaning schedule for the cleanroom, including daily, weekly, and monthly tasks.
   2. Use approved cleaning agents and disinfectants to clean surfaces, equipment, and floors.
   3. Document all cleaning activities, including date, areas cleaned, and personnel involved.
2. Environmental Monitoring
   1. Monitor environmental parameters, such as particle counts, microbial contamination, temperature, and humidity, regularly.
   2. Record monitoring data and review it to ensure compliance with cleanliness standards.
   3. Take corrective actions if environmental parameters deviate from acceptable limits.
3. Maintenance of Cleanroom Equipment
   1. Inspect and maintain cleanroom equipment, such as HEPA filters, air showers, and pressure gauges, regularly.
   2. Replace HEPA
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      filters as per the manufacturer’s recommendations or when necessary.
   3. Document all maintenance activities, including date, tasks performed, and personnel involved.
4. Gowning and Personnel Practices
   1. Ensure all personnel follow proper gowning procedures before entering the cleanroom.
   2. Provide training on cleanroom behavior, including minimizing movement, avoiding unnecessary conversations, and proper hand hygiene.
   3. Monitor and enforce compliance with gowning and behavior standards.
5. Review and Documentation
   1. Review maintenance and cleaning records regularly to identify trends and areas for improvement.
   2. Update maintenance and cleaning procedures based on review findings and regulatory updates.

5) Abbreviations, if any

HEPA: High-Efficiency Particulate Air

6) Documents, if any

Cleaning Logs, Environmental Monitoring Records, Maintenance Logs

7) Reference, if any

Relevant regulatory guidelines such as FDA, EMA, and WHO GMP requirements.

8) SOP Version

Version 1.0