1. Scope

Keywords

Rationale

A standard method for evaluating the risk of contamination when aseptically presenting product does not currently exist. As a result, there is not an agreed upon way to assess and rank different presentation techniques, packaging formats, or designs as to their comparative risk of contamination. This method uses a fluorescent agent to assess the potential for contamination. The method is intended to create a worst case scenario so that there is a high enough failure rate (fluorescent agent transfer) that comparative performance can be assessed without having to test a huge number of packages. Failure with this test method does not mean that the product will actually be contaminated in actual use. To minimize the complexity of this test method, application of the fluorescent agent has been limited to hands. The intention is, in later iterations of this test method, to provide option to contaminate the outer surfaces of the sterile barrier system. An ILS study will be conducted after feedback is received from this subcommittee ballot.