Brookaire White Paper: Pharmaceutical – Commercial HVAC Air Filters

MANUFACTURING FACILITIES – STORAGE AREAS – PACKAGING ENVIRONMENTS

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Air Quality in Pharmaceutical Settings: An Essential Overview

What You Need to Know

As a key decision maker in the pharmaceutical sector, you’ll be one of many professionals driving one of the world’s most important industries. That is especially true here in the USA, which is currently the world’s largest pharmaceutical manufacturer, holding a 42.6% share of the global market, producing medicines worth over $171b USD.

One of the world’s most crucial and dynamic sectors, manufacturing and distributing life-saving drugs, medications and vaccines. Few industries have offered such a transformative impact on an international scale. However, with such a global responsibility comes significant challenges. As a decision-maker responsible for maintaining those strict working and storage standards and regulations on which this industry depends, you’ll understand these challenges better than anyone.

These challenges are broad-reaching, costly and of the highest importance in regards to the treatment of patients in the USA and beyond. While many of these challenges are relevant to manufacturing processes as a whole, they tend to be exacerbated in the pharmaceutical industry for a number of reasons. Primarily, this is due to the need to maintain critical environments for production with respect to temperature, humidity, room pressurization, cleanliness, containment and other factors. With these challenges in-mind, decision makers are faced with making investments in HVAC systems which are many times greater than the average commercial building to support these processes.

Let’s take a look at how some of these challenges are represented through key industry figures and statistics:

The average pharmaceutical plant in the US has an Energy Use Intensity (EUI) of 1,210 kBtu/sq.ft (2,319 kWh/m2). This is in stark contrast to the average commercial office building constructed after 2000, which has an average EUI of 81.4 kBtu/sq.ft (257 kWh/m2) – (Source: Pharmaceutical Engineering)
An analogous air handling unit serving an ISO 14644-1:1999 class 8 (EU Grade C in operation) cleanroom in which a pharmaceutical product is being manufactured would typically condition and supply between 20 and 35 ACPH to the cleanroom in a constant volume control strategy. This represents approximately a four to six fold increase in HVAC energy expenditure before tighter temperature and relative humidity control requirements, increased outside air requirements and additional filtration are considered. With the additional energy consumption of the manufacturing systems and processes themselves, it can be easily seen how the overall energy consumption of pharmaceutical facilities becomes far more intensive than their commercial facility counterparts. – (Source: Pharmaceutical Engineering)
The industry currently spends more than $1 billion on energy consumption every year, generating more emissions than the automotive industry. – (Source: Science Direct)

The Story Behind the Stats: What it Means For You

For any person of responsibility in pharmaceutical manufacturing, these statistics make for important reading. Whilst these facts paint a sobering picture of your industry’s impact in terms of energy consumption, they do little to reflect the importance of adequate HVAC systems and their pivotal impact in the drug manufacturing process.

This observation highlights that your investment in HVAC isn’t only about protecting the health, welfare and comfort of staff working in your facilities. Your considerations must go far beyond those concerns, making HVAC an integral provision of your manufacturing process. It must include systems that can not only control moisture in the air, but also mitigate the contamination of airborne particles by regulating air movements. It must capture and control suspected microorganisms, dust and microbes in order to ensure the sterility on which your processes are based.

Here at Brookaire, we understand the vital importance of HVAC systems in ensuring the necessary favourite conditions for successful pharmaceutical manufacturing. Through this definitive whitepaper, we invite key decision-makers to upgrade their knowledge of these systems. Keep reading to learn more about how our solutions can address many of the challenges you face.

Addressing Challenges in Your Pharmaceutical Facility

As highlighted in the previous section, the HVAC challenges present in the pharmaceutical manufacturing industry are significant. This is especially true in any environment where pharmaceutical products are being manufactured or stored.

Before making any purchasing decisions around your healthcare setting’s HVAC solutions, it is critical that you understand the strict requirements you must satisfy. Pharmaceutical facilities are closely supervised by the U.S. food and drug administration (FDA), which requires manufacturing companies to conform to cGMP (current Good Manufacturing Practices). These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs take proactive steps to ensure that their products are safe, pure, and effective.

Below, we’ve captured some what some of those proactive steps must consider:

Indoor Air Quality Concerns

In pharmaceutical manufacturing environments, indoor air quality is often driven by two key factors: air filtration and air ventilation. To meet the ultra-clean environment required in pharmaceutical production, HVAC systems must incorporate advanced filtration technologies such as HEPA and ULPA filters which are critical for removing fine particulates, microbes, and other airborne contaminants that can compromise product purity and safety. Meanwhile, adequate ventilation can remove airborne contaminants from production areas.

