Standard Operating Procedure for Verification of Compressed Air Quality in Biosimilar Manufacturing
| Department | Biosimilars |
|---|---|
| SOP No. | SOP/BS/124/2025 |
| Supersedes | SOP/BS/124/2022 |
| Page No. | Page 1 of 11 |
| Issue Date | 04/05/2025 |
| Effective Date | 06/05/2025 |
| Review Date | 04/05/2026 |
1. Purpose
To establish a standardized method for verifying the quality of compressed air used in upstream and downstream biosimilar manufacturing operations to ensure compliance with GMP and ISO 8573 air purity standards.
2. Scope
This SOP applies to all compressed air lines used in bioreactors, sampling ports, filter housings, cleaning operations, and product-contact zones in biosimilar production units.
3. Responsibilities
- Engineering: Maintain compressors, dryers, and filtration units. Support sampling activities.
- QC Microbiology: Perform air quality testing and maintain records.
- QA: Review results and ensure air meets regulatory acceptance limits before batch use.
4. Accountability
The Head of Quality Control is accountable for ensuring that compressed air used in manufacturing meets validated microbial, particulate, moisture, and oil vapor specifications.
5. Procedure
5.1 Sampling Frequency
- Perform compressed air quality testing at all critical use points:
- New Installations: Before use
- Routine Monitoring: Quarterly
- After Maintenance: Immediately
5.2 Sampling Setup
- Use a three-way valve and validated air sampler (Annexure-1: Sampling Setup Checklist).
- Allow a 30-second purge before collecting samples to eliminate stagnant air.
- Label sample ports with unique ID (e.g., CA-BR-01, CA-TK-05).
5.3 Parameters and Acceptance Criteria
- Test for:
- Microbial Load: <1 CFU/m³
- Particulate Matter: ≤ ISO 8573-1 Class 5
- Oil Vapor: <0.01 mg/m³
- Dew Point: ≤ -40°C (Class 2)
- Document test methods and results in Annexure-2.
5.4 Action for Out-of-Specification (OOS) Results
- Immediately report to QA and quarantine affected systems.
- Repeat sampling after line purge and filter replacement.
- Investigate root cause using Annexure-3: OOS Investigation Form.
5.5 Documentation
- Maintain compressed air quality records in controlled QC files for a minimum of 5 years.
- Attach reports to corresponding batch folders for traceability.
6. Abbreviations
- CFU: Colony Forming Units
- OOS: Out of Specification
- QC: Quality Control
- GMP: Good Manufacturing Practice
7. Documents
- Sampling Setup Checklist – Annexure-1
- Compressed Air Quality Report – Annexure-2
- OOS Investigation Form – Annexure-3
8. References
- ISO 8573-1: Compressed Air Purity Classes
- WHO TRS 1019 – GMP for Biological Products
- EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Sampling Setup Checklist
| Step | Status | Remarks |
|---|---|---|
| Sampler Calibrated | Yes | Valid till 12/2025 |
| Port Purged | Yes | 30 seconds |
Annexure-2: Compressed Air Quality Report
| Date | Location ID | Microbial | Particles | Oil | Dew Point | Tested By |
|---|---|---|---|---|---|---|
| 04/05/2025 | CA-BR-01 | 0 CFU | Class 5 | 0.005 mg/m³ | -42°C | Ajay Verma |
Annexure-3: OOS Investigation Form
| Date | OOS Parameter | Initial Value | Investigation Summary | Corrective Action |
|---|---|---|---|---|
| 01/05/2025 | Oil | 0.02 mg/m³ | Filter breach | Filter replaced |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 04/05/2025 | 2.0 | Included ISO 8573 compliance parameters and expanded scope | Annual GMP review |