Q&A with Kate Douglass, MS, RN, QP503A qualified,
and Abby Roth, CMQ/QE, QP503A qualified
Although USP <797> was published in both 2008 and 2019 (the 2019 version has been returned to the Expert Committee for reevaluation), many pharmacists continue to pose questions about the intricacies of compliance with the Chapter. In this article, which is Part 3 of a 3-part series on cleaning and disinfecting, the authors review areas of confusion and misinformation regarding USP <797>. Answers are based on USP Chapter requirements, but focus heavily on best practices.
Pharmacy Purchasing & Products: How often should low-linting wipes be changed when cleaning a PEC, and mop heads or mop head covers when cleaning the ceiling, walls, and floors?
Kate Douglass and Abby Roth: Low-linting wipes used in the primary engineering controls (PECs) are not required to be sterile, but we recommend the use of sterile, presaturated wipes (when available) for use inside the PEC as a best practice. Wipes must be changed when they become visibly dirty; however, note that wipes used to clean the PECs should rarely become visibly dirty. If they do, this may signal poor cleaning practices. Cleaning the deck is the only activity that might cause wipes to become visibly dirty.
If a wipe is no longer wet enough to achieve the dwell time of the agent, then it must be changed. One of the most common mistakes in cleaning is under-wetting the target surface. When cleaning ceilings and walls (in that order), the mop head rarely gets visibly dirty. We do, however, have to re-wet the mop head frequently to ensure that the target surface is evenly wet. The mop begins to drag and move differently across the surface when it is no longer sufficiently wet. Workers must be vigilant and continuously evaluate their work relative to wetness and dwell time.
PP&P: Is there a requirement for residue removal in USP <797>?
Douglass and Roth: USP <797> does not discuss residue removal. Some cleaning agents leave behind more residue than others. There is no requirement or reason to remove residues on the ceiling or walls. However, consider removing residues on the floor periodically if it becomes sticky.
At the CriticalPoint Center for Training and Research, we use an accelerated hydrogen peroxide, EPA-registered, one-step bactericidal disinfectant cleaner. It leaves a residue that tends to be minimally sticky as long as the right amount of the agent is used. We remove residues on the floors once a week by wiping the floor with sterile water for irrigation. When the floors are dry, we perform our regular daily cleaning with the cleaning agent. Note that isopropyl alcohol is an excellent residue remover, so while it is being used to sanitize the interior surfaces of the PECs and the staging tables, it is concurrently removing any residue.
PP&P: How important are the expiration dates on the sterile IPA spray bottles or packages of sterile, presaturated wipes?
Douglass and Roth: It is important to adhere to the expiration date that is stated on the packaging. Because beyond-use dates (BUDs) only apply to CSPs, no such dating exists for cleaning agents.
Spray bottles of sterile IPA that come in sterile, wrapped components must be assembled inside a PEC using aseptic technique. The bottle may be used until it is empty, which usually occurs long before the labeled expiration. Soft packages of presaturated wipes must be wiped with sterile IPA before placing them inside the PEC. While these packages can be used in ISO 7 or ISO 5 air, once they are opened in ISO 7 air, they may not be moved into ISO 5 air. Further, when the packages are opened, fingers should touch only the one wipe that is pulled from the package. Staff must use a technique to close the packages that ensures no air is trapped inside and then the flap must be securely resealed. These sterile “presats” are valuable tools, but they are costly; failure to close the packages properly results in premature drying of the wipes.
PP&P: Can the pharmacy be cited for having paper in the buffer room?
Douglass and Roth: There is no prohibition on having paper required for compounding (eg, compounding documentation or labels) in the ISO 7 or 8 spaces. In addition, it is not necessary to transfer compounding documentation and labels into the buffer room in resealable bags. Consider that garbed workers shed more particles and contamination than paper does.
As long as the documentation is never placed in the ISO 5 space, it can enter with the patient-specific or batch components and exit with the final CSPs. Although it is prudent to minimize paper, paper required for documentation is acceptable in the ISO 7 and 8 spaces. Binders and large stacks of paper must not be stored in the ante or buffer rooms.
