Aerosol Challenge Studies
Millipore uses an aerosolized bacterial challenge test to simulate worst-case environmental contamination. This test challenges the Lynx S2S connectors with greater than one million bacteria (in colony-forming units) per device, thus providing the most stringent testing in the industry.
In this test, 30 connector coupling sets, 10 each of the Lynx S2S connector and 10 each of two competitors, were challenged with an aerosolized suspension of Brevundimonas diminuta at equal to or greater than 106 colony-forming units.
The connector coupling sets were connected and actuated in this aerosolized environment. Sterile broth was transferred through the connectors into sterile receiving vessels, then assayed to determine the presence or absence of growth. Device controls were employed to assure proper execution and function of the test.
The negative device control consisted of a connector coupling set, which was connected and actuated within the isolation chamber without being exposed to the challenge organism; the positive device control consisted of a connector coupling set with its barrier film, membrane, or plugs removed prior to being exposed to the challenge organism, and then connected and actuated. The collection vessels and negative and positive controls were incubated and scored for presence or absence of growth for over a five-day period. Samples exhibiting growth were confirmed to be the test microorganism B. diminuta.
All 10 of the Lynx S2S connectors passed this test. Only 2 out of 10 competitor A connectors and 2 out of 10 competitor B connectors passed the test, representing an 80% failure rate. Control results were as expected.
The design of the Lynx S2S connector has demonstrated a quality and robustness that will provide significant benefits to the industry by facilitating sterile transfer of fluids with a high degree of security and safety. One of Millipore’s Mobius® flexible bioprocessing solutions, the Lynx S2S connector delivers safer and robust connection for all unit operations within the biopharmaceutical manufacturing process.