Keeping cleanrooms clean: Choosing the right laboratory equipment is key

Many of the newest and most promising treatments for what were once incurable diseases incorporate living cells and human tissues. Immunotherapies like chimeric antigen receptor therapy (CAR-T) harness the power of a patient’s own immune system to fight cancer, while regenerative medicine may someday heal spinal cord injuries or reverse the brain changes caused by Parkinson’s or Alzheimer’s disease. These are among the most exciting areas in biopharmaceutical research and manufacturing today, but their rising popularity raises questions for laboratory managers tasked with maintaining environmental controls. 

Because live cell and tissue products are extremely sensitive to contamination from microorganisms, viral particles or other airborne impurities, research and manufacturing involving these materials needs to be conducted in a cleanroom environment. This is a space in which airflow is controlled using specialized ventilation systems that keep contaminants out, filter the air to remove dust, microbes and particulates, and optimize temperature and humidity levels to inhibit mold and microbe growth. Cleanroom environments should adhere to Good Manufacturing Practice (GMP) guidelines as outlined in the International Organization for Standardization (ISO) classification 14644-1. All furniture and equipment used in a cleanroom in the United States should be ISO cleanroom-classified by an Occupational Safety and Health Administration (OSHA)-approved testing laboratory. Selecting the right cleanroom equipment is essential for building a lab that can produce high-quality results consistently.

“Cleanroom contamination is a very serious issue,” says Derek Sokolowski, product manager for Cell Culture at PHC Corporation of North America “If a major pharmaceutical company issues a recall for one of its products because a bacterial contaminant was found there, it can cause far-reaching harm. Contamination from things like mold, fungi or mycoplasma has the potential to injure a patient, of course, but a recall can also lower the company’s stock price or prevent lifesaving treatments from reaching all the people who need them. It’s critical to choose lab equipment wisely to reduce the chances of this happening.”

Considerations when selecting laboratory equipment for cleanroom environments

Products such as laboratory-grade refrigerators, cryopreservation equipment and cell culture incubators intended for cleanroom use should be designed and manufactured specifically for these environments and evaluated under ISO 14644-14. This ensures that motors and other components won’t shed too many airborne particles to meet cleanliness requirements. 

Care should also be taken when assessing the quality and reliability of this equipment. Should it fail while in use in a cleanroom environment, it cannot typically be serviced on site without taking the cleanroom out of operation, which can be costly and interfere with production. Such downtime can be prevented with redundancy. Some laboratory freezers, for instance, are available with duplicate refrigeration units built in. If the primary unit stops working, this type of freezer can still maintain ultra-low temperatures until the cleanroom’s next scheduled out-of-service maintenance cycle. 

“Every manufacturer says they make the most reliable equipment, but there are no independent product testing organizations for lab equipment the way there are for consumer goods,” says Joe LaPorte, Chief Innovation Officer at PHC Corporation of North America “Instead, purchasers will need to speak to their peers to figure out which manufacturers have the best track record for quality and reliability. They should also look for one that enforces very strict quality control standards for its products. This means the manufacturer will perform lengthy and extensive testing in extreme environments before making products available to customers.”

Thinking ahead

Cleanroom-certified equipment has been evaluated to verify that it can operate in a cleanroom environment at the time of its manufacture. (This is different from cleanroom-classified equipment, which is considered appropriate for use in an individual cleanroom application, but may not meet the standard in real-world operations, where, for instance, multiple freezers might be running side by side.) But longevity is also an important issue. Maintaining a contaminant-free cleanroom environment is just as critical to the success of biopharmaceutical research and manufacturing processes throughout the entire lifecycle of all the equipment that’s used there. 

Many cell culture incubators, for instance, are lined with pure copper. Copper has intrinsic antimicrobial properties, so its use reduces contamination risks by inhibiting the growth of bacteria and other microorganisms. However, copper oxidizes to develop a patina over time. The presence of the patina doesn’t reduce its antimicrobial nature, but it may slough off in fine dust particles, especially if touched frequently.

“Scientists sometimes worry about the copper patina,” explains Sokolowski. “If they’re going into the incubator, touching it with gloves, moving shelves around—especially if it’s not integrated shelving—it’s possible that particles could come off it, and then float into the room when the door is opened. That’d make the cleanroom ever-so-slightly less clean, which can cause major problems.” 

An incubator with embedded copper—rather than a pure copper interior—may pose fewer particulate contamination risks over time, since less copper is exposed on its surface area.

Asking the right questions of cleanroom equipment manufacturers

Product reliability and longevity aren’t the only issues to consider when sourcing equipment to use in cleanroom environments. Stakeholders should also think about costs as well as ease of use. 

A cell culture incubator that uses a hydrogen peroxide-based decontamination system can be decontaminated in a small fraction of the time it takes to run the traditional high heat decontamination cycle. This makes it so that the incubator can be back up and running much sooner, but it also means that personnel working with it no longer have to worry about burn risks. Hydrogen peroxide decontamination systems also don’t require the use of antimicrobial wipes, so less labor is needed to keep them clean and there’s less waste. An incubator that uses UV light for air purification instead of HEPA filters will be less expensive to operate because there’s no need to dispose of spent filters as biohazardous waste. 

Energy efficiency is important in cleanroom environments, too. ENERGY STAR®-certified equipment will produce less heat while operating, making it easier to keep temperature and humidity levels in the right range. 

“Every ingredient in a cleanroom is subject to scrutiny, because everything has to meet the standard,” LaPorte explains. “From the specialized flooring all the way through the HEPA filter banks and the HVAC system, it’s all mission-critical for the success of the research lab or pharmaceutical application. When it comes to cleanroom-compatible refrigerators, freezers and incubators, the importance of quality should never be overlooked.” 

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