With USP <797> updates becoming enforceable in less than 6 months, facilities should have plans in place to support updated environmental and surface testing requirements.
A major change coming is the increased frequency requirements for environmental monitoring and personnel competency evaluations.
New USP <797> guidelines highlight the areas that require surface testing and how often those areas should be tested. All classified areas must be tested regularly. This includes the primary engineering controls (PEC) and all equipment contained within, all staging areas within the PEC, all work areas within the PEC, and all frequently touched areas.
Samples taken from these areas must be incubated in two stages to simulate proper growth environments for all potential contaminants. The incubation times for different environmental tests varies.
Environmental air and surface samples and glove and fingertip samples must be incubated for no less than 48 hours between 30-35°C followed by incubation between 20-25°C for no less than 120 hours.
Media-fill test samples must be incubated for no less than 168 hours between 30-35°C followed by incubation for an additional 168 hours between 20-25°C.
The frequency of these tests depends on which test is being performed and which classification of sterile compounds the facility prepares. For example, if the facility prepares Category 1 and 2 compounds, surface testing must be done monthly. If the facility prepares Category 3 compounds surface testing must be completed weekly, and at the end of each batch before cleaning and disinfecting.
According to a case study by Pharmacy Purchasing & Products magazine, outsourcing this testing will cost facilities tens of thousands of dollars per year.
Pharmacy leaders must decide if they should outsource and pay third-party providers or insource and develop the necessary SOPs and workflows as well as ensure the necessary staff and equipment are in place.
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Helmer Scientific manufactures professional medical-grade equipment for use with temperature-sensitive applications.
Helmer manufactures incubators and controlled room temperature (CRT) cabinets that can support USP <797> environmental testing requirements, as well as pharmacy and vaccine refrigerators and freezers.
Helmer is also able to design custom products to meet specific pharmacy applications. This option may be valuable to organizations who need equipment to meet certain performance requirements, utilize specific features or fit within a specific footprint.
