Life science industry users of single‑use devices have legitimate questions about the potential for leachables to impact the
quality of their pharmaceutical products. Extractables data using model solvents can be a useful indicator of leachables risk,
but until now users have struggled to make like‑for‑like comparisons between the various single‑use technologies they are
considering. In some cases, cautious users may even choose to stick to what they know rather than open what can seem to be
a Pandora’s Box of new extractables questions. The Bio‑Process Systems Alliance (BPSA) guides do a great job of clearing the
fog and demystifying the myths surrounding the extractables and leachables debate, establishing which testing is most valuable
and which testing is less so. This has obvious benefits, not only for users, but also for suppliers; more uniform customer
expectations will allow us to invest in the right validation data package and avoid expending development resources on generating
data that is of little or no value to customers.
Richard Bhella. Global Product Manager, Single-Use Storage and Delivery Technologies at ATMI Lifesciences.
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Challenges of developing the right materials
The trend towards ever cleaner and purer contact materials is driving single‑use manufacturers to adopt tighter cleanroom
standards and more carefully controlled polymer resins. At ATMI we are extruding our own polymer films and manufacturing our
single‑use products entirely under ISO Class 5/Class 100 cleanroom conditions rather than the less exacting ISO Class 7/Class
10000 conditions that are still the industry norm. All new ATMI films are manufactured using medical grade resins that are
free of animal‑derived components, a trend that has accelerated rapidly in the last couple of years. In addition to the obvious
regulatory compliance advantages of these newer medical grade resins, they also typically have much more stringent change
controls in place. Furthermore, as there are relatively few such resins on the market, there is greater likelihood that films
from different vendors will, in fact, be using the same contact material, which has advantages in validation. Validation
Pharmaceutical contact materials for single‑use processes are under the microscope now more than ever before. In fact, when
our customers are planning to implement a new single‑use technology, the biggest hurdle they face is probably materials validation
— raw materials need to be more traceable, the supply chain needs to be entirely free of animal‑derived components and change
control needs to be more rigorous. What was considered acceptable just a few years ago would not pass muster today. Indeed,
more and more users are looking back at material selection decisions made in the past and asking serious questions about whether
their legacy single‑use technologies may need to be revisited. In such circumstances, the importance of validation cost containment
becomes ever more apparent.
If we can offer new technology made from a material that the client has already validated for contact with their product,
the validation hurdle can be eased dramatically. If the client already has a mixing bag film validated for contact with their
drug product, for example, then validating the same film for storage applications should take much less effort than if the
client was to use a new film. This is the cornerstone of our recent initiative; one film for every application from liquid
and powder storage, to mixing to cell culture and fermentation.
Today, every end‑user must still use their own knowledge and intuition to decide on what tests are required for materials
used for single‑use systems. I would love to see end‑users and single‑use suppliers reach a strong and clear consensus on
materials compatibility testing. We are not quite there yet, but the BPSA guides are a critical step in the right direction.
I look forward to a not‑too‑distant future when contact material harmonisation will allow users to pick the technology that
works best for them without worrying about materials compatibility at all. Given the similarities of contact materials in
the market today, that day may be closer than we think.
