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New technology introduced in 2016 aids innovation growth for pharmaceutical manufacturing.
Flexible manufacturing that allows companies to adjust to market needs is increasingly important. Manufacturers are also pursuing the most efficient equipment that can increase output, reduce downtime, cut costs, and increase overall productivity, while adhering to strict cGMP requirements.
Pharmaceutical manufacturing equipment introduced in 2016 reflect many of these characteristics. The following is a breakdown of some new equipment releases in the areas of solid dosage, parenteral fill/finish, and automation.
Fette unveiled the company’s first capsule filling machine, the FEC40, in April 2016 (1). The dual capsule-filling process doubles the output volume to approximately 400,000 capsules per hour. The FEC40 is available in two configurations, and users can choose between two tamping pin stations and up to four pellet stations. Changes between tamping pin stations are made with the aid of a patented assembly system, making it possible to change between dosing methods as well as products or batches. The machine is controlled through the human machine interface, a 19-inch touchscreen, and integrated keyboard. This provides the user with a comprehensive overview of the relevant machine process and quality parameters.
MG America introduced a capsule filling machine in March 2016 (2). The Planeta 200 capsule filler produces up to 200,000 capsules per hour. Its modular design can be configured for a variety of production requirements, fitting several dosing units simultaneously and enabling one capsule to be filled with differing products. The machine is scalable and can be configured for medium speeds and upgraded later for maximum speeds, reaching different performance levels depending on the number and type of dosing units installed.
Pfizer, GEA, and G-Con won ISPE’s Facility of the Year Award for Equipment Innovation for the Portable, Continuous, Miniature and Modular (PCMM) prototype unit for oral solid-dosage forms, which transforms raw materials into uncoated tablets (3). The unit represents a self-contained and mobile continuous manufacturing system that can be transported to geographical areas of need and installed within days to produce whatever volume of drug is needed.
GEA also introduced the Modul Q rotary tablet press in April 2016 (4). The Modul Q has an output of up to 367,200 tablets per hour and can incorporate 51 punch stations. It features a new control system, the Multi-Control 5, and allows for Type-A tooling.
In June, Pharma Technology Inc, (PTI) introduced new modular high-containment and washing-in-place/washing-off-line solutions (WIP/WOL) for its PharmFlex iSeries Dedusters (5). These new features include dust-tight level three occupation exposure banding, modular contraction with bolt-on high containment, and WIP/WOL modules. These features can be incorporated into both new and existing PharmaFlex dedusters.
In February 2016, NJM Packaging introduced the Dara Moduline filling system for vials, syringes, and cartridges (6). The system integrates aseptic fill/finish systems with Getinge La Calhene’s isolator technology to achieve a class 100 cleanroom working environment when operating the system in a class 100,000 cleanroom. Moduline is a compact and modular solution for filling liquids and powders at speeds of up to 100 units per minute in a footprint only 1150 mm (45 inches) wide and 3200 mm (126 inches) long. The system doses volumes from 0.1 to 100 mL for liquids and from 2-1500 mg for powders while maintaining an accuracy of +/- 0.5%.
Extrafill, a new addition to the Marchesini Group’s syringe filling product line, is a filling and stoppering machine for nested syringes (7). Extrafill can accommodate from two to five stoppering stations, producing 12,000 pieces per hour. The machine is equipped with peristaltic filling pumps and a statistical check by a batch weigher. All production phases are integrated into one monobloc unit designed to combine the two tub opening and syringe filling/stoppering operations under one isolator.
Available industrial data are predicted to quadruple in the next five years, says Andrew Hird, vice-president and general manager of Digital Transformation at Honeywell (8). Pharmaceutical manufacturers that have the ability to harness these data may achieve a competitive advantage, Hird notes. Keith D. Nosbusch, CEO of Rockwell Automation, expects the industry’s reliance on industrial automation to grow in the next 10 years (9). Those unprepared for the future, he says, may be at risk.
