View part 1 here.
By Adam West, Environmental Monitoring and Training Specialist at CriticalPoint
In our last power loss blog, I discussed the importance of planning for the unexpected when it comes to the engineering controls of the pharmacy cleanroom and compounding equipment. However, there are a myriad of elements that designated persons (DPs) must examine if they want to return to compounding activity efficiently and effectively. In part two of our Surviving Power Loss blog series, we cover different high-level topics to consider when unexpected power loss occurs.
Was any other critical equipment affected?
If yes, a DP responsible for quality must be notified to inspect equipment and determine if operational criteria are still meeting the expected parameters. Recalibration and service may apply in this situation, which can take time and planning to complete. If refrigerators, freezers, and/or incubators experienced power loss too, not only will return-to-normal operations need to be confirmed, but the contents inside these devices require evaluation as well (e.g., assessing drug storage conditions and temperatures, conducting visual inspection). DPs must determine if drug quality was negatively influenced during the power loss.
Is cleaning necessary before resuming compounding activity?
Cleaning is inevitable after power loss is restored. However, the level of cleaning depends on the duration of the power outage and the stability (confirmed through recovery testing) of the cleanroom suite conditions once restored. During an outage, your pharmacy cleanroom has lost some level of microbial state of control and controlled environment specification. This means that surface cleaning and disinfection are expected prior to resuming compounding.
We traditionally use the over/under-1-hour time span to determine the level of cleaning needed before resuming activity; but let me remind you, excursion data is still paramount to determining forward action after power loss.
If power is restored in less than 1 hour:
1. Remove all items from PECs. Perform PEC cleaning using a sterile EPA-registered one-step sporicidal agent followed by wiping with sterile 70% IPA after appropriate sporicidal dwell. If any of the PECs are C-PECs, then perform appropriate decontamination, cleaning and disinfection, and wiping with sterile IPA. The step of cleaning and disinfection should be performed with a sterile EPA-registered one-step sporicidal disinfectant cleaner.
2. Perform daily cleaning activities (easily cleanable horizontal surfaces, high-touch surfaces, and floors). Read more >
CriticalPoint focuses on increasing patient safety through a variety of educational compounding offerings concentrating on USP <797>, <800>, and <795>. Partnering with industry experts, we provide the most current and engaging training on industry standards resulting in improved competency and patient safety. Our offerings include: eLearning, Virtual Training, and Standard Operating Procedures (SOPs).
