Preliminary Results for a New Final Package Test to Assess the Quality of Sterile Package Systems

Abstract

This test method allows sterile packaging systems to be tested for contamination under practical conditions without extensive laboratory preparation. Contamination as a result of laboratory errors can be ruled out almost certainly.

Determination of the Efficacy of Sterile Barrier Systems Against Microbial Challenges During Transport and Storage

“…1011 It is influenced by the barrier properties of the packaging-for example, the number of layers in the case of packages or the quality of wrapping material-and by ambient conditions, such as the indoor and outdoor microbial content in the air, changes in temperature and atmospheric pressure, and mechanical stress during handling. 16 These studies show that all these environmental factors are effectively "events" and that neither an exclusively event-related date nor an exclusively time-related expiration date is appropriate. The outdating should be performed on the basis of a scientific-based risk assessment that considers the barrier properties of the package, on the one hand, and the appropriate effectiveness of the barrier packaging necessitated by the specific unavoidable environmental influences, on the other.…”

Test to Determine Sterile Integrity of Wrapped Medical Products at a Probability of Recontamination of 1: 1,000,000

“…Contamination as a result of laboratory errors can be ruled out with almost complete certainty by use of our new microbial test method, which was developed to ascertain the passage of airborne bacteria through the medical device packaging system after sterilization. 6 This method consists of in-figure 1. Graph of the periodic pressure changes and increase of relative humidity in the exposure chamber serting petri plates filled with nutrient agar into the packaging unit prior to sterilization.…”

Examining the Effect of Secondary Packaging on Microbial Penetration into Sterile Medical Device Trays

“…With the ultimate goal of effectively protecting patient safety, investigation of the relative efficacy of secondary packages to prevent microbial ingress into SBSs is warranted. Surprisingly, limited work has been done on the broad area of microbial ingress and medical device packages, 14,[16][17][18] and our search of the literature exposed a broad gap in knowledge regarding the effect of secondary packaging on microbial penetration.…”