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Gerteis roller compactors boost Metrics Contract Services CRO/CMO capabilities in USA
Jona, Switzerland: – Installation of two Gerteis® roller compactors has boosted capacity and capabilities at Metrics Contract Services, a Greenville, North Carolina-based division of Mayne Pharma Group Limited offering worldwide contract development and manufacturing services.
The machines have strengthened the company’s abilities to process highly potent active ingredients and challenging powder formulations. They have also speeded scale up.
In 2014, Metrics Contract Services expanded its dry granulation development and clinical pharmaceutical manufacturing services when it purchased its initial Gerteis® Mini-Pactor® for R&D and small production runs.
Several of Metrics key customers had specified Gerteis® for their compaction needs; including for some potent products. Metrics was then also able to offer the Gerteis® roller compactor service for clients with particularly challenging granulation products that had previously proved difficult to process.
In 2018, Metrics added a second Mini-Pactor® to its granulation capabilities at its new state-of-the-art, oral solid dose commercial manufacturing facility in Greenville, North Carolina, USA. The Gerteis® Mini-Pactor® has a throughput of 10 Grams per trial and up to 100kg/h, allowing work in development, pilot plant, clinical and production. Both Gerteis® units are highly contained, offering occupational exposure limits (OEL) rated in the low single digit µg/m³ levels.
The Gerteis’ design ensures that operator exposure to product is minimized. The Sanitary/Tri Clamp fittings for inlet and outlet on the Gerteis, combined with Mayne Pharma’s flexible containment for other unit operations in small- and large-scale manufacture further enhances operator protection.
The Mini-Pactor® allows optimization within a range of press forces, roller speeds, and gap settings using knurled, smooth, toothed or custom rollers. These two roller compactors will now be used for early phase formulation development, clinical trial production through to commercial manufacture.
The addition of the Gerteis Roller Compactors has enabled “seamless scale-up” of the Metric’s processes, according to Brad Gold, Metrics Vice President of Pharmaceutical Development.
“With the Mini-Pactor, the parameters we develop regarding the pressure, speed, gap and mill gauge easily transfer to the commercial manufacturing. The scale-up is smooth and seamless. The throughput is such that we can produce batches as small as five kilos up to 200-300 kilos with minimal product waste,” Mr. Gold commented.
Gerteis Maschinen + Processengineering AG is a Swiss-based company that has rapidly established itself as a world leader in the field of premium roller compactors. The company’s products and services cover all aspects of dry granulation processes, with unparalleled experience in this field built up since the company was founded in 1986.
Gerteis manufactures a wide range of high quality containment roller compactors that are versatile enough to process a vast range of powders, even notoriously problematic ones at both laboratory and production scales. The company’s patented technologies are widely used by the pharmaceutical, chemical and food industries.
As well as manufacturing machinery, Gerteis offers complete solution packages that help customers increase productivity including support on identifying ideal formulations and in-house training courses on dry granulation processing. Gerteis constantly seeks to expand its knowledge on dry granulation, participating in numerous research collaborations with German universities.
About Metrics Contract Services
Metrics Contract Services is a full-service global contract development and manufacturing organization (CDMO) specializing in oral dosage forms. A subsidiary of Mayne Pharma Group Limited, Metrics Contract Services also offers clients an impressive portfolio of advanced delivery methods for controlled release, bioavailability enhancement and taste masking. Founded as a contract analytical laboratory in 1994, Metrics Contract Services has evolved into a provider of high-quality pharmaceutical formulation development, analytical testing, CTM and Commercial Manufacturing services.
Based in Greenville, NC, Metrics Contract Services offers particular expertise in First-Time-In-Man (FTIM) and Phase I, II, and III Clinical Trial Manufacturing (CTM). Globally, it provides a broad spectrum of contract services to support investigational new drug (IND) and new drug (NDA) submissions to regulatory agencies.
Further information at: www.metricscontractservices.com
Gerteis Mini-Pactor® roller compaction unit