RESUMEN
The microbial contamination of eye drop tips and caps varies between 7.7% and 100%. In seeking patient protection and continuous improvement, the Pharmacy Department in the Sterile Ophthalmological and Oncological Preparations Unit at Cochin Hospital AP-HP, Paris, France, conducted a two-phase study to compare the antimicrobial efficiency and practical use of standard packaging and a marketed eye drop container incorporating a self-decontaminating antimicrobial green technology by Pylote SAS at the tip and cap sites. The first phase was conducted in situ to identify the microbial contaminants of eye drops used in the hospital and community settings. A total of 110 eye drops were included for testing. Staphylococcus species were the most prevalent bacteria. Candida parapsilosis was detected in only one residual content sample and, at the same time, on the cap and tip. The second phase was performed in vitro, according to JIS Z2801. Reductions above one log in Staphylococcus aureus and Pseudomonas aeruginosa counts were noted in Pylote SAS eye drop packaging after 24 h of contact. The practical tests showed satisfactory results. Pylote SAS antimicrobial mineral oxide technology exhibited promising effects that combined effectiveness, safety, and sustainability to protect the patient by preventing infections due to the contamination of eye drop containers.
RESUMEN
The antimicrobial activity of surfaces treated with zinc and/or magnesium mineral oxide microspheres is a patented technology that has been demonstrated in vitro against bacteria and viruses. This study aims to evaluate the efficiency and sustainability of the technology in vitro, under simulation-of-use conditions, and in situ. The tests were undertaken in vitro according to the ISO 22196:2011, ISO 20473:2013, and NF S90-700:2019 standards with adapted parameters. Simulation-of-use tests evaluated the robustness of the activity under worst-case scenarios. The in situ tests were conducted on high-touch surfaces. The in vitro results show efficient antimicrobial activity against referenced strains with a log reduction of >2. The sustainability of this effect was time-dependent and detected at lower temperatures (20 ± 2.5 °C) and humidity (46%) conditions for variable inoculum concentrations and contact times. The simulation of use proved the microsphere's efficiency under harsh mechanical and chemical tests. The in situ studies showed a higher than 90% reduction in CFU/25 cm2 per treated surface versus the untreated surfaces, reaching a targeted value of <50 CFU/cm2. Mineral oxide microspheres can be incorporated into unlimited surface types, including medical devices, to efficiently and sustainably prevent microbial contamination.
RESUMEN
The sterility of eye drop content is a primary concern from manufacturing until opening, as well as during handling by end users, while microbial contamination of the dropper tip and cap are often disregarded. The contamination of these sites during drug administration represents a risk of microbial transmission and ocular infection. In this review, we aim to assess microbial contamination of the dropper tip and cap of in-use eye drops, the associated contributory factors, and the risk of infection. We conducted a literature search of the MEDLINE, PubMed, and Cochrane Central databases. A total of 31 out of 1503 studies were selected. All the studies conducted in different settings that documented microbiologically contaminated in-use eye drops were included. Our review showed that microbial contamination of the dropper tip and cap of in-use eye drops ranged from 7.7 to 100% of the total contaminated tested samples. Documented contributory factors were conflicting across the literature. Studies investigating the association between eye infection and microbial contamination of the dropper tip and cap were scarce. New technologies offer a promising potential for securing the long-term sterility of eye drop content, tips, and caps, which could benefit from more research and well-defined study protocols under real-life scenarios.