Single-use technologies and BDS: a fragile relationship
To successfully store and ship high-value bulk drug substances (BDS), you need materials that are durable, stable at low temperatures, chemically compatible and pure.
So, how is that accomplished? A few of the mainstay materials include stainless steel cans, as well as PETG (Polyethylene terephthalate glycol) and PC (polycarbonate) plastic bottles.
We believe that BDS is an application that has been under-served by single-use technologies. And while we see some single-use technologies starting to claim market share, they come with significant drawbacks.
Today’s most popular single-use BDS technologies are bag-based. The downside of bag containers is that they require plenty of additional protection because they’re vulnerable to punctures, cracking, seam separation and material delamination. From a purity perspective, many bags are created using tie layers (film-like adhesive resins), that can be prone to leaching and contamination.
Many of the latest advances in single-use BDS container designs focus on stability and durability but utilize fragile, poorly compatible materials like PE (Polyethylene). What’s more – these materials aren’t chemically pure and can potentially contaminate critical substances or even fail outright.
What about fluoropolymers for BDS systems?
Fluoropolymers are on the cusp of solving the biggest BDS storage and shipping pain points because of their outstanding durability, temperature stability, chemical compatibility, and material purity.
Despite that, fluoropolymers for BDS systems are rarely offered in a ready-to-use or single-use format. Why is that? It’s mainly because materials like PFA, PTFE and FEP are not gamma stable. Gamma, electron beam and other high energy sterilization methods can degrade materials like PFA, causing material weakening, shedding, particle generation, cracking and even structural failure.
You might think that would put a damper on fluoropolymer use in BDS – but wait! Autoclaving – a sterilization process that uses high-pressure steam – is making a major comeback in the medical device industry for sterilizing fluoropolymer-containing products.
Ready-to-Use PFA & FEP Bottles
Our line of Purillex® PFA and FEP bottles and stability vials are the first to be offered in the bioprocess industry in a ready-to-use format – meaning they’re clean, double-bagged and autoclaved for immediate use.
That’s all well and good, but what the Savillex team is hearing from the wider bioprocess industry is that it wants gamma stable fluoropolymer products, including bottles and vials, so it can meet demand for cryogenic storage and shipment of BDS.
It makes perfect sense; compatibility with gamma and electron beam sterilization methods – both standards within the bioprocess single-use market – would create many new applications for fluoropolymer products.
The question is, do we have such a solution up our sleeves? Stay tuned!.