Autoclave validation services

From qualification to continuous GMP/GLP compliance

Eupry offers pharmaceutical autoclave validation without the multi-vendor chaos, long timelines, or surprise costs.

  • Full IQ/OQ/PQ coverage
  • Digital protocols built for GMP & GLP
  • One vendor, all thermal compliance

Fill out our contact form to get more information or set up a talk with a specialist.

Pharmaceutical technician loading vials into autoclave sterilizer with digital temperature monitoring dashboard overlay

Trusted by 1000+ companies worldwide

  • Agilent Technologies logo with blue starburst dot pattern icon and dark navy company name text
  • AstraZeneca logo with purple wordmark and gold abstract arrow symbol on white background
  • Novonesis company logo in dark green lowercase text on white background
  • Thermo Fisher Scientific logo with red and black text on white background
  • Dechra pharmaceutical company logo featuring a bold dark blue stylized letter D and company name in navy text
  • European Sperm Bank by Fertio logo in dark green text on white background
The autoclave validation challenge

Long timelines, disruptions, disconnected compliance

  • Validation blocks production

    Traditional autoclave validation often requires weeks of downtime, creating scheduling issues and months of production lost.

  • Requalification restarts

    Every year (or after changes), the whole process starts over: vendor scheduling, downtime, costs, and manual reporting.

  • Disconnected validation data

    Validation produces paper work, every cycle requires new manual entries, and auditor questions result in digging through records.

The autoclave validation solution

Faster validation, continuous GMP and GLP compliance

Minimize equipment downtime and connect your validation data directly to ongoing cycle monitoring with Eupry.

Eupry temperature monitoring dashboard on tablet showing data logger graphs, alarms, and logbook entries for Position 01
  • Reduced equipment downtime

    With efficient wireless equipment designed for GMP.

  • From validation to monitoring

    One trail and solution for the entire unit lifecycle.

  • Automated and digital validation

    Zero manual logging with automated digital records.

No more manual work with automated validation

The pre-calibrated Wi-Fi sensors transmit validation data in real-time.

  • No manual data transcription or Excel entry
  • Automated F₀ calculations during PQ studies
  • Live monitoring during validation runs
  • Digital protocols and 3-click reporting
Dashboard showing SMS and email temperature deviation alert on mobile and desktop monitoring platform
Three Eupry team members in circular profile photos: a young woman, an older man, and a younger man

Send us a message

Need more information or a tailored quote? Fill out the form, and we will be in touch as soon as possible.

Initializing ...
Why Eupry

Why choose Eupry for autoclave validation?

  • Validation expertise you can trust

    Our validation engineers have conducted hundreds of qualifications across pharma, biotech, and other GxP industries and understand the regulatory expectations from FDA, EMA, and MHRA inspectors.

  • Digital protocols auditors prefer

    Our digital validation system provides complete data capture. Eevery reading is timestamped and attributed, calibration certificates are embedded, and report can be generated digitally.

  • Complete compliance documentation

    Every validation includes ISO/IEC 17025 calibration with NIST traceability, ISO 17665:2024 and EN 285 compliant protocols, 21 CFR Part 11 ready platform, and GMP aligned qualification approach.

  • One vendor for all your units and facilities

    At Eupry, we handle validation and overall thermal compliance for any temperature-controlled unit or facility in GxP - from your autoclaves, fridges, and freezers to warehouses, cold rooms, and air crafts.

Complete IQ/OQ/PQ equipment validation of autoclaves

Eupry's autoclave validation services include:

V-model diagram showing pharmaceutical qualification stages: URS, Risk Analysis, Design Specs, Acquisition, IQ, OQ, and PQ phases.

Installation qualification (IQ)

We verify correct installation per manufacturer specifications, confirm utility requirements, test safety system functionality, and document ISO/IEC 17025 calibrated instrumentation – all with digital checklists and photo documentation.

V-model diagram showing pharmaceutical qualification stages: URS, Risk Analysis, Design Specs, Acquisition, IQ, OQ highlighted, and PQ.

Operational qualification (OQ)

Empty chamber validation with vacuum leak testing with documented pressure rise rates, Bowie-Dick tests, multi-point heat distribution mapping, EN 285 steam quality verification (dryness, NCG, superheat), and control system and alarm challenge testing.

V-model diagram showing pharmaceutical qualification stages from URS and risk analysis through IQ, OQ, to Performance Qualification.

Performance qualification (PQ)

Loaded chamber validation with worst-case load determination, heat penetration studies, automated F₀ calculations, biological indicator challenges (G. stearothermophilus, 10⁶ CFU), and load dryness verification for porous loads.

End-to-end biological indicator management

Eupry's team manage the complete BI challenge process to provide a full package, proving sterility assurance level achievement.

  • Source certified G. stearothermophilus spore strips
  • Strategic placement in worst-case load locations
  • Post-cycle incubation at our facility or yours (7 days at 55-60°C)
  • Daily growth monitoring with photographic documentation
  • Growth/no-growth certification with BI lot certificates
Isometric clipboard with checklist showing four checked boxes and one unchecked box with text lines
Three pages of Eupry product catalog showing PITH temperature and humidity sensor specs with colorful gradient backgrounds

Download a product catalog

Get an easy overview of all Eupry’s products from validation to calibration and automated monitoring temperatures, humidity, CO2 and more.

Initializing ...

One vendor, one solution, all you need for thermal compliance

Collect validation, monitoring, and calibration in one GxP-compliant solution.

  • Up to 25% lower total cost of ownership
  • Standardized processes across sites
  • One source of truth for all thermal compliance data
  • 3-click audit reports

Get instant access to an easy overview of how the solutions work and the technical specifications.

Eupry Wi-Fi data loggers mounted on wall displaying temperature monitoring dashboard with ISO and FDA 21 CFR Part 11 certifications

Get started with autoclave validation

Frequently asked questions

FAQ about Eupry's autoclave validation services

What types of autoclaves can Eupry's team validate?

Eupry validates all pharmaceutical steam sterilizers: gravity displacement, pre-vacuum, steam-flush pressure-pulse, and pass-through configurations. Sizes from benchtop laboratory autoclaves (20L) to large production sterilizers (500L+). We work with all major manufacturers including Getinge, STERIS, Tuttnauer, Fedegari, and Astell.

Can Eupry validate multiple autoclave load configurations?

Yes. We determine worst-case loads through risk assessment and validate representative configurations. Each unique load configuration requires separate heat penetration mapping and BI challenge testing with documented justification.

Can autoclave validation data transfer to Eupry's monitoring system?

Yes. After validation, the sensors can switch to cycle monitoring mode and every routine sterilization cycle is automatically logged. This creates continuous compliance trail from initial qualification through years of operation.

What happens if we fail an autoclave validation test?

Failures are documented as deviations with root cause investigation. At Eupry, we work with you to correct the issue (often with equipment manufacturer support), then retest the affected qualification phase. Retest costs depend on failure scope - sometimes included, sometimes additional if extensive equipment repair is needed.

Can you validate other TCUs and equipment?

Yes. Eupry's validation services cover all TCUs and facilities in pharma, biotech, and healthcare logistics; from autoclaves to fridges, ULTs, and full warehouses.

Learn more about Eupry's validation services.

What does validation cost?

Pricing based on autoclave size, number of cycles validated, and load configurations. Contact us for a detailed quote based on your specific requirements. No hidden fees - price includes all testing, sensors, calibration, and documentation.