- Case Study
Hermetic sealing with BioPure
- BioClamp selected for PuroVaso, a handling device for powders and tablets
- Silicone gaskets also chosen as part of a total hermetic sealing solution
- Hundreds of BioClamp units and gaskets will likely be required
PuroVaso®, a new product on the market for handling powders and tablets, is using BioPure BioClamp® and BioPure silicone gasket technology on its containers. BioPure is an established brand of the Watson-Marlow Fluid Technology Solutions (WMFTS)
PuroVaso was designed to overcome a specific problem. The manual handling of pharmaceutical products can often be difficult due to the weight of the container. PuroVaso, however, offers a product-to-container weight ratio that ensures operator handling limits are driven by product weight, not the weight of the container. The result is a unique combination of value and performance.
BioClamp fits the bill
In order to fit any valve type with a Tri-clamp connection, PuroVaso engineers had to think carefully about the choice of union clamp fitted to the containers, opting for the BioClamp.
“We selected BioClamp as it was the most suitable solution,” confirms Steve Boswell, Director at PuroVaso. “Influencing factors included weight, suitability for use in pharmaceutical applications, quality, GMP compliance, appearance, and having a trusted partner in WMFTS. In addition, BioClamp performed well in tests and was price-competitive compared with stainless steel alternatives.”
The patented BioClamp, which is moulded from reinforced Nylon 66 USP Class VI, is an extremely popular union clamp that is specifically designed to meet the needs of busy bioprocessing and pharmaceutical laboratories. PuroVaso is using both 4” and 6” BioClamp neck fittings to ensure hermetic sealing between the PuroVaso container and valve. The design is deliberately generic to allow its use with any choice of valve.
PuroVaso opts for BioPure products
Gaskets prove ideal
To complement BioClamp, PuroVaso has also opted to use BioPure 4” silicone gaskets. According to the company, these were selected in preference to silicone gaskets from other manufacturers based on their GMP compliance. Depending on sales, potentially hundreds of silicone gaskets and BioClamp fittings will be acquired over the product life of PuroVaso.
BioPure silicone gaskets are FDA approved and come with industry-leading validation.. They are manufactured and packed in BioPure ISO Class 7 cleanrooms which provide a controlled atmosphere with pressurised air locks and stringent checks. Each cleanroom has at least 30 complete air changes per hour with particulate counts monitored and re-certified every 6 months.
High-purity, platinum-cured silicone gaskets are precision engineered to achieve a smooth-bore, contamination-free fluid path under clamping compression. The gaskets have also been evaluated for extractables using a multi-solvent approach in line with BPOG guidelines. Both flanged and un-flanged size options are available.
To facilitate full traceability, BioPure silicone gaskets feature permanent lot numbers produced by laser etching, while BioClamp has moulded-in lot numbers.