To gauge the level and type of innovation for machinery and equipment for the pharmaceutical industry, Pharmaceutical Technology assembled a roundtable of experts in various fields to share their insights.
Participating in the roundtable were: Richard Denk, director of the pharmaceutical department for Hecht Anlagenbau (Pfaffenhofen/Ilm, Germany); Dieter Forthuber, division president of KMPT USA (Florence, KY); Craig Martin, product manager at Dwyer Instruments; (Michigan City, IN); Bruce Smith, regional manager at SPX Process Equipment (Delavan, WI); Christopher Fournier, vice-president of Mar Cor Purification (Lowell, MA); and Grant Rowe, product manager, respiratory protection, Bullard (Cynthiana, KY).
Bulk solids handlingQ: Industry-wide, what would you identify as the current leading trends in product innovation for equipment for bulk-solids handling? What factors are driving the changes?
Denk: Flexibility in bulk-solid handling is the leading trend of product innovation. In the past this focused on one system, for example a sack and unloading device ordered and installed. Now the requirements dictate that the bulk-solid loading and unloading station should be used to load and unload sacks, bags, different types of drums, super sacks, and intermediate bulk containers without any restriction on different containment levels to reach. The reason for this required flexibility is the manufacturer of the bulk solids wants a multi-purpose facility for handling his current materials (which may be a raw material or an intermediate) with the flexibility to handle different products (yet to be determined) in the future that have more stringent containment requirements. Products are purchased worldwide, and the packaging materials varies between suppliers. Contract manufacturers require this flexibility in the equipment selection since they work for different companies with differing product characteristics.
Q: Industry-wide, what you identify as the most significant development over the past two years in product innovation for equipment for bulk-solids handling?
Denk: Flexible disposable technologies, such as flexible intermediate bulk containers (FIBCs), are becoming more common for handling products in the active pharmaceutical ingredients and pharmaceutical industries. FIBCs can be filled and discharged with containment levels (measured in μg/m3) that previously could only be attained with the use of isolators. Another big advantage of FIBCs is they don't have to be cleaned after use. Cleaning requirements are becoming more and more important, especially in multipurpose applications. For certain materials, such as steroids, hormones, cytotoxic, and teratogenic products, there is no cross-contamination or cross-mixing allowed. The cleaning validation of the packaging material for these types of bulk solids is impossible. Flexible disposable technologies offer the most cost-effective solution in these cases.
Q: Industry-wide, what are the current leading trends in product innovation for solids–liquids separation? What factors are driving the changes?
Forthuber: Combining mechanical and thermal solids/liquid separation into one processing unit or providing automatic, completely contained product transfer between mechanical and thermal machines.
Improving mechanical solids/liquid separation by means of applying pressure and/or employing special membrane technology (e.g. cross-flow filtration) to enhance the filtration capability for very fine particle sizes.
Improving vacuum drying by intensifying product transport and mixing for shorter drying times without the risk of particle degradation.
"Clean" designs: fewer moving parts and surfaces (reducing dead spaces) in the process area; crevice-free design, surface finish for less risk of product residues; and complete discharge (higher yield) and better cleanability.
Continuous processing instead of batch processing. Control and reliability of the process will be the key factor in moving to continuous processing.
New or improved sensor technology to provide touch-free measurements of operating parameters. Examples include ultra-sonic measurement and acoustic measurement for filtration centrifuges.