2.6 Cleaning, Disinfecting, Sporicidal Agents & Sterile 70% IPA

2.6 Cleaning, Disinfecting, Sporicidal Agents & Sterile 70% IPA

Environmental monitoring can only show what cleaning has already achieved. USP <797> Section 7 is one of the most detailed parts of the chapter, and exam items tend to test exact frequencies and the difference between the kinds of agents.

Four different jobs

Surfaces must be cleaned before they are disinfected, unless an EPA-registered one-step disinfectant cleaner is used. Such a product is registered to clean and disinfect in the presence of light to moderate soil. USP's FAQ stresses that sterile 70% IPA is not a one-step disinfectant cleaner. If a sporicidal product is also registered as a one-step disinfectant cleaner, it can do all three jobs at once.

Table 10 minimum frequencies (classified areas and SCA perimeter)

Category 3: a sporicidal disinfectant is applied at least weekly. SCA ceilings are an exception: USP's FAQ says the Table 10 frequencies cover every SCA surface except the ceiling, which is done when visibly soiled or when contamination is known or suspected. Sinks are cleaned and disinfected each day of use, with a sporicidal at least monthly.

Sterile 70% IPA inside the PEC

• Apply it after cleaning and disinfecting, or after a one-step or sporicidal product, to remove any residue.
• Apply it immediately before compounding starts.
• During compounding, apply it to the horizontal work surface, including any removable tray, at least every 30 minutes. If a single compounding process takes more than 30 minutes, do not interrupt it; disinfect the work surface immediately after it ends.
• Always let the IPA dry before starting work.

Agents

• Choose agents based on antimicrobial activity, inactivation by organic matter, residue, shelf life, preparation needs and suitability for the surface.
• Every agent must be left on the surface for at least the manufacturer's minimum contact time. USP's FAQ notes that one product may need 1 minute to kill bacteria but 3 minutes to kill spores.
• In the U.S., disinfectants must be EPA-registered.
• Inside the PEC, all cleaning, disinfecting and sporicidal agents must be sterile, and concentrates must be diluted with sterile water. In classified areas outside the PEC, sterile agents should be used.
• Once opened, sterile agents and supplies (such as a closed container of sterile wipers, or sterile 70% IPA) may be used only for as long as the manufacturer or the facility's SOPs allow.

Supplies and tools

• Wipers, sponges, pads and mop heads must be low-lint; tool handles and holders are the only exception. USP recommends disposable supplies, and disposable supplies are thrown away after each cleaning activity.
• Reusable tools are made of cleanable material (no wood or other porous material). They are dedicated to the classified areas or SCA, are cleaned and disinfected before and after each use, and leave the area only for disposal.
• Inside the PEC, cleaning supplies must be sterile, apart from handles and holders, which are cleaned and disinfected before use.
• Dispose of used supplies in a way that minimizes dispersal, with minimal agitation and away from work surfaces.

Procedure principles

1. Only trained, properly garbed personnel clean, using facility-approved agents and written SOPs. Any change in agents or methods requires retraining.
2. Work from clean to dirty. The same floor mop may be used in the buffer room and then the anteroom, but only in that order.
3. Inside the PEC, work from the cleanest area toward the dirtiest, in overlapping strokes, and keep liquid off the HEPA filter face.
4. Document every cleaning, disinfecting and sporicidal application as the SOPs require.

Hazardous drug areas (USP <800>)

In HD areas, cleaning also has to protect workers. USP <800> adds deactivation (for example, an oxidizer such as sodium hypochlorite) and decontamination (removing the residue) before cleaning, and disinfection is still required in sterile areas. Agents are applied with wetted wipes rather than spray bottles, to avoid spreading HD residue. The C-PEC is decontaminated at least daily when used, between different HDs, after any spill, and before and after certification. The area under its work tray is treated at least monthly (see 6.4).