Australia has largely banned single use plastics… We can accept that the liberal use of these has detrimental effects to our lands and oceans. We fear the reporting of microplastics finding their way into the food chain, we hold our breath anticipating research into nanoplastics will reveal cells ingest these tiny particles, we no longer will need to visit the plastic surgeon, as we are already loaded with the stuff.
You may argue that the ‘limited’ use in pharma is far from the ubiquity of a plastic straw. Cost pressures have been a key driver for the adoption of single-use plastics in pharma, particularly when compared to stainless steel which requires high upfront costs and complex cleaning protocols. The long-term benefit of stainless steel is often overlooked, as is the mission readiness capacity – we are too quick to forget the impossibility to source lab items due to COVID lockdowns. Currently – one shipping channel closes and the global economy is on its knees.
Tyler Menichiello, Chief Editor, Bioprocess Online recently reported on “Insufficient Vendor Data Is Hamstringing Single-Use Adoption”, citing some very concerning data gleaned from the podcast Closing The Adoption Gap For Advanced Single-Use Materials. This conversation featured BioPlan Associates’ director of research, Katrina Cordovado, as well as Joshua Nelson, Ph.D., a senior material qualification specialist at Takeda, and Paul Priebe, a consultant and single-use bioprocessing technology expert
There are standards that regulators impose, when we consider extractables from the material used. This started around 1996, some 30 years ago and we’re still not there with a comprehensive standard and – if I recall it correctly – elastomers are not included as they are out of the scope of the standard. Kinda concerning, given drugs are concurrently being developed, likely extractables / leachables are being administered into people… too bad – so sad!!!
When a company ‘locks’ into a Single Use Technology (SUT) or System (SUS) they seem reluctant to change, Nelson approximated the cost of an extractables study to be roughly USD$30,000 to USD$40,000- perhaps this is a barrier.
During this Bioprocess Online Live event, the audience where asked to cite where they think SUT adoption tends to get stuck. Nearly 62% of attendees cited insufficient vendor data (32.4%) and the validation burden of qualifying SUS (29.4%) as key reasons. Considering this bombshell, imagine you cannot get one of the plastic bits anymore – the company deletes it, the plane fell out of the sky, the boat sunk on the way – I think you would be wishing you chose good old 316SS.
A concern is as the time, resources to test and evaluate, and costs extends to meet standards imposed by regulators will they yield under pharma pressure to pare back the thresholds? There seems to already be murmurings from industry to argue such things as risk-based thresholds, for example, an elastomeric gasket on a pump that pumps 100s or 1000s of litres – wouldn’t that reduce the burden of risk? But wait, isn’t this argument borrowed from reusable camp? If so why go there in the first place?
The question isn’t whether single-use systems are good or bad—but whether they represent the most robust long-term strategy for critical manufacturing infrastructure.
And the most interesting question of all – Is it a bold prediction to suggest the pendulum may swing back to stainless steel?