The BPVs offer the standard benefits compared to stainless steel systems but to stand out in the competitive single-use market ATMI has added other features. Use of ATMI’s Integrity TK8 polymer film is the basis of these other benefits.
ATMI uses the film across the entire Integrity line of single-use vessels for storage and transfer, mixing and bioreactor. Installation of the ATMI range of products allows for validation savings to be made.
Richard Bhella, Global Product Manager, Single-Use Storage & Delivery Technologies at ATMI, told in-PharmaTechnologist the universal film allows users to “validate our film once and leverage that validation for storage, mixing and cell culture”.
“With each validation study costing perhaps in excess of $100,000 (€78,600), and taking several months to accomplish, the savings in money and in time-to-market can be substantial.”
Furthermore, the film is entirely free of animal derived components. It also has “the optimal combination of required features”, such as barrier properties, strength, flexibility, clarity, purity, cleanliness and critical regulatory approvals, said Bhella.
Design process
ATMI developed the BPV using a Design for Six Sigma (DFSS) process. This involved surveying a cross-section of target customers to establish how the product could meet there needs.
“Several design features, such as the end-port boat fitment and the generous overage, are a direct result of this customer-focused approach. Customers strongly validated our "one film" value proposition”, said Bhella.
Adopting DFSS had other benefits. “The DFSS methodologies used to develop our BPV product line allowed us to bring a product to market in less than 18 months, and to have that product meet the needs of the market right out of the gate instead of evolving over time”, said Bhella.