To ensure compliance with USP <800> Hazardous Drugs—Handling in Healthcare Settings and USP <797> Pharmaceutical Compounding—Sterile Preparations, health system pharmacists must have a comprehensive understanding of the chapters and the changes that must occur in their compounding practices to meet the requirements. In particular, the facilities requirements described in USP <800> require many organizations to undertake pharmacy renovations or new pharmacy builds to facilitate compliant compounding practices.
Compliant sterile compounding is a challenge for many organizations. The board of pharmacy permitting process for sterile compounding is lengthy, often spanning several months. State boards of pharmacy may require the submission of USP <797> certification reports, as well as viable and non-viable testing of the buffer and anterooms, prior to initial inspection for a sterile compounding permit. Construction delays due to misinterpretation or misunderstanding of federal regulations by inexperienced contractors can contribute to delayed pharmacy openings and increase construction costs. Thus, it is critical to develop a comprehensive pharmacy construction plan, guided by sound practices and regulatory compliance.
The following information is intended to assist pharmacy departments in construction planning discussions.
Engage with Knowledgeable Partners
Partnering with well-informed, experienced vendors is central to a successful pharmacy construction project, and therefore it is vital that pharmacy leadership have input into the selection of contractors. Work closely with hospital administration to ensure they provide the necessary support and sufficient resources.
When designing a new cleanroom, give serious consideration to hiring a Controlled Environment Testing Association (CETA)-certified vendor to participate in the cleanroom design and layout. CETA is a nonprofit organization devoted to promoting and developing quality assurance within the controlled environment testing industry; CETA-certified vendors in each state are listed at http://www.cetainternational.org/find-a-ceta-member#/. Engaging a pharmacy inspector to review design and floor plans is another expedient tactic.
Provide contractors with copies of USP <797>, USP <800>, and an engineering design article that includes information detailing buffer room HVAC design and exhaust requirements (for example, Zhang J. Understanding pharmaceutical cleanroom design. ASHRAE J. 2004;Sept:29-33.). In addition, provide the contractors with a checklist of design requirements, vetted by the pharmacy leadership team, to ensure a compliant workspace design. Regular meetings with the contractors should be scheduled throughout the planning process. The pharmacy leadership team must be specific in the physical requirements for the ISO-classified spaces and should be prepared to review the list of requirements at each meeting.
Conduct a Workplace Analysis
A workplace analysis will elucidate the scope of the renovation or pharmacy build and should include a review of pharmacy services that will be offered plus the characteristics and quantities of compounded sterile products (CSPs) that the IV rooms will produce.
Robust planning and workflow efficiency are critical to compliant non-sterile hazardous drug compounding. One important consideration is the type and quantity of containment primary engineering control (C-PEC) devices required. Sketch out the ideal pharmacy layout with preferred room dimensions, including ceiling heights and pressurization requirements for the ISO-classified spaces. USP <800> Appendix 2 contains suggested cleanroom designs; USP <797> also contains an appendix with a summary of requirements that will facilitate planning activities.
Choose a Pharmacy Location
A new oncology pharmacy ideally would be positioned adjacent to the infusion treatment center, in close proximity to the clinics, and centrally located in the patient care area. It is important to maximize the allocation of sufficient pharmacy space at the beginning of the project, as it is expensive and difficult to add space after construction is complete.
Design a Floor Plan
When designing a floor plan, incorporate the entire final CSP distribution model, including the receiving, storage, and waste-disposal processes. The design must facilitate open communication between departments (eg, pharmacy and nursing). Review pharmacy entry points closely to maximize overall efficiency and security.
