In industries like pharmaceuticals, healthcare manufacturing and high-tech production, maintaining a clean and controlled environment is critical to ensuring the quality and integrity of products.
While most people are familiar with classified cleanrooms, those that meet stringent ISO or EU GMP standards, not all controlled environments need to be certified to these levels. That’s where unclassified cleanrooms, sometimes referred to as “clean-not-classified” cleanrooms, come in.
What Is an Unclassified Cleanroom?
An unclassified cleanroom is a controlled space designed to limit contamination from external pollutants such as dust, microbes and airborne particles. However, unlike ISO or EU GMP classified cleanrooms, it does not meet the strict air cleanliness levels required for formal certification under standards like ISO 14644-1 or EU GMP Grade D and above.
Despite the lack of classification, these rooms still adhere to many of the same principles and often include environmental controls to meet specific operational requirements.
When Are Unclassified Cleanrooms Used?
Unclassified cleanrooms are ideal in situations where cleanliness and environmental control are necessary, but not to the extent required for formal classification or audit. This might include:
- Pharmaceutical manufacturing support areas
- Nutraceutical or supplement production zones
- Cosmetic or personal care packaging areas
- Medical device assembly
- Specialist electronics or optical component production
These clean-but-not-classified spaces help manufacturers reduce the risk of contamination, improve product quality and maintain a cleaner, more efficient working environment, without the complexity or cost of a fully certified cleanroom.
What Environmental Controls Are Typically Used?
While unclassified cleanrooms don’t need to meet ISO 9 or EU GMP standards, they often incorporate a number of control measures to maintain a stable and clean environment, including:
- Temperature Control
High-performance insulated panels help regulate internal temperatures, protecting products from heat-sensitive degradation and improving worker comfort. - Positive Pressurisation
Maintaining positive air pressure helps prevent the ingress of dust, airborne microbes or other contaminants from less-controlled adjacent areas. - Humidity Control
Regulating humidity is essential to limit bacterial growth, prevent corrosion of sensitive materials, reduce static build-up and stop moisture-related product damage. - Physical Separation
These rooms are often isolated from surrounding workspaces to prevent cross-contamination and ensure a cleaner, more stable environment.
Why Choose an Unclassified Cleanroom?
There are many reasons to opt for an unclassified cleanroom. You might not need a classified space for your product or process, but you still want to:
- Improve hygiene and reduce the risk of contamination
- Extend product shelf life
- Meet internal quality standards
- Prepare for future certification or audits
- Separate high-sensitivity processes from general production
In short, unclassified cleanrooms offer a cost-effective, flexible solution for many controlled manufacturing and packaging needs.
We can help you design and build your unclassified cleanroom, creating a bespoke solution that meets your operational goals.
To discuss your clean not classified cleanroom project with us, give Mark a call on 07585 301 425 or send us an enquiry today.
