Pharmaceutical Cleanrooms

When you’re producing pharmaceuticals, the quality of the environment matters just as much as the quality of your product’s ingredients. Liberty Industries designs and creates cleanrooms and contamination control accessories to comply with stringent industry regulations, minimizing the presence of contaminants by maintaining a highly controlled environment.

Cleanrooms are highly regimented environments with controlled access, ventilation, and environmental conditions to reduce the presence of contaminants within the space. Different industries have different requirements and regulatory standards with which the rooms must comply. Various U.S. organizations set standards for pharmaceutical cleanrooms to ensure that the internal environment — and, by extension, the products you make within it — are safe from dirt, dust, aerosol particulates, and microbes that would otherwise result in contamination. Liberty Industries offers standard and custom cleanrooms built with the necessary protection mechanisms and degree of air ventilation and filtration to fulfill your pharmaceutical operation’s needs.

Requirements for Pharmaceutical Cleanrooms

To be categorized as a true pharma cleanroom, the environment must meet several requirements. The U.S. Food and Drug Administration (FDA) establishes and manages the standards for cleanrooms in pharmaceutical manufacturing, setting requirements to keep medications and other pharmaceutical products safe for consumption and use. Some of the cleanroom guidelines in pharma include the following:

• Flooring. Flooring must have few to no cracks or joints where debris can get caught, build up, or (in the case of microbial contaminants) grow. The flooring material itself must also be resistant to chemical damage so that you can wash the floors with strong cleansing chemicals. One popular flooring option is a three-layer solution: a heat-welded vinyl base layer, a cove or epoxy coating, and an overcoating of urethane.
• Environmental control. A cleanroom in pharmaceutical industry facilities must be equipped for complete control over the internal environment. This includes precise temperature control, humidity management, and even control over the pressure and flow (direction and velocity) of the air.
• Air quality and contaminant control. Your cleanroom must also ensure that everything from dust particles to microorganisms will be less likely to enter, and easy to contain if they do penetrate the space. Requirements for a cleanroom’s degree of air quality, and maintaining that quality throughout production, are set to a high standard in the pharmaceutical industry to safeguard human health.
• Internal activities. To further mitigate the risk of contamination, people within the environment must adhere to certain behaviors. Importantly, workers are trained to properly and promptly shut doors after entrance or exit to maintain optimal air quality. This also includes moving slowly for safety, wearing specialized gowns, and leaving jewelry outside.

All of these cleanroom requirements for pharmaceutical sector businesses work together to safeguard workers and equipment, protect pharmaceutical products from contamination, and keep end users safe from potential health concerns.

Types of Pharmaceutical Cleanroom Equipment

As part of our mission to provide pharmaceutical companies with access to cutting-edge solutions that protect their products and customers, we also offer a range of contamination control supplies and accessories.

Air Showers

For an extra level of protection, manufacturers can install an air shower at the entrance of their cleanroom. Air showers utilize pressurized air to remove loose debris and particulates from incoming personnel and equipment. This significantly reduces the number of particles that gain access to the cleanroom, protecting the environment and its contents from contamination.

Cleanroom Pass-Thrus

Pass-thru boxes or cabinets in a cleanroom’s wall allow personnel to pass materials and tools into and out of the cleanroom efficiently but in a controlled manner. The small cabinets have an interior and exterior door, each of which opens one at a time and only when parts and equipment need to move in and out of the room. These present a much lower contamination risk than having someone bring equipment in through a full-sized doorway.

Laminar Air Flow

Laminar air flow equipment emits uniform streams of fluids, such as air, to regulate air movement within a space. Because these layers of air run parallel instead of perpendicular, at the same speed and direction, there’s less turbulence or interaction between them. This equipment is often incorporated as bio-safety cabinets and laminar flow or chemical fume hoods. By controlling the airflow within a cleanroom, you can minimize the risk of contaminants impacting sensitive specimens, processes, and equipment. You also help protect workers from hazardous pharmaceutical ingredients and pathogens. Cleanrooms working with hazardous substances generally require laminar flow conditions to remain compliant with industry standards.

Pharmaceutical Cleanroom Equipment by Liberty Industries

The right cleanroom and equipment will support your pharmaceutical manufacturing operation in producing high-quality products with boosted efficiency and a reduced risk of contamination. Contact our team to learn more about specialized cleanrooms or supplemental supplies from Liberty Industries, or request a quote today.