New & Improved!

Support Patient Safety with a Robust Cleaning Program
September 2012 - Vol. 9 No. 9 - Page #28

Even if a hospital pharmacy’s primary and secondary engineering controls are sufficient, and strict garbing, hand hygiene, and particulate control measures are put in place, consistent and effective cleaning procedures are still required to continually reduce the overall bioburden present in the facility. Although bacteria do not fly, particulate matter serves as transport vehicles for viable contamination, so care must be taken to reduce sources of particulate matter. Therefore, in addition to establishing a comprehensive and persistent cleaning and disinfecting schedule, products intended for use within engineering controls should be unpacked and wiped down with 70% IPA or another designated agent prior to use. 

In some pharmacy operations, responsibility for cleaning both the controlled environment and the area where drugs are stored falls to pharmacy staff. In larger hospital settings, the environmental services or housekeeping department may be tasked with this responsibility. Some hospital pharmacies elect to integrate the environmental-services department into weekly and monthly cleaning procedures, but perform daily cleaning themselves. Regardless of who performs the cleaning, they must be carefully trained and educated in proper PPE garbing and hand washing, as well as the tenets of the cleaning protocol once established. Routine observation of individuals performing cleaning and inspection of the controlled environment are likewise recommended. Due to the sterile and aseptic requirements of a hospital’s operating room, the OR director is generally an excellent resource to assist in developing a controlled environment cleaning protocol.

Understand and Preserve the Necessary Tools
As with any tools designed to assist pharmacy operations, the correct maintenance conditions must be instilled if the tools are to work properly. Accordingly, it is imperative that your selected cleaning agents’ manufacturer instructions be followed with regard to storage, handling, and dilution. For example, the right dilution often is critical to a solution’s effectiveness, as insufficient dilution can cause damage to floors, sinks, and other surface areas. Some cleaning agents are highly caustic and over time, even when diluted, can cause pitting of stainless steel, especially if it is not cleanroom grade. To assist this process, make glass or plastic graduated cylinders available at the sink where solutions are mixed and thoroughly rinse them after use. Material safety data sheets (MSDS) are readily available from solution manufacturers and must be available on site.

Buckets and other cleaning equipment, such as mop handles, heads, and covers, must be dedicated to the area where they are used. To prevent cross contamination, equipment used to clean walls and ceilings should not be used to clean floors, nor should they be taken outside of the pharmacy area. Conventional mops with cellulose heads can begin shedding in as little as two days, so they should be changed at least every 48 hours. Conventional plastic mop handles also tend to not stand up well to cleaning and need to be replaced approximately once a month. Buckets must be metal free and made of heavy-duty plastic; remember to select a bucket big enough to accommodate your mop heads, but small enough to fit in the sink to be filled.

Protect Staff While Protecting Patients
Based on OSHA regulations, it is strongly recommended to issue each staff member his or her own pair of safety glasses to wear when there is a likelihood of being splashed by chemicals or drugs. Some pharmacies require that compounding staff wear safety glasses at all times, but it is strongly recommended to wear them during cleaning processes as well, as there is a high likelihood of eye exposure to solutions during ceiling cleanings, for instance. In addition, persons responsible for cleaning must garb up and wash their hands in the same manner as compounding personnel. Appropriate garb includes lint-free shoe covers, bouffant caps, masks, safety glasses, and gowns or frocks, as well as beard covers, if needed.

Follow Basic Cleaning Protocols
Cleaning should generally occur from the cleanest area to the dirtiest, eg, ISO Class 5 areas before the floor, and should be performed from top to bottom. For example, the order for a monthly cleaning schedule would be ceilings; walls, windows, and horizontal surfaces; workbench shields; ISO Class 5 surfaces; workbench or hood legs; and finally, the floor. Daily cleanings should be performed at the end of the compounding day. ISO Class 5 workstation work surfaces (IV bar to the bench surface, end panels, interior walls, and compounders) should be wiped with the designated agent at the beginning of each compounding day. In the event of a drug spill, wipe the spill with sterile water using a lint-free wipe, followed by the designated cleaning agent. This process will avoid the occurrence of chemical reactions between pharmaceutical components and cleaning agents.

It is important to make certain that all surfaces are thoroughly coated and wetted with the cleaning agent. The mop must go over every surface of the cleanroom wall, molding, ceiling, return grills, doors, window, handles, etc. It is usually easiest to use lint-free cloths dampened with the cleaning agent to clean molding, door handles, and other areas that are not entirely flat. It may be necessary to keep a stainless steel or plastic step stool in the compounding room for the manual cleaning of hard to reach areas. Such an apparatus also should be cleaned regularly.

Ultimately, there are many factors to consider in designing a cleaning program for a compounding facility. Policies and procedures must be established and staff competencies developed. Keep in mind, the cost of cleaning is related to labor costs from staff time more than it is to physical products. Given this, pharmacy directors can comply with USP <797>’s gowning, hand hygiene, and cleaning requirements now, even if you are waiting for approval to build a cleanroom or to install secondary engineering controls. A $200,000 cleanroom is not worth much if it is not used and maintained correctly. You and your team can make a difference by implementing policies and procedures for cleaning now.


