Deactivation, Decontamination, Cleaning, and Disinfection of sterile HD compounding areas

USP <800> has an entire section dedicated to deactivation, decontamination, cleaning, and disinfecting areas that are used for compounding sterile hazardous drugs (HDs).

The chapter calls for:

• Establishing written procedures
• Training personnel
• Using appropriate personal protective equipment (PPE) resistant to cleaning agents. This includes the use of two pairs of chemo gloves and impermeable disposable gowns
• Using eye protection and face shields required if splashing is likely
• Using respiratory protection if warranted
• Using wetted wipes and not spray bottles to deliver agents for deactivation, decontamination, and cleaning
• Proper disposal of all materials used

Deactivation – Renders the compound inert or inactive. Residue from deactivation must be removed through decontamination (see below). There is no single method for deactivating all known compounds.

Decontamination – Inactivating, neutralizing, or physically removing HD residue from non-disposable surfaces via wipes, pads or towels. This includes work surfaces and under work trays where residue may collect.

Cleaning – Process to remove contaminants – organic and inorganic material – from objects and surfaces using water, detergents, surfactants, solvents, and/or other chemicals. Cleaning may not be performed while compounding activities are occurring.

Disinfection – Process of inhibiting or destroying microorganisms. Required for surfaces where sterile compounding occurs.

Most of the above is common sense. While it may seem complicated, most pharmacies will simply purchase kits designed to walk them through the process. An example of a kit used to meet USP <800> requirements is WipeDown 1-2-3 by Valtek Associates. I’m sure there are others as well.

The WipeDown 1-2-3 product description can be seen below. Notice that the kit contains numbered packets designed to walk you through the process, i.e. Packet #1 – deactivation, Packet #2 – decontamination, Packet #3 – disinfecting/cleaning. Pretty straightforward.

WipeDown 1-2-3 is a sterile 3 step application wipe kit, that when used in sequence, provides deactivation, decontamination, and disinfection/cleaning of sterile compounding surfaces from most hazardous drugs. WipeDown 1-2-3 satisfies both USP compounding sterile preparations and USP hazardous drugs – handling in healthcare settings.
Each Sterile WipeDown 1-2-3 kit includes:

• Packet #1 – HYPO-CHLOR®, 5.25% Sodium Hypochlorite for deactivation
• Packet #2 – THIO-WIPE, 2% USP Thiosulfate for decontamination
• Packet #3 – ALCOH-WIPE®, 70% USP Isopropyl Alcohol for disinfecting/cleaning