ASTM WK90318
New Test Method for Standard Test Method for Evaluating the Risk of Contamination when Aseptically Presenting Product
1. Scope
This test method provides an approach to qualitatively assess the risk of contamination to a sterile device when it is aseptically presented into a sterile field. The source of contamination is limited to contaminates that may be present on the hands of the individual(s) opening the package and presenting the product into the sterile field. A fluorescent agent is used as a surrogate for virus or microbes that may be present. The method can be used with the range of flexible and rigid sterile barrier systems. This test method is intentionally designed to create an extreme scenario with regard to potential contamination on hands. A failure (i.e. transfer of fluorescent agent) does not mean that the product will be contaminated in actual use. This test method does not assess all of the potential sources or modes of contamination when aseptically presenting a product. The method is appropriate for evaluating both flexible and rigid sterile barrier systems.Keywords
Aseptic PresentationRationale
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.
Work Item Status
Date Initiated: 04-16-2024
Technical Contact: Matt TerBush
Item: 001
Ballot: F02.15 (24-01)
Status: Negative Votes Need Resolution