Kate Douglass, MS, RN, APNC, CRNI, is the president of Performance Strategies, LLC, a consulting company assisting the pharmacy, nursing, and health care markets. She has written a number of articles on sterile compounding quality and training.  

 

 

 

 

 


Special PP&P Buyer’s Guide
Disinfecting Cleaners

Pharma-Hol is a validated sterile alcohol composed of 70% isopropyl alcohol and 30% purified water. Available in 16-ounce spray bottles and gallon containers, the trigger sprayers are attached to each 16-ounce bottle prior to double bagging and sterilization, eliminating the potential contamination risk of end-user assembly. This liquid cleaner can be used to remove many surface contaminants and is USP <797> compliant.
From Acute Care Pharmaceuticals

Disinfectant tablets provide a simple solution for cleanroom surface cleaner needs. Simply dissolve half a tablet in one liter of water to create 1772 ppm (mg/liter) of available chlorine. The effervescent tablets completely dissolve in less than eight minutes with no additional effort. Effective as a tuberculocide within ten minutes against Mycobacterium bovis-BCG, each box contains 60 double-bagged tablets. 
From Attentus Medical Sales, Inc

CiDehol ST 70% IPA solution is made using water-for-injection (WFI) water. Sterile alcohol solutions are filtered to 0.2 µ, bottled, and double-bagged in a class 100 cleanroom, then gamma-irradiated and tested for sterility. CiDehol ST is available in 16- and 32-ounce trigger spray bottles and also in one-gallon bottles.
From Decon Labs, Inc

Sanosil S010 is an EPA-registered and patented hydrogen peroxide/silver disinfectant formula. This ready-to-use surface disinfectant is effective in killing 99.99% of bacteria, viruses, and fungi found on pre-cleaned, hard, non-porous, non-food surfaces. Just spray and walk away. The no wipe, no rinse formula reduces the risk of cross-contamination associated with using a rag, wipe, or sponge. Available in 32-ounce spray bottles and gallon bottles for use with Sanosil’s Halo Fogger (see p. 33).
From Sanosil International

TexQ Disinfectant is an EPA-registered quaternary ammonium compound that serves as an effective one-step cleaner and disinfectant against a broad spectrum of bacteria, virus, and fungi. The disinfectant inhibits the growth of mold and mildew and their odors when used as directed. TexQ is free of dyes and fragrance, and available in ready-to-use spray and concentrate gallon bottles.
From Texwipe

 

 

 

 

 


Cleanroom Mats

Pharma-Mats are designed to pick up foot borne contaminants and can be used as a first line of defense for the cleanroom. Refill Pharma-Mats come in a variety of colors and sizes and the non-skid frame allows users to easily move the mat for mopping floors or relocation. Each sheet has a strong adhesive coating that removes dirt on contact.
From Acute Care Pharmaceuticals

ChemoPlus adhesive contamination control floor mats are latex free and serve as a convenient and economical way to trap impurities from foot traffic. They easily adhere to the floor and are simple to peel back in order to expose a new layer. There are 30 peel-back layers per mat and they are available in white or blue. The mats measure 18x46 inches.  
From Covidien

 

 

 

 

 


Cleanroom Gloves, Gowning, and Storage Products

Pharma-Gloves are sterile, 100% nitrile gloves that are lightweight, powder free, and approved for use when handling chemotherapy. These gloves are 12 inches long with a beaded cuff and a 5-millimeter thickness. They are available in a variety of sizes from XS to 2XL. All sizes are packaged 50 pairs per bag and four bags per case.
From Acute Care Pharmaceuticals

ChemoPlus Poly-Coated Impervious Gowns are splash resistant, lightweight, and non-linting. They have a closed front and wraparound style for added protection against spills, as well as long sleeves with knit cuffs and waist ties with hook and loop neck closures. 
From Covidien

ChemoBloc Nitrile Gloves are ambidextrous, easy to double glove, and 8-millimeters thick at fingertips. The unique tear-away feature indicates when the glove has been punctured. The length of the glove from tip to cuff is 12 inches in order to protect wrists. The beaded cuff resists tearing and the gloves are latex free, powder free, and textured. The gloves are available in various sizes including S, M, L and XL. Sterile gloves also are available. 
From Covidien 

Stainless Steel Trays are ideal for use in pharmacy cleanroom operations where multiple items are required for certain tasks. The multipurpose trays can be used for processing, medical supply organizing, or for transporting items via pass-through boxes to the cleanroom. The trays feature easy-grip handles for hassle-free transport and nest when empty. They can be cleaned easily using medical-grade cleaning wipes. Custom stainless steel tray designs also are available to accommodate customer requests.
From Health Care Logistics

