LogoSterilize
Autoclave service bay showing three units in various stages of teardown with stainless steel internals under LED lighting
ASME-Certified · FDA 21 CFR Part 11 Compliant

Certified pressure.
Documented proof.

We tear down pressurized chambers to the gasket, recalibrate to ASME tolerances, and return autoclaves running quieter than the day they shipped — with validation reports that survive any audit.

< 4hr
Emergency Response
±0.5 PSI
Calibration Tolerance
5
OEM Lines Supported
100%
Audit-Ready Reports
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Service Tiers

Every failure mode.
One number to call.

Cycle-count thresholds and response-time guarantees built into every service agreement — no ambiguity, no fine print.
SVC-PM

Preventive Maintenance

Scheduled
≤ 500 cycles
Recommended interval

Full disassembly inspection, gasket and door seal replacement, heating element calibration, and documented cycle log review. Keeps your autoclave inside OSHA and CDC sterilization guidelines.

  • Gasket, door seal & O-ring replacement
  • Pressure transducer calibration ±0.5 PSI
  • Chamber descaling & ultrasonic cleaning
  • Heating element & thermostat verification
  • Biological indicator testing (Class 5 CI)
  • PM completion certificate issued same-day
5-business-day scheduling
SVC-ER

Emergency Repair

Urgent
< 4 hrs
On-site response guarantee

When a flash cycle runs long or a chamber fails to reach temperature, every minute counts. We dispatch a certified technician within four hours — parts van stocked for Tuttnauer, Midmark, Ritter, Pelton & Crane, and Getinge.

  • Error code diagnosis & root-cause report
  • Same-day valve, pump & sensor replacement
  • Post-repair validation cycle documented
  • Loaner unit coordination if >24hr repair
< 4 hour on-site dispatch
SVC-VT

Validation Testing

Compliance
IQ / OQ / PQ
Full qualification protocol

Installation Qualification, Operational Qualification, and Performance Qualification packages that satisfy FDA 21 CFR Part 11, ISO 17665, and AAMI ST79 requirements. Reports formatted for immediate audit submission.

  • Bowie-Dick & vacuum leak testing
  • Temperature mapping (11-point probe array)
  • Load configuration documentation
  • Parametric release data export (CSV/PDF)
  • FDA 483 response-ready report format
  • Annual re-validation scheduling included
48-hour report turnaround

Specifications

We know your
exact machine.

Five OEM lines. Model-specific tooling and firmware. Parts van stocked before we knock on your door.

EST. 1925

Tuttnauer

340+
units serviced
Supported Models
2540M3870MValueklave 1730EZ10EZ11
Class BSteam FlushGravityFlash Cycle
Full OEM Service Level
EST. 1915

Midmark

410+
units serviced
Supported Models
M9M11Ritter M9DM9D-022
Dynamic Air RemovalGravityFlash CycleUSB Logging
Full OEM Service Level
EST. 1982

Ritter

180+
units serviced
Supported Models
M9 LegacyM11 LegacyM11D
GravityFlash CycleAnalog Gauge
Full OEM Service Level
EST. 1901

Pelton & Crane

220+
units serviced
Supported Models
OCMOCRDelta QRValidator 8
GravityPre-VacDental-Grade
Full OEM Service Level
EST. 1904

Getinge

95+
units serviced
Supported Models
GSS67HGSS88H6600 SeriesHS66
Pre-VacClass SPharmaceuticalValidation-Ready
Full OEM Service Level
Calibration Tolerances
±0.5°C
Temperature Accuracy
AAMI ST79
±0.5 PSI
Pressure Calibration
ASME B40.100
< 30 sec
Cycle Time Variance
ISO 17665-1
≥ 99.9%
Vacuum Level
EN 13060
≥ 98%
Drying Efficiency
AAMI ST79
6-log reduction
Biological Indicator
FDA 510(k)

Certifications

The paper trail
that proves it.

