Evolutionary or revolutionary, technical innovation is supporting new gains in pharmaceutical manufacturing and processing efficiency. That is, the technologies are available to help achieve these gains, but only if these players get a chance to get out of the bullpen and have their turn at bat. Let's be honest, it's been a long time since Pharma's leadership in manufacturing excellence was accepted as fact, but there are plenty of drug manufacturers out there (as well as their design, engineering and technology suppliers) who beg to differ.But it's a new year and another season entirely, one spanning an incredibly dynamic, complex global marketplace. The pace of change and the market's dynamics are prompting fresh capital investment in equipment and facilities, especially in the Bio and Contract Pharma sectors. Pressure on global players to improve quality is intensive. Excluding Japan, Asia's Generic Pharma business is spending more than ever to gain compliance and subsequent relief from regulators. All of Pharma's big teams want to play in this World Series, but to do it successfully they have to be competitive; and increasingly, to be competitive manufacturing operations have to be fit, flexible and agile enough to meet the market's challenges while beating other teams playing the field.Pursuing competitive agility through operational excellence is a winning strategy most of Pharma's manufacturing-oriented leadership will recognize. The means to achieve competitive agility is increasingly coming from the Pharma industry's technology and system suppliers. Many companies are delivering technical innovation to support drug development and innovation. These innovators deserve to be recognized. What follows are this year's All-Star Innovators, technologies and systems introduced 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. Just like in the big leagues, products and companies (players and teams) were featured on their own baseball card, complete with performance and other stats.
Take a look at who made this year's roster; there's bound to be something able to help make your process or operational task a winner for your organization.
ANALYTICAL AND MONITORING DEVICES
AMETEK Crystal Engineering's HPC40 Series hand-held calibrator leads off, ready for on-the-run calibration tasks around the plant. Because the HPC40 Series is the world's first mA loop calibrator that is fully temperature compensated from -20o to 50oC, it can deliver the same accuracy whether measuring pressure, current, voltage or temperature. The HPC40 can typically replace several gauges or calibrators and offers a full-color display paired with a new user interface that offers a shallow menu structure allowing tasks to be performed quickly and intuitively.
To help users gain a better understanding of biologic formulations earlier, Malvern Instrument's Zetasizer Helix combines Raman spectroscopy with Zetasizer dynamic light scattering (DLS) technology to conduct highly detailed protein aggregation mechanism studies. According to Malvern Instruments, a key priority for the industry is obtaining a greater understanding and control over the formulation process, a need exacerbated by the increasing adoption of QbD. By allowing users to fully scope protein behavior within a formulation, the device provides insight at the molecular level as to which variables trigger, for example, oligomerization and aggregation, this supporting a QbD approach.
Primex Wireless offers a pervasive, flexible wireless solution with its OneVue Intelligent Monitoring Platform. The platform, says Primex, is unique in that the data generated by sensors is tied to the room, physical equipment (such as refrigerators) or inventory (such as pharmaceuticals) being monitored, rather than to the sensor. As a result, OneVue delivers comprehensive, historical data trails for compliance audits, preventative maintenance, benchmarking, cost comparisons and more - all without requiring users to merge records each time a sensor is changed or assets are moved.
Like the bat is to baseball, so is Thermo Fisher Scientific's Gemini handheld FTIR and Raman analyzer; that is, it's essential, portable and goes where the game is. According to Thermo Fisher, Gemini analyzers require minimal training and are easy to use. The innovative design combines FTIR and Raman spectroscopy in a single, lightweight but rugged handheld instrument that delivers lab-quality analysis on demand. For those substances identifiable by Raman and FTIR, the scanner provides comprehensive analysis, delivering more actionable information to the operator. Switching between analysis techniques is fast and easy using the tactical keypad or touchscreen.
Unified to simplify chromatographic separation and analysis, the Nexara UC from Shimadzu Corp. eliminates the need for complicated sample pre-treatment and enables highly reliable and stable analysis of delicate samples that are prone to oxidation or dissociation if exposed to air. Fully automated, Shimadzu's system can sequentially analyze up to 48 samples via automatic extraction and chromatographic separation combined with high-sensitivity detection of targets by mass spectrometry. According to Shimadzu, the automated extraction and chromatography is achieved using a mobile phase of supercritical fluidic carbon dioxide (that exhibits the solubility of liquids and diffusivity of gases) into which alcohol and other such organic solvents are added.