Sterile Nitrile Gloves for the cleanroom are 100% nitrile and powder-free. Qualified for use in the pharmacy and cleanroom, the gloves are class 100 clean, have a 12-inch cuff, and are right- and left-hand specific. The gloves are available in various sizes and come 50 pairs per pack and four packs per case.
From Josco Products

Technowipe Dispensers are made of specially formulated plastic that will not pit, cloud, or crack from repeated alcohol cleaning. The clear plastic dispensers can fit any brand of 9x9-inch cleaning wipes and is convenient for storage within the pharmacy.
From Technowipe, Inc  

 

 

 

 

 


Pre-saturated and Dry Wipes

Pharma-Wipe is a dry, ISO class 5, lint-less, polyester/cellulose-blended wiper for use in the pharmacy cleanroom. Pharma-Wipes are available in sterile and non-sterile forms as well as in a variety of seizes, including 4x4, 9x9, and 12x12 inches.
From Acute Care Pharmaceuticals

PROSAT Sterile pre-saturated cleanroom wipes are made of melt blown polypropylene fabric (Item#: PS-911EB) or knitted polyester (Item#: PSPS0076). These wipes are saturated with 70% isopropyl alcohol and 30% deionized water, and are sterilized by gamma radiation. PROSAT Sterile wipes come in resealable pouches with tamper-evident labels and are ideal for gloves and surfaces, as well as the routine application of sterile 70% IPA as mandated by USP Chapter <797>. 
From Contec, Inc

SterileSorb is a sterile, cellulose and polyester blend, non-woven wipe for cleanroom applications. The strong and durable hydro-entangled fabric offers extreme absorbency while maintaining low levels of particles and extractables. SterileSorb is excellent for wiping and absorbing spills, and ideal for general purpose cleaning within primary engineering controls and surrounding buffer areas. It is validated to a Sterility Assurance Level of 10-6 in accordance with standards and recommended practices of the AAMI Guidelines. 
From Contec, Inc

Editor's PickSurface Safe is a two-step applicator kit for cleansing contaminated chemotherapy work surfaces in the cleanroom. The first towelette contains high potency bleach—2%(W/W) specially formulated sodium hypochlorite soap solution. The second towelette contains a bleach-inactivating agent—1% (W/W) sodium thiosulfate solution and 0.9%(W/W) benzyl alcohol. Each Surface Safe kit contains 15 twin packets.
From Covidien

CiDehol 70 Wipes are pre-saturated with 70% isopropyl alcohol and 30% USP-grade water. These wipes are for cleaning hard surfaces, production areas, and equipment in hospital cleanrooms and labs. Simply wipe the surface to be cleaned, and allow excess moisture to evaporate. Wipes measure 6x7 inches and are available in a convenient pop-up container, which contains 160 wipes.
From Decon Labs, Inc

Hypo-Chlor Wipes are sterile, ready-to-use cleanroom wipes pre-saturated with 5.25% sodium hypochlorite for routine cleaning and effective decontamination in sterile pharmacy compounding areas. This unique formulation neutralizes chemotherapy drugs and is especially effective when used to clean chemotherapy hoods. Wipes have laser-cut sealed edges, are non-shedding, and are suited for introduction into ISO class 5 areas. Each resealable package of 20 wipes preserves cleanliness and solvent saturation levels.
From Health Care Logistics

Technowipe Lint-Free Wipes are designed to meet USP <797> cleaning guidelines that require low-shedding wipes for use within the pharmacy cleanroom. The wipes are conveniently packaged in reclosable, clear bags in order to avoid environmental contamination and are available in both 9x9-inch or 12x12-inch sizes. 
From Technowipe, Inc


Surface Cleaning & Disinfecting Systems

The Attentus S-Mop is a cleanroom mopping system for critical environments. The system consists of sterile, lint-free, high-absorbent, 100% microfiber mop pads, a fluid dispensing handle for your cleaning solution, and a maneuverable head. The microfiber pads remove bioburden and are recyclable after use. Also available for the S-Mop are premeasured disinfectant tablets that are effervescent to help standardize the cleaning process and minimize aerosolization of cleaning solutions.
From Attentus Medical Sales, Inc

The VertiKlean MAX Mopping System uses a disposable polyester and foam mop head designed to apply disinfectants for general cleaning of ceilings, walls, and floors. For maximum absorbency, the mop head features a single layer of hydrophilic polyurethane foam that is laminated onto polyester fabric and backed by a semi-rigid, thermoformed plate that snaps onto the stainless steel mop head frame.
From Josco Products

The Halo Fogger automatically dispenses a dry mist of atomized disinfectant into the air. The droplets fill the room and are drawn into every nook, crevice, and corner, reaching surfaces that regular cleaning and disinfecting cannot reach. The Halo Fogger delivers greater coverage for a more thorough and effective supplemental disinfecting of all surfaces in the room, reducing the risk of cross-contamination associated with using a rag, wipe, or sponge. Compact and portable, the Halo Fogger is a cost-effective and easy-to-use automated cleaning system.
From Sanosil International

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