Pharma Specialist Opts For BioPure Products To Optimise Hermetic Sealing

BioPure Products are used for the effective handling of powders and tablets in life science applications. BioPure is an established brand of the Watson-Marlow Fluid Technology Group (WMFTG).

Based in Derbyshire, S3 Process houses an experienced team of consultants and project managers who support clients through design, build, testing, installation and validation to ensure every piece of process equipment is delivered as part of a fully integrated solution. The company is committed to the continuous improvement of process manufacturing, working closely with clients to identify innovations that can deliver tangible efficiencies.

A case in point is the latest product from S3 Process, PuroVaso®, which 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, S3 Process engineers had to think carefully about the choice of union clamp fitted to PuroVaso®, opting for the BioClamp®.

“We selected BioClamp® as it was the most suitable solution,” confirms Steve Boswell, Director at S3 Process. “Influencing factors included weight, suitability for use in pharmaceutical applications, quality, GMP compliance, appearance, and having a trusted partner in WMFTG. 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. S3 Process 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.

Gaskets prove ideal
To complement BioClamp®, S3 Process 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.