When you’re shopping for a new piece of lab equipment, your URS, FAT, and SAT are a key set of documents that help prevent expensive mistakes:

• Your User Requirement Specification (URS) ensures you are ordering equipment with the right features
• The Factory Acceptance Test (FAT) documents that the factory built the equipment as specified, and it functioned properly at that time
• The Site Acceptance Test (SAT) documentation logs that the equipment functioned properly on arrival and after installation

Producing and retaining these documents is standard procedure in some sectors (especially biotech, including pharmaceutical and medical device research and production), where it might even be mandatory.

Even if you are in a field where you aren’t likely to ever be asked to show anyone your URS, FAT, or SAT, adopting a process that mirrors this framework is important. Doing so ensures you’re getting a piece of equipment that will fit your needs and work within your constraints, certifies that the equipment you ordered was built to spec and functioning before leaving the factory, and documents that the equipment arrived in working order and was properly installed on site.

Why Do URS, FAT, and SAT Matter When Buying an Autoclave?

In fields like pharmaceutical manufacturing or food and beverage production, regulatory bodies (such as the FDA) are responsible for validating that production processes are safe, effective, and reliable. In these cases, the autoclave user’s URS (User Requirement Specification) serves as the foundational document the regulatory body uses to confirm that the autoclave is fit for purpose. Each additional document in the “validation lifecycle”—the FAT, the SAT, and potentially IQ/OQ/PQ (i.e., Installation Qualification/Operational Qualification/Performance Qualification) paperwork—build upon the previous documents to establish that the autoclave was properly designed, constructed, and installed, continues to work well, and performs tasks as expected within defined parameters.

Most autoclave users do not need formal URS, FAT, or SAT documentation, nor fully documented IQ/OQ/PQ services. Nonetheless, every autoclave user benefits from following a procurement process that begins by determining precisely what you need your autoclave to do and what limitations are present in your facility (essentially creating a URS). From there, it is good practice to create checklists that include manufacturer confirmation that the autoclave was individually tested prior to leaving the factory (akin to the FAT), and confirming with your service tech or installer that the unit powered up and ran normally on installation (i.e., performing a basic SAT). Making sure to include autoclave equipment testing in your regular autoclave maintenance cycle would then fulfill the OQ/PQ portions of this framework. (Here is our comprehensive suggested maintenance plan for Priorclave autoclaves, as well as the low-effort, “good enough” plan many busy autoclave users prefer.)

FAQ

Are URS, FAT, and SAT included in the cost of a new autoclave or other lab equipment?

No. As a rule, if there is additional documentation required, there is going to be an additional fee:

• URS: Since the responsibility for drafting and owning the URS lays entirely with the end user, there is no additional fee from the manufacturer. Many manufacturers help support drafting the URS by supplying templates and other documentation.
• FAT: FAT documentation is available from most equipment manufacturers, usually for a fee, because it requires additional testing specific to that autoclave or use case.
• SAT: Depending on your institution’s structure, SAT documentation could come from your operations or maintenance team, or the installer can provide it. When provided by an outside installer, this documentation might cost extra or might be included in the installation fee, as part of onsite commissioning services or a service contract.

At Priorclave, our consultative sales process aims to discover and clarify the users needs and site limitations so that drafting a formal URS is just a matter of typing up your notes from our chat.

If I don’t have a FAT, does that mean my autoclave went straight from the assembly line to the shipping crate without any testing?

We certainly hope not! Every reputable autoclave manufacturer should perform at least basic tests on every single unit they produce. Prior to buying, you should ask what these tests are, and what the pass/fail parameters are.

At Priorclave, we retain complete control over every aspect of every component in each of our autoclaves. Our manufacturing system incorporates an ISO9001 Quality Management System, full EMC Compliance Testing, and monitored approval of vessel design and welding procedures to the requirements of the European Pressure Equipment Directive 97/23/EC. Before leaving our factory, all Priorclaves are subjected to rigorous electrical safety tests to the appropriate standards. We also retain full control of the production process for our ASME-stamped 316L stainless steel pressure vessels, each of which undergoes hydrostatic testing in accordance with the requirements of the European Pressure Equipment Directive (PED) prior to shipping.

How can I be sure my autoclave will perform to our specifications?

The best way to ensure your machine will serve your needs is to have it built to your specifications. Every Priorclave steam autoclave begins with a conversation. Our team explores your sterilization needs and helps you determine the right configuration of the right autoclave model for your tasks, facilities, and material requirements. Then, that autoclave is built by hand in our London factory. Priorclave is one of the very few industrial autoclave manufacturers in the world that retains complete control of its supply chain by manufacturing all principal components in-house–including the 316L stainless steel pressure vessels and programmable control systems.

All Priorclave installations are supported by a dedicated team of service engineers at our facility, who in turn support a global network of authorized distributors and service agents. Priorclave is proud to offer all autoclave customers free lifetime technical support and an extensive warranty.

Ready to discuss your equipment needs? Reach out to us today.