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Clinical Trial Manufacturing

A facility that was built for drug product development and CTM manufacturing.

Metrics Contract Services offers GMP manufacturing areas for development and clinical trial material manufacturing:

  • Twelve manufacturing rooms
  • Five suites for potent actives (OEL at or above 1mcg/m3 room air)
  • Two suites for potent actives with 100% contained equipment (OEL at or above 30ng/m3 room air)
  • Our manufacturing area can accommodate large CTM batches if needed
  • All facilities are regularly inspected and meet DEA guidelines for Schedule II-V controlled substances

CTM and commercial batch capacity

  • 450kg dry blend (one portion)
  • 450kg wet granulation (three portions) by high shear granulation/FBD

Full analytical support for your drug product development and CTM manufacturing project is available, including custom analytical methods development and validation, release testing, stability studies and microbiology testing. Metrics Contract Services offers seamless scale-up services to commercial manufacture from your CTM batch. Technology transfer is a key scientific offering at Metrics Contract Services, and our experienced scientists and manufacturing staff will ensure your project is successfully transferred to your specifications.

 

Click below image for a detailed layout of the manufacturing facilities in our building.



To learn more about our manufacturing and packaging capabilities in Australia, visit Mayne Pharma

 

CTM Manufacturing Equipment 

The following equipment for solid oral dosages is maintained at our Greenville, NC site. 

  • Blender; Turbula T2F
  • Blender, V-shell; 1 pt to 2 qt; Patterson-Kelly
  • Blenders (2), V-shell; 8 qt; Keith Machinery
  • Blender, Cross-flow; 16 qt; Patterson Kelley
  • Blender, Bin-type; 1, 2, 3 cu.ft. (5-30 kg capacity); Flo-Bin

Granulators/Mixers

  • Granulator, Vertical-shaft, High-shear (2); up to 1.5 kg; Key KG-5
  • Granulator, Vertical-shaft, High-shear; 8-25 kg; Fielder PMA 25/65
  • Granulator, Vertical-shaft, High-shear; 3 kg capacity; Fuji 10-liter

Mills/Micronizers

  • Impact mill, Table-top; Fitzpatrick FitzMill Model L1A

Fluid Bed Processors/Dryers

  • Fluid-Bed Processor (Dryer/top spray granulating/bead coating); 40/60 liter bowls; Glatt GPCG-10 with 7” Wurster HS and 12” Wurster HS columns
  • Tray Dryer; O’Hara LC II-X
  • Tray Dryer; O’Hara Labcoat M 

Tablet Presses

  • Rotary Presses (2); 10 station, B-tooling, GlobePharma MiniPress II, Piccola PLC-C, SMI Instrumentation
  • Rotary Presses (3); 16 station, B-tooling, SMI Instrumentation; Manesty Betapress
  • Rotary Presses (2); 27 station, B-tooling; Manesty Diamond Unipress
  • Rotary Press; 35 station, B-tooling; Stokes BiLayer Tablet Press
  • Rotary Press; 36 station, B-tooling; Fette 2200i
  • Rotary Press; 24 station, B-tooling; Fette 1200i
  • Single Station Press; Key Minipress SC-2; Globe Pharma MTCM-11
  • Rotary Press; 14 station, B/D tooling, SMI Compacta, SMI Instrumentation
  • Rotary Press; 19 station, B-tooling, SMI Compacta, SMI Instrumentation

Capsule Fillers

  • Semi-Automatic Capsule Filler; 15,000 capsules/hr.; Sizes 00, 0, 1, 3; Elanco Quali-fill Model 8S
  • Semi-Automatic Capsule Filler; 25,000 Capsules/hr.; Size 0; Shionogi Qualicaps Model 10
  • HiBar PO510; Hard Gelatin Capsule Liquid Filler

Coating & Printing Equipment

  • Tablet Pan Coater; 15, 24 and 30 inch diameter pans (<1 kg to 40 kg); O’Hara LabCoat II-X
  • Tablet Pan Coaters (3); 8.5, 12, 15 and 19 inch diameter pans (200 g to 3 kg); O’Hara LabCoat M & MX

Packaging Inspecting Equipment (3 packaging lines)

