Disposable trends are on the rise and offer optimal conditions for manufacturing processes. According to Dr. Sternberger-Rützel, “In 2012, pharmaceutical manufacturers will be increasingly drawn to the simplicity and speed of disposable systems, which easily meet industry standards. Assembled in DIN ISO 14644-1 class 7 cleanrooms, the latest single-use components are connected to the product stream via sterile plug-and-play connections and are easily removed, bagged and disposed of without breaking connections and exposing the environment to the product.”
Investing in new or used equipment varies widely in the industry, contingent upon manufacturing needs, and cost is not necessarily a factor. “Big pharma uses used equipment to a certain extent, where possible. If for any reason a purchase of new equipment is faster, including qualification/validation, most of the time new equipment is the first choice, as time is money,” said Mr. Nolte at L.B. Bohle. “Used equipment can be more expensive than new equipment. The investment is not only the cost of hardware, it’s the overall cost including all planning and integration steps. The cost ratio between hardware and controls/documentation for new equipment for instance is constantly moving to the controls/documentation side. It can be as 50% for the hardware costs and 50% for the controls/documentation cost.”
However, starting from scratch with the installation of new equipment can be more time consuming, particularly for existing manufacturing processes and projects. Mr. Hicks at Federal Equipment noted, “Our customers routinely seek out both new and used equipment depending upon their own manufacturing mix and given opportunities. With a short timeframe to get a new product launched, used equipment becomes a much more viable option over new equipment. If the need is for spares, replacement equipment, or additional capacity with similar equipment, used equipment is always a lower cost option. However, new products sometimes require very specific, custom-built equipment. The more specialized the piece of equipment, the harder it is to source on the secondary market, which favors the purchase of new equipment.”
“For packaging and processing equipment suppliers it is vital to be abreast of the trends and to develop machinery that helps manufacturers deal with the increasing demands of a changing environment, and to develop solutions tailored to meet their needs,” said Dr. Sternberger-Rützel.
Equipment for the latest manufacturing processes, containment solutions for a growing HPAPI segment, flexibility of scale for new therapies such as personalized medicine, and short start-up times and easy changeovers are on trend and equipment providers are charged with designing the equipment that can manufacture and package these increasingly complex drug products. Whether making repairs to existing equipment or purchasing new or used, equipment is integral to a reliable manufacturing process that produces quality product on a regular basis and having all of these options are essential.