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. Pass-thru refrigerators are the perfect solution for improving the USP <797> clean room workflow. Here are some of the benefits of having a pass-thru refrigerator for your USP <797> clean room:
- Cleaner, safer environment with less risk of contamination
- Less foot traffic in and out of the cleanroom
- Easily transport inventory and finished products
- Eliminate dirty carts entering the clean room
- Dramatically reduced use of PPE with less technicians entering the clean room
In addition to workflow efficiency inside the clean room, proper cleaning is just as important in maintaining the clean room. A clear cleaning schedule and procedure should be outlined, and all pharmacy staff should be trained on the cleaning procedures. Facilities should consider utilizing the same materials inside and outside the clean room in order to make cleaning more efficient for staff. Having the same materials on the floor and walls inside and outside the clean room prevents pharmacy staff from needing to grab different supplies or equipment, and it makes it easier to clean.
Here is a sample cleanroom cleaning schedule implemented by one facility.
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, we have a case study from Moses H. Cone Memorial Hospital.