Specialist cleanroom design and engineering for UK industry. We provide full working drawings, airflow calculations, and technical specifications compliant with ISO 14644-4:2022 and EU GMP Annex 1 requirements.

Technical Cleanroom Design Specifications

A compliant cleanroom design (DQ) is the critical first step in any controlled environment project. At ISO Cleanroom, we translate your operational requirements into detailed blueprints that satisfy regulatory boards and internal quality standards.

Our design packages include full working drawings, precise design calculations, and comprehensive product specifications for all selected materials. Whether you are operating in advanced engineering or aseptic pharmaceutical processing, our designs provide a "source of truth" for the entire Cleanroom Build process.

The design process starts with a robust user requirement specification (URS). A good quality document that captures all of the requirements of the new facility is vital to a successful outcome. This is the document that the completed cleanroom will be validated against.

Below is a simplified version of what should be included in the URS.

PART 1. Describe your process

1. A brief description of the planned process within your cleanroom
2. A description of the product flow within your cleanroom
3. A list of standards your process must conform to

PART 2. Specifying the Correct ISO Classification

The foundation of any design is the required air cleanliness level. Most industries refer to the ISO 14644-1:2015 standard to define minimum particulate limits.

For sectors where the required classification is not strictly regulated, or there is no precedent already set such as you find in R&D, we use the following industry benchmarks to help specify the appropriate ISO level:

EU GMP Design for Aseptic Processing

For pharmaceutical and life science facilities, we align our designs with EU GMP grades. This is essential for future proofing your compliance.

• Grade A: Critical zones for high-risk operations, such as aseptic filling and connections.
• Grade B: Background support for Grade A zones.
• Grade C & D: Clean areas for less critical stages of manufacture, such as solution preparation and equipment cleaning.

In order to design a space to achieve the required cleanliness level we need to understand the amount of challenge that your equipment, process and your personnel are going to place on the filtration system. If the particle burden level is not known, we will carry out a particle study.

PART 3. Environmental Controls

Although not part of the ISO 14644 certification, many applications require environmental controls to protect sensitive processes, equipment or materials. Common environmental controls are temperature and humidity levels but other controls we regularly come across are ESD, light and vibration.

Temperature and humidity parameters and the accepted variant must be defined during the initial design brief to ensure HVAC efficiency and cost-effective operation.

In order to design an efficient system, we assess:

• Heat Loadings: Total heat gain from equipment within the room.
• Moisture loadings: Total liquid volume used over a defined time period.
• Occupancy Levels: The maximum number of people working in the space.

ESD, light and vibration limits need to be defined as part of the URS to ensure the correct choice of plant and materials.

PART 4. Monitoring and Annex 1 Compliance

Once your cleanroom is operational you will require data to confirm its continued compliance to your URS.

Periodic cleanroom testing by an external company should be carried out in line with the frequency table found in ISO 14644-2:2019 but this testing is over and above the monitoring of the cleanroom.

You can monitor many variables within a cleanroom; pressure, particulate levels, temperature, humidity, light levels, vibration levels, noise. Which information you need to monitor to ensure the success of your process should be documented in the URS.

With the recent updates to EU GMP Annex 1, there is a heightened focus on continuous monitoring across the whole cleanroom industry. However, it is not necessary for all cleanrooms to continually monitor all variables. It is important to consider

1. What you need to monitor for your process
2. The frequency of monitoring your process requires

We work with industry partners to ensure your design includes the frequency and type of monitoring required for your specific process.

Design

Using the URS as the blueprint we can then evaluate the information and design the plant, filtration and airflow to achieve the specification.

Selecting the Build Position

This may have already been determined but it is worth mentioning here that ceiling height is a critical dimension. While some processes benefit from cross-flow air, the majority of modern applications require vertical airflow. This necessitates sufficient space above the ceiling for air filtration plants, ductwork, and other Cleanroom System Build components.

Spatial and Equipment Considerations

We design your layout to account for every piece of equipment and the maximum number of personnel all identified in the URS. This ensures that objects within the room do not obstruct the critical airflow paths required to maintain your classification.

Optimising Airflow and Spatial Planning

A common failure in cleanroom performance is "over-population" or poor spatial planning. All cleanrooms rely on consistent airflow to remove particulates. We will discuss how moving large equipment effects airflow patterns.

Why Partner with ISO Cleanroom?

We are specialists in solving complex design challenges. Our team has designed controlled environments in extreme locations, including the Antarctic, underground facilities, and even on moving trains.

Our Design-to-Handover Package Includes:

• Full Validation Readiness: Designs that facilitate seamless Cleanroom Validation (IQ/OQ/PQ).
• Maintenance Integration: Planning for easy access to filters and services to simplify future Cleanroom Maintenance.
• Modularity: Layouts that allow for future Cleanroom Upgrades or expansion.

Specialist Services for your Controlled Environment

• Cleanroom Build – Turnkey construction and installation.
• Cleanroom Validation – Performance testing to ISO standards.
• Cleanroom Maintenance – Emergency repairs and planned servicing.
• Cleanroom Upgrades – Modernising and expanding facilities.
• Cleanroom Rental – Short-term certified solutions.