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 a containment system that does a lot more than transfer powders. DoverPac® was purposely designed for ease of use in handling pharmaceutical products and should not be grouped in with commonly used “super sacks” or other big bags adjusted for pharmaceutical applications. In 1996, pharmaceutical manufacturers were starting to develop more potent drug compounds than ever before and came to ILC Dover seeking a better solution for containment and to deal with cost control issues due to the high cost of stainless-steel containment devices. ILC Dover was given the opportunity to create a system to contain less than 1 microgram per cubic meter—the “gold standard” at that time. The DoverPac® would have to handle dry powders and wet cake, as well as blockbuster drug batch sizes and large batch sizes, typically greater than 5,000 kgs.
In-line sampling was another problem that needed to be solved—the concept of not breaking containment to take a sample. Dealing with single-use technology, however, required a film that would resist solvents and static. That film also had to be FDA-compliant, as well as compliant to other global standards. And finally, as a single-use technology concept, it would mean no cleaning required. Keeping all of this in mind, ILC Dover set out to create a groundbreaking high-containment solution that would overcome common powder issues to deliver a cGMP process altogether.
How Does DoverPac® Technology Work?
DoverPac® has a straightforward process of connecting, clamping, opening, and using the DoverPac®, and then sealing the DoverPac® and disconnecting. This process repeats the same steps over and over again, and it becomes effortless for operators to use in the long run. The technology starts with the patented O-ring Cannister, which is connected to the process via a tri-clamp connection. This is a stainless-steel reusable device. When the DoverPac® is in the fill position, it connects to the O-ring Cannister using an integral O-ring and easy-to-use clamps that lock it and seal it. Once a Cannister is filled, the DoverPac® will move to the next process for discharging and then connect to another O-ring canister to repeat the process over again in an efficient and effective manner.
DoverPac® is made with an ArmorFlex® liner inside and is installed to a conductive polypropylene restraint on the outside. The ArmorFlex® liner is high-strength, static-dissipative, and solvent-resistant, meeting all pharmaceutical requirements. It meets global product contact standards and has successfully passed stability trials for thousands of molecules to date. Over the past 25 years, every large pharmaceutical company has used this to process molecules. This construction is also UNDOT certified for global transportation and has gone through rigorous drop tests to ensure system safety. It is also a Type C FIBC certified when using the ArmorFlex® materials with it.
Another big problem back in 1996 was sampling in line without breaking containment. DoverPac® solved that problem by including a sleeve for in-line high-containment sampling. Now, samples can be taken at the beginning, middle, or end of the process, or whenever required, because there is no operator exposure, and the sample is tamperproof when taken to the quality area. Let’s take a look at some of the advantages of using DoverPac® technology over traditional stainless-steel IBCs.
Advantages of DoverPac® Technology
The main design philosophy of the DoverPac® is to contain powder at the source. This means not using local ventilation-type exhaust systems, which just move the risk to another location. We also need a reliable seal system to attach multiple DoverPac® units in a seamless fashion. The crimp-lock system was designed as ILC Dover’s sealing process that allows for an efficient removal process when using multiple DoverPac®s in filling operations.
Overall, this system was made to keep operators and environments safe throughout the process, as well as during removal and disposal activities. It’s important to point out that when disposing of DoverPac®, there’s no risk of operator exposure or contamination to the environment. If you’re interested in learning more about the DoverPac® performance characteristics, check out our webinar.
DoverPac® is ideal for applications less than 150.0 nanograms/m3, but if you seek multi-level containment, look no further than the Co-axial Neck DoverPac® option, developed for high-risk processes to assure containment levels below 50.0 nanograms/m3. This is an excellent option for micronized powders, or highly potent compounds that are already difficult to process.
There are many powder flow advantages with DoverPac® technology. The DoverPac® neck is 200mm or 300mm diameter with no valve to block flow, thus allowing poor-flowing powders and even wet cake to fill and discharge with ease. This results in less product being lost in the transfer, especially when compared to traditional stainless-steel IBCs. Now, let’s discuss cleaning and how the DoverPac® eliminates cleaning costs and frees up time for additional operations.
DoverPac® creates less than 5.0kg of plastic waste. This is compared to the costs of rinse water and chemicals for cleaning the IBC, which is typically over 500 liters per IBC, including all the wastewater disposal and operator time and cost savings. The DoverPac® itself can be disposed of to eliminate all of the cleaning associated with other types of hard-walled technologies. If you’ve worked with stainless-steel IBCs in the past, you will understand the rigorous and expensive process it takes to thoroughly clean them and re-qualify them for the next lot. The rinse water, the chemicals, the disposal costs, and operator expenses taken to re-validate the unit often results in a large amount of production time being lost to the cleaning process.
ILC Dover and DoverPac® Technology
If you’re interested in learning more about DoverPac® technology, watch our latest webinar. Reach out to ILC Dover with questions and to find out how we can optimize your process with DoverPac® technology today.