With an increasing emphasis on both operator safety and product protection, manufacturing oncology drugs, hormonal products and/or other highly potent compounds has been put under the pharmaceutical spotlight in recent years. Historically, the only option was to use cumbersome air suits to prevent the operators being exposed to the drug being processed and avoid cross-contamination with other products manufactured in the same facility.
GEA specializes in contained materials handling solutions for pharmaceutical and healthcare companies and believes that personal protection equipment (PPE)-free drug production is a near-future possibility.
“It’s more than that, actually,” says Phil Gabb, Sales Director: “It’s a real possibility, right now, because that’s what we’ve achieved with several of our existing customers.” We’re already using a combination of in-house containment technologies, he explained, and not just for the main processing operations, but also for 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).”
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.”
GEA was fundamentally involved and worked with an international working group to create a guide to containment testing. Now published by the International Society for Pharmaceutical Engineering (ISPE) and known as SMEPAC (Standardised Measurement of Equipment Particulate Airborne Concentration), this guide defines the test processes and parameters needed to assess the different levels of containment required throughout a plant. Keeping the real operating conditions of the final installation in mind, GEA can determine what level of containment is required where, optimizing the manufacturing process and making it efficient, safe and cost-effective.
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.”
GEA 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).
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.”
GEA can assist and advise you to determine what level of containment is required where and when, optimizing 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.
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