Choose USP <800> Compliant Cleaning Supplies


February 2020 - Vol.17 No. 2 - Page #8


Q&A with Lee B. Murdaugh, RPh, PhD
Director of Accreditation and Medication Safety
Cardinal Health Innovative Delivery Solutions

 

Pharmacy Purchasing & Products: Which areas in the pharmacy must be cleaned under USP <800> requirements?

Lee B. Murdaugh, RPh, PhD: All areas where hazardous drugs (HDs) are handled must be cleaned, including the following:

  • HD compounding areas (both sterile and nonsterile), such as ISO Class 7 negative-pressure buffer rooms and containment segregated compounding areas (C-SCAs)
  • Negative-pressure HD storage rooms
  • Pass-through chambers opening into HD compounding and storage rooms
  • Spaces used to unpack HDs received from vendors
  • Areas where HDs are administered
  • Areas where HD spills have occurred

In addition to surfaces, such as floors, countertops, and furniture, any equipment used in these areas must be cleaned as well, including:

  • Containment primary engineering controls (C-PECs), such as biological safety cabinets (BSCs), compounding aseptic containment isolators (CACIs), containment ventilated enclosures (CVEs), and robots
  • Reusable compounding equipment (eg, repeater pumps, mortars and pestles, spatulas)
  • Transport equipment (eg, bins, boxes, carts)
  • Refrigerators and freezers
  • Other reusable equipment (eg, goggles, face shields, respirators, cleaning tools)

PP&P: What is the objective behind each cleaning step described in USP <800>?

Murdaugh: USP <800> requires four steps for cleaning areas where HDs are handled:

  1. Deactivation is the process that inactivates HDs and renders them inert
  2. Decontamination removes HD residue from surfaces
  3. Cleaning removes contamination, such as microbes, dirt, soil, and drug residues
  4. Disinfection inhibits or destroys microorganisms, which is required for sterile compounding areas

In addition to these steps, cleaning processes must comply with the requirements in USP <795> for non-sterile compounding areas and USP <797> for sterile compounding areas.

PP&P: What are the considerations for selecting USP <800> compliant cleaning products and supplies?

Murdaugh: Choosing cleaning agents, supplies, and personal protective equipment (PPE) that are compliant with USP <800> requirements is critical to ensuring comprehensive compliance with all elements of the chapter. However, when taking into account the variety of products available on the market, the process of choosing ones that are <800> compliant may seem daunting. Pay close attention to USP requirements when selecting products for cleaning activities in HD areas, as USP <800> includes specific requirements for some products applicable to these locations (see SIDEBAR).

PP&P: What training and competency assessments are necessary to ensure all staff members understand the required cleaning processes?

Murdaugh: USP <800> requires that personnel who handle HDs undergo both didactic and experiential training for tasks specific to their job function before independently performing any cleaning activities. The person providing the training must be qualified and competent to perform the tasks. See TABLE 1 for elements to include in personnel training.

Staff must be trained initially upon hire and prior to the use of any new HD, equipment, or supplies, as well as whenever new or updated policies and procedures (P&Ps) are put in place. In addition, USP <800> requires that personnel demonstrate competency initially and at least every 12 months thereafter (note that state boards of pharmacy or other state regulations may require more frequent assessments). Competency assessment for cleaning must cover all elements necessary to perform cleaning activities. The assessment must include both a didactic and an observational evaluation; written testing assesses staff knowledge of cleaning principles, work practices, and P&Ps, while direct observation is used to assess skills and the ability to correctly perform cleaning activities.

It is critical to establish thresholds (ie, passing scores) for competencies. Staff members who fail competency assessments must not be permitted to perform cleaning activities until appropriate corrective actions are taken, including retraining and retesting with a passing score.

In addition to conducting formal competency assessments, be sure to observe staff performing cleaning on an ongoing basis, which facilitates immediate corrective action when required. Training and competency assessments must be documented manually or electronically and retained in personnel records.

PP&P: How can cleaning personnel avoid adverse events from exposure to cleaning agents?

Murdaugh: Appropriate work practices and correct use of PPE reduce the potential for adverse effects from cleaning agents. Pay careful attention to work practices that reduce and mitigate exposure to cleaning agents (see TABLE 2).

Choose garb and PPE that are resistant to cleaning agents. USP <800> requires that staff wear two pairs of disposable gloves tested to American Society for Testing and Materials (ASTM) standard D6978 and a disposable gown with back closures that is impermeable to cleaning solutions. Coated gowns that shed liquids are recommended.

In addition, double shoe covers must be worn in HD compounding areas and when cleaning HD spills; to reduce permeation of cleaning agents and HD residues, shoe covers that are water-resistant or water-proof are suggested. Hair covers, masks, and facial hair covers are required in HD compounding areas.

If there is a risk of splashing, goggles and face shields must be worn for eye and face protection. Depending on the cleaning activity, a respirator may be needed for protection from airborne particulates, as well as vapors, splashes, and sprays. NIOSH-approved N95 respirators provide protection from particulates, but not from vapors, gases, and sprays. NIOSH-approved R95 respirators (which are somewhat oil resistant) may be effective at reducing exposure to irritating fumes and vapors from cleaning agents. However, for cleaning activities with a risk of splashes or sprays—or for personnel for whom R95 respirators are not effective against respiratory irritation—full-face chemical cartridge or air purifying-type respirators (eg, PAPR, CAPR) may be necessary.

Finally, designate waste containers for disposable PPE, cleaning supplies, and spill cleaning materials. The containers must comply with federal, state, and local laws and regulations for HD waste, including any required labeling.

PP&P: How can damage to surfaces from cleaning agents be avoided?

