Are you reacting to or responding to the USP chapter 800?
Particular concern to the industry recently are newly minted regulations from USP, specifically Chapter 800, which promulgates a whole new set of standards to protect employees in these facilities in relation to general safety, surface and air quality and associated control protocols. Air and surface disinfection requirements are a major part of these new regulations. They stipulate air and surface parameters, but cannot and do not specifically recommend products or procedures to achieve these enhanced standards. These unknowns are what is causing major concern in the industry, as when an inspection team does walk through the door they don’t know what the inspectors are looking for in relation to policies and procedures, let alone disinfection chemicals or other disinfection technologies i.e. are they good enough to satisfy the inspectors predicated on the vagueness of the new regulations?
Enforcement is the responsibility of the FDA and respective State Pharmacy Regulatory Boards. Inspections by either entity can occur at any time and are unannounced. However, the FDA and State Pharmacy Boards typically do not play well together and their inspection efforts are usually not coordinated.
That, conjunctive with the unfortunate fungal meningitis out break at The New England Compounding Pharmacy that produced in excess of 14,000 doses of contaminated steroidal injections resulting in multiple deaths and injuries have accelerated this scrutiny from the FDA , State Pharmacy Boards and USP . Direct regulation of the industry is inexorable and inevitable. Most compounding pharmacies currently employ manual disinfection cleaning techniques using a variety of disinfection bactericides, sporicides, virucides and fungicides. Studies have shown that even the best terminal manual cleaning protocols only achieve a 40-60% reduction in residual bio-burden.
Consequently, forward thinking, innovative compounding operations are strategically reacting to this increased regulatory and inspection activity by implementing comprehensive decontamination protocols to preempt outbreaks or chronic contamination problems at their facilities, as well as pragmatically and consistently reducing overall facility bio-burden. Touchless, total room disinfection systems such as the Halo Disinfection System that offer a consistent and comprehensive disinfection capability with a 99.9999% kill on all known pathogens (air and exposed surfaces) alongside our established duplicable protocol is a responsive way to insure your facilities adherence to the chapter 800.