The challenges and innovations of designing and building a cleanroom facility
By Andrew Benson
Airology’s MD Andrew Benson has written an article for Cleanroom Technology magazine, “The challenges and innovations of designing and building a cleanroom.” For the purpose of the article he uses Xeal Pharma as a case study.
Airology Systems Ltd – Xeal Pharma Case Study
Objective
Xeal Pharma are specialists in pharmaceutical production and distribution and found themselves with an urgent requirement to expand their production facility to meet increased demand. As a result, they turned to Airology due to our specialist knowledge and asked for our recommendations.
They required an ISO7 multiroom cleanroom facility with temperature control, two room close control system, filtration, pressure monitoring and extraction for washroom.
The Process
Airology was commissioned to design and build the cleanroom to meet the client’s specific requirements. Initially, we worked with the client to survey a dedicated empty warehouse, working over several months to finalise the layout and design that would facilitate the efficient transition of their product and personnel at each stage of production.
Site Survey
The first stage of any build is the site survey to make sure everything is suitable such as
- Floor layout
- Structural integrity
- Access points
- Proximity to utilities
Collaboration Design
It was important that the design was done with full collaboration of the client to meet requirements in:
- Production requirements
- Workflow
- Future expansion plans
Various teams from Xeal Pharma gave their input including:
- Production
- Quality Control
- Maintenance
Cleanroom Facility Design Finalisation
We came up with a design that looked at every aspect from raw material storage to final product and packaging. We had to optimise the layout to:
- Minimise contamination risk
- Streamline workflows
- Facilitate smooth transition between production stages
The design had to meet ISO 7 Cleanroom requirements for
- Air quality
- Temperature control
- Cleanliness
Efficient Space Utilisation
This was an important part of the project. Space within the cleanroom facility was utilised to optimise the layout of workstations, equipment, and storage areas. making sure each area was set up for personnel, equipment and processes whilst still meeting with compliance with ISO 7 standards.
Close Control in Two Cleanrooms
We addressed the requirement for close environmental temperature and humidity control by implementing specialised, in-room, free standing HVAC systems and monitoring equipment. Advanced sensor and control systems were included to maintain precise temperature and environmental conditions in critical production areas.
Transition to New Cleanroom Facility
It was important to work closely with the client to develop a detailed transition plan for moving their personnel and equipment into the new facility. We developed a co-ordinated plan to minimise downtime and other disruptions to production.
Compliance Assurance
ISO 7 compliance was prioritised throughout the design and construction process. We worked close with regulatory authorities to make sure the cleanroom facility met all necessary requirements and guidelines.
Equipment Integration and Selection
Materials were selected to be cleanroom compatible and minimise generation of particles and contaminants. Equipment was installed to enhance across the facility to enhance operational efficiency.
Safety and Training
Safety and training is always one of our priorities when creating a cleanroom facility. Our design included:
- Emergency fire exits
- Fire suppression systems
- Personal protective equipment (PPE)
We provided a comprehensive training programme, making sure personnel understood cleanroom protocols and how to maintain a clean environment.
Quality Control and Validation
Rigorous control measures were implemented during construction of the cleanroom facility. We ensured all components met the specified standard.
A validation plan was developed to verify the facility operates within the defined parameters and complies with ISO 7 Cleanroom requirements.
Challenges in Creating the Cleanroom Facility
Maintenance: Cleanrooms require ongoing maintenance to sustain the desired level of cleanliness. Regular monitoring, testing, and cleaning are necessary to ensure that the cleanroom remains compliant with industry standards. The cost of maintenance can be substantial over the life of the cleanroom.
Stringent Standards: Cleanrooms must adhere to specific cleanliness standards,such as ISO 14644 or Federal Standard 209E. Achieving and maintaining
compliance with these standards can be challenging, as any deviation can lead to contamination and compromise the integrity of the cleanroom environment.
HVAC Systems: The heating, ventilation, and air conditioning (HVAC) systems in cleanrooms play a critical role in maintaining cleanliness levels. Designing and maintaining HVAC systems that provide the required air cleanliness, temperature, and humidity control can be complex and costly.
Contamination Control: Preventing contamination from external sources, as well as controlling contamination generated within the cleanroom, is a constant challenge. Strict protocols for gowning, equipment sterilisation, and material handling are essential to minimise the risk of introducing contaminants.
Personnel Training: Proper training for personnel working in cleanrooms is crucial. Employees need to understand and adhere to strict protocols to
minimize the risk of contamination. This includes proper gowning procedures, hygiene practices, and awareness of potential sources of contamination.
Materials and Equipment Selection: Choosing the right materials and equipment that are compatible with the cleanroom environment is essential. Certain materials may release particles or gases that can compromise cleanliness levels. Careful selection and testing of materials are necessary to ensure they meet cleanroom requirements.
Flexibility and Adaptability: Industries and processes within cleanrooms may evolve over time. Designing cleanrooms with flexibility and adaptability in mind allows for easier modifications to accommodate changes in technology or processes without compromising cleanliness levels.
Validation and Certification: Cleanrooms must undergo validation and certification processes to ensure they meet the required standards. Obtaining and maintaining certification can be time-consuming and may involve shutting down operations for testing and inspections.
Energy Efficiency: Balancing the need for a clean environment with energy efficiency is a challenge. HVAC systems in cleanrooms often consume a
significant amount of energy, and finding ways to reduce energy consumption without compromising cleanliness is an ongoing consideration.
Resilience: It is critical to ensure that a Clean Room can run constantly, and measures are put in place to ensure that total system failure can be avoided and managed with minimal disruption.
The Innovations
Despite the challenges, cleanrooms are essential for many industries, and advances in technology and construction techniques continue to address some of these issues.
- Particular innovations provided by Airology, and the Design team were: – Supply and installation of re-circulatory filtration systems with integrated
above ceiling heating and cooling units – the combined systems supply filtered, and temperature controlled clean air to the room. - The number of fan filter units is determined by the air changes required to meet the associated standard.
- Fan filter units are evenly spaced within the ceiling over the area to provide an even air distribution.
- Each fan filter unit is connected to a low level return air grille which draws air at low level form the room and returns to the fan filter unit at high level for re-conditioning.
- The high level fan filter and low level return provides a dedicated air path from high to low level within the room.
- Delivering via individual fan filter units positioned in the ceiling eliminates the need for external or internal air handling unit plant space.
- Multiple fan filter units in the ceiling provides resilience and overcomes single point failure – critical to any Clean Room operation.
Final Result and Delivery of the Cleanroom Facility
By working closely with Xeal Pharma we were able to design and install a ISO 7 compliant cleanroom facility that fitted in with their exact requirements. They benefitted from:
- Increased production of products
- Designated close control rooms
- Appointed washroom area for product container cleaning
- Reduced cost due to less outsourcing
- Ability to grow their business and fulfil growing demands of the industry
Final Outcome Cleanroom Facility
The commitment by the client to Airology to provide a complete design and install ‘Turnkey’ package together with continuous collaboration between all parties has ensured the client obtained exactly the Clean Room facility he envisaged.
The client now has a first-class project with the knowledge and understanding that the facility will securely deliver for both now and the future.
(This article was originally written for Cleanroom Technology magazine and has been adapted for our website. You can read the original article here: Cleanroom Technology)
More images from this project can be found in the case study: Xeal Pharma ISO 7 Cleanroom, Birmingham
