The ISO 14644 standard’s definition of a cleanroom is a cleanroom is a “room within which the number concentration of airborne particles is controlled and classified, and which is designed, constructed and operated in a manner to control the introduction, generation and retention of particles inside the room.
Cleanrooms are essential for industries requiring controlled environments, e.g. the manufacture of pharmaceuticals, semiconductors, medical devices and aerospace products. A cleanroom’s purpose is to prevent contamination, ensuring product quality and safety, in the Pharmaceutical environment patient safety is critical.
Designing, constructing and validating a cleanroom requires collaboration between multiple stakeholders, each playing a crucial role in the process. Whether you are exploring cleanrooms for the first time or preparing for a new project, that requires and additional cleanroom, understanding these key players and their contributions is essential.
Cleanrooms operate by removing pollutants, particles, and contaminants from external air. This process broadly involves the following steps:
Creating a cleanroom involves a diverse group of professionals working together, so who are the key stakeholders and what are their responsibilities:
The individuals in an organisation who will operate the cleanroom are central to the process, this group may include production, quality and engineering staff. End users provide essential input about cleanliness requirements (e.g. ISO Class 5, ISO Class 7, GMP Grade C), workflow and operational needs and specific equipment or processes that will be included in the cleanroom.
End user’s understanding and insights into their process guides the overall design to ensure the cleanroom meets industry, operational and where applicable, regulatory, standards.
Design engineers are responsible for designing the physical structure and systems of the cleanroom, including architectural and mechanical and electrical systems. Design engineer’s expertise ensures the correct layout and space utilisation, integration of HVAC systems, lighting and utilities and compliance with industry and/or regulatory standards, e.g. ISO 14644 or GMP.
Design Engineers play a crucial role in turning the end user’s vision into a functional design.
Cleanroom suppliers and Contractors specialise in cleanrooms and bring the design to life. They use industry-specific materials, such as suitable walls and ceiling systems, seamless chemical-resistant flooring and HEPA filtration systems
Their products and skills, together with supporting technical information and/or commissioning reports, ensure the construction meets both cleanliness standards, operational demands and where applicable, regulatory requirements.
These professionals are responsible for ensuring the cleanroom meets regulatory and industry standards. They focus on an in-depth understanding of the regulatory standards in the country where the cleanroom will be sited. Regulatory review of the User Requirement Specification (URS) for the cleanroom and initial design to ensure the proposed layout will meet the process and regulatory requirements. As well as, oversight of qualification/validation documentation and processes while ensuring conditions in the cleanroom are compliant, e.g. air quality, airflow, and pressure differentials to identify and address potential risks, deviations and nonconformances.
Project managers oversee the entire process, acting as a bridge between the stakeholders. Their role includes managing budgets and timelines, coordinating communication between teams and addressing challenges to keep the project on track and within budget
When designing and constructing a cleanroom, all stakeholders must align on the following factors:
Cleanrooms are classified based on the level of cleanliness required. For example ISO Class 5: Ideal for critical environments like semiconductor manufacturing and GMP Grade C: Common in non-sterile pharmaceutical production, e.g. manufacture of oral capsules
Understanding and adhering to these regulatory classifications and standards is essential.
The cleanroom layout must balance productivity with contamination control and meeting any regulatory requirement. For example unidirectional airflow to minimise particulate contamination, segregated areas for personnel and materials, as well as, separate routes out of the cleanroom for finished product and waste.
Cleanroom materials must be durable, easy to clean, and resistant to contamination and to cleaning agents and disinfectants. Common options for a ISO Class 7 cleanroom may include a cleanroom wall panel and ceiling system and a seamless vinyl or resin flooring.
Stakeholders must prioritise open communication to prevent costly delays and ensure realistic expectations.
Frequent project meetings and clear documentation help keep everyones expectations aligned.
Ensuring compliance experts are engaged early to navigate regulations and avoid costly rework.
Early collaboration with equipment suppliers ensures seamless integration of systems such as an Environmental Monitoring System (EMS).
Cleanroom design and construction is a highly collaborative process involving multiple stakeholders, each bringing their unique expertise to the table. From design engineers to end users, project managers and compliance experts, each role is vital to creating a cleanroom that meets operational and regulatory standards.
By fostering open communication and understanding the responsibilities of each stakeholder, you can ensure a smoother process and a successful outcome. Whether you’re just starting or looking to refine your approach, collaboration is the key to your cleanroom success.
Our design and build specialists have experience working with customers in all kinds of industries on a global scale, achieving great results time and time again. We’d love to work with you as well!
