Stancold delivers a range of specialist build packages, including hygienic panelling, cold stores, industrial partitions and firewalls, each with its own drivers and project processes. Cleanroom envelope packages are one of the more complex and highly regulated project types we undertake.
Nearly every cleanroom job begins with a User Requirements Specification (URS). A URS is the basis for most of our cleanroom envelope installations, but it does not always become relevant for the other project types we undertake, regardless of size or complexity.
In this blog post, we’ll explore why a URS matters specifically for cleanroom projects, what it delivers and how our envelope packages link to the URS document.
What is a User Requirement Specification Document?
The User Requirement Specification is the foundation for an entire turnkey cleanroom project, derived from the end user. Countless other industries, even outside of construction utilise the concept of a User Requirement Specification, but it becomes even more critical in the context of a cleanroom environment. Even though the document comes from the end user, they often have a specialist consultant draft its contents.
The specialist cleanroom consultant will know what questions to ask the end user to decipher what the document needs to contain. If the end user has the resource and internal knowledge to draft their own URS, it could be done internally. Larger companies often have the capacity to draft the URS without an external cleanroom consultant.
At its core, the URS sets forth what the cleanroom space is being created for, what it needs to achieve, the regulations the space needs to be built to and the considerations that all parties must take in its creation.
Despite having different formats, depending on the author(s), every URS typically contains the same core set of information.
Aligning the Various Stakeholders Involved in a Cleanroom Project
When an end user needs a cleanroom built, whether it is for advanced manufacturing, research, pharmaceutical development or other applications, their goal is clear, but that goal must be translated into a physical space that conforms to GMP or ISO requirements and aligns with the project scope.
A URS document also aligns stakeholders on the expectations and project scope. A cleanroom project would rarely involve just one contractor. In many cases, multiple contractors are brought in to manage various elements of the build. These could include equipment suppliers, electrical contractors, HVAC contractors and envelope build specialists like Stancold. A clear URS document ensures all these stakeholders are working in harmony towards the same goal.
The stakeholder alignment provided by a URS document ensures that all contractors involved are pricing for the same scope. If two contractors are bidding for a certain element of a project, as Stancold would do for the envelope construction, it is important that they all price to provide the same finished solution, and there is no room for misunderstanding.
‘Contractors can take the exact specifications from the relevant part of the URS project and utilise their respective expertise to price the solution they feel is not only most applicable but also cost-effective,’ says Stancold’s Business Development Director Mark Kendrick. ‘Any insights or solutions need to derive from what is set out in the URS, so the end user or turnkey contractor will know that each subcontractor is pricing towards the same end goal.’
Plus, any questions a contractor has about their respective role in the project or what they are pricing for can be linked to the URS. ‘When I have a clarifying question about what we are pricing for after reading a URS document,’ says Mark, ‘I will put the question directly on the document in the relevant place to streamline communication.’
The URS as an Audit Trail
The URS provides a paper trail for later audits and validation to make the cleanroom space operational. Part of a URS is often how the requirements of the space will be testable and auditable. The document will link back to ISO and GMP standards, referencing the specific regulations and how the cleanroom needs to be built and tested to meet them.
The validation team will have a clear path on how each requirement was met by the testing measures outlined in the URS document. For example, for a cleanroom space to meet an ISO 8 classification, each cubic meter must contain less than 3.52 million particles ≥0.5 μm per cubic metre of air. The URS will typically reference the required standards and performance criteria.
The URS will list the elements the cleanroom needs to be tested for, such as pressure, filter integrity, airflow and cleanability. It keeps every stakeholder aligned on what needs to be tested, how it will be verified and at which stage of the project those tests must take place.
Our Place in a Cleanroom URS
Not every URS document looks the same, but most will include the same elements in one order or another. Our relevant part in the URS is usually in a section labelled ‘Material and Construction Requirements’ or ‘Building Fabric’. There are no uniform section names or placements in the document, so it is up to our team to determine the sections that are relevant.
In many cases, the cleanroom URS does not specifically tell us which panel system must be utilised to build the envelope, but our experts read the requirements listed in the sections relevant to the envelope and determine the most applicable and cost-effective system to put forward.
‘Specifying a cleanroom system from the URS document is like a game of Guess Who,’ says Mark. ‘We look at all the requirements specified for the envelope system, what the space needs to achieve in terms of process, environment and certification, and the general layout they are looking for to determine which system we will put forward for our envelope works.’
For example, if the URS dictates that the cleanroom space needs to be semi-flush or fully flush, there are envelope systems we would put forward that can achieve each.
Also, in some URS documents, requirements will be classed as either ‘essential’ or ‘desirable’. Essential requirements are for regulations, compliance or necessary to the end user’s operations. As the name would suggest, desirable requirements would be beneficial for the cleanroom space, but the end user does not absolutely need them.
For instance, the requirement for the walls to be fully flushed would be an essential requirement, while the placement of control equipment could be a desirable requirement.
While there will be one section specifically related to Stancold’s cleanroom envelope package, it is very important for our specialists to understand every part of the URS to determine which system they specify.
Other sections, such as the facility’s required performance, purpose and mechanical elements, give our team even more insight into which system will be most applicable and the considerations we must take during the latter design stages of the project. This could relate to walk-on maintenance for ceilings, the placement of lighting within the cleanroom space and classifications the cleanroom must achieve, among other components.
Why Cleanrooms Require a URS and Our Other Construction Packages Don’t Always Include One
This blog piece brings up the question of why Stancold’s other project types do not often require a URS as often as cleanrooms do. Our team deliver industrial cold storage construction, multi-room food and beverage production fit-out and warehouse segmentation projects across the UK, but for these other projects, we do not encounter documents that take the same approach as a cleanrooom URS. Projects that take place in a food producer’s site sometimes start with a User Requirement Specification, but they are approaching it from a slightly different angle than cleanroom projects.
For firewalls and industrial partitioning, the requirements come from building regulations, the rules designed to keep the building structurally safe and protect the people inside it. Cleanrooms, however, sit under process‑driven regulatory frameworks such as ISO and GMP, which exist to ensure products are manufactured safely for consumers. Therefore, the cleanroom space must be designed and built around the needs of the process and the environmental conditions that the process requires, hence the need for this type of URS document.
Food and beverage production facilities are also guided by regulatory frameworks such as BRC and SALSA, but these frameworks focus on operational processes rather than environmental performance. The hygienic and temperature-controlled solutions Stancold delivers for food and beverage production spaces do play into what BRC and SALSA require, but not to the extent where they dictate how the space is engineered. BRC and SALSA specify how the space must be used, while ISO and GMP specify how the space must perform.
Delivering Cleanroom URS Requirements with Precision and Expertise
Cleanroom projects involve a wide range of coordinated activities to ensure the final space meets every requirement set out in the URS. While only certain sections relate directly to Stancold’s envelope package, our team must understand the full set of environmental and process needs to deliver the most appropriate and cost-effective solution.
Turnkey cleanroom contractors and principal contractors can depend on Stancold to integrate smoothly into the wider project, providing an efficient envelope package delivery that aligns with the work of all other specialist contractors involved.
If you would like to learn more about how Stancold plans and delivers cleanroom envelope solutions for projects across the UK, get in touch with our team:
📞 0117 316 7000
