Laboratory Test Request

Ophthalmic Medical Device Research Study of UV-C Disinfection Effectiveness

Project Description

USA Contract Microbiology Laboratory needed for ophthalmic medical device research study
Aim 1: Assess effectiveness of UV-C disinfection on reducing pathogen load (BS 8628 protocol)
? Eyedropper bottles and 4 ophthalmic medical devices are inoculated with a suspension of microorganism and interfering substance (replicating clean or dirty conditions) in triplicate per each organism and left to dry. Two control carriers are prepared similarly and will be left outside the test chamber with similar environmental conditions.
? Can consider inoculating stainless steel carriers if challenging to inoculate named objects
? Organisms: Staph aureus, Pseudomonas aeruginosa, E. Coli; Mycobacterium terrae (HLD criteria); adenovirus, herpes simplex virus; Candida albicans, Aspergillus
? The devices or bottles are placed inside the UV disinfection device, which is subsequently placed within the test chamber and the disinfection cycle is run as described below
? The chamber must be equilibrated for temperature (as standard 20 ± 1 °C) and relative humidity (30-60%) before starting the cycle.
? The total UV disinfection contact time is recorded, starting from when UV LEDs switch on to when they are switched off.
? The critical areas of inoculated objects and/or carriers are swabbed and placed onto appropriate media. The results are counted, and the achieved efficacy is expressed in LOG reduction.
? Bottles: tip/threads of eyedropper
? Applanation tip: contact surface/apex
? tip: probe bulb
? contact laser lens: contact surface/meniscus
? Treatment: Exposure of specified medical devices to UV-C light of varying durations (60 s, 90 s, 120 s, 180 s, 210 s)
? Pre/post treatment analysis of CFUs/plate; target 10^6 log fold reduction in bacterial concentration to meet CDC high-level disinfection standards

Project Information

Number:24-00360

Industry:Medical Devices

This request is closed and is no longer accepting quotes. Register or Log In to receive alerts when similar requests open in the future.
Home Health Equipment,Hygiene, Personal Care, and  Toiletries,Medical Devices,Medical Devices (Reusable),Medical Devices - Sterile,Medical Disposables,

Test Request: 24-01122

USA Contract laboratory needed to perform ASTM compression testing for a nonelastic wound dressing or bandage compliant ... view


Test Request: 24-01118

Contract Research Organization CRO needed to run a porcine model animal study to compare performance with our synthetic ... view


Test Request: 24-01113

California Laboratory to test how their reinforced medical tubing product can be seen under x-ray and fluro in compariso... view