Procedure for Validation of Compressed Air Quality
| Department | Quality Assurance (QA)/Validation/Engineering/Production |
|---|---|
| SOP No. | SOP/Ointment/142 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for the validation of compressed air quality used in ointment manufacturing. Proper validation ensures that compressed air meets required purity standards and does not contaminate the manufacturing environment or product.
2. Scope
This SOP applies to all personnel in the Quality Assurance (QA), Validation, Engineering, and Production departments responsible for the validation, monitoring, and control of compressed air systems used in production and laboratory settings.
3. Responsibilities
- QA Officer: Ensures compliance with compressed air validation protocols.
- Validation Team: Develops and executes compressed air validation protocols.
- Engineering Team: Maintains and calibrates compressed air systems.
- Production Supervisor: Ensures validated compressed air is used in manufacturing.
- QA Manager: Reviews and approves compressed air validation reports.
4. Accountability
The QA and Engineering Managers are accountable for ensuring that compressed air validation is conducted as per GMP, FDA, ICH, and WHO guidelines.
5. Procedure
5.1 Phases of Compressed Air Validation
Compressed air validation follows three key phases:
- Installation Qualification (IQ): Ensures compressed air system installation meets specifications.
- Operational Qualification (OQ): Confirms compressed air
quality meets required parameters under operating conditions.
Performance Qualification (PQ): Validates continuous air quality performance under real production conditions.
5.2 Installation Qualification (IQ)
- Verify installation of compressed air components:
- Compressors
- Air dryers
- Filters (particulate, coalescing, and activated carbon)
- Pressure regulators
- Check system piping for leaks and contamination.
- Confirm that all system components meet manufacturer specifications.
- Ensure proper calibration of pressure gauges and air quality sensors.
- Document installation records and approve IQ reports.
5.3 Operational Qualification (OQ)
- Test the compressed air system to verify operational effectiveness.
- Evaluate system performance under different conditions:
- Pressure stability and regulation
- Airflow capacity and distribution
- Moisture and dew point control
- Particulate and microbial contamination levels
- Check the effectiveness of alarms and control mechanisms.
- Record OQ data and approve reports before proceeding to PQ.
5.4 Performance Qualification (PQ)
- Assess compressed air system stability under actual production conditions.
- Monitor air quality parameters over multiple production cycles.
- Conduct air quality testing, including:
- Particulate count (ISO 8573-1)
- Oil contamination analysis
- Moisture and dew point measurement
- Microbial contamination testing
- Ensure that compressed air conditions meet GMP requirements.
- Document and approve PQ results before final validation approval.
5.5 Routine Monitoring and Revalidation
- Schedule routine compressed air performance monitoring.
- Conduct periodic revalidation after major maintenance or modifications.
- Ensure continuous logging of pressure, dew point, and particulate levels.
5.6 Handling Deviations
- If compressed air system fails validation criteria:
- Identify root cause and document findings.
- Implement corrective and preventive actions (CAPA).
- Requalify compressed air system after adjustments.
- Maintain all deviation records for regulatory audits.
5.7 Documentation and Review
- Maintain all validation records in the Compressed Air Validation Log.
- QA must review and approve all validation reports.
- Ensure records are available for regulatory inspections.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- IQ – Installation Qualification
- OQ – Operational Qualification
- PQ – Performance Qualification
- CAPA – Corrective and Preventive Actions
- ISO – International Organization for Standardization
7. Documents
- Compressed Air Validation Protocol (Annexure-1)
- Compressed Air Validation Log (Annexure-2)
8. References
- ISO 8573-1: Air Quality Standards
- ICH Q7 – Good Manufacturing Practice Guide
- WHO Guidelines for Compressed Air Validation
- US FDA Guidance on Compressed Air Systems in Pharmaceutical Facilities
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Compressed Air Validation Protocol
| Compressed Air Component | Validation Phase | Test Parameter | Acceptance Criteria |
|---|---|---|---|
| Air Filters | PQ | Filtration Efficiency | 99.99% for 0.01 µm particles |
| Compressor System | OQ | Pressure Regulation | ± 2% of setpoint |