Cross-contamination problems with PTFE-lined ball valves in pharmaceutical Active Pharmaceutical Ingredient (API) applications:
Pharmaceutical manufacturing facilities have frequently used lined ball valves for their pharmaceutical API lines, even though they were aware that the cavity in the ball valve was a potential dead space where slurry could “hold up” and remain in place. This has the potential to cause cross-contamination problems between batches.
An additional downside is that where contamination was an issue, they would have to follow a costly and time-consuming clean-in-place procedure of stripping down, cleaning, reassembling, and testing.
Case study: Butterfly valves PTFE-lined as a solution
The problem: a large multinational pharmaceutical plant had such an issue. They wanted a valve with a bubble-tight shut-off and thought the ball valve was their only option
The solution: ESI installed the EBRO T211 Virgin PTFE lined butterfly Valve on trial
The advantages:
- No cavity
- Bubble-tight shut exceeds Class VI per DIN 3230
- 3mm virgin PTFE-lined disc
- Space saving
- Reduce plant downtime
- Stabilised, fully machined virgin PTFE construction
Since the first valve was trialled, the site has replaced the above 150 lined ball valves with the EBRO T211 PTFE lined Butterfly Valve
If your site is suffering from extended downtime due to the need to clean-lined ball valves, then please send us an enquiry form or contact ESI at +353 21 4510900 or +44 1633 877505 to review your application and see how we can help.
Another problem often encountered with shear-sensitive API is that it needs to be pumped. This has the potential for reciprocal issues: the pump can damage the shear-sensitive crystals, and the product can damage the pump.
There is a solution, and where ESI have installed it, customers have reported considerable product-yield improvements.
The pump ESI applied in these situations doesn’t use centrifugal force or positive displacement. Instead, the Discflo pump uses the principles of boundary layer and viscous drag to create a laminar flow. This means no damage is caused to the crystals. More detailed technical information on the Discflo pump is available on our website.