RT Journal Article
SR Electronic
T1 Microbial Contamination and Isolator Gloves: If It All Came Down to the Size of a Hole?
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 699
OP 706
DO 10.5731/pdajpst.2023.012913
VO 78
IS 6
A1 Filaire, Edith
A1 Rochette, Vincent
A1 Pierre, Elodie
A1 Arethuse, Franck
A1 Champagnat, Pascal
A1 Coppens, Patrick
A1 Gohier, Eric
A1 Mounier, Cyril
A1 Toussaint, Antoine
A1 Triquet, Julien
A1 Poinsot, Christian
YR 2024
UL http://journal.pda.org/content/78/6/699.abstract
AB Isolators play a critical role in protecting both the product and the environment, as well as the personnel involved in pharmaceutical manufacturing, analytical procedures, and sterility testing. Gloves attached to the windows and doors of the isolator are designed to facilitate intervention, testing, and safety. However, due to their inherent characteristics and vulnerability to puncture or loss of integrity, they are recognized as a significant potential source of contamination. In addition to the possible pathways of contamination transfer, the size of glove holes plays a critical role in determining the risk of contamination. In this study, chlorosulphonated polyethylene (CSM) gloves were exposed to an aerosol containing Bacillus subtilis or Staphylococcus aureus. This assessment aimed to ascertain the integrity of the gloves' seal. It was postulated that, below a certain aperture size, gloves used in isolator systems could establish an effective seal even if the external surface of the gloves exhibited modifications. Calibrated holes of different diameters (0.3, 0.5, 1, and 1.5 mm) were created using a femtosecond laser drilling technology. The holes were located on the tip of the middle finger. Based on the context of our study, passage of microorganisms through glove holes of a certain size does occur. Under the experimental conditions chosen, the cutoff for passage was determined to be a 0.5-mm hole, regardless of the microorganism evaluated. Although this study has some limitations, including the lack of a panel of microorganisms evaluated and the investigation of a single glove type called CSM, the high level of “worst case” challenge conditions provides compelling data to support our results. It would now be interesting to carry out studies at different production sites to assess their risk of contamination and relate this to their glove failure.