Page 121 - Assurance of Sterility for Sensitive Combination Products and Materials

Package/container closures 105

and storage and after exposure to expected condition (ISO 11607-1:2016:
paragraph 6.3 [72]). Demonstration of preservation of product performance
is typically done at the same time.

Defining the distribution and storage environment
According to the ISO 13485:2016 paragraph 4.2.3 [35], the organization
has to include “specifications or procedures for packaging, storage, handling and
distribution” into the medical device file. Products must be protected from
alteration, contamination, or damage when exposed to expected conditions
and hazards. ASTM D4169 [73] and ISTA guidelines [74] provide the basis
for testing packaging systems to demonstrate that they are suitable for the
intended use. Testing should be done with the device or at least a surrogate
with similar weight and shape. Establishing worst-case scenarios enables
leveraging data over packaging and device families.

Clinical use: Aseptic technique and usability aspects
In addition to the packaging being a barrier, the packaging must facilitate
the aseptic presentation of the medical device during use in the clinical en-
vironment. In ISO 11139 [75], aseptic presentation is defined as “transfer of
sterile contents from its sterile barrier system using conditions and proce-
dures that minimize the risk of microbial contamination.” Observations in
health-care facilities highlight the differences in the level of training and ap-
proaches to managing sterile fields and handling packages. The increased at-
tention to the causes of HAIs has resulted in increased awareness on aseptic
presentation. Trier et al. [76] documented a very interesting study in 2014
showing that contamination rates can indeed be significant. Regulations
include requirements for medical device designs (including their SBSs) to
enable easy and safe handling to minimize the risks of infections, and conse-
quently manufacturers need to include aseptic presentation in their formal
risk analysis. This topic needs to be considered in the broader context of
usability of the device with its SBSs, which also covers aspects such as label-
ing and the ability to assess SBS integrity. ISO 11607-1 [72] currently does
not provide specific design recommendations to facilitate aseptic presenta-
tion. The revised version of ISO 11607 likely to be published end of 2018
will include a new requirement to conduct a “usability evaluation for aseptic
presentation” with a focus on a few key aspects that provide some insights
into necessary design features. The Sterile Barrier Association has published
a guidance document on aspects to consider for usability of SBSs, which
includes aseptic presentation [77].