The Central Pharmacy
Limiting built-in cabinetry while maximizing modular workstations and countertops in the central pharmacy area can increase the level of customization. Because volumes typically increase over time in an outpatient oncology pharmacy business model, utilizing modular systems makes it easier to adjust workstations to ensure efficiency. Technology innovations are common, so it is important to consider adding additional power supply outlets and phone and data network jacks. The electrical plans should indicate the height of outlets from the floor or at the counter surface; be sure to consider equipment placement to ensure that the jacks are in the optimal locations. A generator to back up electrical supply is often a prudent addition to prevent loss of refrigerated drug product, especially after hours, although this option may or may not be available at satellite locations. Consider installing cameras in the central workroom positioned on entry areas and the entrance to the containment secondary engineering control (C-SEC) areas. Cameras can assist in the review of personal protective equipment (PPE) compliance as well as help identify security breaches.
Buffer Rooms and Anterooms
Secondary engineering controls (SECs) include the buffer rooms and anterooms. Designs for these ISO 7- and ISO 8-classified areas must be efficient and allow for up to 50% volume growth.
Be sure to install sufficient electrical outlets and network drops in the buffer room. A refrigerator may be installed in the buffer room to meet negative pressure hazardous drug storage requirements. Utilize pressure monitors that can be calibrated and that display a numerical value; ensure that the locations of the monitors are appropriate to the rooms that are monitored. Non-hazardous drug buffer rooms require air returns placed low to the floor and behind or near particle-generating areas, such as compressors; this positive-pressure area should have a pressure monitor. Consider adding a HEPA-filtered air supply inside the buffer rooms and anterooms near the entrance of the room, and if the room is a positive pressure environment, add a return low to the floor near the door to protect the air quality of the rooms.
Anterooms adjacent to hazardous drug buffer rooms require ISO Class 7 standards, while anterooms adjacent to non-hazardous drug buffer rooms require ISO Class 8 standards. A knee-operated, foot pedal-operated, or hand-motion activated task sink is preferred in the anteroom. Sufficient space should be allocated for proper garbing. A contrasting color line of demarcation should be heat-welded into the floor to separate the clean and dirty sides of the room.
The HVAC system must be dedicated to the pharmacy compounding areas in order to avoid ongoing challenges with temperature, humidity, particulate, and microbial growth. The air supply from the HVAC system into the buffer rooms and anterooms must be HEPA-filtered air at the ceiling level. Utilizing ceiling HEPA filter units with adjustable fans for each unit to facilitate test and balance activities is preferable. Ensure that the clean air supply is not positioned directly above where a technician will work in a biological safety cabinet (BSC), because workers may complain that the air supply is too cool. Leave 10 to 12 inches in between and behind each BSC so that there is a gap to facilitate proper cleaning around the units. The ducts should be constructed from galvanized steel or aluminum, which prevent microbial growth. Due to the rigid nature of the galvanized duct, adequate ceiling height is essential to allow for adequate BSC height and to provide a comfortable and ergonomically appropriate workspace.
Proper exhaust configuration is important in the negative pressure areas. The return air must be exhausted to the exterior of the building with a stack height and location to prevent the exhaust from recirculating into air supply for the building. At the distal end of the exterior exhaust pipe, there should be an adjustable fan that is set at a slightly higher amperage than the exhaust of the BSC; this pulls the exhaust air within the negative pressure duct from the BSCs to the outside air. Pharmacy should ensure the engineers are aware of this requirement and include it in the plans.
The pharmacist should keep a copy of the manufacturer’s exhaust specifications for each BSC. The exhaust calculations for the room must factor in the exhaust from each cabinet. Each Class II Type A1 or A2 must have a thimble connection for a canopy exhaust; each BSC Class II Type B1 or B2 must be hard-ducted. Current NSF/ANSI 49 Standards mandate that Class II Type A1 or A2 cabinets with canopy connections must be fitted with an audible and visual exhaust (eg, thimble flap) alarm to alert the users that the exhaust is venting into the IV room instead to the outside air. If the thimble flaps are closed, then the exhaust is under negative pressure.
