Standards for Compounding Sterile Preparations
USP <797> details the procedures and requirements for compounding sterile preparations and sets standards that are applicable to all practice settings in which sterile preparations are compounded. Helmer Scientific aims to provide cold storage equipment for your clean room applications.
Interlock Pass-through Refrigerator Case Study
Learn how Moses Cone Memorial Hospital is enhancing clean room workflows with an interlock refrigerator.
Pass-through Refrigerator Case Study
Learn how Ephraim McDowell is increasing efficiency & better meeting USP <797> regulation.
The Goal of USP <797>
The goal of this chapter is to help prevent patient harm from inaccurate or contaminated compounded sterile products (CSPs).
Since the standards became official in 2004, they have been widely adopted, are enforced by many state boards of pharmacy, and surveyable by many accreditation organizations. The Compounding Expert Committee continues to review and revise the chapter based on the public comments submitted.
Understanding USP <797>
Understanding USP <797> and state and local requirements is essential for any facility when it comes to clean room spaces.
UPS <797> encourages facilities to keep only necessary items inside of the actual clean room. Personnel who are not affiliated with compounding shouldn't be entering classified spaces, including the anteroom, to limit risk of contamination. Pass-through cabinets & refrigerators support the recommendations above.
USP <797> & Pass-thru Refrigerators
A look inside the General Chapter
As described in USP <797> a pass-through is defined as an enclosure with seals on interlocking doors that are positioned between two spaces for minimizing particulate transfer while moving materials from one space to another.
Airlocks and interlocking doors can be used to facilitate better control of air balance between a higher classified area and an area of lesser air quality (e.g., between the buffer area and ante-area), or between a classified area and an unclassified area (e.g., between the ante-area and an uncontrolled area such as a hallway). If a pass-through is used, it must only be opened one door at a time; both doors must never be opened at the same time.
Interlocking Pass-through Refrigerator
Helping You Comply with USP <797>
To assist pharmacies in meeting USP <797> regulations, Helmer Scientific developed the market’s first interlocking pass-through refrigerator. The Interlock Pass-Thru refrigerator is designed for use in the pharmacy and clean rooms which are built for USP <797> compliance. The i.Lock™ technology allows doors on one side of the pass-through cabinet to electronically lock when doors on the opposite side are opened.
This technology is designed to prohibit both sides of the pass-thru refrigerator from being opened simultaneously, therefore, helping you maintain cleaner air flow. The Interlock pass-thru refrigerator from Helmer Scientific helps support compliance, clean room air quality, and enhanced pharmacy workflows.
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