compounding pharmacy: infection control

We previously discussed distribution pharmacies. Whether distributing regionally or acting as an in-house department for a hospital, compounding pharmacies create precious medical medications that must be kept sterile and free of contamination during the entire production process. But how does a pharmacy protect this process? ¬ The department uses a multi-pronged approach to infection control to ensure the compounding suite of rooms are kept clean of contaminants. In addition to the department protocols, local code authorities, Dept. of Health (DOH), and national (e.g. USP797 & USP800) have their own regulations for maintaining a clean environment and process.

Finishes Finishes Finishes - The Physical Environment: Both DOH and USP (United States Pharmacopeia) regulations jointly require stringent design standards for the compounding suite of rooms within a pharmacy department. This suite is typically composed of at least one Ante Room, Clean Compounding Room, Chemo Compounding Room, and Hazard Storage Room. In order to maintain a clean space, each room is designed to be as seamless a box as possible.

• Flooring materials are selected to be highly durable, and also chemically resistant and have some slight factor of slip resistance to increase staff safety. Flooring must be heat welded together, this permanently bonds the flooring together and eliminates seams that bacteria and liquids can fall into out of reach of cleaning products. Lastly, the flooring is wrapped up the wall a minimum of 6 inches, this eliminates a sharp 90° joint at the wall which is difficult to clean, instead creating a rounded cove that is easy to wipe down and mop.

• Wall finishes can be addressed a couple different ways. One method are standard gypsum walls that are coated in a high-performance paint, such as an epoxy grade paint, to give walls chemical resistance and a small amount of durability. Walls in compounding suites are wiped down routinely by the staff and need to withstand alcohol bases or similar cleaning product types. One drawback to painted walls is they are subject to damage from rolling carts. Paint at the end of the day acts more like a skin than armor and can be pierced, once damaged the exposed gypsum is a contamination concern and must be addressed immediately. Such wall repair may require the room to be shut down and, in turn, creates disruption to the entire compounding suite. Alternatively, walls can be covered in solid pre-manufactured panels. Panels vary in thickness and type, e.g. rigid plastic sheets, fiberglass reinforced plastic, or acrylic polymer (solid surface). Each type has slight variations between them but largely the goal is to provide the walls with a highly durable and moisture impervious surface. These panels can be cleaned easily and withstand rolling carts. Seams between the panels/flooring/ceiling are ideally addressed with a permanent bond, where this is not feasible then caulking that is appropriate to the environment is utilized. 100% silicone sealant is economical and easy to work with but does not last in the long run when routinely exposed to cleaning chemicals. Mixed sealants or security grade variants should be considered to provide a longer lasting solution. One example recently used is resilient flooring and wall panels that can be heat welded together where the cove base and panel meets in lieu of caulking.

• Ceilings are best addressed with a gypsum board hard lid. This type of ceiling can be painted with the same high-performance paint (like walls) and provide a better seal for air flow and HVAC balancing. With a gypsum ceiling all mechanical and electrical fixtures are caulked to the ceiling for infection control as well as air leakage prevention. Staff can also wipe down the ceiling more easily than an acoustical lay-in ceiling. In certain conditions cleanable acoustical lay-in ceiling is permissible. Lay-in ceilings utilize a suspended grid and vinyl coated acoustical panels set into the grid layout. These panels have to be sealed to the grid or utilize special accessory clips that hold the panel down tightly to the grid to prevent air leakage. The suspended grid system creates joints across the ceiling that potential bacteria can inhabit, these small ridges and crevices are difficult to clean thoroughly, thus making it a more challenging surface to maintain.

After all the above is considered you have to plug in doors, frames, relites, and pass-thru boxes into the design to allow separation of spaces and staff utility. Doors are kept closed at all times to keep air pressure maintained in each room. Automatic doors are very effective, they can be coordinated electronically so no more than one door can be opened at a time, this is called an interlocking system. These power door types also allow staff to activate them via a wave sensor or push plate eliminating the need for staff to touch the doors altogether. Relites (interior windows) are used for observation as well as visual communication between staff members. Staff cannot freely walk into each room with having the proper attire. Such protective gear is limited for use to each room so staff must take off one set and put on a clean set to transfer to a new room. Thus, the use of relites or communication systems are often used to allow communication without physically crossing borders. Additionally, the transfer of product is efficiently performed via pass-thru boxes to avoid the hassle of gowning to move them from room to room. These pass-thrus have coordinated hatches on either side to allow access from two adjoining rooms, this allows the staff member who has product ready the ability to pass off the items to a pharmacist or technician without having to leave their space.

To further assist with the design, it is ideal to use the interior finish colors to your advantage. Staff are required to wash hands or don their protective gear at certain locations within the suite. Locations where specific activities are required can be enhanced by allocating accent colors or borders in the floor or walls to visually reinforce the space and its function. Consider that flooring colors are a simple but effective way to create borders or zones indicating function or environment change. For example, the entry point to the suite where handwashing and gear checks are required before proceeding is a perfect area to have its own color that spans the physical footprint of the area. Additionally, staff need an environment that promotes visual acuity in terms of both lighting levels and purity of environment. To this end it is recommended you avoid distracting patterns, utilize solid colors (in controlled amounts), and provide high light levels across the rooms. A medium to medium-dark flooring color paired with bright white ceilings and walls is a great way to allow ample light reflection without creating glare from below (staff are constantly looking down while at workbenches). Another reason for light colored walls and ceilings in particular is they will show dirt buildup more readily. While these surfaces are routinely cleaned it is important that staff can see anything that may have spilled or shed onto these surfaces. On projects we normally talk about concealing wear and tear with patterns or color but in this case you want the opposite! A compounding suite is a unique and challenging space to coordinate and design, but every detail counts!