Meeting Diverse & Changing Requirements

In your pharmaceutical manufacturing environment, you will be responsible for maintaining environmental requirements, such as specific temperature, humidity, and cleanliness levels. With this in-mind, your solutions must be able to adapt to customizable settings. Systems must be designed to comply with international, federal, and state regulations, including FDA’s cGMP guidelines. These regulations mandate that HVAC systems not only support the proper manufacture and storage of pharmaceuticals but also ensure traceability and accountability in changes or upgrades to the systems.

Balancing Quality & Efficiency

Economic efficiency is paramount in large-scale pharmaceutical production, with the sector currently spending over $171bn USD per year on energy consumption. HVAC systems should therefore be evaluated for their operational and energy efficiency to reduce overhead costs while maintaining the high-quality conditions required for pharmaceutical manufacturing. This includes considering systems with variable speed drives, energy recovery mechanisms, and other modern technologies that reduce energy consumption.

Integration with Other Systems

HVAC systems in pharmaceutical settings should integrate seamlessly with other critical systems, including building management systems (BMS), process control systems, and safety alarms. This integration helps ensure coordinated operations, enhances real-time monitoring, and supports automated adjustments based on predefined environmental parameters. On top of that, to ensure smooth functioning, the HVAC system needs to adhere to standards and norms like GMP (good manufacturing practice), GLP (good laboratory practice), GAMP (good automated manufacturing practice), and GxP (good x practice).

Protection of Sensitive Components

The stability and efficacy of pharmaceutical products can be heavily influenced by environmental conditions. HVAC systems must ensure a controlled environment to protect sensitive manufacturing equipment from temperature fluctuations, humidity, and particulate contamination, which could otherwise lead to equipment malfunction or product degradation.

HVAC Maintenance Requirements

To minimize disruption in high-stakes pharmaceutical environments, HVAC systems should be designed for ease of installation and maintenance. Quick-connect systems, modular components, and clear access points for maintenance staff can help reduce system downtime and labor costs associated with HVAC maintenance.

HVAC Disposal Costs

Selecting HVAC components that are not only high in performance but also environmentally sustainable is vital. Use of components that have a lower carbon footprint and are recyclable can mitigate environmental impact and potentially reduce disposal costs associated with system upgrades or replacements.

How Can You Meet the Challenge?

With such extreme demands facing your pharmaceutical manufacturing facility’s air filtration units, it is vital to partner with a HVAC specialist that provides solutions that are capable of meeting these critical needs effectively.

That’s where Brookaire comes in. We leverage decades of air filtration experience to offer best-in-class solutions for every challenge you face.

Meeting the Air Quality Challenge

Brookaire provides advanced filtration solutions, including HEPA and ULPA filters, which are crucial for pharmaceutical settings where even the smallest particles can compromise product integrity. Our filters meet stringent efficiency standards, capturing over 99.97% of particulates as small as 0.3 microns. Additionally, our products are designed for optimal air exchange rates, ensuring not only compliance with regulatory standards but also supporting a sterile environment essential for pharmaceutical production. By integrating these high-efficiency air filters into customizable HVAC systems, Brookaire helps maintain the critical cleanliness required in pharmaceutical manufacturing.

Meeting the Diverse & Changing Requirements Challenge

Brookaire recommends HVAC systems which are engineered to be highly adaptable, supporting a variety of environmental conditions demanded in pharmaceutical manufacturing. Filtration solutions can be tailored to specific temperature, humidity, and cleanliness requirements, ensuring compliance with FDA’s cGMP guidelines. We also recommend the use of modular systems that can easily be upgraded or adjusted as production needs change or as new regulations are enacted, ensuring that pharmaceutical facilities can remain agile and responsive to industry demands.

Meeting the Energy Challenge

To address the dual needs of operational efficiency and quality assurance in pharmaceutical settings, Brookaire offers energy-efficient HVAC products that do not compromise on performance. Our system recommendations include features like variable speed drives and energy recovery ventilators that significantly reduce energy consumption while maintaining the precise environmental control needed for pharmaceutical processes. This approach not only helps lower energy costs but also aligns with sustainability goals by reducing the overall carbon footprint of facilities.

Meeting the Component Protection Challenge

Understanding the critical nature of pharmaceutical manufacturing environments, Brookaire recommends HVAC solutions that provide stable and controlled conditions to protect sensitive manufacturing components. This protective environment helps prevent costly downtimes and prolongs the operational lifecycle of essential equipment.

