A: Over time, compounding aseptic containment isolators (CACIs) become a reservoir of multiple toxic agents and many manufacturers recommend against ever completely opening the device to avoid employee exposure. CACIs are not all constructed the same so it is important to consult with the manufacturer as to the correct procedure for reaching any area in or under the work surfaces of the CACI that may harbor drug residue. The following are general cleaning procedures that may be modified for use with your specific CACI.
Before beginning any process within a CACI, it is imperative to verify that the gloves, sleeves, and all gaskets are intact. Glove changes should always be done using a technique that does not open the CACI main chamber. New gloves are replaced over the old gloves from the outside and the old gloves are removed from the inside (check with the manufacturer for the correct procedure). Pinholes and worn areas in the sleeves are common issues, and any damaged parts should be replaced. If the CACI must be opened to replace these, cleaning must be done beforehand to minimize exposure.
Assemble all needed supplies and PPE before beginning. Ensure that adequate gloves, wipers, and containment bags are readily available. Wear additional gloves that directly cover skin whenever cleaning a CACI. Change the gloves that are closest to skin frequently to avoid possible permeation of any drug residue through the gloves and absorption through the skin.
Because the design of CACIs differ, some are easier to open than others. For example, those with laminar airflow plenums under the work surface may accumulate residue in this area—just like a biological safety cabinet. To access this area, the work surface must be raised, and with the negative pressure of the CACI pulling against it, physical exertion is required.
Initial cleaning of all reachable surfaces is recommended and be sure to discard all cleaning material in the appropriate hazardous drug waste container before executing cleaning procedures that require the CACI to be opened. This should reduce the likelihood of exposure.
Visually assess the CACI to see if there are any spots that will require special cleaning. Before opening the front of the CACI, clean all reachable surfaces in the main chamber and the antechamber with sterile water and a small amount of detergent to reduce any remaining drug residue and limit possible hazardous drug exposure. Then, rinse with wipers saturated with sterile water. Contain all contaminated cleaning materials and gloves for appropriate disposal.
After the initial cleaning, a complete cleaning may be performed. When completely cleaning a CACI, full PPE, including respiratory protection as well as extra gloves, should be worn to avoid exposure to any toxic vapors or fumes that could become volatile. PPE must include a properly fitted NIOSH respirator rated for particles and vapors—avoid using an N-95 mask, which filters particles only. Ensure that all cleaning procedures are done during a quiet period when no other activities or people are in the room, and allow adequate time to complete the procedure.
Upon opening the CACI, be sure the blower motors are running so any fumes or vapors can be removed. During this process you will be drawing the ambient room air and particles into the device, so your cleaning procedure will require two stages. First, start with sterile water to remove as much drug residue as possible from within the device. Be sure to contain all cleaning materials as you proceed (including wipers) and dispose them properly. Follow the sterile water with a 2% bleach solution mixed with a high-pH germicidal detergent (eg, Lysol IC). Next, wipe every surface with a 1% sodium thiosulfate solution to prevent the bleach from pitting and damaging the stainless steel. Finally, wipe down all surfaces with sterile isopropyl alcohol (sIPA), which is a suitable disinfecting agent only to those areas that cannot be reached unless the front is open; then, close the front and disinfect the rest of the CACI from inside. All waste from your cleaning procedure, including disposable PPE, should be handled as RCRA hazardous waste and disposed of in a black RCRA-container, not a yellow (trace waste) container.
After completing this process, close up the CACI and wipe down all exterior surfaces of the device. Change out the fixed gloves after this step, as there may be bleach-detergent residue on them. Use the bleach-detergent mixture on any areas possibly touched during cleaning, then rinse and disinfect.
Finally, complete a disinfection of the inner chambers again (paying particular attention to the glove gauntlets) using a sterile disinfectant, such as sIPA, to ensure that the microbial integrity of the inner chambers of the device can be re-established.
To have your hospital pharmacy practice questions answered in coming issues of PP&P, please contact Senior Editor Michelle Janowitz at firstname.lastname@example.org
Eric S. Kastango, MBA, RPh, FASHP, is the president, CEO, and owner of Clinical IQ LLC, a provider of customized process and educational strategies for the pharmaceutical, medical device, and health care industries. A member of USP’s Sterile Compounding Committee, he has practiced in the field of both hospital and home care pharmacy since 1980.
Luci A. Power, MS, RPh, is an independent lecturer and consultant on pharmacy IV and hazardous drug systems. She was with the department of pharmaceutical services at the University of California Medical Center in San Francisco for over 25 years serving in various capacities, including senior pharmacist and manager of the parenteral support services, and manager of IV additive services where she was responsible for inpatient chemotherapy and other hazardous drug compounding.
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