Autoclave Sterilization

Thermal paper fades
in 5 years. Your F0
calculations should not.

Upload your autoclave CSV export. Get an ISO 17665-compliant validation certificate with F0 lethality calculation, thermal profile chart, hold time analysis, and SHA-256 integrity hashing. Permanent, tamper-evident, auditor-ready.

Validate Your Data → View Sample Certificate
The Problem

Records in Filing Cabinets, Desk Drawers, and Shoeboxes

The FDA flagged thermal paper as unreliable in 1983. Forty years later, most sterile processing departments still rely on it. The records fade. The liability does not.

"Records kept in filing cabinets, desk drawers, and even shoeboxes -- it was exceedingly difficult to determine which items were in the load."

-- Sterile processing industry analysis, describing the current state of autoclave documentation
1983

FDA flagged thermal paper

The FDA identified thermal paper printouts as unreliable records over 40 years ago. Printouts fade in 5-7 years. Yet most autoclaves still use thermal printers as the primary record.

78%

Sterile processing units understaffed

78% of sterile processing units lack adequate staff. Workers load sterilizers incorrectly, miss indicator checks, and forget to document. Documentation is the first thing to be skipped when time is short.

44

FDA citations since 2021

44 FDA 483 citations specifically for sterilization validation deficiencies since 2021. Common findings: no documented protocols, inadequate statistical rationale, failure to revalidate after equipment changes.

$15K-$100K

Enterprise validation costs

Basic IQ/OQ/PQ costs $300-$800 per autoclave. Full EO sterilization validation runs $15,000-$100,000 with shelf-life testing. Enterprise validation software like Kaye and Ellab costs $10,000+ per year.

Sound familiar?

How It Works

Three Steps. Thirty Seconds.

No enterprise software deployment. No multi-week implementation. No vendor lock-in.
1

Export CSV From Your Autoclave

Export the temperature data from your autoclave's recording system as a standard CSV file.

Compatible: Tuttnauer, Steris, Getinge, Ellab, Kaye format, any CSV
2

Upload to ProofKit

Set your sterilization target (121C or 134C), hold time, F0 minimum, and sensor uncertainty. Or select a preset.

Pre-configured: ISO 17665, EN 285, AAMI ST79, custom
3

Download Validation Certificate

Receive a signed PDF with PASS/FAIL verdict, F0 lethality, thermal profile chart, hold time analysis, and SHA-256 evidence bundle.

Output: PDF certificate + evidence.zip with manifest
Certificate Contents

What Your Inspector Receives

Every certificate replaces a fading thermal printout with permanent, tamper-evident documentation.
  • PASS/FAIL verdict -- clear determination against sterilization specification
  • F0 lethality value -- integrated lethality calculation with Z=10C reference
  • Thermal profile chart -- time-temperature curve with target/threshold lines and shaded hold interval
  • Sterilization specification box -- target temp, hold time, F0 minimum, sensor uncertainty
  • Results box -- peak temperature, ramp rate, time-to-threshold, continuous hold duration
  • Multi-sensor analysis -- per-probe breakdown for multi-point temperature mapping
  • QR verification code -- scan to verify certificate integrity online
  • SHA-256 evidence bundle -- manifest with per-file hashes and root hash for tamper detection
  • Original CSV preserved -- raw data included in evidence.zip for full traceability
ProofKit Certificate
Autoclave Sterilization Validation
PASS
autoclave_cycle_042.csv
Target
134.0 C
Hold Time
18.2 min
F0 Value
847.3
Ramp Rate
4.7 C/min
Peak Temp
135.8 C
Integrity
Verified
sha256:e3b0c4...
Standards Compliance

Documentation Your Inspectors Expect

ProofKit validates against the standards that govern moist heat sterilization in healthcare and pharmaceutical environments.
ISO 17665
Sterilization of health care products -- Moist heat. Defines requirements for development, validation, and routine control of moist heat sterilization processes. The primary international standard for autoclave validation.
EN 285
Large steam sterilizers -- Performance requirements and test methods. European standard specifying design, construction, and performance testing for large steam sterilizers used in healthcare.
ANSI/AAMI ST79
Comprehensive guide to steam sterilization and sterility assurance in health care facilities. The definitive US standard covering all aspects of steam sterilization including validation, monitoring, and documentation.
21 CFR Part 11
FDA regulation on electronic records and electronic signatures. Requires validated systems, audit trails, and record integrity. ProofKit provides SHA-256 integrity hashing and cryptographic verification for tamper evidence.
Comparison

ProofKit vs. The Alternatives

Enterprise validation systems cost $10,000+ per year. Thermal paper fades in 5 years. Excel requires manual F0 calculations.
Feature ProofKit Excel (Manual) Ellab ValSuite Kaye Validator
Works with any autoclave CSV Yes Yes No -- Ellab sensors only No -- Kaye sensors only
Certificate in < 60 seconds Yes No -- hours Minutes Minutes
Automated F0 calculation Yes No -- manual Yes Yes
SHA-256 tamper evidence Yes No No No
AI-powered analysis Yes No No No
No hardware required Yes -- web-based Yes No -- $1,500-$3,000/sensor No -- enterprise hardware
Records last forever Yes -- digital PDF If backed up Yes Yes
Annual cost $1,788/yr Free (labor cost) $10,000+/year $10,000+/year
AI Analysis

ProofKit Doesn't Just Validate. It Explains.

