Standard Operating Procedure for Monitoring and Maintaining Cleanroom Classifications
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/176/2025 |
| Supersedes | SOP/TAB/176/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
To define the procedures for monitoring and maintaining the cleanliness and classification of cleanrooms in the tablet manufacturing facility, ensuring that the environment meets regulatory requirements and GMP standards.
2. Scope
This SOP applies to all cleanrooms used in tablet manufacturing, including production areas, packaging rooms, and any other controlled environments within the manufacturing facility.
3. Responsibilities
- Facilities Management: Responsible for monitoring cleanroom conditions, ensuring that environmental parameters are within acceptable limits, and maintaining cleanroom equipment.
- Quality Assurance (QA): Responsible for overseeing the cleanroom classification, ensuring that the facility complies with GMP guidelines, and reviewing environmental monitoring data.
- Production Supervisors: Responsible for ensuring that the personnel follow the established cleanroom protocols and wear appropriate protective clothing during operations.
- Cleaning Personnel: Responsible for maintaining the cleanliness of cleanroom surfaces, equipment, and floors as per the cleaning schedule and procedures.
4. Accountability
The Facilities Manager is accountable for the proper maintenance and monitoring of cleanroom environments. The QA Manager ensures compliance with cleanroom classification and regulatory standards.
5. Procedure
5.1 Cleanroom Classification
- Classify cleanrooms according to ISO 14644-1 standards or other applicable regulatory guidelines, which define particle concentration limits for different classifications (e.g., ISO Class 5, ISO Class 7, etc.).
- Ensure that cleanrooms are regularly assessed to verify that they meet the required classification standards. Classifications should be reviewed annually or whenever significant changes occur (e.g., equipment installation or layout changes).
- Maintain records of cleanroom classifications, including the results of any reclassification activities, for regulatory inspections and audits (Annexure-1).
5.2 Environmental Monitoring
- Perform regular environmental monitoring to assess the cleanroom conditions. This includes monitoring particle counts, temperature, humidity, airflow, and microbial contamination levels.
- Install particle counters at appropriate locations in the cleanroom to measure air cleanliness and ensure it is within the specified limits for the cleanroom class.
- Monitor air velocity and pressure differentials to ensure proper airflow direction and prevent contamination from outside the controlled area.
- Document all monitoring results and compare them against established specifications. If environmental conditions fall outside the acceptable range, initiate corrective actions as per the deviation management procedure (Annexure-2).
5.3 Corrective and Preventive Actions (CAPA)
- If any deviations are identified during environmental monitoring, the cause must be investigated promptly, and appropriate corrective actions must be taken to restore the cleanroom to its proper classification.
- After corrective actions, the cleanroom should be re-monitored to ensure that the environmental parameters are within acceptable limits.
- Preventive actions should be implemented to prevent similar deviations in the future, such as improving cleaning procedures, adjusting airflow systems, or retraining personnel (Annexure-3).
5.4 Personnel Entry and Exit Protocol
- All personnel entering cleanrooms must undergo proper gowning procedures, including wearing cleanroom suits, gloves, masks, and shoe covers, to minimize contamination.
- Implement an entry and exit log system to track personnel movements within cleanrooms, ensuring that only authorized personnel have access to sensitive areas (Annexure-4).
- Ensure that airlocks are used at cleanroom entrances and that air pressure differentials are maintained to prevent contaminants from entering the cleanroom.
5.5 Cleanroom Cleaning and Maintenance
- Establish a cleaning schedule to ensure that cleanroom surfaces, equipment, and floors are cleaned and disinfected regularly.
- Ensure that cleaning personnel are trained on proper cleaning procedures and use approved cleaning agents that are suitable for the cleanroom environment.
- Document cleaning activities and verify that they meet the established cleaning protocols (Annexure-5).
- Inspect and maintain cleanroom equipment (e.g., particle counters, HVAC systems) to ensure that they are functioning correctly and not contributing to contamination.
5.6 Record Keeping
- Maintain detailed records of cleanroom classifications, environmental monitoring data, corrective actions, and cleaning procedures for regulatory compliance and internal audits.
- Ensure that records are securely stored and easily accessible for review during inspections or audits. Records should be retained for a minimum of five years or as required by regulatory guidelines (Annexure-6).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- CAPA: Corrective and Preventive Action
7. Documents
- Cleanroom Classification Record (Annexure-1)
- Environmental Monitoring Log (Annexure-2)
- Corrective and Preventive Action (CAPA) Report (Annexure-3)
- Personnel Entry and Exit Log (Annexure-4)
- Cleaning Log (Annexure-5)
- Cleanroom Record Retention Log (Annexure-6)
8. References
- ISO 14644-1 – Cleanrooms and Associated Controlled Environments – Part 1: Classification of Air Cleanliness
- USP <797> – Pharmaceutical Compounding – Sterile Preparations
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Cleanroom Classification Record
| Cleanroom Location | Classification | Last Review Date | Reviewed By |
|---|---|---|---|
| Production Area 1 | ISO Class 5 | 01/01/2026 | John Doe |
Annexure-2: Environmental Monitoring Log
| Monitoring Date | Particle Count | Temperature | Humidity | Remarks |
|---|---|---|---|---|
| 02/01/2026 | Class 5 | 20°C | 40% | Within acceptable limits |
Annexure-3: Corrective and Preventive Action (CAPA) Report
| CAPA ID | Issue | Corrective Action | Preventive Action | Completion Date |
|---|---|---|---|---|
| 001 | Particle contamination in ISO Class 5 | Recalibrated particle counter | Increased frequency of checks | 10/01/2026 |
Annexure-4: Personnel Entry and Exit Log
| Employee Name | Entry Time | Exit Time | Area Accessed | Signature |
|---|---|---|---|---|
| John Doe | 08:00 AM | 04:00 PM | Production Area 1 | Signature |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/02/2025 | 2.0 | Updated cleanroom monitoring procedure | Enhanced CAPA process and training | QA Head |