Pharmacy OneSource Blog

A Novel, Sporicidal Formulation of Ethanol for Glove Decontamination – An Option for Sterile Compounders?

Posted on 02/17/16

How_to_Stay_Compliant_with_USP_797.jpg

A concise communication recently published in the Infection Control & Hospital Epidemiology (ICHE) journal¹ provides effectiveness data on a novel formulation of ethanol used for glove decontamination to prevent Clostridium difficile (spores) hand contamination during glove removal. Inoculum of 1 x 10⁴ log spores of C. difficile was placed on the gloved hands of each volunteer and rubbed to cover the entire surface of the gloves until dry.

Test solutions included the novel, sporicidal ethanol formulation (70% ethanol adjusted to pH 1.3 with hydrochloric acid), as well as, 1:10 and 1:100 dilutions of sodium hypochlorite (bleach), and 70% ethanol with no pH adjustment/additives. These test solutions were applied for 30 seconds and then cultured on C. difficile selective media. The log-10 colony forming unit of spores was calculated by subtracting spore counts recovered from treated gloves from the counts recovered from untreated control gloves. This study was performed in triplicate and a one-way analysis of variance with Tukey correction was used to compare log reductions.

The study found that the novel, sporicidal ethanol formulation was effective in rapidly reducing C. difficile spores by approximately two logs, with a further reduction when applied as a wipe. The reduction achieved by the sporicidal ethanol was equivalent to the 1:100 dilution of bleach solution. In USP Chapter 797, both its current version and proposed revised version, require periodic glove disinfection between procedures while compounding sterile preparations or when in contact with non-sterile surfaces using sterile 70% isopropyl alcohol (IPA). Typically the application of 70% IPA is by aerosol spray, not wipes. It is common knowledge that 70% IPA is not sporicidal, so would this novel, sporicidal ethanol formulation be a better alternative for routine glove decontamination in the pharmacy?

The researchers state that they are investigating formulations with pH 3.5 that they anticipate will be safer if repeated skin exposure should occur. Furthermore, any gloves subjected to such disinfection should be assessed for chemical compatibility with repeated exposure to this sporicidal ethanol formulation. In my opinion, this novel glove decontamination strategy warrants further study from the pharmaceutical sterile compounding perspective.

References

  1. Myreen E. Tomas, Michelle M. Nerandzic, Jennifer L. Cadnum, Thriveen S. C. Mana, Annette Jencson, Venkata Sunskesula, Sirisha Kundrapu, Brigid M. Wilson and Curtis J. Donskey. A Novel, Sporicidal Formulation of Ethanol for Glove Decontamination to Prevent Clostridium difficile Hand Contamination During Glove Removal. Infection Control & Hospital Epidemiology, available on CJO2015. doi:10.1017/ice.2015.289.

Topics: Sterile Compounding

About the Author

Keith H. St. John, MT(ASCP), MS, CIC has served as an Infection Preventionist for the past 30 years, including over 17 years of managing Infection Prevention and Control programs and personnel at major tertiary teaching institutions that include pediatric as well as adult hospital settings. Keith is a clinical microbiologist by training and is certified in Infection Control & Epidemiology (CIC). Keith’s rich professional experience includes: Past President of the Certification board of Infection Control & Epidemiology (CBIC); publications in medical and infection control journals; presentation at national and regional conferences; and former faculty associate at Temple Dental and Medical School. Mr. St. John is also a former member of APIC’s Governmental Affairs Committee, Education Committee, Practice Guidance Council and Research Foundation. He has served APIC as Chapter President & Board member, Editorial Board and reviewer for AJIC, APIC Text Revision Task Force (x2) and Pharmacy chapter co-author. Keith has been a volunteer member of the United States Pharmacopeia Convention Expert Compounding Committee since 2005, sharing his expertise on the revision of USP Chapter <797>, Pharmaceutical Compounding – Sterile Preparations. In addition to APIC, he is an active member of the Healthcare Infection Society (UK) and the Society for Health Epidemiology of America (SHEA). Keith received his Master’s of Science degree in Clinical Microbiology from Thomas Jefferson University in Philadelphia and his Bachelor of Science degree in Medical Technology from the University of Delaware.