Healthcare USP 797
The healthcare industry is increasingly engaged in pharmaceutical compounding to personalize medications for patients. The prerequisite for compounding operations in compliance with USP 797 Pharmaceutical Compounding – Sterile Preparations in the USP National Formulary. Arcoplast Wall and Ceiling Systems are designed to provide a specialized sterile environment for compounding operations. The anti-microbial surfaces do not support the colonization of fungus, mold or bacteria. In addition, the impervious nature of the panels creates a highly cleanable surface that is resistant to Steris Spor-Klenz RTU and other disinfecting agents used in high containment biosecurity labs. Arcoplast provides the perfect solution for the sterile requirements of pharmaceutical compounding.
USP 800 Compounding
What is USP 800 for Hazardous Drugs?
The USP 800 chapter for Hazardous Drug Handling in Healthcare is a set of controls that standardizes the handling of hazardous drugs. The chapter applies to all healthcare personnel who handle both sterile and nonsterile hazardous drugs during transport, storage, compounding, dispensing, administration and all other activities. The standards were set in place to help promote patient safety, worker safety, and environmental protection. The development of USP 800 was based on public reports from healthcare personnel having had exposure to hazardous drugs.
How can Arcoplast assist with your Hazardous Drug processing facilities?
The Arcoplast Wall and Ceiling System is composed of the most ideal products necessary for your Critical Environment. These products are designed for the renovation and new construction of facilities that are compounding both sterile and non-sterile hazardous drugs. These facilities are some of the most important in our healthcare sector which are depended on by millions of people on a daily basis.
The engineering controls for the compounding of hazardous drugs are complex with requirements for cleaning of contamination, exterior venting and negative pressure requirements.
The cleaning of the Hazardous Drug contamination, surfaces for ceilings, walls and fixtures in both sterile and nonsterile compounding must be smooth, impervious, free from cracks and crevices and non-shedding. The Arcoplast Engineered Polymer Panel has an acrylic finish that is available in a high gloss surface with high chemical/stain resistance designed specifically for decontamination in critical environments.
The primary containment cabinet or vessel for sterile and non-sterile is preferred to be exhausted to the outside. The sterile requires an ISO Class 5 or better air quality, such as a Class II or III biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI). The non-sterile does not have a designated ISO Classification but must be decontaminated and cleaned as required to eliminate risk to personnel. The Arcoplast ceiling panel with multiple thicknesses is designed to accommodate any size or shape exhaust stack. The Arcoplast panels can be cut easily and by utilizing the Two-Component Finishing Compound you can be assured that the negative pressure required will not be compromised.
The secondary containment area requires a negative pressure for both sterile and non-sterile hazardous drug which is of the highest importance for containment and segregation of compounding areas. These areas must maintain a negative pressure of 0.01 to 0.03 inches of water column relative to all adjacent areas at all times. The Arcoplast Wall and Ceiling System has third party testing and been proven in the most extreme laboratory environments. The panel systems are tested to ASTM E 2178 Air Pressure Decay Test to both Negative and Positive 4 Inches of WC when installed using the Arcoplast Two-Component Finishing Compound.