DoverPac® High Containment FIBC System
DoverPac® Containment Systems are the global standard for disposable process and powder containment systems. In 1997, ILC Dover worked in collaboration with Eli Lilly to develop a flexible intermediate bulk container (FIBC) that provides high levels of reliable containment during both charging and offloading activities during solid oral dosage production and API manufacturing operations.
DoverPac® is the only single use FIBC that will effectively transfer powder between processes and meet containment levels of <0.5 µg/m3. One of the key elements of the DoverPac® line of products is their ArmorFlex® material. These films are formulated at ILC Dover with a unique blend of safe and effective anti-static additives, allowing for contact with a wide range of solvents, as well as being able to deliver superior elongation performance for ruggedness and high strength. The revolutionary ArmorFlex® film delivers permanent static dissipative properties while meeting FDA and EU regulations, and also passes the ever-important Chilworth Incendivity tests. Certified Type C and UNDOT certified units are available as needed.
The DoverPac® FIBC technology provides the safest and easiest powder fill and transfer operations on the market, with no inverting, no costly lifts, and no split butterfly valves needed during use. There are multiple standard sizes (up to 2000L) in stock to meet your needs, from high volume bulk handling to low volume HPAPI. The DoverPac® system follows all of the critical design specifications of being able to contain at the source with no need for open nozzle charging, hence keeping all powder at the source and minimizing exposure to the operator and environment. The flexible wall design is a huge benefit for poor flowing powders. Operators have the ability to easily manipulate the flexible wall to assure even the poorest flowing powders are completely discharged, without having to break the containment to see if the bin has been fully emptied of powder. Another great feature is the ability to dock the DoverPac® at an offset when space is tight, allowing for an optimal environment for the operator’s activities.
The DoverPac® QbD Approach – Built for Critical Containment Applications
DoverPac® was built and specifically designed for handling potent pharmaceutical powders and not just some derivative applied to this space. The key part of the DoverPac® system starts with the ArmorFlex® film. As mentioned, this quality-driven film was developed with powder handling in mind, providing a static dissipative film with a robust resistance to a number of pharmaceutical solvents. In continuation of the QbD approach, the shape of the FIBC was developed with repose geometry to assure the best possible flow of powder when discharging. This flexible containment system was built with production equipment in mind to facilitate superior powder flow and compatibility for all of the various types of hoppers used in the industry today. The DoverPac® system also maintains closed charging minimizing the risk of contamination and particularly cross contamination in a facility sharing the production of multiple products. The process is contained at the source for operator and environment protection, which also keeps contamination completely out of the process.
Keeping the QbD approach in mind, the entire system can easily repeat the same transfer procedures for greater operator efficiency and enhanced use during large-scale bulk transfer activities. For example, the DoverPac® “shower cap” securely protects the process until the next DoverPac® is docked, and the “Bag Out Sleeve” is a simple process to remove the shower cap and the DoverPac® can then be efficiently discharged for a seamless and effective transfer. Another unique QbD feature of the DoverPac® is the highly contained in-line sampling sleeves. As many of us in the industry already know, sampling is required for most production processes and is quite difficult to perform in high containment environments. DoverPac® has an integral sample sleeve with the ability to take fully contained samples at any time. The sleeve is 48” long and can be used to manually “grab” segregated samples at the beginning, middle, and end of the fill right into the DoverPac®. The sample sleeve can be easily crimped and safely transferred to QA or another location with only the powder inside so no exposure can occur.
A Review of Applications and Performance Data using DoverPac®
Let’s take a look at some of the applications and associated performance data for the DoverPac® Containment System. Production facilities that perform API manufacturing and Highly Potent chemical synthesis can truly benefit from integrating the DoverPac® System into their operations. As mentioned before, the DoverPac® process remains closed and completely contained at the source, thus complying with typical company policy and FDA inspectors, as it is their preference to see no open man-way charging into reactors. DoverPac® was designed with the ability to handle multiple types of powders in a closed system. Production teams can operate with everything from dry powders to wet cake from a centrifuge and can be handled and transferred seamlessly within a multi-step synthesis or process and safely contained within the DoverPac® system.
If your team works with complicated Solid Oral dosage production, DoverPac® can meet your containment needs throughout every step of the process. DoverPac® has the ability to contain transfers between each production process, including:
- Milling, such as with a Comil
- Hot melt extrusion
- Direct compression
ILC Dover has gathered performance data using the ISP SMEPAC protocol from dozens of companies and specific applications and has had very good results regarding safety and efficiency during fill and transfer. Over the course of multiple types of sampling and transfer studies, the performance data was excellent and in many instances showing below the level of detection or extremely low levels of detection, thus providing an overall very high level of containment and consistent results over many different applications in the industry.
Comparing Cost and Performance of the DoverPac® to Traditional IBC Systems
When comparing DoverPac® to traditional rigid stainless-steel IBC systems, there are dramatic cost-savings and performance-enhancing benefits when using the DoverPac® System. Life Cycle Analysis (LCA) results show significant utility savings, including less water consumption and energy costs when using single-use FIBC systems like the DoverPac®. Traditional stainless-steel IBC systems require a large amount of capital to purchase and maintain, including cleaning, cleaning validation, and hold times that use up valuable resources and take a long amount of time that ultimately slows production cadence and overall operations. Single-use FIBC systems remove the entire cleaning burden while also preventing cross-contamination from unsatisfactory cleaning in between product runs. Many companies who switch to single-use containment technology end up cutting their operating budget and project time in half or more!
When comparing the cleaning costs of traditional stainless-steel IBC systems versus the minimal disposal costs and time savings of the DoverPac® system, the choice is clear on which system is the best option for your facility.
Cleaning Rigid IBC Systems:
- Potentially an unknown amount of retained powder after cleaning
- The first rinse must be captured for proper disposal
- Detergent and rinse needs to be captured, treated, and properly disposed
- Drying period hold times created additional energy costs
- Disassembly of the containment valve for cleaning adds costs
- Floor space must be dedicated for rigid systems, cleaning, and storage
Disposal of DoverPac® FIBC System:
- Complete powder discharge including a check to minimize retention
- Seal and separate procedure that requires virtually no extra cleaning
- No containment valve needed
- No floor space dedicated for the equipment
- Disposal via incineration is a very low cost
Does your team have a need for single use flexible isolation technology in your facility? To see the DoverPac® Containment System in action, be sure to watch the full webinar for more information.