New Definition for Sterile Compounding

manufacturing of sterile products is the most critical and difficult type of compounding. The whole chapter was open for public comments during September. We managed to get our hands on a non-paper that has been submitted from the USP.

The new law Defines “sterile compounding” as compounding drug products for injection, inhalation or administration in the eyes. This is broader than current law that focuses on compounding sterile injectable products only.

This USP 797 update will affect over 500 contract filling facilities that mostly perform OTC drug fills. Usually these plants operate in ISO 7 clean rooms, but with the current update, they’ll need to assure ISO class 5 environment for all sterile preparations. This legislation will potentially put out of commission over 200 models of liquid filling machinery that simply cannot be present inside a ISO 5 clean room.

The list below is a small sample of compounded sterile preparations:
Intracavernosal injections (i.e. Trimix / Bimix Injections)
Ophthalmic Drops and Injections
Intrathecal Pump Reservoir
IV Protocols (i.e. Myers’ Cocktail, etc.)
Immunotherapy / Low Dose Allergens (Skycare Pharmacy Exclusive)
Immunotherapy / Custom Allergen Extract (Skycare Pharmacy Exclusive)
Vitamins, Minerals & Amino Acids
Chelation Therapy / Heavy Metal Detox
Urological compounding
Veterinary medicine
…and many others…

Here at Aseptic Enclosures we have a broad product and services line dedicated to USP 797 compliance. Our XLTC Isolators can be added to any production line that operates with benchtop machinery assuring segregated compounding areas that will guarantee a USP 797 compliance.
For Facilities that handle a larger scale production, we offer gap and consultation services in addition to our Planning & Design projects where we deliver a conceptual design that can be added to your facility’s A/E plan.
Give us a call at 800.418.9289 and let us know more about your upcoming project and we’ll be happy to help.

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