Study disproves misconception about contamination of sterile IPA bottles.

ISOPROPYL ALCOHOL—it is used throughout the life science cleanroom to sanitize work surfaces, gloves, and tools. It is sprayed ubiquitously. It is also commonly accepted that IPA spray bottles can disperse biological contaminants.

Logically, if spores exist in an environment and the trigger mechanism of the bottle pulls in contaminated air, those spores can be dispersed all over your cleanroom. But does that really happen? This study disproves that widespread misconception. You can have your bottles . . . and spray them too!

Peering into a life science cleanroom you will see varying forms of sanitizers, the most commonly used is 70% isopropyl alcohol, also called isopropanol or simply IPA. [1] IPA is a sanitizer. [2] It kills vegetative organisms by breaking down cell walls. IPA is effective against common skin flora and some viruses like vaccina, herpes simplex, and influenza. [3] IPA is not a panacea; it isineffective against spores from both molds and bacteria like bacillus spp.

The EC Guide to Good Manufacturing Practice Revision to Annex 1 -Manufacture of Sterile Medicinal Products, states that, “Disinfectants and detergents should be monitored for microbial contamination; dilutions should be kept in previously cleaned containers and should only be stored for defined periods unless sterilized. Sanitizers, disinfectants, and detergents used in Grades A and B areas should be sterile prior to use.” [4] This means that it is required to validate the sterility of IPA bottles used in ISO Class 5 life science cleanrooms. A way to save time and money is to purchase prepared sterile IPA that comes with certificates of compliance, analysis, and irradiation permanufactured lot to ensure that the product you are purchasing meets USP sterilityrequirements.

Trigger-spray bottles perform by expelling IPA then aspirating the environmental air to re-pressurize the bottle. If that air should have spores present, it is likely that the alcohol could become contaminated. How long can an alcohol bottle remain inside a controlled environment? At what point will it become or could it become contaminated? According to Elements for a Successful Disinfection Program in the Pharmaceutical Environment, “To prevent introduction of contamination, disinfectants should be sterile, appropriately handled in suitable (e.g., sterile) containers, and used for no longer than the predefined period specified by written procedures.” [1] It can be extrapolated that companies are required to validate the amount of time a sanitizer bottle can be used inside the controlled environment. Usage can range from discarding after every shift, to daily, weekly, monthly, or until the bottle runs out. As long as the data to support that the inside of the bottle is sterile and still 70% IPA and the outside of the bottle is alsoclean, they can do as they wish. Regulatory bodies like to see that there is control and validation. The easiest way would be to discard bottles after every shift, with no chance for cross-contamination and no need for further validation. It’s not that simple. Alcohol is made from petroleum, agrowingly expensive raw material. It is also a hazardous chemical and a VOCof which the EPA tracks emissions.