Compressed Air Quality Specification
This specification defines the Quality Unit–approved quality acceptance criteria and decision requirements for compressed air used in GMP-relevant operations.
Authoritative Quality Control specification defining compressed air quality acceptance criteria and decision logic. This document does not define system design, maintenance, monitoring methods, or operational procedures.
1. Purpose
To establish Quality Unit–approved acceptance criteria for compressed air used in GMP operations, ensuring that compressed air does not introduce contamination or adversely impact product quality, material integrity, or equipment cleanliness.
2. Scope
This specification applies to compressed air systems where compressed air directly contacts products, components, packaging materials, or GMP-critical surfaces, or where such contact is reasonably foreseeable.
Applicable Business Domains include:
- Facilities & Engineering (FAC)
- Production (PROD)
- Packaging (PKG)
- Quality Assurance (QA)
- Quality Control (QC)
3. Ownership & Governance
- Owner: Quality Control (Quality Unit)
- Approver: Quality Control Operations (QCO)
- Change Control: Quality Management System (QMS)
- Requirement Authority: QC-REQ-IDX
- QC-REQ-IDX Reference: QC-UTIL-001
Compressed air quality acceptance criteria defined in this specification shall not be modified outside approved QMS change control.
4. Compressed Air Quality Acceptance Criteria
| Parameter | Acceptance Criteria | Applicability |
|---|---|---|
| Particulates | No visible particulates; filtration suitable for GMP use | All GMP-relevant compressed air use points |
| Oil / Hydrocarbons | Free from oil and hydrocarbon contamination | All GMP-relevant compressed air use points |
| Moisture | Dry air with no visible condensate or water | All GMP-relevant compressed air use points |
| Microbiological Contamination | Compressed air shall not introduce microbiological contamination | Where compressed air contacts exposed product or components |
Where more stringent compressed air quality requirements are defined by product, process, or regulatory expectations, the more restrictive criteria shall apply.
5. Decision Logic
- Compressed air meeting acceptance criteria is considered conforming.
- Single, isolated quality concerns require documented review by Quality Assurance.
- Repeated, significant, or confirmed contamination requires escalation to Quality Control for impact assessment.
- Final determinations regarding compressed air suitability reside with the Quality Unit.
6. Escalation Requirements
Quality Assurance must escalate to Quality Control or QCO when any of the following occur:
- Evidence of oil, moisture, or particulate contamination
- Compressed air quality failures impacting GMP operations
- Recurring or unresolved compressed air quality deviations
- Potential impact to product quality or equipment cleanliness
- Monitoring reliability or data integrity concerns
7. Records & Evidence
Records supporting compliance with this specification include, but are not limited to:
- Compressed air quality monitoring or test records
- Deviation and investigation documentation
- Quality Assurance reviews and escalation records
- Quality Unit determinations regarding compressed air suitability