Honeywell added the Uniformance Suite and the ControlEdge Programmable Logic Controller (PLC) to the company’s Industrial Internet of Things (IIoT) technologies product line. Honeywell’s Uniformance Suite is a fully integrated system of process software solutions that turn plant data into actionable information to enable smart operations (10). The suite can store data, detect events based on underlying correlations, link process metrics with business key performance indicators, and incorporate analytical capabilities. The ControlEdge PLC offers universal input/output, providing remote configuration and late design-change flexibility for improved project implementation (11). The controller is suitable for process industries requiring discrete control for specific PLC applications and will be offered to end users, original equipment manufacturers, engineering, procurement, and construction companies.
Rockwell Automation released the FactoryTalk AssetCentre v7.0 software, which automates discovery and tracks the status of devices, network switches, and software on workstation computers across an entire facility (12). FactoryTalk also streamlines life-cycle management and helps decrease unplanned downtime. The software’s asset-inventory agent scans a network to discover the hardware, firmware, and software information for assets active in the facility. Factory-Talk’s automated discovery helps to patch security vulnerabilities, helping companies mitigate risks.
Siemens opened its Cyber Security Operation Center (CSOC) for the protection of industrial facilities in March 2016 (13). The company has a joint CSOC in Munich and Lisbon and one in Milford, OH. Security specialists based at these sites monitor industrial facilities around the world for cyber threats and warn companies in the event of security incidents. The company also released version 8.2 of its Simatic PCS 7 process control system (14). The system offers individual and networked plant monitoring, and employees can now access plant information from mobile terminals. Both the Cyber Security Operation Center and the Simatic PCS 7 are part of Siemens’ Plant Security Services, which supports companies in the manufacturing and processing industries.
1. Fette Compacting, “Interphex 2016: Fette Compacting FEC40–Next-generation capsule filling technology,” Press Release, April 26, 2016.
2. MG America, “At Interphex, MG America to Introduce Four New Machines, Including Next-Generation Planeta Capsule Filler,” Press Release, April 27, 2016.
3. GEA, “Pharmaceutical tablet production goes mobile with award-winning technology from GEA,” Press Release, March 10, 2016.
4. GEA, “GEA’s MODUL Q Debuts in North America,” Press Release, March 23, 2016.
5. Pharma Technology Inc., “Pharma Technology Inc. Introduces Value-Added Modular High-Containment and WHIP/WOL Solutions for PharmaFlex iSeries Dedusters,” Press Release, June 27, 2016.
6. NJM Packaging, “NJM Packaging Introduces Dara ModulineTM Aseptic Filling System Inside an Isolator,” Press Release, Feb. 25, 2016.
7. Marchesini Group, “Interphex 2016: Marchesini Group to showcase Extrafill,” Press Release, Feb. 18, 2016.
8. Honeywell, “Honeywell Process Solutions’ Digital Transformation Business to Help Customers Benefit from Industrial Internet of Things,” Press Release, June 28, 2016.
9. Rockwell Automation, “Rockwell Automation CEO to Address How Scalable Internet of Things Technologies Enhance the Connected Enterprise,” Press Release, December 3, 2015.
10. Honeywell, “Honeywell Introduces Uniformance Suite as Industrial Internet of Things (IIoT) Analytics Platform,” Press Release, June 14, 2016.
11. Honeywell, “Honeywell Launches Controledge Programmable Logic Controller,” Press Release, June 16, 2016.
12. Rockwell Automation, “FactoryTalk AssetCentre Software Simplifies Life-Cycle Management, Automates Asset Discovery,” Press Release, June 9, 2016.
13. Siemens, “Siemens opens Cyber Security Operation Centers for the protection of industrial facilities,” Press Release, March 17, 2016.
14. Siemens, “Intuitive operation and efficient engineering of process plants,” Press Release, March 11, 2016.
Vol. 40, No. 8
When referring to this article, please cite it as The Editors of Pharmaceutical Technology, "New Equipment Meets Need for Innovation in Pharma Manufacturing," Pharmaceutical Technology 40 (8) 2016.