www . refrigerationandaircon . co . za RACA Journal I July 2024 21
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A critical component of the design process is the User Requirements Specification ( URS ). " The client needs to produce a URS , which is a document that clearly outlines what they need and under what conditions . This specification is essential for ensuring that the facility meets regulatory standards and operates as intended .”
The URS is particularly important in pharmaceutical manufacturing , where a responsible pharmacist must ensure that the production conditions align with the requirements for drug safety and efficacy . " It ' s not just about classification ; it ' s also about temperature and relative humidity . These factors are major cost drivers in the design and construction of clean rooms .”
Rennie provides some context on the costs involved . " Typical air conditioning for an office might be about R1 000 per square metre , but for a clean room , the costs can be perhaps R8 000 ," he says , reflecting the advanced systems required to maintain the stringent conditions necessary for pharmaceutical production .
FROM INITIAL PLANNING TO FINAL EXECUTION " We create detailed drawings and renderings of the facility , which we present to the client before construction begins . This allows clients to visualise the final product and make any necessary adjustments early in the process .”
The design and construction of clean rooms for pharmaceutical manufacturing involves significant financial and technical considerations . " The numbers get big very quickly ," Rennie acknowledges . " For that reason , you ' ve got to write that URS intelligently to make the project feasible . You have to question what is actually needed and be highly precise in defining the requirements to avoid unnecessary expenses .”
Once the URS is established , the design process begins , focusing on minimising costs by distinguishing between primary and secondary areas . " Primary areas are classified spaces , while secondary areas are for packing , storage or other purposes that don ' t need classification . This strategic planning helps manage costs without compromising the quality and compliance of the facility .
" An architect who understands GMP ( Good Manufacturing Practice ) is essential ," Rennie states . GMP dictates how people and products should flow through the facility to maintain safety and efficiency . Alongside the architect , a skilled HVAC engineer is crucial to manage the costs and technical aspects of the facility ' s air-conditioning and ventilation systems .
During the URS phase , it ' s also crucial to determine which standards the facility will comply with . Rennie mentions several key standards , including ASHRAE guidelines , ISO standards , and those set by various regulatory bodies like SAPRA ( South African Health Products Regulatory Authority ) and the World Health Organization ( WHO ). " These standards constantly evolving and staying updated is vital ."
Additionally , organisations like the International Society for Pharmaceutical Engineering ( ISPE ) play an important role in advancing clean room technology and methodologies .
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A pharmaceutical manufacturing entity encompasses various specialised areas , each with unique requirements such as raw materials brought in through quarantines .
" They are constantly looking at new ways of doing things to improve efficiency .”
One of the most challenging aspects of clean room design is budgeting . " Arriving at an actual cost with all these moving parts is quite difficult ," Rennie admits . The complexity of the requirements , combined with the need for precision and compliance , makes the budgeting process a significant hurdle . However , by working closely with clients and thoroughly understanding their needs , one can develop accurate and feasible budgets .
There is a continuous evolution of this field . " These things are being rewritten and advancing all the time with organisations and standards bodies constantly updating guidelines and best practices . Innovations in clean room design and technology will continue to drive improvements in safety , efficiency and cost-effectiveness .”
A pharmaceutical manufacturing entity encompasses various specialised areas , each with unique requirements such as raw materials brought in through quarantines ," Rennie explains . After production , the products move to a finished goods warehouse , which also requires controlled conditions , albeit less stringent than those in the manufacturing area . " Generally , the products are sealed , so there are no special filtration requirements . It ’ s more about maintaining the right conditions ," he adds .
PARTICLE CONTROL AND AIRFLOW MANAGEMENT The execution phase involves providing the client with different options for finishes and ensuring the facility ' s design minimises contamination risks . " For example , doors are designed to be high level with flat surfaces to avoid accumulation of dust and other particles ," Rennie says . Since bacteria and viruses travel on dust particles , controlling particle levels in the air is crucial for maintaining a sterile environment .
www . refrigerationandaircon . co . za RACA Journal I July 2024 21