Q&A with Kevin N. Hansen, PharmD, MS, BCPS; Arpit Mehta, PharmD, MPH; Daniel P. O’Neil, PharmD, MS, BCPS; and Matthew Wolf, PharmD, MS
When building or renovating a cleanroom to meet USP <797> and <800> standards, it is often necessary to concomitantly provide safe, high-quality compounded sterile preparations to patients, a situation that can present unique challenges. On December 1st, 2019, a major revision to USP <797> Pharmaceutical Compounding—Sterile Preparations and the newly created USP <800> Hazardous Drugs—Handling in Healthcare Settings will become enforceable. Each of these chapters provides new minimum standards for cleanroom design, equipment, personnel practices, and more, all designed to ensure quality and safety for patients and employees. To implement these standards, many hospitals require significant facility changes to meet the new cleanroom specifications, and are busy preparing their facilities to meet the requirements.
The following discussion examines the approaches four hospitals across the United States have taken to renovate existing cleanrooms and build new cleanrooms to meet these new standards. These approaches can be considered best practices for designing the inpatient pharmacy cleanroom of the future.
Cleanroom Design Considerations
Pharmacy Purchasing & Products: How can pharmacy ensure that all surfaces in the cleanroom are cleanable?
Hansen, Mehta, O’Neil, and Wolf: Floors should be made of continuous sheet vinyl or poured epoxy with coved corners, while walls should be composed of smooth, non-porous material, often modular pre-fabricated panels or drywall, with epoxy-based paint. Make sure the walls are as smooth as possible, and avoid the incorporation of ledges or window sills, where particulates can accumulate. For tile ceilings, both the tiles and the support grid should be impervious to the cleaning agents used, and the tiles must be caulked in place to ensure the room is sealed. Install cleanroom light fixtures such that there are no gaps or leaks in the ceiling.
Consider which cleaning agents will be used and how these products will impact the surfaces of the space. All workbenches, computer stations, and carts in the sterile compounding room must be made of stainless steel or a non-porous, wipeable material. When possible, install wheels or casters on carts and workbenches, to provide mobility during daily and terminal cleaning. Solid, stainless-steel carts and shelving can be wiped down easily.
PP&P: What are the considerations for choosing cleanroom doors?
Hansen, Mehta, O’Neil, and Wolf: The main doors of the sterile compounding room must be wide enough to move equipment in and out, and all the doors in the compounding area should be electronically interlocking. The interlocking mechanism ensures that if one door is open, any other door in that series is prohibited from opening. Be sure to work with the door vendor to activate this function, as it is not typically standard for general public access doors. If electronic interlocking features are not an option, the same functionality can be achieved through appropriate workflow and training, but this alternative requires real-time monitoring to ensure compliance.
Review the safety features that come standard on sliding glass doors. Touchless door open technology (ie, wave open) should be included. Also consider including the option to manually push open the door in an emergency. Other features are less desirable; for example, several light current barriers may be included, which prevent door closure while a staff member is in close range. Depending on the size of the cleanroom, this safety feature may prohibit the door from closing in a timely manner. Be sure to discuss these issues with the vendor before installation.
PP&P: How can pharmacy ensure that the workspace maintains a state of control during dynamic operating conditions?
Hansen, Mehta, O’Neil, and Wolf: With the understanding that compounding volume and staff levels will change over time as hospitals grow and patient volumes increase, several considerations should be taken into account to maintain a proper state of control. Install a dedicated air handler with back-up power to provide air supply well above the minimums set in USP <797>. A target of double the air changes per hour (ACPH) required in USP <797> will provide a sufficient cushion to maintain environmental levels within compliance in a busy IV room.
Other factors should be considered to minimize potential downtime in the cleanroom due to ongoing maintenance and repair. For stick-built cleanrooms constructed with drywall, extra consideration must be given to prevent drywall damage from carts and hoods. Non-porous, plastic wall protection can shield the lower half of walls, which are at risk of being bumped and damaged.
PP&P: When designing a cleanroom, what important issues are often overlooked?
Hansen, Mehta, O’Neil, and Wolf: Significant attention is usually spent on ensuring appropriate air handling and room pressures. While this is important, do not neglect other critical issues, such as where data jacks, power outlets, and wireless routers are to be placed. Additionally, access to chilled water lines should be considered if IV robotics or other cleanroom automation with this requirement is being considered. Remember that it is much easier to prepare for these features when the room is under construction than to remedy the situation later after the room is otherwise operational.
PP&P: What are the considerations when choosing equipment for the cleanroom?
