The rising use of high-potency active pharmaceutical ingredients (HPAPIs) in drug development, driven largely by growing demand for targeted oncology medicines, is highlighting the need for superior containment systems capable of safely handling these dangerous, difficult molecules.
These potent drug compounds, which are used in much smaller quantities, first started seeing increased usage in the 1990s. By 1996, pharmaceutical manufacturers had begun to approach their containment solutions partner for a better and more cost-effective containment solution than traditional stainless-steel devices.
As the issue grew in the pharmaceutical community, ILC Dover was given the opportunity to create a system to contain less than one microgram per cubic meter – the ‘gold standard’ at that time. The solution would need to handle dry powders and wet cake, as well as blockbuster drug batch sizes and large batch sizes, typically greater than 5,000kg.
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, and the DoverPac system was born.
Superior powder flow properties
DoverPac is a powerful technology for handling potent active pharmaceutical ingredients and transfers in pharmaceutical processes. The 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.
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, 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.
Another big problem back in 1996 was sampling in line without breaking containment. DoverPac solved that 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.
Over the past 25 years, every large pharmaceutical company has used DoverPac to process molecules. The construction meets global product contact standards and has successfully passed stability trials for thousands of molecules to date. DoverPac 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.
DoverPac vs stainless-steel IBC
There are many advantages of using DoverPac technology over traditional stainless-steel IBCs.
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. There is also need for 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 DoverPacs in filling operations.
Overall, the 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.
DoverPac is ideal for applications less than 150.0 nanograms/m3. Manufacturers seeking multi-level containment can 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 micronised powders, or highly potent compounds that are already difficult to process.
There are also 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.
Zero cleaning
Last but in no way least is the technology’s ability to eliminate cleaning costs and free up time for additional operations. The DoverPac itself can be disposed of to eliminate all of the cleaning associated with other types of hard-walled technologies, creating less than 5kg of plastic waste.
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.
To learn more about the DoverPac technology, you can watch ILC Dover’s latest webinar, where the company discusses the system’s two key benefits: superior powder flow and zero cleaning. Reach out to ILC Dover with questions to discover how they can optimise your process with DoverPac technology today.
