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. The goal of this chapter is to help prevent patient harm from inaccurate or contaminated compounded sterile products (CSPs). Since the standards became official, they have been widely adopted, are enforced by many state boards of pharmacy, and may be surveyable by accreditation organizations.
Workflows in and around USP <797> clean rooms are essential to preventing contamination and maintaining a clean and safe environment for compounding sterile preparations. The process for technicians to garb personal protective equipment (PPE) to pick up finished product and transport it out of the cleanroom is time consuming, expensive, and potentially unsafe. Technicians are required to garb every single time they enter the room, which leads to lost time and a very high level of PPE usage.
Humans are the leading source of cleanroom contamination. Carts entering a clean room to retrieve sterile products also introduce contaminates. Limiting foot traffic into the clean room can help prevent contamination and compromising the clean room.
Pass-thru refrigerators enable facilities to limit personnel allowed inside the clean room and improve the USP <797> clean room workflow. Here are some of the benefits of having a pass-thru refrigerator for your clean room:
- Cleaner, safer environment with less risk of contamination
- Less foot traffic in and out of the cleanroom
- Easily transport of inventory and finished products
- Easy transport of inventory and finished products
- Eliminate dirty carts entering the clean room
- Dramatically reduced use of PPE with less technicians entering the clean room
Pass-thru refrigerators allow clean room technicians to place large batches into the refrigerator without leaving the clean room. Outside technicians can then access the batches located in the refrigerator via the main pharmacy area without having to don PPE, saving on PPE expenses. Moreover, this means less foot traffic and no cart traffic in and out of the clean room leading to a more controlled environment.
OTHER BLOGS YOU MIGHT BE INTERESTED IN...
- Interlock Pass-thru Pharmacy Refrigerators for Your USP <797> Clean Room
- USP<797>/<800> Status and Cold Storage Implications
- Infographic: Understanding USP <800> and How it Relates to Your Refrigerator
- USP <800> Refrigerator Frequently Asked Questions Answered
To learn more about how interlocking pass-thru refrigerators can reduce risk, enhance workflows and meet compliance requirements, read our case study: Moses H. Cone Memorial Hospital Enhances Clean Room Workflows with Interlocking Pass-thru Refrigerators.
