Any successful baseball player knows that the key to unlocking greatness lies in thinking ahead to the next play — figure out exactly what pitch the ace is about to throw, or exactly when that baserunner is about to break — and you are one step ahead of the competition. Back this forward-thinking philosophy with a talented team, and you have a sure winner.
As pharma companies push to innovate drug product offerings, they will undoubtedly need new technology to manufacture their products. But technology alone is no longer sufficient. In the new, non-blockbuster-reliant era of pharma, capital expenses have to be applicable to more than one process or product, seamlessly integrate with existing systems, and add true, measurable value to both present and future processes.
Smart pharmaceutical equipment suppliers are listening to their customers and using that feedback to develop and launch truly innovative products that were solving clearly defined problems in the industry. The end result? Equipment suppliers are driving, rather than merely supporting, manufacturing and process innovation in the pharmaceutical industry. This month’s cover story highlights and applauds those who have distinguished themselves as leaders in pharmaceutical equipment innovation.
Now introducing this year’s All-Star Innovators: technologies and systems launched within the last 12 months that, based on their relative applicational and technical merits, were selected by Pharmaceutical Manufacturing’s editors and reviewers to be on this year’s All-Star Innovators Roster.
ANALYTICAL AND MONITORING DEVICES
Analytical and monitoring devices are essential for a field that requires precision, reliability and repeatability. Pharmaceutical products must be able to demonstrate perfect quality, and the right analytical tools are needed to not only obtain, but validate and maintain that quality.
Leading off in this category is Keit’s microFTS, a Fourier Transform Infrared (FTIR) spectrometer developed with a novel optical design for improved in-line process monitoring. The instrument was originally developed for the space program, making it inherently smaller, lighter and more rugged than current systems, and able to function despite extreme environmental vibration. The microFTS has no moving parts, setting it apart from other FTIRs, and enabling a new standard for real-time liquid-state analyses.
Pharmaceutical analysis experts, Chiralabs, ran tests using multiple common substances to find out how consistently the microFTS would perform. The reports confirmed the microFTS’ ability to detect and analyze common solvents used in pharmaceutical, chemical and petro-chemical industries with high consistency.
BrightSpec has developed a rapid and chromatography-free quantitative sampling method for the ppm analysis of low volatility impurities in solid powders and complex liquids. This application of FT-MRR (Fourier transform molecular rotational resonance) using millimeter waves in the 260-290 GHz range is the first purely spectroscopic approach to a problem that is usually constrained to the realm of Gas Chromatography Mass Spectrometry.
The BrightSpec product and services portfolio uses FT-MRR spectroscopy in the microwave range (2-8 GHz) to perform three essential chiral analysis measurements: 1. Quantitative analysis of diastereomers produced in the synthesis of molecules with multiple chiral centers. 2. Quantitative enantiomeric excess measurements for chiral molecules. 3. Determination of the three-dimensional structure of a chiral molecule.
Currently, each of these analyses requires different measurement technologies that are expensive, time consuming and highly technical. In order to meet the needs of target markets, BrightSpec is developing instruments that can perform this analysis on molecules in drug discovery applications.
Batting in the power spot is WIKA’s Diaphragm Monitoring System. The system alerts operators immediately if the diaphragm in a seal assembly fails, helping prevent contamination of the process media and unscheduled downtime.
Diaphragm seals are installed to help maintain the integrity of process media for product safety and quality. However, repeated exposure to harsh chemicals and extreme conditions can weaken the diaphragm membrane and cause it to fail. This failure can go undetected, leading to possible process contamination.
WIKA’s monitoring system is designed with primary and secondary diaphragms. If the primary diaphragm is breached, it will trigger a visual, audio or electrical alert. The secondary diaphragm will continue to function, providing reliable pressure readings until repairs can be made.
Bioprocessing equipment encompasses bioreactor vessels and all related equipment needed to maintain a streamlined reaction within a sterile environment. As the demand for biopharmaceuticals grows, drug manufacturers are looking for new strategies to meet these global needs. Often this results in the need to create more efficient bioprocessing systems and employ single-use technology to reduce cleaning and production costs.
First up, ITT Corporation’s Engineered Valves brand has launched a new line of hygienic diaphragm valves — Pure-Flo EnviZion — designed to dramatically reduce maintenance time and total cost of ownership for today’s biopharma manufacturing facilities.