Murdaugh: When selecting cleaning agents, evaluate compatibility of the cleaning agent with the surfaces to be cleaned; consult the manufacturer or vendor labeling for compatibility information.

It is imperative to follow the cleaning agent manufacturer’s instructions for use. Some agents require a pre-cleaning step or a rinse-after-use step. In addition, consult the literature regarding the damaging characteristics of various types of cleaning agents; some are corrosive, while others may leave behind sticky residues. Additional rinsing or application of another agent may be needed to reduce the potential for damage. For example, bleach is corrosive, and application of a neutralizer, such as sodium thiosulfate or a detergent, is required to deactivate it.

PP&P: What labeling should appear on USP <800> compliant cleaning products?

Murdaugh: Product labeling serves to indicate compliance with specific requirements defined in USP <800>. Products that require labeling that confirms compliance with the Chapter include the following:

  • Cleaning agents should be labeled as EPA-registered and should provide information regarding compatibility with various surface materials and cleaning applicators (eg, wipers, mop pads).
  • Gloves must be labeled as meeting ASTM standard D6978; information regarding permeability to HDs is required for gowns.
  • Use respirators that are labeled as NIOSH-approved. Information regarding effectiveness against different types of hazardous agents should be included.

Although compliance details should be printed on the packaging, not all products contain the necessary information. If the required data is not included in the labeling, be sure to consult the manufacturer’s website or contact the manufacturer to confirm that the product meets USP <800> requirements.

PP&P: How can pharmacy verify that their cleaning practices are sufficient?

Murdaugh: Although not required by the chapter, USP <800> recommends that surface wipe sampling for HD residues be performed to evaluate the effectiveness of HD handling processes, including cleaning. USP recommends initial sampling to establish a baseline, followed by testing every 6 months, or more often as needed.

Wipe sampling kits are commercially available, although currently no agencies certify their effectiveness. The ASHP Guidelines on Handling Hazardous Drugs offer guidance on selecting wipe sampling kits.

It is important to note that in HD sterile compounding areas USP <797> requires surface sampling for microbial contamination to evaluate the effectiveness of cleaning processes to reduce microbial contaminants. Sampling is performed using devices containing growth media such as trypticase soy agar (TSA) with additives (eg, polysorbate 80 and lecithin) to neutralize the effects of cleaning agent residues. Sampling devices (eg, plates, paddles) are commercially available from many vendors.


Lee B. Murdaugh, RPh, PhD, is the director of accreditation and medication safety for Cardinal Health Innovative Delivery Solutions. She is the author and editor of the American Society of Health-System Pharmacists (ASHP) publication Competence Assessment Tools for Health-System Pharmacies and co-author of Assuring Continuous Compliance with Joint Commission Standards: A Pharmacy Guide. Lee’s experience also includes providing USP <797> and <800> expertise and support to pharmacies.


SIDEBAR

Choosing Cleaning Supplies for HD Areas

USP <800> includes specific criteria for cleaning agents and PPE (including gloves, gowns, eye and face protection, and respiratory protection) to support HD protection.

Cleaning Agents

Cleaning agents must be compatible with the types of surfaces to which they are applied, as well as to the cleaning tools and supplies (eg, wipers, mop pads, sponges) used. Consult the manufacturer or supplier information to determine compatibility with the materials used in your facility.

Agents used for deactivation and decontamination must demonstrate that they are effective for HDs; use EPA-registered oxidizing agents, such as peroxide-containing formulations and sodium hypochlorite (bleach). In addition, if the manufacturer’s HD labeling lists a specific agent(s) for deactivation and decontamination, the specific agent(s) should be used.

Garb and PPE

Gloves

Gloves must be powder-free and meet the American Society for Testing and Materials (ASTM) standard D6978 for permeability to chemotherapy drugs. Consult the manufacturer or supplier labeling, or other information, to ensure gloves meet this specific standard. Note that while there are other testing standards for permeability, USP <800> requires ASTM standard D6978. Gloves must be sterile if used for sterile compounding.

Gowns

Gowns must be resistant to permeation by HDs; disposable, with back closure; and long sleeved with elastic or knit cuffs fitting snugly at the wrist. Seams and closures must not allow HDs to pass through.

Because there are no standard permeability tests for gowns, some manufacturers test gowns for permeability to specific HDs or use ASTM standards. Information regarding permeation to HDs is, in most cases, available from the gown manufacturer or supplier. Consider utilizing coated gowns composed of laminate materials, such as polyethylene-coated polypropylene, which offers better protection than uncoated materials. Sleeve covers are not required by USP <800>, but if used, should be resistant to permeation.

Eye and Face Protection

Appropriate eye and face protection must be worn during cleaning when there is a risk of splashing and spills. Use of prescription glasses, safety glasses, or face shields alone does not provide adequate eye protection from splashing; goggles are required. Face shields may be used with goggles to provide extra protection.

Respiratory Protection

Respirators should be used for cleaning activities during which airborne HD contamination may be generated, including cleaning under the work tray of a BSC or CACI and cleaning an HD spill.

A fit tested, NIOSH-certified N95 or more protective respirator is usually adequate. However, it is important to note that while NIOSH-approved N95 respirators provide protection from particulates, they do not protect against vapors, gases, and direct splashes. Full-face chemical cartridge and air purifying-type respirators (eg, PAPR, CAPR) provide additional protection against vapors, gases, and volatized substances.

When selecting appropriate respiratory protection, assess the specific needs of your facility for situations requiring such protection, and consider the specific HDs used.


TABLE 1

Required Elements of a Robust Staff Training Program

Proper training is crucial to protecting staff from exposure to hazardous drugs (HDs). A training program for personnel who clean HD areas must include the following:


TABLE 2

Work Practices that Mitigate Employee Exposure to Cleaning Products


Cleaning Supplies Resources List

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