Walls, Ceilings, and Flooring
USP <797> requires that walls, ceilings, and flooring be constructed of materials or modular systems that can withstand the cleaning standards. Two-part epoxy paint is preferred. Ask the contractors to provide a cut sheet for the paint that is used to ensure that is it rated for cleanrooms. The ceiling tiles must be washable and a gasket system installed. (Note that USP <797> requires only caulked ceiling tiles, while the state of Florida, where our hospital is located, requires both caulking and a gasket system.) The ceiling tiles are caulked to the ceiling grid; ensure that the perimeter of the ceiling grid and the edges around the ducts are caulked to seal the area from particle intrusion. Specify that the contractors use a white caulk or a color that matches the ceiling and not clear caulk, which can give the appearance of the tiles not seating properly or of debris in the caulk. The vinyl flooring must be a no-wax product that extends a few inches up the wall. The seams must be heat-welded. The top of the flooring must be caulked to the wall. Non-glass doors must be painted on all sides, including the top edge of the door, and the top of the door frame must be painted to facilitate cleaning.
Hazardous Drug Storage
Hazardous drugs stored outside of the buffer rooms should be stored under negative pressure. There must be 12 air changes per hour and a dedicated exhaust. The hazardous drug storage area should also have a pressure monitor with a numerical display. Consider adding a work surface for decontamination of the outside of hazardous drug vials upon arrival into the department.
Windows, Pass-Throughs, and Cameras
It is helpful to install viewing windows from the central pharmacy and the anteroom into the buffer rooms to allow surveyors to observe practice from outside the buffer room. Pass-through windows increase efficiency; the preferred window is constructed from stainless steel with interlocking doors to reduce microbial growth. An efficient design includes a HEPA-filtered purge pass-through window from the hazardous drug buffer room to the nursing area medication room to facilitate distribution. Consider installing cameras at the ceiling level in the buffer rooms and anteroom so that compliance with PPE, cleaning procedures, and other standard operating processes can be monitored.
Periodically monitor progress during the construction phase. It is important to meet with the HVAC subcontractor at the site to visualize the above-ceiling ducting of the supply air, the return air, and the exhaust ducts before construction is complete. Include the engineering manager who will be responsible for the new pharmacy area on the construction site walk-through. This is an opportune time to ask questions about the air and exhaust systems and take photographs.
Current pharmacy permit application process regulations require 30 to 60 days’ completion time after the construction to allow for the certification of the PECs, SECs, and viable and non-viable particle testing for air and surface sampling. Because the HVAC and exhaust requirements are stringent, do not sign off on the completion of the project until at least 60 days after the non-viable and viable testing results are completed and have been certified as meeting requirements.
A checklist for constructing an oncology pharmacy is included in the SIDEBAR. A suggested reading list is available at pppmag.com/oncph
Andrea Ledford, PharmD, BCOP, CP, is oncology pharmacy manager at the UF Cancer Center at Orlando Health. She completed a BS in pharmaceutical science and a PharmD from Virginia Commonwealth University Medical College of Virginia, and obtained board-certification in oncology pharmacy in 2002. Andrea’s responsibilities include managing pharmacy operations and financial oversight for four cancer center locations, clinical pharmacy services, investigational drug services, PGY2 oncology residency, and the patient-assistance program for adult inpatient and outpatient oncology patients.
Brian Wetzel, BS, MHA, is the chief operating officer for the UF Cancer Center at Orlando Health. He completed a BS from Florida Southern College and an MHA from the University of St Francis. Brian is responsible for daily operations and financial management of four cancer center locations, including medical oncology, radiation oncology, infusion areas, pharmacy services, nursing, and laboratory services. In addition, he provides oversight of facility design and cancer program development.
Checklist for Constructing an Oncology Pharmacy
Hazardous Drug Buffer Room (ISO Class 7)
Non-Hazardous Drug Buffer Room (ISO Class 7)
Anteroom (ISO Class 7 or 8)
Hazardous Drug Storage Room
*Note that USP <797> requires only caulked ceiling tiles, while the state of Florida, where our hospital is located, requires both caulking and a gasket system.