Media and buffer preparation is a key part of the biopharmaceutical manufacturing process. Although this step doesn’t have to be carried out in sterile conditions, improving the powder transfer process makes preparation cleaner, safer, and more efficient while protecting personnel and cutting time and costs.
The Issues of Powder Handling
Powder ingredients for media and buffers have historically been transferred using scoops and weighed and mixed in buckets or open top bags. Many companies are starting to move to single-use systems, but the transfer of dry ingredients still results in fine airborne particles that can cause employee health issues and a slight risk of ignition.
Airborne particles eventually settle onto surfaces, so cleaning between batches must be performed to prevent contamination. This task lengthens the time needed for changeover and increases labor costs.
Process waste also results from using disposable bags that are difficult to fill quickly and accurately. And systems can trap powders in dispensing lines. Such issues make it difficult for users to adhere to recipes, which affects reproducibility throughout a manufacturing chain.
Finding the Solution
To provide a practical solution, single-use powder handling bags should be
- robust and purpose-designed
- easy to fill and seal
- easy to discharge, quickly and completely
Robust and Designed for Purpose
Many companies have developed powder-handling systems, but these units are derived from existing liquid-containment systems. ILC Dover has been working in flexible films since its inception in 1947, with projects ranging from NASA spacesuits to drug manufacturing. ILC Dover’s DoverPac® containment systems division specializes in powder containment systems and has purpose-designed the EZ BioPac™ containers for powder handling in the biopharmaceutical industry.
Easy to Fill and Seal
Packs with narrow openings are harder and slower to fill. They also increase the risk of spillage. The EZ BioPac™ containment system has an open funnel-like top for easier and quicker filling, and it fits into a light, nonmetallic frame that holds the top open with no separate funnel required. The large target opening reduces the chance of overfilling and makes it easier to fine-tune the weight of product, leading to a more accurate fill.
Traditional-style single-use bags become contaminated on the outside as product spills or overflows. EZ BioPac system has a protective outer skirt that reduces surface contamination and makes sealing and handling cleaner. The EZ BioPac is simple to seal because it requires just a fold in the bag’s upper neck, which is then sealed with integral cable ties.
The filled EZ BioPac™ system is self-supporting, making it easier to move around and store. EZ Biopac™ units can be filled centrally and stored where they are needed, saving time and resources. The range of sizes available off the shelf (1100 L) or as custom orders means that the right volume of bagged raw materials is always available. The EZ BioPac™ system has been designed to be robust and easy to handle with built in handles or lifting loops, depending on the size.
Discharge Easily, Quickly, and Completely
Media and buffers must be formulated accurately to ensure that an entire manufacturing process is as reliable and reproducible as possible. By contrast with many of its competitors, the EZ BioPac™ has a separate filling inlet and discharge outlet, keeping the flow path clean until its contents are transferred. To preclude incomplete emptying because of static build up, the EZ BioPac™ containment systems are made from ArmorFlex® 114 antistatic film, which meets FDA, USP, and EU regulatory compliance standards, and their dynamic three-dimensional design facilitates optimum flow performance.
What’s in the Future
As powder-handling requirements evolve, single-use products and systems must adapt to effectively address safety, efficacy, ergonomics, and cross contamination while improving efficiencies and reducing risks.