How flexible is flexible pharmaceutical filling?
By Greg Speakman
Vice President Sales and Marketing
My teenage daughter goes to ballet class. One day she convinced me that we should go to the gym together. We went, worked out, and then …….. we stretched. Side by side. Picture if you will a teenage ballerina doing the splits beside her previously assumed to be fit father barely touching his toes. (It wasn’t pretty.)
Based on different expectations both could be called flexible, but one was clearly Flexible.
In the pharmaceutical world, many people are talking about Flexible Filling. Let’s talk through what Flexibility really means.
Why is there a trend towards Flexible Pharmaceutical Filling? Well, as pharma companies develop more targeted medicines that address smaller patient populations, their filling requirements change. Gone are the days of a dedicated high-volume line producing hundreds of millions of doses of one medicine in one container. Increasingly, we see requirements for facilities which can produce a number of different medicines in a number of different container formats. Further, we see requirements from pharma companies to have these facilities operate in many new geographies.
With our past experience in developing medicines, supplying clinical trials, and operating pharma production facilities, we at Vanrx champion flexibility. We have identified five key drivers of Flexibility for the process of manufacturing injectable medicines.
- Filling vials, syringes, and cartridges.
Vanrx believes that to be truly Flexible a single filling system needs to be able to fill multiple container formats including vials, syringes, and cartridges, in sizes ranging from 1 ml to 50 ml. A pharma company may deal with small molecules as well as biologics, and pre-filled syringes as well as vials. The products may be oxygen-sensitive, highly potent, or lyophilized. Truly Flexible filling will support them by producing all these variations in one workcell.
2. Optimizing for 20,000 dose batches.
With specialty therapeutics and clinical batches, there definitely are smaller production batches. Further, batch sizes and product characteristics vary widely. Today’s Flexible Filling solutions need to be cost and resource-optimized to produce batches of less than 20,000 units and facility capacity of 5 million units per year. For higher capacity, clone the workcell.
3. Supporting one-hour changeover between medicines and formats.
To effectively support the product mix, fast changeovers between medicines and formats is paramount. Some so-called flexible systems can take up to 20 hours to change between different sizes of vials, not even considering changing over to syringes. Truly Flexible systems can do a complete changeover between container formats in less than one hour.
This fast changeover is accomplished through the use of nested containers and closures, wash down systems integrated into the filling workcell, and a minimalist, disposable flow path.
4. Reduced infrastructure and resource requirements
Truly flexible systems require less floor space, as low as 38 square meters. Integrated isolation and filling require less stringent environmental controls in the facility. The nested components and gloveless robotic processes require far less operator activity and handling.
5. Being able to be quickly replicated.
Flexibility doesn’t apply to a single line, workcell, or facility. Pharma companies are being guided to produce medicines in many geographies. Today’s Flexibility means the ability to quickly and efficiently increase capacity in a facility by duplicating a production workcell and create a new facility in a new geography by duplicating an existing production facility.
Today’s workcell model filling systems, integrated isolator, simplified container handling, and use of modular clean rooms all support this growth model.
So, next time your boss leans over your shoulder and asks:
“Can you squeeze a high-priority clinical run of 3,000 syringes into your (already locked down) schedule of producing four other medicines?”
“Why aren’t those filling lines running?”
“How long will it take us to be able to produce this medicine in Brazil/Russia/Turkey/Tierra del Fuego?”
consider what the flexibility requirement really is, and ask yourself if you want to be the ballerina or her dad.