Boosting Profitability with Single-Use Powder Transfer

Many biopharmaceutical manufacturers are implementing single-use containment for transfer of media and buffer materials to prevent feedstock contamination and promote worker safety. But the type of containment system used can have a significant impact on productivity and profitability. Equipment should be evaluated and chosen carefully.

Pertinent Questions
Systems should be analyzed not only for their basic ability to contain powders of interest, but also for how efficiently they integrate into production process. For instance, could the system introduce productivity bottlenecks, increase material waste and the cost of raw materials, or complicate changeover of a line to new products? Is it robust enough to provide reliable transfer throughout the production run? And has it been designed specifically to contain and release powders? The answers to those questions are crucial to identifying and implementing a sound powder-transfer system.

Issues of Powder Handling
Media and buffer ingredients used in powder form have historically been transferred from stock containers using open scoops, funnels, and bags then carried and dumped directly into production vessels because sterility isn’t typically required at that early manufacturing stage.

Although sterility may not be an issue, biopharmaceutical production managers have come to recognize that worker exposure to airborne particulates and a potential for cross-contamination at line change-over can be a factor. Consequently, some production managers have implemented single-use systems for powder transfer. Unfortunately, many early systems were simply adapted from liquid-handling systems already in use at the time and converted to handle powders. Such systems often have inherent shortcomings. Instead, production managers should look for systems designed from the ground up to handle biopharmaceutical powders.

Keys to Efficient Powder Transfer and Containment
The most efficient powder containment and transfer product will feature

Equipment suppliers should answer all of the following questions in the affirmative:

Evaluating Potential Systems
Unlike systems adapted from an existing liquid-handling system, ILC Dover’s EZ BioPac® system was designed specifically to handle powders in biopharmaceutical applications. EZ BioPac® vessels offer a large-diameter, open-funnel top for easier, quicker filling. A light, nonmetallic frame holds the top open, eliminating the need for a separate funnel and the cleaning that goes with it. Moreover, if an operator overshoots the target weight, he or she can easily scoop out the overage until the weight is exact.

The EZ BioPac® system also lessens air dispersal, lowering cross-contamination risk and perhaps reducing cleaning frequency. Lower powder dispersal also reduces ignition risk and staff exposure to inhaled particulates.

The EZ BioPac® system uses separate fill and discharge openings, so the discharge flow path remains clean and untouched by powder until transfer is initiated, and because all EZ BioPac® containment packs are fabricated from proprietary ArmorFlex® 114 antistatic film, they release their contents virtually completely, reducing ingredient waste and improving batch-to-batch consistency.

Summary and Conclusion
The EZ BioPac® system from ILC Dover substantially lessens the amount of powder that disperses into the air, reduces the time needed for changeover, lowers staff costs, and frees staff to work on more vital jobs, which all contribute to profitability.

Chris Rombach is director of global strategic sales at ILC Dover, 1 Moonwalker Road, Frederica DE 19946; 1-302-335-3911 x792; [email protected].