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Consolidated Introduces First-Ever Remote Validation Service

Arthur Trapotsis
Written by: Arthur Trapotsis

MS Biochemical Engineering, MBA, Consultant

If you are the owner or operator of a laboratory or medical autoclave, it’s in your best interest to ensure that your unit is operating at optimal performance levels at all times. To that end, it’s important to validate your autoclave, both upon initial installation and on a routine basis.

In this blog post, we’ll explain what autoclave validation is, as well as introduce Consolidated Sterilization Systems’ new remote autoclave validation service.

What is Autoclave Validation?

At a high level, validation refers to the process by which a technician verifies that an autoclave’s installation, operation, and performance meet the user’s requirements and the manufacturer’s specifications.

In order to be considered “validated” — as well as to comply with the current USA and International Standards for steam sterilization as established in ISO 17665 — an autoclave must undergo three qualification tests. Each qualification test is designed to assess a different aspect of the autoclave’s functionality:

  • Installation Qualification (IQ): IQ provides documentary evidence that the unit has been built and installed to your specifications, and that all supporting devices — utilities, specifically — are available and properly connected. The IQ process methodically documents all aspects of the installation, the machine’s 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.
  • Operation Qualification (OQ): OQ provides documentary evidence that the sterilizer operates in accordance with design specifications. The OQ test examines the autoclave’s ability to run the sterilization process correctly and to respond appropriately to error conditions, assuring that the unit operates as intended.
  • Performance Qualification (PQ): PQ documents the autoclave’s ability to achieve the desired outcome — that is, to sterilize specific loads when operated in accordance with predefined operating procedures.

Though it is possible to request individual qualification tests — say, an IQ without an OQ or a PQ — it is standard to perform all three within a single validation. As part of our Steril-Q™ validation program, Consolidated develops a custom protocol for each of these qualification tests tailored to the particular unit being validated.

How Does the Validation Process Typically Work?

The validation process typically begins with a consultative interview, during which the Consolidated team will work with you to understand your sterilization needs, including your usual process and the different materials you need to sterilize. Using this information, as well as supplementary materials, such as autoclave manuals, we’ll create customized protocols for each of our three qualification tests.

Once we’ve established those protocols, we send a trained and qualified representative onsite to administer each qualification test. For a comprehensive breakdown of what takes places during each test, we recommend reading our complete validation series, which we’ve linked below:

When all three qualification tests are complete, we compile a final report, which includes all attachment documents, including:

  • Pre-testing sensor calibration accuracy verification
  •  Printed data for review and signature
  • Photos of load items and sensor placement
  • Photos of incubated biological indicators (including positive and negative controls)
  • Post-testing sensor calibration accuracy verification
  • Test equipment calibration certificates
  • Author/executor credentials

The final report with all attachments is typically hundreds of pages long. In addition to the final report, we also deliver a summary report, which is an executive summary of our findings.

How Has Consolidated Adapted the Validation Process to a Remote Experience?

Two years ago, Consolidated Sterilizer Systems began exploring the possibility of providing a remote validation service in order to streamline the process and provide service to a larger audience. To date, we are the only organization in our industry to offer this service, and we can conduct remote validation for any autoclave on the market, regardless of make or model.

Schedule Your Remote Validation Appointment Today >>

Remote validation works like this: Similar to our in-person validation service, we begin by conducting a consultative interview, which we use to develop our custom qualification test protocols. During this initial step, we’ll also work with you to designate a qualified individual from your team to perform the remote validation.

Once we’ve established the necessary protocols, we ship all necessary equipment to your facility. This high-precision, easy-to-use equipment includes pre-calibrated sensors, a video headset, and a wireless modem that creates a remote access point for all of our equipment, so that we can remotely control equipment without connecting to your Wi-Fi network. For the sake of COVID safety, we sanitize all equipment before sending it to you, and again upon return.

After your designated individual has finished unpacking and setting up all of the hardware, a Consolidated validation specialist will establish a connection with the equipment and remotely coach your designated individual through each qualification test. One of the hidden benefits of remote validation is that the person responsible for doing the work on your behalf acquires a new skillset.

Once validation is complete, the Consolidated team will download all data generated throughout the process via our personal Wi-Fi link, conduct a thorough analysis of all data and downloads, and sign off on the results. We’ll then compile our findings in the final and summary reports, which we will ship to you for review and signature.

And just like that, your validation is complete.

There are a few major benefits to this service: First and foremost, it’s safe. In light of COVID-19, remote validation enables our clients to receive the same level of service they’re accustomed to, without the risk of exposure. Second, it’s more efficient. As mentioned above, in-person validation requires a representative to travel to your location, which could sometimes lead to delays and even repeat trips. Third, it’s cost-effective. Without the representative’s travel costs — hotel, airfare, car rental, and so on — factored into the cost of service, you save money.

Schedule Your Remote Validation Appointment Today >>

“[Consolidated] provides superior customer service and are very knowledgeable and easy to work with. I highly recommend them.”

— A Happy Remote Validation Customer from an International Biotechnology Company

Are you ready to validate your autoclave? Do so safely and efficiently with Consolidated Sterilization Systems — contact us today to schedule your remote validation appointment.

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