Most Canadians use air conditioning only in the summer. At the Biologics Manufacturing Centre, it runs every day, all year long.
But this isn't your average air conditioning system. The Biologics Manufacturing Centre's heat, ventilation and air conditioning (HVAC) system spans almost the full length of one floor of the facility and is an intricate, high-tech system that is interconnected with just about everything else in the facility.
That's because the HVAC system is absolutely critical in ensuring the facility is compliant with the strict requirements of good manufacturing practices (GMP). It maintains the optimal environmental conditions in the production suites (clean rooms). This is where the biomanufacturing experts manipulate the live cells needed to produce a vaccine that triggers an immune response without actually causing the illness. This is why a very high level of cleanliness is required to ensure these rooms are safe from contamination. The clean rooms at the Biologics Manufacturing Centre are classified according to the allowable limit of particulates. Some rooms are grade D (really clean), others are grade C (even cleaner!).
What does any of this have to do with air conditioning? An essential part of the facility's design, the HVAC system keeps the temperature steady and accurate and controls the humidity, because even a tiny amount of condensation could become a source of contamination with devastating effects on vaccine production.
The HVAC system also provides correct air circulation, including balancing the direction of air flow using positive and negative pressure to direct particulates away from the clean rooms. And it keeps the air very, very fresh. Depending on the particular room, the HVAC system changes the HEPA-filtered air 15 or 30 times per hour.
Other factors for optimal conditions
The HVAC system is critical to maintaining optimal conditions in the clean rooms. It is one example of the Biologics Manufacturing Centre's complex design to ensure vaccines are manufactured in a GMP-compliant environment.
However, GMP requirements are multi-faceted. Other factors for maintaining optimal conditions include intense cleaning methods and strict limits on the number of people allowed inside the clean rooms.
In addition, everyone who enters the clean rooms at the Biologics Manufacturing Centre must comply with strict gowning procedures, which can take up to 20 minutes to complete. These gowning procedures include putting on the proper clean room apparel, which must be done using the proper donning techniques (yes, there is a defined and precise procedure for how to gown. It takes a lot of practice, and may require annual re-certification for some areas).
The biomanufacturing experts add layers of gowning as they progress into cleaner rooms. They must also pass through 2 sets of pressurized doors, with each section being cleaner than the previous. These strict rules are intended to keep contaminating particles out of the clean rooms.
In addition to proper gowning, anyone working in the clean rooms must follow strict procedures for how to perform their tasks in the room, so everything is done to avoid shedding particles in the room.
Experts at the facility have prepared, tested, written, and trained staff on hundreds of standard operating procedures for conducting every task performed in the clean rooms. These procedures are critical because if there is variation in how something is done by two different people, it could have a significant impact on the intended product.
Does the HVAC system actually work as it is supposed to?
With such an important role to play in maintaining GMP compliance, the HVAC system needs to work properly at all times. It must be continually monitored and regularly validated to make sure the air pressure remains constant, the air flow is optimized and the filters are working properly.
In addition, the clean rooms are continuously monitored for particulates. If the size or number of particles strays too close to the allowable limits, the system will be shut down until the problem is resolved. This is obviously something that everyone wants to avoid, so strict and regular maintenance and testing of the HVAC system is critical.
Before receiving a drug establishment licence, as a new biomanufacturing facility, the Biologics Manufacturing Centre must have the HVAC system qualified as part of the commissioning, qualification and validation process.
Read the other stories in this series to learn more.
Update: Following an inspection in July, Health Canada issued a drug establishment licence for the Biologics Manufacturing Centre on August 5, 2022.
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