Pharmacists who carry out sterile compounding are no strangers to the stringent garbing and sterilization requirements required by USP General Chapter <797>. While USP <797> is the universally accepted guideline for cleanroom garbing requirements, state pharmacy board requirements may supersede this standard.
At a minimum, every cleanroom environment requires shoe covers, hair nets, and a lab coat or frock. In USP-designated cleanrooms, sterile parenteral drugs require the complete absence of microorganisms, so sterile garments, laminar air flow hoods, and sterile PPE are required.
Garbing requirements in cleanroom settings also vary by ISO classification and application. ISO Class 7 or 8 cleanrooms, for example, may only require frocks, while ISO Class 5 or 6 cleanrooms require cleanroom coveralls, along with hoods, sterile gloves, and booties.
USP <797> also recommends that only pharmacists performing sterile compounding activities enter the cleanroom environment, which, paired with the various garbing requirements, can make supplying the cleanroom and delivering compounded medication ready for patient administration a cumbersome task.
Pass-thru refrigerators provide a solution that supports workflow efficiency while still adhering to USP <797> standards for sterile compounding environments. Implementing pass-thru refrigeration technology provides the ability to stock and inventory cleanroom environments from the anteroom side, which does not require garbing. This saves time, reduces the cost of PPE, and limits access to the cleanroom environment, reducing the risk of accidental contamination.
One requirement of pass-thru refrigerators used in USP <797> cleanrooms is the cleanroom-side doors and the anteroom-side doors not be opened simultaneously. GX Solutions Pass-Thru Refrigerators from Helmer Scientific are available with optional i.Lock™ technology, which is an electronically controlled feature that automatically locks the doors on one side of a pass-thru refrigerator when doors on the other side are open.
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While pass-thru refrigerators used in sterile compounding environments provide workflow efficiency, they are also required to perform under a different workload than standard refrigerators. Data shows pass-thru refrigerators are accessed more often for longer durations, so it is important to ensure any pass-thru unit placed in service can provide the temperature performance required to protect the items stored in it.
We have developed a white paper outlining the unique performance requirements of pass-thru refrigerators in the pharmacy environment. We also compared those requirements with the performance of the new GX Solutions Pass-Thru Refrigerator from Helmer Scientific.
