What Cleaning Supplies Are Required for USP <797> Compliance?

Quick Answer:

USP <797> cleaning programs typically require low-linting wipes, sterile wipes and mop covers where appropriate, compatible cleaning agents and disinfectants, a sporicidal disinfectant, sterile 70% isopropyl alcohol for the primary engineering control, cleanroom mop systems, and dedicated tools that do not introduce contamination. The exact products, frequencies, and techniques must be defined in the facility’s written standard operating procedures (SOPs) and tailored to the surface, classified area, and compounding activity.

USP <797> establishes standards for preparing compounded sterile preparations. Cleaning supplies support compliance, but a product alone does not make a facility compliant. Facilities should qualify materials for their intended use, follow the current chapter and applicable regulations, and document cleaning and disinfection activities.

Why are cleaning supplies important for USP <797> compliance?

Appropriate cleaning supplies help remove residues, particles, and microorganisms without introducing excessive lint, additional particles, or incompatible chemicals into the compounding environment.

Cleaning removes surface contamination and residue; disinfection uses a chemical agent to reduce viable microorganisms. Both steps must be performed using qualified materials and documented procedures to protect compounded sterile preparations.

What types of wipes are used in USP <797> compounding areas?

USP <797> compounding areas commonly use low-linting cleanroom wipes, sterile wipes for aseptic applications, polyester wipes for critical cleaning, nonwoven wipes for general cleaning, and presaturated wipes when a controlled amount of solution is preferred.

• Use wipes with low particle and fiber shedding – as specified on the Product Information sheet.
• Select sterile products when required by the application and SOP.
• Confirm compatibility with the disinfectant and the surface.
• Choose the size, absorbency, and construction for the task.

Berkshire offers cleanroom wipes for controlled and aseptic environments.

Are sterile wipes required in USP <797> cleanrooms?

Sterile wipes are used when the facility’s SOP, risk assessment, product labeling, or regulatory requirements call for sterile cleaning materials, particularly in critical aseptic applications. Not every wipe used throughout a compounding facility needs to be sterile.

Facilities should verify sterility documentation, packaging configuration, particle performance, absorbency, and chemical compatibility before approving a wipe for a specific area.

What disinfectants are used in USP <797> pharmacies?

USP <797> pharmacies use one or more compatible disinfectants, along with a sporicidal disinfectant, in accordance with written SOPs. Sterile 70% isopropyl alcohol is commonly used in the primary engineering control, while other agents may be used in classified rooms and support areas.

Potential disinfectant chemistries include isopropyl alcohol, hydrogen peroxide-based products, hypochlorous acid products, quaternary ammonium compounds, sodium hypochlorite products, and other EPA-registered disinfectants. Selection should be based on efficacy, required contact time, residue, material compatibility, personnel safety, and the facility’s microbial control strategy.

What is a sporicidal disinfectant?

A sporicidal disinfectant is formulated and labeled to inactivate bacterial spores, which can survive routine disinfection. USP <797> cleaning programs include sporicidal disinfection at frequencies established by the chapter and the facility’s SOPs.

Apply the product for its full labeled contact time, follow safety requirements, and remove residue when the label or procedure requires it.

Should surfaces be cleaned before they are disinfected?

Yes. Remove visible soil, residue, and contaminants before or during disinfection so the disinfectant can contact the surface effectively.

Facilities should specify the approved sequence, wiping pattern, contact time, and any required residue-removal step in their SOPs.

What supplies are needed to clean a laminar airflow workbench or other PEC?

Cleaning a primary engineering control (PEC), such as a laminar airflow workbench, biological safety cabinet, compounding aseptic isolator, or compounding aseptic containment isolator, typically requires sterile, low-linting wipes, sterile 70% IPA, approved cleaning and disinfecting agents, and tools that can reach all interior surfaces without damaging the unit.

Follow the PEC manufacturer’s instructions and the facility’s SOP. Clean in a way that preserves first air and avoids blocking HEPA-filtered airflow or introducing contaminants into critical sites.

What cleaning supplies should be used in ISO Class 5 areas?

ISO Class 5 areas require qualified, low-particle supplies appropriate for critical aseptic work, commonly including sterile, low-linting wipes, sterile 70% IPA, approved sterile cleaning or disinfecting agents, and sterile tools or mop covers as needed.

Material selection should account for sterility, particle release, absorbency, extractables, surface and disinfectant compatibility, packaging, and ease of aseptic transfer.

How do you choose USP <797> cleaning supplies?

Choose USP <797> cleaning supplies by matching each product to the classified area, surface, cleaning objective, sterility requirement, disinfectant chemistry, and the written SOP.

• Confirm the product is suitable for the intended ISO classification and task.
• Review sterility, irradiation, and lot documentation as applicable.
• Evaluate lint, particles, absorbency, durability, and extractables.
• Verify chemical and surface compatibility.
• Account for contact time, residue, and worker-safety requirements.
• Train personnel and document use within the facility’s cleaning program.

Berkshire’s USP <797> and USP <800> cleaning supplies include wipes, mop systems, swabs, and other contamination-control products for compounding environments.

Does using a product labeled for cleanrooms guarantee USP <797> compliance?

No. Compliance depends on the facility, engineering controls, personnel practices, qualified products, written SOPs, training, documentation, and consistent execution of the full contamination-control program.

Can the same wipes and mops be used in every compounding area?

Not always. Materials should be selected and dedicated by area or task as needed to prevent cross-contamination and comply with the facility’s SOPs.

How often should USP <797> surfaces be cleaned and disinfected?

Frequency depends on the surface, room classification, compounding activity, spills, contamination events, and current USP <797> requirements. The facility’s SOP must specify the required frequency for each area and task.

Always consult the current USP <797> chapter, product labels, equipment manufacturer instructions, and applicable federal, state, and local requirements. This article provides general contamination-control information and does not constitute legal or regulatory advice.