AUTOMATION, CONTROL AND SENSING
Denso Robotics' VS-050 Six Axis Aseptic Robot possesses ISO 5 cleanroom rating and specially designed coverings for applications where biocontamination control is required. Pharmaceutical, medical and life sciences sectors, says Denso, can benefit from the unit's high speed and features like a protective outer coating, and sealed joints allow the VS-050 to be safely sterilized with hydrogen peroxide or UV light. The smooth, rounded exterior of the robot has no external screws, to keep dirt, dust or other contaminants from adhering to its surface. Wires are internally embedded up to the flange and the control-cable connector is located on the bottom of the robot, further streamlining the arm and facilitating cleaning.
The CMSX Closed Loop Controller from Festo delivers proportional closed-loop control, energy savings, safety at nearly half the price. The positioner was designed from the ground up, according to the company, to answer the shortcomings of today's closed loop proportional position controllers for quarter turn actuators, namely in the areas of cost, energy consumption and safety. Made from a technical polymer, the housing makes it ideal for indoor and outdoor applications. Most positioners, says Festo, cannot match the control, feedback and simple set up of the CMSX, which meets the IP65 standard for dust and water protection as well as the ISO 5211 mounting standard.
Knowing exactly what's going on with a batch during bioprocessing is important and Stratophase's Ranger Solo sensor technology provides the data one needs to control feeding effectively. Ranger Solo technology is targeted at single use systems and offers the same functionality as the company's Ranger Probe. Ranger Solo can be integrated into all bioprocessing systems enabling bioprocess managers to automate their feeding regimes by observing the metabolic rate of their process in real time. In addition, Ranger can be used to rapidly determine, identify and react to key process characteristics, such as maximum metabolic rate and process completion.
GF Piping Systems' Pressure Regulating Valve Family is well-suited to high-purity piping system duty. Its elastomer-free piston and modular design, in addition to its elastomer-free capability provided by the proprietary piston design, high-purity operation is further enhanced via the valve's threaded bonnet, which has no exposed metal bolts. The central housing nut does away with re-torqueing for easier operation and compact design enables installation in limited space. Other outstanding characteristics include its modular system that allows the user to easily adjust the set pressure range and quickly go from reducing to retaining (or vice versa) by simply switching the cartridge.
BIO PROCESSING
Ready to bring enhanced single-use efficiencies to fluid transfer, AdvantaPure, NewAge Industries' AdvantaPass combines single-use tubing, connectors and seals with permanent, wall-mounted, stainless-steel components to eliminate cleaning validations associated with clean room protocols. AdvantaPass is the first system of its kind to offer complete isolation between manufacturing environments when transferring multiple lines of fluid through a single wall portal. The technology offers a practical, safe, secure and easy way to move large volumes of liquids from one room to another while maintaining separate atmospheres and minimizing cross-contamination risks.
3M Purification has introduced a new class of clarifying products designed to help biopharmaceutical manufacturers achieve high product purity early in the manufacturing process. According to 3M, its Emphaze AEX Hybrid Purifier offers improved efficiency and process economics and can deliver the highest possible level of product protein purity early in biopharmaceutical downstream process. By targeting the removal of particularly problematic impurities from entering the protein A column earlier, says 3M, a profound impact on the entire downstream process can be realized.
Need a bigger bat for commercial scale bioprocessing? The Mobius 2000 Liter Single-Use Bioreactor from EMD Millipore might be just what is needed to hit that home run. Sporting the industry's first bottom-loading drawer, EMD Millipore says this enables the easiest Flexware assembly installation on the market. A patent-pending baffle design offers the mixing performance of a stainless-steel bioreactor with no cleaning required. A 5:1 turndown ratio provides the most flexible seeding and growth strategy.
With 2000-liter bioreactors up stream, clarification needs to be at similar scale to avoid bottlenecks. To get past such constraints, Sartorius Stedim Biotech introduced Sartoclear Dynamics clarification line. Used in combination with precipitation, this technology, says the company, transforms harvesting from a two-stage process into a single-stage operation saving valuable footprint and time. Sartoclear Dynamics consists of prefilled single-use bags containing ultrapure diatomaceous earth (DE) in a choice of 0.5 kg to 10 kg. Sartorius says customers can expect cconsistent results, ease of use, tremendous speed and linear scalability from this Biopharma player.