Hansen, Mehta, O’Neil, and Wolf: All workbenches, computer stations, and carts in the sterile compounding room should be flat stainless steel (no wire) or other materials that can be easily cleaned with wipes. Wheels or casters are good additions to carts and workbenches so they can be moved to facilitate daily and terminal cleaning. To clean behind hoods, consider placing hoods on casters so they can be moved; hoods can also be mounted to the wall.
PP&P: What are some methods for transferring medications and supplies into and out of the cleanroom?
Hansen, Mehta, O’Neil, and Wolf: Transferring medications and supplies into and out of the cleanroom space can impede workflow efficiency if not carefully considered. Many pass-through options are available. For example, an interlocking window, cart, or even an entire room can be dedicated to material transfer. Consider the volume going into and out of the buffer room; for smaller hospitals, a window pass-through may be sufficient, while larger hospitals may find dedicated transfer in-and-out rooms may better suit the workload. With an ISO Class 8 transfer room, material can be moved in bulk, transfers are not confined by the size of the cart or the window pass-through.
Some hospitals may implement high-density shelving outside of the cleanroom, while larger hospitals may utilize a HEPA-filtered medication carousel for storage of medication and supplies in the anteroom.
PP&P: Under USP <797>, is it acceptable to have electronics (eg, televisions, computers, printers) inside the buffer space?
Hansen, Mehta, O’Neil, and Wolf: As technology becomes more ubiquitous, so does health care’s reliance on electronic devices; this holds true in the cleanroom as well. Incorporating television screens, track boards, computers for photo capture and gravimetric technology, and printers for compounding equipment should be considered in every cleanroom redesign. Carefully evaluate their placement in relation to the ISO Class 5 compounding area as well as low wall air returns.
During the design phase, include any electronic equipment in the drawings, and ensure that the low wall air return placement is in close proximity; this ensures that any particles that could be produced by certain equipment are immediately sent to a HEPA filter for removal and to avoid out-of-specification air quality in the classified spaces.
When selecting paper and/or labels for printing, use stock that is specifically designed to be low-linting.
PP&P: What type of sink and shelving are ideal for the cleanroom?
Hansen, Mehta, O’Neil, and Wolf: The sink for the compounding area should be placed in either the anteroom or the scrub room, not in the cleanroom. To ensure appropriate hand hygiene, utilize a hands-free, stainless-steel, deep scrub sink. Solid stainless steel shelving in the cleanroom and anteroom supports ease of cleaning during the daily and monthly cleanings.
Communication and Workflow
PP&P: What are the considerations for building a cleanroom that will be operational for decades?
Hansen, Mehta, O’Neil, and Wolf: When designing a cleanroom to last 20-30 years, keep in mind that the current technology will likely evolve over the next few years. Therefore, include ample structure to support technological capabilities. Data ports for internet connection at or near each hood may prove valuable for future computers or IV workflow technologies. If computer workstations are placed within the cleanroom, data outlets must also be available to support them. Data ports will also be necessary should an automated dispensing cabinet be incorporated into the compounding area. Including emergency (red) outlets is also critical for refrigerators, freezers, IV robots, or IV pump technology, to ensure the pharmacy can continue to operate during power outages.
Contractors may be unfamiliar with these requirements, so working closely with them is essential to ensure the cleanroom is configured correctly to support current and future workflow.
PP&P: What options are available for communicating with staff inside the cleanroom and vice-versa?
Hansen, Mehta, O’Neil, and Wolf: Communication into and out of the cleanroom can occur both visually and audibly. Windows support visualization into the cleanroom (assuming ledges are minimized and proper caulking occurs) and can play an important role in communication between employees if assistance or a QA check is required. Audible communication is critical to check on the status of products being prepared or to relay important information into the cleanroom. Phones or intercom systems can be used; however, note that intercom systems are typically fixed into a wall unit, which would prevent long-term flexibility if workstation locations change. Phone intercom systems may be best to weather changes in future workflow.
While proper communication is central to any safe and efficient workflow, interruption and distractions should be minimized. Consider placing phones or intercom systems away from compounding or checking locations.
PP&P: Are music systems acceptable in practice?
Hansen, Mehta, O’Neil, and Wolf: Because USP does not prohibit use of music, whether or not to include a music system is primarily a departmental or manager-specific decision. There are debates about whether music can enhance or distract focus from a job. If such a system is desired, placing a sound system into the wall or ceiling is certainly easiest during the building phase, and can also be viewed as a staff satisfaction factor. As a best practice, house the sound connection outside of the cleanroom to ensure both viable and non-viable particles are minimized.
