Prefabricated factory systems to ensure reliable HVAC in the pharmaceutical industry
Cleanrooms and other spaces involved in the production of pharmaceuticals must be, well, clean, to say the least. A gust of wind bringing in dust and other outdoor pollutants? Personnel operating the machines sneezing or shedding clothing fibres or skin flakes? Chemicals emitted by building materials? All of these are big no-nos. That’s why it’s so important to have well-designed HVAC in the pharmaceutical industry.
HVAC, or heating, ventilation, and air conditioning plays a major role in producing safe, high-quality pharmaceutical products. Designing HVAC systems for pharmaceutical factories involves adhering to good manufacturing practices (GMP) to prevent contamination and cross-contamination. A top-quality HVAC system not only maintains product integrity but also protects the environment and the personnel involved.
The World Health Organisation (WHO) has published the WHO Guidelines on good manufacturing practices for heating, ventilation, and air-conditioning systems for non-sterile pharmaceutical dosage forms, with necessary amendments made subsequent to their original publication in 2006. These guidelines cover recommendations for HVAC systems in pharma facilities which manufacture non-sterile dosage forms like tablets, capsules, powders, creams, liquids, and ointments. The guidelines are extremely comprehensive, including design of premises, HVAC systems and components, full fresh air systems and recirculation systems, air filtration, airflow direction and pressure differentials, temperature and relative humidity, dust, vapour and fume control, protection of the environment, commissioning, qualification, and maintenance in their purview.
Given the large number of elements involved, you can see that maintaining high-quality HVAC in the pharmaceutical industry is no piece of cake. Adhering to HVAC-related GMP begins at facility design and goes all the way up to commissioning, validation, and factory operations. Prefabricated factory solutions are the best way to meet these myriad specifications. But before we get into the details of how modular cleanrooms and factories can help, we must understand the basic elements involved.
Understanding cleanrooms, air-handling, and HVAC in the pharma industry
According to the WHO guidelines, a cleanroom (or a clean area) refers to a room, zone, or area with defined environmental control of particulate and microbial contamination. It is constructed and used to minimise the introduction, generation, and retention of contaminants within it.
An air-handling unit (AHU, also referred to as a central air-conditioning unit) conditions the air and provides the required airflow in the facility.
HVAC, or heating, ventilation, and air-conditioning systems are also referred to as environmental control systems. They are usually made up of some combination of heating units, cooling units, ventilation systems, ducts, boilers, filters, temperature control systems, humidifiers, etc. Every HVAC system may not have all these units; the term HVAC system is generally an umbrella term for the interconnected air control systems used to condition the atmosphere. The four basic functions of HVAC in the pharmaceutical industry are to control airborne particles like dust and microorganisms and to maintain room pressure, moisture levels, and temperature.
Air-handling units are part of HVAC systems, but not just any part. They are fundamental to the functioning of an HVAC system in the pharma industry. With air filters, energy recovery components, fans, (de)humidifiers, and heating and cooling components, they are designed to handle and condition the air processed in the HVAC system.
Facility construction ???????? HVAC systems in the pharma industry
Factory design and construction go hand-in-hand with HVAC systems in the pharma industry. The design requirements of HVAC systems influence the architectural design and layout of the building, especially regarding doorways, lobbies, and airlock positions. This is because features such as these influence room pressure, pressure cascades, pressure differentials, contamination, and cross-contamination control, all of which have an impact on indoor air quality in the factory.
Additionally, inappropriate temperature, ventilation, and moisture levels can adversely impact the safety, efficacy, and quality of pharmaceutical products and the equipment used to make them. This is why the design of HVAC in pharmaceutical industry applications should be kept in mind from the initial design stage of the pharmaceutical manufacturing plant, whether it is modular or not.
There are inextricable connections between manufacturing facility design, HVAC systems, and pharma product quality. Considering these interlinkages, the WHO guidelines have certain HVAC-related requirements for premises where pharmaceutical products are manufactured.
Infiltration of unfiltered air into the manufacturing facility should be prevented. The production facilities should be maintained at a positive pressure relative to the outside to prevent contaminants from entering. (When negative pressure needs to be preserved, other precautions must be taken.) The level of cleanliness of each area should be determined based on the products manufactured, their vulnerability to degradation, and the process used.
Additionally, in designing and building HVAC systems in the pharmaceutical industry, manufacturers should be careful that materials for constructing the HVAC system do not themselves become a source of contamination. Air intake and exhaust terminals should be well-placed in relation to each other to prevent cross-contamination. And air handling units should be provided with appropriately-designed drains to eliminate any condensate that may form in them.
These are only a few of the measures biopharma manufacturers should take to ensure that their HVAC systems support the hygiene levels required in the facility. But as you can see, they are crucial to any high-quality pharmaceutical manufacturing operation. This is why it is important that pharma companies develop the most effective ways to achieve these non-negotiable standards.
How modular cleanrooms and factory systems by PodTech™ can help
Achieving the highly controlled environmental levels specified by GMP guidelines is far from easy. However, prefabricated systems offer some novel advantages which make the entire process a lot smoother than traditional design and construction.
Fully self-contained
As self-contained units which provide you with absolute control over temperature, humidity, particle levels, and other environmental factors, PodTech™’s modular cleanrooms help biopharma manufacturers meet rigorous cleanliness standards. These prefabricated cleanrooms come equipped with HEPA or ULPA filters to dilute and eliminate airborne chemicals, particles, and bacteria. The cleanrooms themselves are constructed using materials that don’t emit chemicals or other contaminants.
Essential inclusions
PodTech™’s modular cleanrooms also include specialised HVAC systems for the pharma industry, lighting, plumbing, monitoring, and more. Other PodTech™ offerings also come with dedicated air handling, building management systems, fire protection, and electrical and process utility distribution. Since the same process partner handles all these design elements, you can be assured that no other component of your facility compromises on required indoor environmental conditions.
Cost-effectiveness
Since modular cleanrooms like those offered by PodTech™ are self-supporting, with no need for structural support from existing building infrastructure, they are easy to integrate into preexisting facilities. This makes them a simple, popular, and cost-effective choice for biopharma manufacturers working on tight budgets and timelines but not wanting to compromise on product safety and quality.
Small installation team
Since PodTech™’s modular cleanrooms are fabricated and pre-validated before being shipped to your project site, on-site assembly is simpler and faster than for conventional systems. This means that a smaller installation team is required, translating to a lower risk of human errors and lower chances of contamination.
For any biopharma manufacturer who prioritises product safety and, consequently, HVAC systems used in the pharmaceutical industry, deploying prefabricated systems is a no-brainer. With HVAC and air handling, building management, fire protection, plumbing, lighting, monitoring, and validation all taken care of, modular cleanrooms and pharmaceutical factories are the future of biopharmaceutical capacity. Partner with PodTech™ to join this journey.