SOP for Validation of Compressed Air Quality – V 2.0

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