Meeting the Maintenance Challenge

Brookaire emphasises ease of maintenance to ensure minimal disruption in pharmaceutical operations. Our HVAC solutions feature design considerations like accessibility for quick repairs and preventative maintenance. We also offer maintenance services that include regular check-ups and rapid response to any issues, ensuring that HVAC systems operate at peak efficiency with minimal downtime.

Meeting the Disposal Challenge

Recognizing the importance of sustainable practices, Brookaire provides eco-friendly HVAC solutions that minimize disposal costs and environmental impact. Our high-efficiency filters and system components are designed to have longer life spans and are made from materials that are recyclable, reducing waste and disposal challenges. Additionally, our team can assist in planning for end-of-life system recycling, helping pharmaceutical facilities manage disposal responsibly and sustainably.

Brookaire: How We’re Helping Pharmaceutical Facilities

Brookaire’s diverse range of products ensures high performance, energy efficiency, and durability needed in pharmaceutical manufacturing facilities. Our service extends beyond mere supply; we partner with pharmaceutical companies to elevate their operational efficiency and air quality standards. Explore why Brookaire is more than just an air filter supplier.

Efficiency: Enhancing Pharmaceutical Manufacturing

30-Minute Delivery Window: Time is of the essence in pharmaceutical manufacturing. Our precise 30-minute delivery windows ensure your operations face minimal interruptions, helping maintain the critical flow of production activities.
Scheduled Site Delivery 24/7: We adapt to your manufacturing schedule, delivering outside standard business hours to accommodate the continuous production cycles typical in pharmaceutical environments.
Reduce Staff Travel Time: By delivering directly to your site, we eliminate the need for your staff to leave for pickups, allowing them to remain focused on their specialized tasks.
Maximize Staff Efficiency: Our efficient delivery services convert saved time into productive work, optimizing the output of your pharmaceutical manufacturing staff.
Ease of Installation: Brookaire air filters are engineered for compatibility with complex pharmaceutical HVAC systems, ensuring easy installation that doesn’t disrupt the sterile environments critical to drug production.

Satisfaction: Maintaining Your Facility’s High Standards

We Care: We recognize that the reputation of your pharmaceutical facility hinges on maintaining highly controlled environments. Our commitment to quality minimizes operational disruptions and supports compliance with strict regulatory standards.
Highest-Quality Materials: We utilize the finest US-made materials suitable for pharmaceutical applications, ensuring that our products support the rigorous cleanliness required for safe drug production.
Advanced Manufacturing Processes: Our state-of-the-art manufacturing techniques guarantee products meet precise specifications, crucial for maintaining the integrity of pharmaceutical manufacturing processes.
Partnership Approach: We view our relationship with pharmaceutical facilities as a strategic partnership, where your operational success is a testament to our product performance.

Customized Solutions for Specific Pharmaceutical Needs

Tailored Manufacturing: Our facility can produce air filters of any size and specification, meeting the unique environmental requirements of pharmaceutical production, from labs to cleanrooms.
Quick & Flexible Production: Recognizing the urgent needs of the pharmaceutical industry, we offer rapid production cycles, ensuring your custom orders are ready within 48 hours, maintaining your facility’s efficiency.
Simple Ordering Process: Placing an order for custom filters is straightforward. Provide your specifications, and we handle the rest, from confirmation to production, streamlining your procurement process.
Assured Quality: Every custom filter is rigorously tested to meet high quality standards. Using superior materials and accurate manufacturing, we ensure that each filter performs optimally in your pharmaceutical environment.

Your Premier Knowledge Resource for Pharmaceutical HVAC Needs

Expert Team Available: Our team of HVAC experts is ready to assist with any queries, offering quick, informed advice and solutions that address the unique challenges of pharmaceutical manufacturing.
Educational Blogs & Articles: We offer a plethora of insightful articles and maintenance tips through our blogs, designed to inform and enhance the operations of pharmaceutical facilities.
Guides & Technical Support: Our comprehensive guides and personalized technical support are tailored to the complex needs of pharmaceutical manufacturing, ensuring you have access to expert advice to maintain optimal HVAC performance in your facility.

The Inventory Every Pharmaceutical Setting Needs

Merv 10, Pleated Air Filter

Brookaire’s pleated MERV 10 air filter is the most common style filter used in HVAC systems. These filters are fabricated using a wire backed synthetic media assembled within a beverage board cardboard frame. Pleated MERV 10 air filters come in a vast array of standard size die cut frames in 1″, 2″ & 4″ depths. The pleated style design provides additional surface area of media maximizing the air flow and efficiency. These air filters provide the perfect balance of air flow and efficiency. Pleated MERV 10 filters are commonly used in high end residential and commercial HVAC systems.