Also note that mobile phones should not be permitted past the line of demarcation.
PP&P: What are the options for notifying staff of STAT products?
Hansen, Mehta, O’Neil, and Wolf: Many methods can be used to notify staff that STAT medications are needed. For example, a colored bin system can be effective if an employee is stationed near a pass-through. A light switch, controlled both on the inside and outside of the cleanroom, has been used to act as an alert. Traditional intercoms or phones have also been utilized with success. Regardless of the method chosen, a clear and efficient process should be developed during the design phase.
PP&P: What are some considerations for incorporating IV workflow software technology into the cleanroom?
Hansen, Mehta, O’Neil, and Wolf: Whether an IV workflow software system is already in place or is planned for future installation, it is important to assign appropriate space, electrical outlets, and data ports to facilitate the system. In addition to the standard gravimetric and volumetric device screens, some institutions have found success using televisions or large screens to project compounding work queues.
PP&P: What other factors are important when preparing for a new cleanroom?
Hansen, Mehta, O’Neil, and Wolf: Keep in mind other equipment or technology that may be adopted in the future, and consider what the necessary requirements to support this equipment. For example, IV robots may require a chilled water line, while other equipment may require pneumatic air. Pass-through carousels, or other high-density storage, may also be a future option and will have specific height and weight considerations.
Finally, under USP <800>, it will be important to separate hazardous and non-hazardous product workflow, which requires a review of hazardous drug receiving, storage, preparation, cleaning, and delivery processes within the cleanroom.
PP&P: What lessons have been learned throughout the design and construction phases of building a new cleanroom?
Hansen, Mehta, O’Neil, and Wolf: It is vital for staff to read and understand the regulations, standards, and guidelines for pharmacy cleanrooms. This includes but is not limited to: USP <797>, USP <800>, CETA CAG 003, ISO 14644, FDA guidance documents, etc.
Do not assume that the design and construction teams have fully read and/or understand all of the requirements. It is important for pharmacy to be at the table for all key decisions and to educate the key stakeholders as to the requirements.
PP&P: What are some lessons learned around certification of the cleanroom suite?
Hansen, Mehta, O’Neil, and Wolf: Involving the certification company well in advance of the actual certification is highly recommended. Having the certification company visit the construction site to ensure that the HEPA filter housing is appropriate with the required aerosol injection and sample port is crucial. If moving to a new location, have the certification company certify the room well in advance of the move, which allows for any minor changes/repairs prior to the move.
Having the HEPA filters tested to the room integrity prior to performing the terminal clean of the cleanroom is recommended to ensure any leaks are patched. This is important as if any leaks are realized, which could contaminate the cleanroom and make the terminal clean ineffective.
Pharmacy should learn from the historic compounding tragedies of the past and commit to ensuring patient harm from compounded sterile preparations are never events. Building a USP <797> and USP <800> compliant cleanroom is the first step toward this goal.
Moreover, as hospitals prepare to comply with the major revisions in the compounding standards, opportunities exist to exceed these standards with best practices in facility design, equipment, communication, and workflow. Set the bar high to ensure safe, compliant compounding of sterile preparations.
Kevin N. Hansen, PharmD, MS, BCPS, the assistant director of pharmacy at Moses H. Cone Memorial Hospital, provides oversight and leadership for pharmaceutical compounding and perioperative services pharmacy. He graduated from the Lake Erie College of Osteopathic Medicine with a Doctor of Pharmacy degree and received an MS in Pharmaceutical Sciences from the University of North Carolina Eshelman School of Pharmacy.
Arpit Mehta, PharmD, MPH, is the director of pharmacy at Allegheny General Hospital in Pittsburgh, Pennsylvania. He received a PharmD from Lake Erie College of Osteopathic Medicine School of Pharmacy in 2012 and completed a PGY1/PGY2 health system pharmacy administration residency at West Penn Allegheny Health System. Arpit received his MPH from University of Pittsburgh–Pitt Public Health in 2013.
Daniel P. O’Neil, PharmD, MS, BCPS, is the assistant director of pharmacy at West Virginia University Medicine. He completed his PharmD at Lake Erie College of Osteopathic Medicine and his MS in health-system pharmacy administration at the University of North Carolina Eshelman School of Pharmacy.
Matt Wolf, PharmD, MS is a pharmacy manager and clinical assistant professor at Froedtert and the Medical College of Wisconsin in Milwaukee. He oversees IV compounding at Froedtert Hospital and Infusion Center. Matt received his pharmacy degree from the University of Michigan and completed a 2-year administrative residency at the University of Wisconsin.
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