Every certification active, every standard current. Click any document to preview — the same files your auditor will see.

Official certification document with seal and signatures on white paper
Pressure Systems
Active

ASME Boiler & Pressure Vessel Certification

ASME-BPV-2024 · American Society of Mechanical Engineers

Section VIII Division 1 compliance for pressure vessel inspection and recertification.

FDA compliance documentation folder with regulatory stamps
Electronic Records
Active

FDA 21 CFR Part 11 Compliance Audit

FDA-CFR11-2025 · U.S. Food & Drug Administration

Electronic records and signatures compliance for pharmaceutical and surgical validation documentation.

Laboratory certification document with ISO quality management seal
Sterilization Process
Active

ISO 17665-1 Moist Heat Sterilization

ISO-17665-2024 · International Organization for Standardization

Moist heat sterilization of healthcare products — process development, validation, and routine control.

Medical compliance certificate with blue institutional header and official signatures
Healthcare Sterilization
Active

AAMI ST79 Comprehensive Guide Compliance

AAMI-ST79-2024 · Association for the Advancement of Medical Instrumentation

Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities.

From the Field

"Our Midmark M11 was throwing E004 errors mid-cycle. Sterilize had a tech on-site in under three hours, replaced the solenoid valve, ran a full validation cycle, and handed us documentation before our afternoon patient load. That report is still in our infection-control binder."

Professional woman with dark hair in dental office setting
Rachel Dominguez
Practice Manager · Eastside Dental Group, Chicago IL
3
units

"We manage 44 autoclaves across six surgical suites. Sterilize built us a PM schedule tied to cycle counts, not calendar dates. Our next Joint Commission survey went cleaner than any we've had in eight years."

Professional man in business attire in healthcare facility
Marcus Okafor
Facility Director · Midwest Surgical Partners, Indianapolis IN
44
units

"The IQ/OQ/PQ package they delivered for our new Getinge line was formatted exactly as our QA team needed — parametric release data, load configurations, everything. Zero back-and-forth with the auditor."

Professional woman in lab coat in pharmaceutical research setting
Priya Nair
Infection Control Officer · NovaBio Pharmaceutical Labs, Boston MA
8
units

Coverage

57 techs across
6 service regions.

Parts vans stocked before dispatch. If we can't reach you in the guaranteed window, the service call is on us.

840+
Dental Clinics
290+
Surgical Centers
420+
Tattoo Studios
130+
Pharma Labs

Great Lakes

Active
HQ: Chicago, IL
IllinoisIndianaMichiganWisconsinOhio
12 certified techs
< 4 hrs

Northeast Corridor

Active
HQ: Boston, MA
MassachusettsConnecticutRhode IslandNew Hampshire
8 certified techs
< 4 hrs

Mid-Atlantic

Active
HQ: Philadelphia, PA
New YorkNew JerseyPennsylvaniaMarylandDelaware
10 certified techs
< 4 hrs

Southeast

Active
HQ: Atlanta, GA
GeorgiaFloridaNorth CarolinaSouth CarolinaTennessee
9 certified techs
< 6 hrs

Southwest

Active
HQ: Dallas, TX
TexasArizonaNew MexicoOklahoma
7 certified techs
< 6 hrs

West Coast

Active
HQ: Los Angeles, CA
CaliforniaOregonWashingtonNevada
11 certified techs
< 4 hrs

Don't see your region? We're expanding. Describe your situation and we'll route the nearest certified technician.


Request Service

Tell us your machine.
We'll know what to bring.

Manufacturer and model first — so the technician arrives with the right parts, not a question.

Free Resource
PM Checklist

24-point preventive maintenance checklist formatted for Tuttnauer, Midmark, and Getinge. Used by 840+ practices.

Service Guarantee
Parts and labor warranted 12 months
Validation reports in 48 hours
< 4hr emergency dispatch or call is free
24/7 technical support hotline