PP&P: When remodeling the cleanroom suite, should UV lights be installed?
Douglass and Roth: We do not recommend the use of UV lights, whether built into the ceiling or wheeled in from elsewhere in the hospital. These lights are more appropriate for high bioburden spaces, such as patient rooms. Because ante and buffer rooms have very low bioburden, if we follow the contamination control principles of proper material handling, hand hygiene, garbing, and conduct in cleanrooms, and maintain engineering controls that are working as intended, then this technology is definitely not necessary in cleanrooms.
Also, it is critical to note that use of UV lights is not a substitute for cleaning. These lights are disinfectants and do not clean the space by physically removing dirt and debris. When surfaces have not been cleaned to reduce the debris and dirt, they cannot be disinfected. Because these lights are “additive” only, they do not eliminate the need to perform manual cleaning with an EPA-registered, one-step disinfectant cleaner.
PP&P: If monthly cleaning is outsourced to the hospital’s environmental services (EVS) staff, can their SOPs be used for cleaning?
Douglass and Roth: You must create your own SOPs. Pharmacy can outsource many services (eg, environmental sampling, cleaning, certification, etc), but it cannot outsource the responsibility for proper cleaning, which always resides with the pharmacy. Cleaning sterile compounding spaces is significantly different than cleaning any other space in the hospital.
Whether outsourcing daily or monthly cleaning, pharmacy should be aware of the following:
PP&P: What cleaning is required after certification?
Douglass and Roth: USP <797> does not detail specific requirements for cleaning after certification activities. However, check to see if your state has regulations governing cleaning after smoke testing or certification.
We believe cleaning must be performed before resuming compounding after certification services. We have done a preliminary study of the condition of the ISO 5 space by performing air and surface sampling inside the PEC after certification. Based on those results, we recommend cleaning and disinfecting all interior surfaces of the PEC with an EPA-registered, one-step sporicidal disinfectant cleaner and then wiping all surfaces with sterile IPA after the dwell time is achieved.
In the ISO 7 and 8 spaces, coordinate certification to occur immediately before monthly cleaning is due, so the space will be cleaned with the EPA-registered, one-step, sporicidal disinfectant cleaner after certification activities. At a minimum, after certification activities, perform a daily cleaning using the EPA-registered, one-step, sporicidal disinfectant cleaner.
PP&P: At the end of the day on Fridays, the PECs, buffer rooms, and the ante-room are cleaned. If no one enters the rooms again until Monday, must they be cleaned again before compounding on Monday morning?
Douglass and Roth: According to USP <797> (2008), which is currently enforceable, you do not have to clean Monday morning before beginning compounding. There is no rationale for cleaning if you left the room clean, all the engineering controls working, and if no particle-generating activity occurred. However, we recommend wiping every interior surface of the PECs with sterile IPA before starting to compound.
USP <797> (2019) includes a provision stating that “If compounding is not performed daily, cleaning and disinfecting must be completed before initiating compounding.” We do not agree with this requirement and can find no rationale to support it; however, your pharmacy must perform cleaning on Monday morning should USP <797> (2019) become enforceable as written. Perhaps if the new sterile compounding expert committee takes a second look at this requirement, we may see a change.
Kate Douglass, MS, RN, QP503A qualified, is the vice president and chief development officer of CriticalPoint, LLC, a health care training and development company. She is a co-author of CriticalPoint’s Interactive USP Chapter <797> and <800> Gap Analysis Tools and co-director of the USP Sterile Compounding Compliance Study. Kate has personally supervised the design, engineering, and build of pharmacy compounding facilities that met or exceeded USP requirements.
Abby Roth, CMQ/QE, QP503A qualified, is the director, learning and development at CriticalPoint, LLC. In her current role she develops curriculum for CriticalPoint’s e-learning modules and live training classes. She is a faculty member for the Sterile Compounding Boot Camp Live Training Series. Prior to joining CriticalPoint, Abby served as the director of microbiology for Clinical IQ, LLC, and as a quality director at a contract microbiology laboratory specializing in environmental monitoring.
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