1. A germicidal detergent must be used as one of the designated cleaning agents to clean all surfaces. During daily and monthly cleaning, all surfaces (including primary engineering controls [PECs]) must be cleaned with a germicidal detergent (eg, Virex, Lysol IC, Quatsyl-256) that is diluted per manufacturer’s specifications prior to using sterile 70% isopropyl alcohol (IPA). IPA used alone is not sufficient for any surface. In the case of PECs, the germicidal cleaning agent should be allowed to dry before applying sterile 70% IPA. USP <797> states that the compounding surfaces inside of a PEC be cleaned at specified intervals: at the beginning of each shift, before each batch, every 30 minutes during ongoing compounding, after spills, and when the surface is contaminated.
2. Detailed information about germicidal detergents for use in pharmacy compounding environments should be memorialized in written policy, procedure, and documentation forms (paper or electronic). Policies and procedures (P&Ps) need to state what germicidal agents can be used in the pharmacy along with the required dilution of each respective agent. It is a recommended best practice to create a form to document cleaning solution preparation. The form also should specify the amount of the agent for each commonly used amount of water (depending on your buckets or containers). The right dilution is critical to a solution’s germicidal effectiveness. A concentrated solution can cause damage to floors, sinks, and other surface areas and an overly diluted solution will not be effective.
3. Clean from cleanest to dirtiest and from top to bottom. For daily cleaning, begin with the inside of the PECs, followed by all easily cleanable horizontal surfaces (carts, shelving, stools, etc), then floors. Move from the buffer area to the ante areas. Daily cleaning should begin at the end of each compounding day (or occur once daily for 24-hour compounding facilities). During monthly cleaning, start with ceilings, walls, and windows. Follow with ISO Class 5 surfaces (inside your PECs), workbench shields, all outer aspects of the workbench horizontal surfaces (top and bottom of shelving), legs and wheels of shelving/carts/hoods, trash receptacles, and floor.
4. Daily cleaning of PECs includes cleaning all interior surfaces. Interior surfaces of the PEC include interior hood ceiling, back grill, sides, IV bar, hooks, and the deck (compounding surface). This cleaning also includes anything that remains in the hood on a semi-permanent basis, such as a sharps unit, crimping devices, and automated compounding devices. Clean the item and the surface underneath. The same applies for isolators; in addition, clean all surfaces of the ante-chamber (if applicable), as well as isolator sleeves (gauntlets) and gloves.
5. If performing hazardous drug (HD) compounding, deactivation of all PEC surfaces must be performed before undertaking daily cleaning with the germicidal detergent. Sterile 70% IPA does not deactivate HDs; therefore, cleaning with IPA serves only to spread existing HD contamination. The safety data sheet/material safety data sheet for each HD may specify chemical agents that can be used to deactivate it; however, many are deactivated first by using a simple 2% sodium hypochlorite solution. It may be necessary to use sodium thiosulfate after using the bleach to inactivate the chlorine to keep it from corroding or pitting the stainless steel work surfaces. Of note, daily cleaning with a germicidal detergent negates the need for sodium thiosulfate, as the disinfecting agent solution will inactivate the sodium hypochlorite. Because all cleaning and rinsing solutions must be treated as contaminated waste, pre-moistened wipes may be the most convenient. Conversely, spray bottles of solutions can be used to wet wipes in order to avoid using buckets to mix cleaning solutions.
6. Use sterile water to dilute the designated cleaning agent to clean the inside of the PECs. Ideally, sterile water (sterile water for injection or irrigation) should be used to dilute germicidal agents used inside of the ISO Class 5 areas. While neither these areas, nor the buckets/wipes used are sterile, use of sterile water to dilute disinfectants reduces pyrogens and potential bioburden. Regular tap water can be used for any areas outside of the PEC. Note the exception for vertical flow work benches in the cleanroom (ie, long stainless steel tables with 100% HEPA coverage and plastic panels hanging from the ceiling). The ceiling (HEPA filters) and back wall, inside of the polycarbonate panels, and table surface are considered the inside of this type of PEC, and therefore, should be cleaned with a germicidal detergent diluted with sterile water.
7. It is preferred that once-daily cleaning activities be performed at the end of the compounding day (for non–24-hour operations). Ideally, cleaning of the general compounding area (buffer area/cleanroom and anteroom/area) occurs at the end of the compounding day to prevent any component residue from sitting overnight and increasing the potential to promote bacterial growth. If cleaning occurs at the start of the compounding day, adequate time must be given to allow all cleaned surfaces to dry prior to compounding. Should compounding occur after-hours (eg, on-call), additional cleaning might be necessary at the start of the next business day.
8. Non-pharmacy employees who perform cleaning must receive training and successfully complete competency verification in cleaning procedures, hand hygiene, and garbing. All personnel who perform cleaning functions must receive training and successfully complete competency assessments in hand hygiene and garbing, as well as cleaning and disinfecting. Cleaning of the buffer area/cleanroom, segregated compounding area, and anteroom/ante-area may be performed by trained and competent non-pharmacy personnel; however, they should not clean ISO Class 5 PECs.
9. Cleaning is one key element of an overall sterile compounding quality management program. The combination of facility metrics and personnel-related metrics result in a facility that is in control and suitable for compounding sterile medications.
10. Development of a quality culture that emphasizes and expects compliance with cleaning cannot be overemphasized. Pharmacy and organizational leadership must set clear expectations and provide the necessary support to execute pharmacy’s quality program. Develop detailed and current P&Ps to avoid gaps between what is stated in the policy versus what occurs in practice.
Kate Douglass, MS, RN, APN,C, CRNI, is vice-president of CriticalPoint, a health care training and development company. She is one of the USP <797> study co-directors.
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