Pharmaceutical researchers, compounding pharmacists, and other healthcare researchers and workers today are facing an array of new rules and regulations related to the receipt and storage of hazardous drugs. While recommendations have always been a part of lab life, researchers and lab workers now have to adjust to complex and evolving guidelines and oversight. The concern and confusion around USP<800> is understandable, but next month adherence will be an obligation, not an option. With the December 1, 2019 implementation deadline looming, there’s pressure to comply with this standard without waylaying workflows or breaking the bank.
First of all, it’s important to remember why these guidelines exist. USP<800>, and its predecessor USP<797>, aim to protect patients and healthcare workers who handle or otherwise come into contact with hazardous drugs. Few people need to be reminded of the risks associated with unsafe and unregulated practices, which could lead to life-threatening exposure and devastating legal repercussions.
Dangers like these are why USP<800> is predicted to spark a new age of regulatory oversight. In addition to human safety concerns, non-compliance will have other ramifications, including fines, suspensions, and loss of licenses. These penalties are expected to become far more severe as regulatory bodies put a greater emphasis on compliance monitoring.
Many researchers and pharmacists fear that the only way to avoid these repercussions is to make extensive renovations to their facilities. This undertaking would likely require a significant monetary investment – tens of thousands of dollars, if not more. Furthermore, the remodel could entail a several months’ long commitment that considerably hinders a pharmacy’s efficiency and efficacy. Some larger facilities may be able to bear this burden, but smaller clinical settings could find themselves in dire straits, risking regulatory action on one end and/or financial distress on the other.
Fortunately, some of these renovations may not be necessary. Before you embark on a construction project that involves a costly ventilation system in your cleanroom specifically for your cold storage systems, consider whether compliance can be achieved far less invasively with a new line of refrigerators. In some cases, these can be immediately incorporated into your cleanroom environment – no renovations necessary.
Although there is no universal standard for a USP<800>-compliant refrigerator, there are several factors to consider to ensure that the one you purchase meets these stringent requirements. We’re proud to offer several biomedical lab refrigerators that conform to these needs within our Thermo Scientific TSX Series.
An extensive line of biomedical-grade refrigerators, our TSX units are ready right out of the box for cleanroom use, providing pharmacists and other industry professionals with a compliant unit that doesn’t sacrifice on safety or efficiency. In alignment with USP requirements, all TSX units offer:
- Low particulate generation – Unlike traditional refrigeration systems, our variable-speed and solid-state units do not require added measures for venting outside of the cleanroom. This is because they generate low levels of particulates and also have extremely low vibration. Both features significantly reduce particulate shedding from the unit as well as the surrounding products, contributing to total-room compliance. These capabilities contribute to our TSX series’ extremely low International Standards Organization (ISO) classes. Our units range from ISO 7 to ISO 5, making them ideal to meet and even exceed USP requirements for cleanrooms.
- Low heat output and superior temperature control – Our TSX refrigerators are ENERGY STAR-certified and continuously adjust to ensure more stable temperatures than conventional units. This can result in as much as 50 percent energy savings and contributes to an overall cooler working environment, while also providing a reliable and accurate storage solution for your precious samples. Although these features are not mandated by USP compliance guidelines, reducing the heat from your cold storage system can lighten the burden placed on your HVAC system. In turn, it becomes easier for your ventilation system to properly regulate the space, aiding in compliance and generating long-term energy savings.
- Easy cleaning and maintenance – Not all USP guidelines are head-scratchers. Simple and routine equipment cleaning is a vital part of the USP compliance picture, too. The challenge comes with refrigerators that possess many mechanical parts or other nooks and crannies that can collect dust and harbor contaminants. Variable-speed and solid-state options have fewer components and crevices, which makes your regular cleaning routine a breeze. As an added bonus, less mechanical parts ensure greater reliability and a longer life for the unit, as there are fewer mechanisms that can weaken and fail over time.
USP<800> compliance is by no means simple, but the efforts you take now will help improve health and save lives in the future. Our TSX series can meet your compliance requirements easily and immediately, while also providing the sample safety and quality control you need to deliver the best clinical care.
Learn more about our TSX series of USP-compliant cold storage solutions and how we can help you ensure compliance ahead of the December 1st deadline here: www.thermofisher.com/tsx.