PROCESS HARDWARE
Installing a Delta DSV Steam Trap from Delta Steam Systems can knock some 20 percent off one's boiler fuel bill says the company. The Delta DSV steam trap uses flash steam to create a back pressure inside the venturi. As the condensate is forced through the trap's orifice by the upstream pressure, the resultant pressure drop generates flash steam. This flash steam is about 1,000 times the volume of the condensate so the sudden expansion accelerates the condensate in the venturi. This sudden acceleration creates an equal and opposite force or back pressure inside the venturi, which restricts the flow of less dense steam through the orifice while allowing the denser condensate to be ejected. Delta Venturi Orifice steam traps have an expected lifespan in excess of 30 years. All steam traps are constructed from stainless steel and come with a 10-year mechanical and performance guarantee.
Secotec TF Refrigerated Dryers from Kaeser Compressors Inc. handle flows from 520 to 1060 cfm. Kaeser says its new design pushes the boundaries of compressed air refrigerated dryer performance thanks to its game-changing thermal storage system. The dryers' internal design also makes it possible to reduce pressure loss across the dryer to 2.2 psi (compared to 2.9 and higher for conventional models). These dryers include Sigma Control Smart, a micro-processor based controller which controls the thermal storage process. It also has an alarm and service message memory, as well as remote on/off control capability. An optional Ethernet interface for connecting to a master control system is also available.
SOLID DOSE PROCESSING
Fit for high-output OSD processing lines, the GKF 2600 Capsule Filling Machine from Bosch Packaging Technology offers high output and configuration flexibility. Capable of filling 156,000 capsules an hour, Bosch's high-performance machine doses powders, pellet, tablets and liquids, as well as combinations, precisely and reliably. The machine, says Bosch, is equipped with new filling technologies for different products, an optimized drive concept, significantly enhanced sensor technology for process control, as well as a demand-oriented containment concept.
The XT600 High Speed Double Rotary Press from KORSCH America Inc. is specifically geared toward the high volume production of single and bi-layer tablets. Its exchangeable turret, says Korsch, offers the flexibility to produce a tablet of virtually any size and shape with the highest efficiency. The XT600 offers an extremely space-efficient design with a small footprint and ample access for cleaning, changeover, and turret exchange. The unit features a 60 kN or 100 kN compression column for precompression and main compression, plus proven compression dwell bar. Korsch is offering a completely new HMI environment which includes a smart-touch 19-inch HMI display providing an intuitive operating experience. The control capability is supplemented by a comprehensive array of multi-media online help, which features pictures, videos, drawings, and access to machine manuals to support the machine operation, maintenance and troubleshooting.
INFORMATION TECHNOLOGIES
Waters' NuGenesis Lab Management System is a powerful alternative to a traditional Laboratory Information Management System (LIMS), with advances, says Waters, that enable deeper insight into scientific challenges, accelerated decision-making, better business results and compliance with government regulations. Offering a user-centric platform that encompasses a Scientific Data Management System (SDMS), Electronic Laboratory Notebook (ELN) and Laboratory Execution System (LES), the system offers an optional, secure web-client for sample submissions and results management, and a complete stability protocol management and testing solution to facilitate a consistent regimented workflow across lab operations. Waters says NuGenesis enables science-driven chemical, environmental, food and pharmaceutical companies to connect and communicate across their laboratory operations, maximizing consistency and efficiency across products, labs and countries.
PACKAGING AND HANDLING
Marchesini Group's Integra 320 integrates primary and secondary packaging process for faster set up and production tempo. Innovative and ergonomic, Marchesini says the 320 is designed to be installed in rooms of different classes to save time and expense. The integrated robotized blister line offers a mix of innovation and the best of Italian packaging technology, says the company. A new pitch-control system, cartoning section, and carton-opening and product-insertion system has boosted performance to up to 320 blisters and more than 260 cartons a minute. All this, says Marchesini, is incorporated in a very small footprint, thanks to the integration of the blister thermoforming and carton packaging phases in a compact line.
Robots are great efficiency drivers, but only if they can handle what's being manipulated without damaging it - especially if the item is fragile or delicate. The principal behind Parker's Piezo Gripper's piezo electric technology is the fact that it measures changes in pressure, acceleration, strain or force and converts those inputs into an electrical charge suitable for the safe handling of products of any size, configuration or delicacy. Piezo is Greek for "press" or "squeeze". With the appropriate combination of proximity and position and distance sensors, a piezo-equipped robot can be suited to a wide variety of material handling applications, especially in Pharma packaging's big leagues.
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