Undocumented HEPA filter failures cost pharmaceutical manufacturers $50K–$200K in FDA remediation, plus product recall risk. 68% of FDA facility inspections identify HEPA documentation gaps. Oxmaint closes the gap between field execution and auditable compliance records — digitizing DOP/PAO testing, leak detection, and filter replacement across your cleanrooms. Book a demo.
Three operations require documented FDA compliance: DOP/PAO integrity testing, periodic leak detection, and certified filter replacement. Oxmaint captures all three digitally in real-time — eliminating paper trails and documentation gaps before FDA inspection.
Three Critical Operations Where Documentation Failures Create Regulatory Risk
Book a demo to see how Oxmaint structures compliance for all three operations.
DOP/PAO testing required per ISO 14644 Annex D upon installation and after replacement. All test points must achieve ≤0.01% penetration with full location mapping and certified technician sign-off. Oxmaint auto-flags failures, archives test certificates, and locks cleanroom status until validation passes.
Periodic aerosol leak testing per ISO 14644 intervals (typically quarterly or semi-annual) with documented evidence of system integrity. Pressure differential trending identifies degraded filters requiring replacement. Oxmaint schedules tests, captures results with technician ID and timestamp, and triggers alerts when filters approach replacement threshold.
Filter replacement requires complete chain-of-custody documentation: serial numbers, supplier certification, pre/post-replacement DOP/PAO validation, and installation dates locked in audit trail. No operational gap where cleanroom operates at risk. Oxmaint schedules replacements, captures pre/post validation in sequence, prevents cleanroom re-certification until all validation data is complete.
Real-Time Documentation. Zero Paper Trails.
DOP/PAO tests, leak detection results, and filter replacement records captured on mobile in the cleanroom. Book a demo to see the workflow.
Oxmaint HEPA Filter Management — Implementation Workflow
Deployment timeline: 3 to 5 weeks. From asset registration to FDA-ready documentation without IT projects.
Register every HEPA filter location, ISO Class classification, specifications, and current filter age. Configure testing intervals per ISO 14644 and USP. Import historical records to establish compliance baseline.
Configure DOP/PAO test forms, leak detection records, and filter replacement templates as mobile-first digital forms. Technicians access records via QR-scanned filter locations. Test readings entered in real-time at equipment. Status locked until all test points pass compliance threshold.
Dashboard displays filter test currency, overdue leak detection, pressure differential trends, and FDA audit readiness. Quality and Manufacturing leadership visibility with real-time filter health status. Automated escalation alerts for overdue testing or at-risk filters.
All HEPA test records, leak detection evidence, and filter replacement certificates exportable in FDA inspection-ready format. Meets 21 CFR Part 11 electronic records requirements. Complete chain-of-custody for every filter change documented and audit-exportable in under 2 hours.
FDA, EU GMP, and Multi-Regional Compliance — One Platform
Oxmaint pre-configures HEPA filter testing templates for FDA 21 CFR Part 11 (USA), EU GMP Annex 1 (Europe), Health Sciences Authority (Singapore), TGA (Australia), and ISED (Canada). Single platform supports all jurisdictions.
FDA, EU GMP, and Regional Requirements — One System
Single platform for all jurisdictions. Book a demo for your scope.
Oxmaint vs. General-Purpose CMMS — HEPA Filter Management
Most CMMS platforms handle maintenance work orders. None handle FDA 21 CFR Part 11 electronic records for HEPA integrity testing, automated leak detection scheduling, or filter genealogy configured for pharmaceutical cleanrooms.
| HEPA Management Capability | Oxmaint | MaintainX | UpKeep | Fiix | Limble | IBM Maximo | Hippo CMMS | Infor EAM |
|---|---|---|---|---|---|---|---|---|
| FDA 21 CFR Part 11 electronic records | Yes | Generic | No | No | No | Yes | No | Partial |
| DOP/PAO test template with pass/fail gate | Yes | Generic | No | No | No | Custom | No | Custom |
| Leak detection scheduling per ISO 14644 | Yes | Generic | Generic | Partial | Generic | Yes | Generic | Yes |
| Pressure differential trending and alerts | Yes | No | No | No | No | Custom | No | Custom |
| Filter replacement chain-of-custody | Yes | Generic | No | No | No | Custom | No | Partial |
| FDA audit export — ready in under 2 hours | Yes | Partial | Partial | Partial | Partial | Yes | Partial | Yes |
Industry Compliance Gap — Current State
Measurable Results
From 57% to 97% HEPA Test Compliance — in 60 Days
Pharmaceutical manufacturers that move from paper-based filter testing to Oxmaint's digital HEPA compliance system close the documentation gap before the next FDA inspection — not after. Book a demo to see your current HEPA filter compliance gap identified in the first deployment session.
Core Capabilities
Automatic pass/fail gate. All test points locked until compliance met. FDA 21 CFR Part 11 records.
Leak detection and pressure monitoring on ISO 14644 intervals. Technician alerts before deadline.
Complete compliance package in under 2 hours. All records 21 CFR Part 11-compliant and searchable.
Documentation Impact
| Area | Current State | With Oxmaint |
|---|---|---|
| HEPA test record retrieval | 4-7 days, manual search | Under 15 minutes, automated |
| Filter replacement documentation | Disconnected, multiple systems | Centralized genealogy with full chain-of-custody |
| FDA audit preparation | 2 weeks of manual record gathering | Automated export in under 2 hours |
Questions
Close the HEPA Gap Before Your Next FDA Inspection
DOP/PAO testing, leak detection, pressure monitoring, and filter genealogy — live in Oxmaint within 3–5 weeks. Book a demo with your Quality or Manufacturing leadership.