  • Accumulator Table (3); SureKap Model SKT-36A
  • Bottle Cappers (3); SureKap Model SK6000-SP
  • Bottle Labeler (1); NJM-CLI UNI-300V
  • Cap Retorquer (3); SureKap Model SK600
  • Cap Torquer; Swanmatic C-300
  • Conveyor with 2 right angles; SureKap Model SKC4520
  • Induction Sealer (3); Pillar Model 2KW
  • Shrink Tunnel; Axon EZ-24-BR
  • Swift Count/Swift Pack Tablet/Capsule Filler
  • Tablet/Capsule Bottle Filler (2); 60 bottles/minute; Countec Model DMC-60; Countec Model DMC-120
  • Unscrambler Table (2); SureKap Model SKT-36U
  • Portable Induction Sealer; Enercon Compak Jr. and Enercon SuperSeal Jr.
  • Cottoner (2); Lakso 52
  • IMA Bottle Unscrambler (1); Model A300
  • Omega Bottle Unscrambler (1); Model 3D-RP-1-10
  • Omega Shrink Bundler (1); Model FSB-SL-20
  • ZEPF Shrink Bundler (1); Model SA 27
  • NJM/CLI Topserter (1); Model 305VPL
  • NJM/CLI Minicolt 120 Labeler (1)
  • Omega Desiccant Feeder; CDF101
  • Countec Desiccant Feeder; CT-0G-120
  • Inspector (1); MW Technologies
  • In-Line Checkweighers (2); Mettler Hi-Speed XE2
  • Liquid Filler; IMA Fillit and Fillkit
  • Orifice Seating Device; Tirelli Mini-Nebel
  • Video Jet Printer; Model 1210

Balances/Checkweighers

  • Analytical Balances (numerous); Mettler, O’Haus, others
  • Checkweigher/Sorters; Key Int’l Model CW-2001, Sade P4 and (2) Sade P2, Qualicaps CW180

Test Equipment

  • Moisture Analyzers (2); Arizona Instruments Compu-Trac Max 2000, MA-35 Sartorious
  • Powder/Granule Tap Density Tester; VanKel Model 50-1000
  • Powder/Granule Sonic Sifter (2); Gilson GA-1
  • Tablet Hardness Testers (5); Key Int’l HT-300; HT-500
  • Tablet Friabilators (4); Natoli FT400
  • Tablet/Capsule Disintegration Tester; Van-Kel 71A660A3

Miscellaneous Equipment

  • Capsule Bander, Laboratory-scale; Elanco (Shionogi) Quali-Fill
  • Capsule Polisher/Selector (2); Key Int’l CP350
  • Capsule Checkerweighter; Qualicaps CWI-80
  • Extruder; Luwa EXKS-1
  • Liquid Filler; Development-scale (5 mL to 2 liter volumes); Accutek Model SAPD1
  • Marumerizer; Luwa QJ-400
  • Safeline (2); MC 333
  • Metal Detector; Metalchek MET 30+
  • Peristaltic Liquid Pumps (3); Cole-Parmer, MasterFlex
  • Powder Filler, Laboratory-scale; San Diego Scientific Instruments DOA-2300A
  • Powder Filler (2); All-Fill SHAA SV600 and All-Fill B-350e
  • Low Dose Powder Dispenser; Mettler Toledo Quantos QB1
  • Sifters, Mechanical; MM Industries Vorti-Siv RBF-15 (2), RBF-2; Kason Model 24 (2)
  • Spheronizer; Luwa QJ230
  • Tablet Dedusters (8); Key Int’l CP TD101WD
  • Tablet Thickness Sorter; MW Technologies, RS-200-12
  • Vacuums, Portable HEPA (12); Nilfisk GS-811, GM-80, 3151
  • Vertical Drum Dumper; Custom Design & Machine
  • M.W. Technologies Tablet Sorter; Model RS200-4 (1), Model RS200-12 (1)
  • Tablet and Capsule Inspection System; M.W. Technologies, Model RB-300
  • Tablet and Capsule Printer (2); Hartnett Delta, double sided
  • Jacketed Tank; 350L with bottom agitation
  • Blister Packaging; EZ Blister II, Thermoformed and Cold-formed