SINGLE-USE TECHNOLOGY AND PARTICULATES
When introducing single-use equipment, users—to their credit—are keen to monitor all manner of parameters they would not necessarily
contemplate studying for a stainless-steel system. Particulates, extractables, and leachables all come under examination with
The concern lies in making sure the product does not become adulterated during its manufacture. The vessels hosting production
are made from plastic, so there is always the potential for extractables or leachables to find their way into the product
from or through the film, or for gas permeation through the walls of the vessel. It's the same story in the final packaging
because extractables, leachables, and gas permeation are all potential problems with plastic vials. And in general, particulates
are a concern; they can either come from the equipment itself or from the atmosphere around the systems.
In the past, a final product was inspected for particulate contamination—first by eye and later, as automated systems became
available, by machine. Often, any particulates found in traditional systems were not given much attention; they were either
not large enough for concern or there was not the right technology to isolate their source. Single-use products change this
level of scrutiny because there is suddenly better product visibility. Suppliers are expected, and are now able, to tell manufacturers
what particles might be present and where they potentially came from.
This added material tracing and product-tracking capability brings an unexpected benefit of product quality and, thus, provides
a patient safety benefit. Because the process is better studied, more traceable and more defined, the quality bar is automatically
raised. The product-contact surfaces are better understood because they have been investigated in detail, and the validation
process now generates more data than ever before.
WHAT THIS MEANS FOR THE INDUSTRY
Biopharma producers rely on their suppliers much more than they have in the past. For a single-use-only facility, the suppliers
are the new product, and often process, experts. Moreover, they essentially control the factory; if the bag and vessel suppliers
ever cannot deliver, production could cease. All this reliance has created demand for greater support, supply-chain contingencies,
and documentation than ever before. Companies that take advantage of single-use technologies are doing so because of the various
benefits they offer. Undoubtedly, single-use technologies have allowed these companies to identify new ways to ensure quality
of end product for patients.
Single-use suppliers are working hard to characterize anything—particle or otherwise—that might be present, and identify if
it originates from the bag, the tubing, or a fitting. The elimination of particulates has been a recent driver for the industry.
Customers want to know whether the particles are native (i.e., originating from the single-use system) or foreign, such as
from a piece of paper in the cleanroom. Ultimately, customers want suppliers to ensure that particles are eliminated.
Being able to detect and quantify particles is the first step, and the next step in improving product quality is to eliminate
them. Each step brings us closer to the vision of better protecting patients and ensuring the drug products they ingest have
the intended effect, with no adverse risk factors from preventable causes.
Eric Isberg is global product manager, Integrity single-use fluid technologies, at ATMI, firstname.lastname@example.org