It is generally accepted that the most expensive piece of equipment in any compounding operation is the cleanroom itself. Since the advent of USP general chapter <797> much has been written and discussed about the need and cost of constructing and maintaining a compliant cleanroom. Regardless of the configuration of your compounding area, the cost of cleaning and properly maintaining it at peak efficiency should always be a priority.

The cleaning and disinfecting of the compounding area is central to the proper operation of the cleanroom. Chapter <797> describes cleaning and disinfecting practices, which apply to all ISO 5 compounding areas, as well as buffer areas, ante-areas, and segregated compounding areas. Also described in <797>, compounding personnel are responsible for ensuring that the frequency of cleaning is in accordance with the requirements (Table 1).

In addition, compounding personnel are responsible for selecting the disinfecting products used in these areas. Consider any organizational or situational policies regarding disinfectant selection to assure continuity within the larger health system. The selection of specific agents is outside the focus of this article, since the selection and use of disinfectants in healthcare facilities is guided by many properties (i.e., microbial activity, inactivation by organic matter, residue potential, and shelf life). Appendix II from General Chapter <797> provides an outline of microbicidal activity and properties of common disinfectants used in healthcare ( Table 2).

The Cost of Cleaning
Just as it is often said that “an ounce of prevention is worth a pound of cure,” so too must be the approach to cleaning your compounding areas. Because environmental contact has been identified as a major source of the microbial contamination of compounded sterile preparations (CSPs), scrupulous attention to cleaning and disinfecting the sterile compounding areas is required to minimize this source of CSP contamination.

Once compounding policies and procedures have been written and a successful daily workflow has been established, regular cleaning cycles must be incorporated into the daily cleanroom routine to assure that the compounding can proceed without incident. It is important to note that a properly designed environmental testing program is a good indicator of how well your environmental controls and cleaning practices are working.

It may seem elementary, but a key factor in ensuring that the daily clean cycles occur without interruption is to make sure that all the cleaning products, tools, and related supplies and equipment are available and easily accessible to the compounding personnel.  The value of proper and complete training for all compounding personnel on the most effective methods of cleaning cannot be understated. An investment in up-front personnel training yields savings both in time and materials. 

Develop a Streamlined Shopping List
Given the wide variance in size, design, and requirements of different cleanrooms, no one shopping list will apply to all facilities. Your organization’s standard menu of supplies and equipment must be developed in-house to reflect the practices established within your standard operating procedures (SOPs).
In general, this list will include

• Mop handles and mop covers
  
• Crevice tools and tool covers
  
• Buckets
• Wipers
  
• Dry wipes
  
• Pre-wetted wipes
• Cleaning swabs
  
• Disinfectants
  
• Isopropyl Alcohol
• Quaternary Ammonium
  
• Phenolics
  
• Chlorine
• Iodophors
  
• Contamination control mats

When selecting the products and equipment for inclusion on your standard supply list, on-site comparative testing and review of all the manufacturer’s literature may help avoid unpleasant surprises. Once this menu has been standardized, the key task for personnel then becomes predicting the quantity of materials that will be consumed on a regular basis. If personnel training reflects actual practice, an informal, in-house time and motion study can help establish baselines for the quantities of each product used in your cleaning protocol. Developing a standard list of daily, weekly, and monthly tasks in a checklist format may help assure that you have accounted for all necessary activities and have proper equipment and materials in stock to respond to all the tasks on your list.

Click here to view Sample Daily, Click here to view Sample Weekly, and Click here to view Monthly Cleaning Activities Checklists.

Budgetary Strategies and Resources
Careful observation toward eliminating inconsistent or wasteful practices will assist in assuring standard operating practices are followed. Stand­ardizing cleaning practices wherever possible is critical in helping produce a consistent, quality preparation from your compounding area. Furthermore, controlling these processes will help management predict the consumption of products over time. Useful strategies to aid in budgetary development for these products should include

• Maximize GPO or contract pricing — Review GPO approved sources to reduce expenditures and eliminate market price purchases of these goods.
  
• Buy standard sized products — Resist the temptation to stock all sizes within a product category.

• Buy ready-to-use products when available — Depending on your cleanroom configuration, pre-moistened products (i.e., wipers, swabs, or mop heads) can save time and money when used properly.
  
• Buy stock packages in reasonable sizes — Dispenser packages and pre-moistened products can save money, but if the packages are too large for your needs and thus are not consumed within a reasonable time period, they may become unusable or less effective due to drying or possible contamination over time.
• Invest in quality equipment — Stainless steel mop handles and specialized crevice tools may seem like a luxury, but saved time equals saved money. Buying tools made of quality components will yield a longer, more useful life, therefore saving money over time.

Additional Resources
The most effective long-term strategy may be to revisit your facility’s SOPs in order to cost-justify the number and types of cleaning products used. Most reputable manufacturers will be happy to provide test data, suggested operating procedures and other useful resources to assure that their products are being properly utilized. Some will even share average utilization data to assist you in developing an inaugural year budget. These resources are helpful in both educating staff and in establishing utilization par levels for budgetary development and operational planning. 

Conclusion
Developing a working budget for your compounding operations can be a daunting task. Changes in regulations have mandated a change in the type and number of products required to assist in safeguarding the quality and sterility of final preparations. Attention to staff training and education, as well as inventory management, will help ensure that these items are properly selected and used.

Lou Diorio, RPh, is a principal of LDT Health Solutions, Inc, a quality management consulting company and a graduate of Long Island University’s Schwartz College of Pharmacy, where he is also an adjunct professor of pharmacy practice and preceptor of pharmacy students. Lou has practiced in and managed pharmacies in hospital, home care, and retail settings.

David Thomas, RPh, MBA, is a principal of LDT Health Solutions, Inc.  Dave previously served as the director of IT operations for SoluNet, LLC, manager of implementation and technology development for Baxter Healthcare, and as the technology systems manager for Baxter’s COMPASS Group, respectively. Before his 15-year tenure with Baxter, Dave held hospital practice and management positions for five years. Dave is a graduate of St. Louis College of Pharmacy.