White FFKMs – what’s the big deal?
From valves and screw feeders through to reactor vessels and pipe couplings, sealing for life science applications involves highly specialised challenges. Not only do you have the concerns of seal performance and long term reliability in high temperatures and aggressive chemical environments, but the nature of life science means you need to have total confidence that your chosen material will not put human health at risk.
In the recent past, when it came to seal technology the manufacture of APIs (Active Pharmaceutical Ingredients) involved a known trade-off between thermal and chemical resistance and physical performance. With innovations in elastomeric sealing – and chiefly the development of high purity white perfluoroelastomers (FFKM) – this trade-off is no longer a concern. But what is it about white FFKMs which have changed sealing in life science applications?
The best of both worlds
The ability to resist thermal and chemical extremes is a must in pharmaceutical applications. The operating environments of process lines for pharmaceutical manufacturing often include APIs, and cleaning regimes are notoriously harsh.
Stage II sterilisation processes use high temperature steam and are chemically aggressive, conditions under which many sealing materials struggle to perform reliably. FFKM is the ultimate elastomer material which is resistant to these harsh operating environments, while conforming to two key regulatory standards in:
With FFKM, pharmaceutical engineers have a robust, reliable seal with outstanding mechanical properties and virtually universal chemical resistance – and critically, could be used safely in pharmaceutical manufacturing equipment.
Imagine you’re an engineer trying to develop an FFKM which will provide excellent mechanical performance. You’ll discover it’s much easier to make it black. Carbon black filler has significant reinforcing effects on the finished seal. Nevertheless, as strong as FFKM seals are, on rare occasions any seal can shed particles. If you’re running an oil rig, particles from a black seal won’t bother you at all. In life science applications, black specks in the product can lead to a loss of a production batch.
With white FFKM seals, which are FDA and USP Class VI compliant, operators lose none of the mechanical strength while eliminating risk of product loss through visible contamination. This can have significant savings on manufacturing costs as well as reduced equipment downtime.
Performance aside, the development of white FFKM seals – indistinguishable from black FFKMs in terms of performance – has had a marked impact on stockholding efficiency. By standardising to white FFKM, it is easier to maintain stock and cut down on the sheer volume of space involved in holding inventory of both white and black seals to cover all applications.
Making the difference to big pharma
Many of the world’s leading research-based pharmaceutical and healthcare companies are already seeing the benefits of using white FFKM sealing materials. Working with a Global Pharmaceutical Manufacturer, Precision Polymer Engineering material scientists and application engineers were able to review their sealing systems and identify improvements using Finite Element Analysis (FEA). Precision Polymer Engineering’s white FFKM – from the Perlast® range – was subsequently adopted to cover their dynamic sealing applications, pumps and valves.
The improvements in time between seal changes achieved resulted in the implementation of Perlast® seals across a further seven of their pharmaceutical process lines.
Summary of white FFKM feature and benefits:
- High temperature capability (-15°C to +260°C)
- Universal chemical resistance
- Outstanding mechanical properties
- FDA compliant
- USP Class VI compliant
- Extended maintenance cycles
- Lower cost of ownership
- Reduced process contamination
- Consolidation of inventory and reduced stock holding
How could you benefit?
Perlast® G74S has been specifically developed for pharmaceutical applications due to its exceptional chemical resistance, FDA compliance and comparable strength to its black FFKM counterpart.
If you’d like to discuss your requirements with one of our engineers, and improve your process lines as many global pharmaceutical manufacturers already have, visit our Contact Us page to find your nearest sealing specialist.