Why the Pharmaceuticals Sector Is Adopting Single-Use Technology
A new paradigm is taking place in the world of pharmaceuticals, with a shift away from re-used, re-washed and re-sterilized equipment and eastwards the adoption of single-use sterile systems.
The traditional pharmaceutical production model has rested on manufacturing big batches, on a large-scale, of medicines for relatively numerous populations of patients. This has come under challenge with the U.S. Food and Drug Administration's guidance document on biosimilars (a biologic medical product which is almost an identical copy of an original product that is manufactured by a different company) and personalized medicines (see: "Why precision medicine is important for pharmacists"). Moreover, biotechnology companies often work on the smaller-scale, developing medicinal products in smaller quantities.
Reducing costs and environmental footprint
This means that the traditional model of using stainless vessels, mixers and connectors, as so forth, and then recycling these by washing, rinsing, and re-sterilization is proving less attractive. These technologies are, according to Cleanroom Technology, costly; they are energy-hungry and thus carry an environmental impact; and they are at risk from contamination should a control mechanism break down, something that is of particular concern with sterile biologics products manufacture, where products are intended for the young, old or infirm.
Instead, the sector is turning towards single-use, sterile, disposable technology either in the form of individual items or as complete systems. Single-use technologies for biopharmaceuticals include PVC, polyethylene, polycarbonates, and polyamides. Single-use disposable technologies are generally manufactured from plastic polymers involving processes of injection molding, extruding and blow molding.
This is a market that is expected to grow considerably, according to a report issued by Industry Today. The market, into 2018, is expected to rise to $3,000 million. Growth is also predicted in a second industry report, also released in December 2017, with steady increases in sales forecast until 2024.
There are several reasons for the growth forecast. The advantages of single-use technology can be surmised as: eliminating the need for cleaning; removing the requirements for the pharmaceutical company to perform in-house sterilization (typically by autoclaving - a moist heat sterilization process) for all components; reducing the use of cleaning chemicals; assisting with storage requirements; lowering process downtime; and increasing process flexibility and reducing risks of cross-contamination.
Other advantages include sterility assurance. Here assurance is achieved by a reduction in the possibility of cross-transference of microorganisms; minimizing the risk of environmental microbial contamination, and by a reduction with the risk that contamination could be introduced into the process through a failed or inadequate sterilization cycle.
Barriers to entry
Not all companies are seeking to completely adopt such technologies, however. Some companies are following a hybrid course of mixing disposables with reprocessed items. Other companies are reluctant to implement due to cost or due to a lack of suitable devices for their particular systems. A further barrier to implementation is a lack of common standardization, according to analyst Adrian Hennersey of ABEC. If customers push for this, the commentator states, this will lead to lower manufacturing costs and make the prospect of single-use technology more attractive.
Learn more about Flex's involvement in the MedTech and pharma industries today.