Merv 10, High Capacity Pleated Air Filter

With lower initial resistance and better dust holding capacity, this is the high capacity version of Brookaire’s pleated MERV 10 air filter . These filters are fabricated using a wire backed synthetic media assembled within a beverage board cardboard frame. High Capacity Pleated MERV 10 air filters come in a vast array of standard size die cut frames in 1″, 2″ & 4″ depths. The pleated style design provides additional surface area of media maximizing the air flow and efficiency. These air filters provide the perfect balance of air flow and efficiency. Pleated MERV 10 filters are commonly used in high end residential and commercial HVAC systems.

Merv 11, Pleated Air Filter

Brookaire’s pleated MERV 11 air filter widely used in HVAC systems. The filters are manufactured using a wired backed synthetic media assembled within a beverage board cardboard frame. Pleated MERV 11 air filters come in a vast array of standard size die cut frames in 1″, 2″ & 4″ depths. The pleated style design provides additional surface area of media maximizing the air flow and efficiency. These air filters provide a great balance of air flow and efficiency. Pleated MERV 11 filters are commonly used in high end residential and superior commercial HVAC systems as an upgrade to standard pleated MERV 8 air filters. They can also be used when the HVAC system’s airflow capacity does not allow for MERV 13 use, but higher grade filtration is required. Captures: Legionella, Humidifier dust, lead dust, milled flour, auto emission particles, nebulizer drops, and more! Made in the USA.

Merv 13, Pleated Air Filter

Brookaire’s MERV 13 pleated air filters are best in class. Made with synthetic media wire backed and inserted into a sturdy moisture resistance beverage kraft board frame it achieves long service life. This high performance pleated air filter provides the highest initial and sustained efficiency along with a lowest initial pressure drop in its class. The MERV13 media made with Nanofiber technology enabling great air flow while sustaining high filtration achieving MERV 13 per ANSI/ASHRAE Std. 52.2. These filters are available in 1″, 2″ and 4″ depths in a full range of standard and custom size. MERV 13 pleated filters are used as a pre-filter for high end final filters.

Typical Applications: Superior Commercial Buildings, Hospital and Pharmaceutical, Education Facilities, Gyms, Hospitality
Captures: All bacteria, droplet nuclei, droplet borne viruses, cooking oil, most smoke (3rd hand smoke), insecticide dust, most face powder, most paint, pigments.

Ring Panels, Ring Links & Cube Filters

Brookaire’s Ring Panels, Ring Links & Cube Filters are made with a graduated density polyester media with a dry tackifier on the downstream side. It is designed to replace pleated and/or fiberglass throwaway filters. MERV 8

Mini-Pleat Air Filters

Brookaire Mini-Pleat Air Filters. Synthetic Filter Media, next generation mini pleat compact filters in polyester media, high surface area, high dust holding capacity, low pressure drop, increased filter life & ensured filtration performance with plastic ABS or cardboard die cut frame, best for green building concept and variable volume areas.

V-Bank Air Filters

Brookaire V-Bank Air Filters. Synthetic Filter Media, Next generation mini pleat compact filters in polyester media, high surface area, high dust holding capacity, low pressure drop, increased filter life & ensured filtration performance with plastic ABS frame, best for green building concept and variable volume areas.

HEPA Filters

Brookaire’s HEPA (High Efficiency Particulate Absorbing) Filters are designed with premium air filter media to maximize the amount of particles removed from the air when installed in an HVAC system. HEPA filters are commonly used in critical environments like clean rooms for pharmaceuticals, hospitals, food manufacturing, data centers and more. The use of HEPA filters increases the protection of your HVAC equipment while providing maximum efficiency in removing contaminants from the air. True HEPA air filters are at least 99.97% efficient in capturing particles between 3 – 10 microns.

Metal Mesh Filters

Introducing Brookaire’s Metal Mesh Filters, crafted from high-quality aluminum and designed for durability and reusability. These washable filters are an eco-friendly and cost-effective solution for your HVAC needs, providing excellent filtration without the need for constant replacement. They can be reused multiple times, reducing waste and saving on the cost of frequent filter replacements. Ideal for both commercial and residential systems, these filters are not just a practical choice but an investment in sustainability.

V-Belts

The outside fabric wrap is treated with highly oil and heat resistant, engineered synthetic rubber, specifically compounded for superior wear resistance, proven through thousands of hours of customer use to be durable and dependable. The helically wound tensile cords are specially manufactured with twisted, heat and chemically set, polyester material. The body rubber is a highly engineered synthetic rubber compound, specially compounded for cool running, crack resistance, and excellent bonding to the outside fabric and tensile cords.