Thermal printouts give you a squiggle line. ProofKit gives you the engineering analysis your quality team needs.
Before: Raw Output
Result: PASS
Target: 134.0 C
Hold Time: 18.2 min
F0: 847.3
Ramp Rate: 4.7 C/min
Peak: 135.8 C
After: ProofKit AI Analysis

Sterilization Validation Summary: This cycle achieved successful sterilization with an F0 of 847.3 -- approximately 71x the minimum requirement of 12. The 18.2-minute hold at 134C+ exceeds the 3-minute minimum for prion-effective cycles.

Temperature uniformity across the hold phase shows less than 0.8C variation, indicating effective steam penetration. The 4.7 C/min ramp rate is within expected range for this chamber volume.

Note: F0 significantly exceeds minimum requirements. If cycle time reduction is desirable, consider validating a shorter hold time while maintaining adequate lethality margin. Consult AAMI ST79 for minimum hold time requirements at 134C.
Pricing

82% Less Than Enterprise Validation Software

Start free. Upgrade when your volume requires it.

Professional

$149/mo
100 certificates per month
  • All industry templates
  • AI-powered analysis
  • F0 lethality calculation
  • No watermark
  • SHA-256 evidence bundles
  • Priority email support
Get Professional

Business

BEST VALUE
$349/mo
500 certificates per month
  • Everything in Professional
  • Batch processing
  • API access
  • Multi-user accounts
  • Custom report branding
  • Phone support
Get Business

ROI Calculator: Autoclave

Ellab / Kaye
enterprise tools
=
$10K+/yr
typical cost
vs.
$1,788/yr
ProofKit Professional
=
82% savings
per year
FAQ

Frequently Asked Questions

How does ProofKit calculate F0 value?

ProofKit calculates F0 using the standard lethality integration method. F0 represents the equivalent time in minutes at 121.1C that would produce the same lethality as the actual time-temperature profile. The calculation uses a Z-value of 10C (the standard for steam sterilization of Geobacillus stearothermophilus) and integrates the lethal rate across all time points in the temperature log. An F0 of 12 or higher is typically required for standard sterilization cycles.

What is the D-value and how does ProofKit use it?

The D-value (decimal reduction time) is the time required at a specific temperature to reduce the microbial population by 90% (one log reduction). ProofKit uses the D-value in conjunction with the Z-value to calculate accumulated lethality (F0). The standard reference organism for steam sterilization is Geobacillus stearothermophilus with a D-value of approximately 1-2 minutes at 121.1C. The overkill approach requires a minimum F0 of 12, providing a 12-log reduction safety margin.

Can ProofKit detect vacuum integrity issues?

ProofKit analyzes the temperature profile for anomalies that may indicate vacuum integrity issues. Irregular temperature patterns during pre-vacuum phases, unusually slow temperature ramps, or persistent temperature differentials across multiple sensors can indicate air leaks, vacuum pump degradation, or steam quality problems. The AI analysis flags these patterns with specific recommendations for investigation.

How does ProofKit handle biological indicator correlation?

ProofKit validates the physical parameters (temperature, time, F0) from your autoclave CSV data. Biological indicator (BI) results should be recorded separately as part of your sterile processing documentation and cross-referenced with the ProofKit certificate by cycle number and date. The certificate provides all physical validation data demonstrating whether thermal conditions were sufficient for biological indicator kill.

What triggers a revalidation requirement?

ISO 17665 and AAMI ST79 require revalidation after: equipment modification or major repair, change in load configuration or maximum load size, change in packaging or wrapping materials, relocation of the sterilizer, or routine annual requalification. ProofKit makes revalidation straightforward -- upload the new qualification cycle data, set the sterilization spec, and generate a fresh certificate. Each certificate includes a SHA-256 evidence bundle as a permanent validation record.

Which autoclave brands are compatible with ProofKit?

ProofKit works with any autoclave or sterilizer that exports CSV data with timestamp and temperature columns. This includes exports from Tuttnauer, Steris, Getinge, Ellab, Kaye, and any SCADA or BMS system. ProofKit also reads data from standalone validation loggers. If your autoclave or logger exports CSV, ProofKit can read it. No proprietary software required.

Your next FDA inspection is coming. Be ready.

Upload your sterilization data. Download a certificate that outlasts thermal paper by decades.

Validate Your Data →