INTERPHEX 2012: 3 Manufacturing Challenges Single-Use Aims To Overcome
By Lori Clapper, Editor
Single-use technology was again a dominant theme at INTERPHEX this year, featuring prominently in both the conference schedule and in booths throughout the exhibit hall. With pharmaceutical and biopharmaceutical manufacturers under growing pressure to produce mass quantities of high-quality drug products in less time and at lower costs, the industry continues to explore the benefits of replacing or integrating its traditional stainless steel equipment with disposable technologies — from mixing systems and bioreactors, to filtration systems and connectors. While I was at the show, I spent some time attending single-use focused sessions and speaking with a number of disposable product vendors, to explore the major challenges manufacturers face and how single-use technology is adapting to help overcome them.
1. Protecting Investment
Economics has been a big driver for the growth in single-use technologies, primarily because it can reduce capital investment in processing facilities and equipment. However, the increasing adoption of single-use technology has brought with it a new financial concern — protecting the drug maker’s investment in the product itself. Since the value of a drug grows as it moves downstream, manufacturers need to know that batches are protected from leakage or sterility breach. Richard Bhella, global product manager with ATMI, put it to me succinctly: “Manufacturers are putting a lot of high-value product in a plastic bag. This makes them nervous, because millions of dollars of product could end up on the floor if there is a leak.” ATMI developed the Helium Integrity Testing (HIT) system to give manufacturers assurance that their batches will be safe. “HIT is much more sensitive than pressure hold testing,” Bhella said. “Pressure hold can detect holes down to approximately 100 microns in size, but HIT testing can go below 10 microns.”
2. Saving Time
Time is a prime directive in the implementation of single-use technologies. If a contract manufacturing organization (CMO) needs a new system in place or a company is opening a brand new facility, there is high demand for single-use solutions that can be quickly set up, to avoid production interruptions. According to Millie Ullah, senior global product Manager at Thermo Fisher Scientific, an entire single-use facility can now be set up in as little as six months —and scale is no longer an issue. For example, HyClone’s new HyPerforma Single-Use Bioreactor system comes on a mobile skid and can be up and running within a day, even at a 2000-liter scale, according to Ullah.
Process efficiency is another time-related driver of single-use technologies. If a hose or connector is too small for an application, flow is drastically reduced and time is wasted. John Boehm, business unit manager for bioprocessing with Colder Products, said this challenge drove the development of the AseptiQuik X large-format single-use connector. He added that these connectors (available in 3/4” and 1” configurations) allow quick and easy sterile connections for high-flow applications like single-use bioreactors, mixers, and transfer lines. “If you have a 1,000 liter bioreactor or a 2,000 liter mixer, harvesting could take hours. By going to a large, 1” flow connector, versus a standard .5” flow, you can reduce that process time to minutes,” Boehm said.
3. Meeting Cleaning Requirements
The need to reduce or eliminate the cost and time associated with cleaning verification and validation is also a major driver of new single-use technologies. To address this challenge, Pall Life Sciences launched its Allegro Single-Use Filling Needles at INTERPHEX. I spoke with Helene Pora, VP of single-use technology, about the customer issues that drove the development of this new technology. “The main challenge was really the difficulty of cleaning,” Pora said. Filling needles have such narrow lumens that it’s tough to know whether they are really clean. “That’s why there’s a strong push within the industry, and from regulatory authorities, to develop new single-use filling technology,” Pora added. As single-use solutions, Allegro needles don’t require cleaning or validation, are free of particles and endotoxins, and are ready to use out of the package, thus maximizing manufacturing time and decreasing turnaround time.
Looking Ahead
Even with all these (and other) single-use advancements on display at INTERPHEX, there is still a question that remains virtually unanswered: Will the continued growth of single-use systems produce more waste? Pall’s Pora and colleague Bruce Rawlings tackled this issue in a recent article on Pharmaceutical Online, “Waste Management in Single-Use Systems: Exploding the Myths”. They claim that the proportion of waste produced between single-use systems and traditional reusable, stainless systems is more balanced than what you might expect. The reasons being that reusable systems produce liquid waste in the form of water and chemicals from cleaning processes, and that larger pharmaceutical plants produce a large share of solid waste in the form of packaging, paper, disposable garments, etc.
Certain materials like external packaging and labeling items can be recycled. However, safety risks prevent other single-use materials from being reused. Right now, all disposable materials that can’t be recycled are dumped into landfills or incinerated. Is this the best solution, or could there be a better alternative in the future?