Containment Solutions for Personal Protection Equipment-Free Drug Production

Phil Black - PII Editor 22/04/2014

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With an increasing emphasis on both operator safety and product protection, GEA Pharma Systems has pioneered pharmaceutical containment. Phil Gabb, Sales Director, pondered the question: is PPE-free drug production a near-future possibility?

“It’s actually a real possibility,” says Phil, “because that’s what we’ve achieved with several of our existing customers.” We’re already using a combination of the containment technologies that we have, he explained, from Buck®, Courtoy™, Aeromatic-Fielder™ and Collette™, not just for the main processing operations, but also for all the transfer steps between the unit operations — for cleaning in place or for contained offline cleaning, and for sampling and in-process control. “In fact,” he added, “there’s no longer a need for any drug production system to have personal protective equipment (PPE).”

Whether the pharmaceutical industry is ready to adopt this paradigm shift in containment is another matter. “Not all customers are ready,” notes Phil. A key requirement to operate such a system is a higher standard of operator training and a better maintenance regime. “You’re using engineering solutions and equipment design solutions to achieve operator protection, as opposed to wearing PPE, which is a relatively easy thing for companies to train their staff to use. This is a higher technical requirement, so whereas some customers and some markets take to that very easily, others find it something of a challenge.”

Drivers and Benefits
There are a number of drivers behind this switch to PPE-free manufacturing: first is the ongoing and increasing focus on operator safety; European and American customers have had this in place for many years. “Yet, some people miss the fact that every country in the world — including those that are sometimes considered to be less well developed — are all under increasing pressure from governments and from their national health and safety executives to improve the working conditions of their personnel — both in general and in the pharmaceutical industry in particular — with regards to operators being exposed to what are increasingly potent drugs,” Phil points out.

From a regulatory perspective, there is an ongoing push for more stringent guidance with geographically diverse timescales: Europe and North America implemented legislation 15 years ago, for example, and in China, under the aegis of a so-called “increased GMP standard,” there is a massive drive for increased operator safety. There are financial implications as well. “Indeed, there are cost penalties to implementing a containment solution, but there are also cost benefits,” says Phil. “If you keep the problem inside the system, you don’t contaminate the outside of the equipment, and you don’t contaminate the room. And when you come to cleaning the line, for product changeover, for example, or to start a new batch, the amount of downtime or labour required to clean the room and/or the outside of the equipment is dramatically reduced. You actually get higher, most cost-effective operability.”

Another direct benefit is that, in the past, many customers would buy an IBC washing system — to not only wash the inside of the container, but also the outside (a bit like a pharmaceutical car wash!). Now, with a contained system, the outside of the container does not become contaminated, as it’s not a product contact surface and, as such, you can operate a much simpler — and therefore much cheaper — IBC washing system. And, by keeping the product inside the system, you can manufacture different products in parallel without the risk of cross-contamination.

Says Phil: “In the past, you would only be able to process one product at a time, unless you had a complex setup involving airlocks, cleanrooms and isolators, to avoid the risk of product loss or contamination. We’re now seeing customers deciding to run potent facilities without having airlocks on every single room. That’s not only a big saving in costs, it’s a big saving on footprint and, subsequently, running costs: fewer rooms, less HVAC, less expense. And they’re doing that purely on the basis that with a good containment system, the product remains inside the equipment and does not enter the room; there’s no risk of exposure or contamination.”

The GEA Advantage
GEA Pharma Systems has a long history of expertise and an unparalleled depth of experience in the field of containment. The company not only offers a comprehensive range of robust and compliant containment products, it also boasts unrivalled experience in identifying the most appropriate solution and a thorough understanding of containment risk analysis.

And, although there’s a vast array of available equipment and machinery from a number of suppliers, one of the key benefits of working with GEA is that we can actually supply an entire, completely integrated, containment system, from raw materials handling right the way through to tableting, notes Phil. One of the big challenges with any containment system is the integration of all the different pieces of process equipment. It’s not just about having split valves, it’s about making sure that the materials handling system integrates with the granulation equipment and with the compression equipment. GEA offers group-wide technical solutions that can be integrated into complete lines.

This is becoming increasingly important with the growth in oncology and hormonal products, especially in batch direct compression systems (in which the ingredients are blended in an IBC and fed directly into the tablet press). There, the combination of Buck® and Courtoy™ products has been very successful.

Looking further ahead, if PPE-free working environments are already with us, what does the future hold for containment?

“Just a few years ago,” says Phil, “the trend was to develop equipment that was as contained as possible. What we’ve now put more of an emphasis on is applying some science to evaluating operator risk and establishing how much containment is actually needed for a particular process or application. It’s very easy to over specify the containment requirement for a product. And if you do that, you end up with equipment that’s not only more expensive to buy, it’s also more difficult to operate, maintain and clean. And that doesn’t benefit anybody.”

On Display
Interpack 2014 will take place in May (8–14) in Düsseldorf, Germany. GEA Pharma Systems, the leading international supplier of advanced processing technologies for the production of oral and parenteral dosage forms, will be exhibiting (Hall 7a). On the Interpack stand, we will be showing a post hoist, for lifting an IBC, and two different pieces of process equipment: one is a CourtoyTM tablet press; the other one is an IBC milling system wherein all of the process connections are achieved using Buck® split valves.

A totally contained process line will also be on display. Comprising a through-the-wall PharmaConnect® granulation and blending system, and a FlexStream™ fluid bed dryer, the plant will highlight contained product transfer using the disposable Hicoflex® system and milling product directly into a Buck System™ IBC via a Buck® TC split valve. From dispensed raw materials to finished tablet, the system on show will clearly demonstrate the flexibility that can be achieved throughout the process in a totally contained environment. It illustrates how GEA can provide a complete, application-specific solution for your containment needs, whether through integration or split valve technology.

GEA Pharma Systems can assist and advise you to determine what level of containment is required where and when, optimising the manufacturing process and making it efficient, safe and cost-effective. We provide tailor made containment for the pharmaceutical industry — for now and for the future. Contact us today to learn more about our extensive containment experience and challenge us to develop a PPE-free solution for your production line.