Our client, a specialist in pharmaceutical production and distribution, requested our recommendations for an urgent requirement to expand their production facility to meet their increased demand.
The client required an ISO Class 7 multiroom cleanroom facility with temperature control, specialist two room close control system, filtration, pressure monitoring and extraction for Washroom.
The process
We were appointed to design and build the cleanroom facility to enable our client to meet their growing demands by creating a large space for their production.
We evaluated factors such as floor layout, structural integrity, access points, and proximity to utilities
After extensive surveying of a dedicated empty warehouse space, we worked with the client over several months to finalise the layout/design that would ensure an efficient transition of their product and personnel in each stage of production.
Particular attention was given to the layout of the facility and the size of each area to create the most efficient use of space together with specialist close environmental control to two rooms within the proposed facility.
Site Survey
We began with a thorough survey of the empty warehouse space to assess its suitability for a cleanroom facility evaluating factors such as floor layout, structural integrity, access points, and proximity to utilities.
Collaborative design
We then engaged in an extensive collaboration design process with the client to understand their specific production requirements, workflow, and future expansion plans.
We implemented specialised in-room free-standing HVAC systems and monitoring equipment
We also made sure that production staff, quality control, and maintenance teams were all included in the design process.
Layout and design finalisation
At this point, Airology considered the entire production process from raw material storage to finished product packaging to optimise the layout to minimise contamination risks, streamline workflows and facilitate a smooth transition between production stages.
We finalised the design based on ISO Class 7 cleanroom standards, including specific requirements for air quality, temperature control, and cleanliness.
Efficient space utilisation: Maximising the efficient use of space within the cleanroom facility and optimising the layout of equipment, workstations, and storage areas has ensured that each designated area is appropriately sized to accommodate personnel, equipment, and processes while maintaining compliance with ISO Class 7 standards.
Advanced sensors and control systems were installed to maintain precise temperature and environmental conditions in these critical production areas
Close control in two cleanrooms: As an important factor, Airology addressed the requirement for close environmental temperature and humidity control in two specific cleanrooms by implementing specialised in-room free-standing HVAC systems and monitoring equipment.
Advanced sensors and control systems were installed to maintain precise temperature and environmental conditions in these critical production areas.
Transition planning
In conjunction with the client, Airology developed a detailed transition plan for moving personnel and equipment into the new cleanroom facility.
We also coordinated with the client's production schedule to minimise downtime and disruptions during the transition phase.
Compliance assurance
Airology prioritised compliance with ISO Class 7 standards throughout the design and construction phases and worked closely with regulatory authorities to ensure that the cleanroom facility met all necessary guidelines and requirements.
Equipment selection and integration
All materials were selected to be cleanroom-compatible equipment and to minimise the generation of particles and contaminants.
A validation plan was developed
The equipment was seamlessly installed into the overall facility layout to enhance operational efficiency.
Safety and training
Airology prioritised safety considerations in the design, including emergency exits, fire suppression systems, and personnel protective equipment (PPE) and developed a comprehensive training programme for personnel to ensure they understand cleanroom protocols and how to maintain a clean environment.
Quality control and validation
We implemented rigorous quality control measures during the construction process to ensure that all components meet specified standards.
A validation plan was developed to verify that the cleanroom facility operates within the defined parameters and complies with ISO Class 7 requirements.
The challenges
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.
Despite the challenges, cleanrooms are essential for many industries
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.
Balancing the need for a clean environment with energy efficiency is a challenge
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 cleanroom 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.
There were a few particular customisation innovations provided by Airology, and the Design team:
- 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 (FFU) is determined by the air changes required to meet the associated standard.
- FFUs are evenly spaced within the ceiling over the area to provide an even air distribution.
- Each FFU 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 cleanroom operation.
Results
Working closely with the client and after successful installation of the new ISO Class 7 cleanroom facility, our client has benefited from:
- The ability to produce larger amounts of their products
- Designated rooms with close control
- Designated washroom area for product container cleaning
- Reduced costs as outsourcing have been eliminated
- The capability to grow their business and meet the growing
demands of the industry
The Outcome
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 cleanroom 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.
