Page 146 - Assurance of Sterility for Sensitive Combination Products and Materials

128 Assurance of sterility for sensitive combination products and materials

[18, 100] also provide the EU Commission with the delegated authority to
adopt so-called “common specifications” if standards are not considered suf-
ficient. Despite this new tool, the promotion of consensus standard and the
involvement of authorities in the development process will be important
for all countries to create the foundation for patient safety and sustainable
innovation in the context of a global economy. This is even more critical to
countries like India that are in the process of adopting new modern MDRs.
Minimizing packaging waste has long been a focus of various regulations
with the objective to minimize landfill and incineration and increase recy-
cling rates that reduce the impact on the environment. The emergence of
global climate change initiatives that limits CO 2 and greenhouse gas emissions
will likely result in further regulations that will impact the development of
products and its packaging. In 2008, ISO and CEN have adopted a guide on
addressing environmental issues in product standards [101]. More and more
standards with environmental clauses are emerging, such as the 2018 revision
of ISO11607. The EU has announced the “Circular Economy” initiative in
2015 [102] with an extensive action plan. The objective is that “the value of
products, materials and resources is maintained in the economy for as long as possible, and
the generation of waste [is] minimised,” so that total carbon dioxide emissions are
lowered. These initiatives will shake the status-quo, create new business oppor-
tunities, and boost innovation. The entire supply chain including the packag-
ing system designs will have to be reconsidered. “Life-cycle thinking” covering
all environmental aspects at all stages of a product lifecycle will become an
important skill for product and packaging designers and engineers. Targeted
technical guides have emerged, like the HPRC Design Guidelines for Optimal
Hospital Plastics Recycling [103] published by the Hospital Plastics Recycling
Council and TIR65:2015 Sustainability of medical devices—Elements of a respon-
sible product life cycle [104] published by AAMI, goes beyond simply addressing
waste. Sustainability is indeed a much larger issue that will increasingly drive
purchasing decisions, the ability of corporations to attract talent, business ethics
and of course business success. All of these will be important drivers and inputs
for product and packaging developments in the future.

References
[1] International Organization for Standardization, ISO 11607-1:2006/Amd 1:2014
Packaging for Terminally Sterilized Medical Devices—Part, Vol. 1, Requirements for
materials, sterile barrier systems and packaging systems, Geneva, 2014.
[2] International Organization for Standardization, ISO 11607-2:2006/Amd 1:2014
Packaging for Terminally Sterilized Medical Devices—Part, Vol. 2, Validation require-
ments for forming, sealing and assembly processes, Geneva, 2014.
[3] Sterilization of Medical Products, Kilmer Conference Proceedings, National Confer-