In a recent webinar, DoverPac® for HPAPI Transfers, ILC Dover discussed the two key benefits of DoverPac® technology: superior powder flow properties and zero cleaning.
DoverPac technology is purpose-built to handle highly potent active pharmaceutical ingredients (HPAPIs) with precision and safety, streamlining critical transfers in pharmaceutical processes. DoverPac offers high containment, exceptional powder flow, and single-use convenience, eliminating the need for cleaning, which results in significant cost and time savings compared to traditional intermediate bulk containers (IBCs) and split butterfly valve systems.
DoverPac is a flexible intermediate bulk container (FIBC) that drastically reduces cleaning requirements in pharmaceutical powder transfer, enhancing production efficiency and reducing operational costs. Its flexible wall technology handles challenging, poor-flow powders, ensuring smooth mass flow with minimal powder retention—an essential feature for maximizing product recovery and maintaining process integrity.
In this webinar, Scott Patterson, Vice President of PharmBio Technical Sales at ILC Dover, took an in-depth look at the diverse applications and advantages of DoverPac. Don’t miss this opportunity to learn how our technology can elevate your pharmaceutical processes. Continue reading for an overview.
The Origins of DoverPac
DoverPac was purpose-built for pharmaceutical applications and designed to address specific containment and cost-control needs that standard containers couldn’t meet. In the mid-1990s, as pharmaceutical manufacturers began working with increasingly potent drug compounds, they required advanced solutions for high containment (less than one microgram per cubic meter), the ability to handle both dry powders and wet cake, and capacity for large batch sizes (over 5000 kilograms). Additionally, the system needed to support in-line containment sampling, use a film that resists solvents and static, comply with FDA and global standards, and be fully disposable to eliminate cleaning requirements.
How DoverPac Works
The DoverPac operates through a simple, repeatable process of connecting, clamping, opening, using, sealing, and disconnecting, making it easy to integrate into pharmaceutical workflows. The system includes a reusable stainless-steel o-ring canister that connects via a tri-clamp, providing a secure base. When positioned for filling, the DoverPac attaches to the o-ring canister with an integral o-ring and clamps. After filling, a seal and separation process enables seamless movement to the next operation for discharge, following the same straightforward steps.
Built with an ArmorFlex® liner inside a conductive polypropylene restraint, DoverPac provides strength, static dissipation, and solvent resistance, meeting stringent pharmaceutical processing standards. This durable material has undergone stability trials on thousands of molecules, holds global transport certification from the United Nations Department of Transportation (UN/DOT), and complies with Type C FIBC standards. It also features an integrated sleeve for in-line high-containment sampling, allowing samples to be collected at any stage without operator exposure, ensuring tamper-proof quality.
High containment capability was a key design criterion, focusing on containment at the source to prevent any powder escape. CrimpLoc™ ensures secure sealing and connects multiple DoverPac units without dust leakage, protecting operators, the environment, and downstream disposal processes.
DoverPac Design Advantages
DoverPac offers a game-changing approach for industries that require the safe handling of potent materials and challenging powders. With its high-containment performance, quick disposal capabilities, and cost-efficient design, DoverPac provides a seamless, eco-friendly alternative to traditional containment solutions.
High HPAPI Containment Performance & Powder Flow Benefits
Containment studies demonstrate DoverPac consistently achieving exceptional control, with airborne concentrations under 30 nanograms per cubic meter during filling and 130 nanograms per cubic meter during discharge. The system supports smooth, mass powder flow with 200- or 300-mm diameter inlet and outlet necks, allowing unrestricted discharge for challenging powders or wet cake. This capability minimizes product loss and maximizes material recovery by ensuring minimal powder retention.
Ready-to-Use & Rapid Disposal
DoverPac is a ready-to-use, quick-disposal solution that eliminates the need for cleaning. It has a shelf life of up to five years and, after discharge, can be immediately disposed of with a high-containment crimp. This feature drastically reduces waste compared to the significant water and chemical use required for IBC cleaning, offering an eco-friendly, time-efficient alternative.
Cost Efficiency Compared to Stainless Steel Systems
Stainless steel IBCs involve high capital costs due to added requirements, such as split butterfly valves, post lifts, and bin washers, which also occupy significant floor space and necessitate ongoing maintenance. Additionally, the downtime for cleaning and validation increases costs and impacts production schedules—challenges avoided with DoverPac, which is ready for immediate reuse in subsequent production cycles, supporting streamlined operations and faster throughput.
Workflow Applications: Chemical Synthesis & Conical Milling
In chemical synthesis workflows, DoverPac excels at containing powders, wet cake, and final HPAPI products throughout the production process. It facilitates contamination-free transfer during crucial steps such as charging into dryers and reactors. This high-containment capability is essential for managing potent compounds and protecting both product quality and operator safety. The system’s reliable containment and easy handling make it ideal for maintaining a sterile environment and meeting strict regulatory standards in synthesis operations.
For conical milling workflows, DoverPac integrates seamlessly with flexible isolators that feed powder from drums directly into the mill, all under high-containment conditions. This approach supports controlled milling or de-lumping of materials while minimizing operator exposure. After processing, the powder is packed into DoverPac bags, which achieve containment levels below 50 nanograms per cubic meter, even under rigorous containment testing protocols. This capability makes DoverPac a valuable tool in pharmaceutical processes where precise containment and minimized powder retention are critical, especially when handling micronized or poorly flowing powders.
Your Journey to Zero Cleaning & Superior Powder Flow
DoverPac® is purpose-built for the pharmaceutical industry, offering an advanced high-containment solution that achieves nanogram-level containment during powder transfers. Its large, open neck and flexible wall design ensure complete discharge with minimal powder retention, maximizing material recovery. As a cost-effective, single-use solution, DoverPac® eliminates the need for cleaning, allowing for increased production time and efficiency. Versatile and reliable, it can seamlessly integrate into various pharmaceutical workflows, from chemical synthesis to oral solid dosage manufacturing.
If you’re interested in learning more about DoverPac® technology, watch our latest webinar. For further assistance, our team is here to help – contact us here.