Autoclave Validation and Qualification

Autoclave Validation and Qualification

Consolidated offers autoclave validation services, otherwise known as Steril-Q™, for any type of autoclave on the market, regardless of make or model. These validation services help our clients comply with the current USA and International Standard for steam sterilization as set forth in ISO 17665.

Consolidated’s Steril-Q™ validation program includes an array of documentation, tools and expertise required to successfully qualify and validate a new or existing autoclave within accepted IQ/OQ/PQ protocols. Services include installation, operation, and performance qualification (IQ/OQ/PQ) protocols and/or execution of these protocols. These component programs, explained below, may be purchased individually or as a complete suite of professional services.

New! Consolidated is now offering remote validation services. A consolidated validation expert can conduct validation testing remotely on your piece of lab equipment.

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A comprehensive Guide to Every Autoclave Validation Test
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Validation Services
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Validation Services
Validation Services
Consolidated offers the following validation services individually or as a complete suite of professional services. Contact Consolidated for more details.
IQ

Installation Qualification

Installation Qualification (IQ) provides documentary evidence that the equipment has been built and installed to specification, and that all supporting services (i.e., utilities such as electricity, water, and steam) are available and connected properly. The IQ process methodically documents all aspects of the installation, the machine components, and any testing equipment used to provide a complete, closed-loop assessment. In addition, IQ includes NIST traceable calibration verification of the unit’s critical components.

  • IQ is typically carried out concurrently with or after the equipment installation at the user’s facility. The IQ is performed by following a specific IQ protocol tailored for each piece of equipment.
  • IQ can be performed by a third party using the Consolidated IQ Protocol, or by an authorized Consolidated Steril-Q™ representative following the IQ Protocol.
Service Order #
IQ Protocol Only
IQT
The customer provides site utilities and all labor. Consolidated provides a customized IQ protocol.
IQ Protocol, Execution and Final Printed Report
IQF
The customer provides site utilities. Consolidated supplies labor, implementation/execution, IQ Protocol, test equipment, and calibration standards. Consolidated will deliver a completed IQ Protocol.
Contact for Pricing
OQ

Operation Qualification

Operational Qualification (OQ) provides documented evidence that the sterilizer operates in accordance with design specifications. The OQ validation examines the autoclave’s ability to run the sterilization process correctly and to respond appropriately to error conditions, assuring that the sterilizer performs as intended.

  • Alarm conditions and expected results, as well as vacuum leak test performance (if applicable) are verified.
  • Empty chamber temperature mapping is performed to verify and document that the temperature range delivered throughout the empty autoclave is within required specifications.
  • If required, verification of sterilization efficacy using biological indicators (BI) may be carried out to meet a strict interpretation of the standard. (BI testing with a full load is performed in the Performance Qualification phase.)
  • OQ can be performed by a third party using the Consolidated OQ Protocol, or by an authorized Consolidated Steril-Q™ representative following the OQ Protocol.
Service Order #
OQ Protocol Only
OQT
The customer provides site utilities and all labor. Consolidated provides a customized OQ protocol.
OQ Protocol, Execution and Final Printed Report
OQF
The customer provides site utilities. Consolidated supplies labor, implementation/execution, IQ Protocol, test equipment, and calibration standards. Consolidated will deliver a completed OQ Protocol.
Contact for Pricing
PQ

Performance Qualification

Performance Qualification (PQ) documents the sterilizer’s ability to achieve the desired outcome (i.e. sterilization of specific loads when operated in accordance with predefined operating procedures).

  • The sterilizer is tested with actual production loads.
  • Thermocouples are placed within the load items at positions presenting process challenge locations.
  • In addition to temperature mapping, biological indicators (BI’s) may be used to demonstrate compliance with all user requirements.
  • Prior to PQ all required methods and Standard Operating Procedures must be finalized and operator training completed.
Service Order #
PQ Protocol Only
PQT
The customer provides site utilities and all labor. Consolidated provides a customized PQ protocol.
PQ Protocol, Execution and Final Printed Report
PQF
The customer provides site utilities. Consolidated supplies labor, implementation/execution, IQ Protocol, test equipment, and calibration standards. Consolidated will deliver a completed PQ Protocol.
Contact for Pricing
FAT

Factory Acceptance Testing

Factory Acceptance Testing (FAT) is a process used to evaluate the sterilizer after assembly and to verify that its operation complies with design specifications prior to shipment. Through this process all sterilizer components and controls are confirmed. Sterilizer functionality is qualified, verified and documented. Any deviation or abnormalities observed during testing are documented in an exception report and remediated prior to shipment.

  • The FAT is performed at Consolidated’s corporate headquarters before the unit is shipped.
Service Order #
FAT
FAT
The customer provides site utilities and all labor. Consolidated provides a customized FAT protocol.
Contact for Pricing
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