An isolator/glovebox is a miniature version of a cleanroom and is often certified to ISO cleanroom classifications. Therefore, the cleaning methods for cleanroom environments as described in IEST-RP-CC018.4, Cleanroom Housekeeping: Operating and Monitoring Procedures and International Standard ISO 14644-5, Cleanrooms and associated controlled environments – Part 5:Operations may be used to clean an isolator/glovebox. All cleaning should be carried out both before and after every manufacturing, preparation, or dispensing session, as well as in between activities that may result in cross contamination.
The recommended cleaning sequence for both a cleanroom and an isolator/glovebox is:
- Clean from the cleanest area to the dirtiest area
- Vertical airflow—top to bottom
- Horizontal airflow—wall to return
An example of a generic standard operating procedure for cleaning an isolator/glovebox is listed below.
- Begin by wearing all the appropriate PPE (personal protective equipment). This should be determined by the safety manager.
- Be certain the system is in operation.
- Put on approved disposable gloves. Wipe the outside of the isolator/glovebox front and sides with approved cleaning materials and wiper. NOTE: Toss soiled wipers into a waste chute or appropriate waste disposal device after each step or when the clean surface of wiper is soiled.
- Wipe down gloved hands and the containers of cleaning products to be used with wipers pre-saturated with sterile 70% Isopropyl Alcohol (or approved cleaner) and place products in the isolator/glovebox. Check that all tools used to clean the isolator/glovebox are wiped clean before cleaning interior. Remove the disposable gloves.
- Place hands into the integrated gloves of the isolator/glovebox. Mist and wipe down integrated gloves with new clean wiper. A new surface of the wiper is used to wipe each individual surface.
- Mist and wipe the inside of the isolator/glovebox in the same order as cleaning a cleanroom as mentioned above. Care must be taken when cleaning the top of the isolator/glovebox so as to not destroy the HEPA filter. Do not allow any liquid to contaminate the filter face. Any section and/or corner that cannot be reached with integrated gloves can be cleaned using a commercially available isolator cleaning tool or other recommended device designed for the task.
- Remove soiled wipers and waste chute or appropriate waste removal device using appropriate waste removal procedure.
- Remove cleaning materials from isolator/glovebox.
- Record all cleaning on Isolator Cleaning Documentation Checklist.
This cleanroom tip was taken from “Recommended Practices in Isolator/Glovebox Cleaning” by Jan Eudy.
ENTRIES OPEN:
Establish your company as a technology leader. For 50 years, the R&D 100 Awards, widely recognized as the “Oscars of Invention,” have showcased products of technological significance. Learn more.
