[an NSF Graduated Center] Founded in 2006, the Center for Structured Organic Particulate Systems (C-SOPS) brings together a cross-disciplinary team of researchers from major universities to work closely with industry leaders and regulatory authorities to improve the way pharmaceuticals, foods and agriculture products are manufactured. C-SOPS focuses on advancing the scientific foundation for the optimal design of SOPS with advanced functionality while developing the methodologies for their active control and manufacturing. Headquartered at Rutgers University, C-SOPS partners include the New Jersey Institute of Technology, Purdue University, the University of Puerto Rico at Mayaguez, and more than 40 industrial consortium member companies. C-SOPS is committed to modernizing pharmaceutical manufacturing by developing the science and engineering methods for designing, scaling, optimizing and controlling dosage forms and relevant manufacturing processes. Teams of qualified engineers and scientists at C-SOPS use cutting-edge technology to address fundamental scientific challenges and to apply this knowledge to develop and optimize new manufacturing methods. C-SOPS aims to support manufacturing development from concept to qualification.
Research Areas
From day one, our emphasis has been on the science-based development of pharmaceutical products and processes through high impact research, to enable efficient and effective manufacturing. We remain committed to this goal and, in our next phase, we will optimize our efforts to maximize impact, progress, and pathways to adoption for emerging advanced pharmaceutical manufacturing technology.
As we reach our 10th year anniversary and “graduate” from NSF support, C-SOPS is in an excellent position to continue to drive innovation in pharmaceutical manufacturing. As a strong partner both for Industry and for the FDA, C-SOPS is in a unique position to facilitate the integration and implementation of new manufacturing technologies. Strong support from our members, growing partnerships with leading adopters of continuous technology and with the FDA, and a number of new and exciting initiatives are coming together to enable success in the next phase of our center.
Moving forward, C-SOPS’ core research program will focus increasingly on continuous manufacturing technologies, emphasizing the key aspects needed to make them reliable, easy to implement, and easy to operate.
In addition, in recent months, working directly with companies such as Janssen and government agencies such as the NSF and FDA, we have been able to launch several high-value/high-impact projects. In this mode of engagement, C-SOPS focus on the partner strategic interests and needs, achieving a much deeper level of collaboration. At the present time, several efforts are under way to expand these partnerships and developing new ones. Some of the new project areas are given below:
Material Characterization and Processibility for Continuous Tablet Manufacturing
This theme will address aspects of CM, including design, prediction, and optimization of formulation platforms based on materials property characterization and modification. It includes establishing relationships between key material properties of powder blends and “tabletability” of the blend and means to expand regimes of feasibility for direct compression (DC) as well as dry granulation (DG). Powder agglomeration, sticking and prevention/mitigation thereof will be also addressed with respect to CM platforms (both DC and DG). Expanded database of associated properties, including cohesion, flow, packing density, compactibility, and Drucker-Prager cap properties will be generated and continually updated on pharmaHUB.
Process and Unit Operations Modeling
This theme will be geared towards developing comprehensive process modeling tool-box consisting of unit operations, controller and sensor models together with a material property library, and executive system for assembling and executing integrated process simulations. It involves employing of the reduced order modeling methodologies to be used for flowsheet models, optimization and control. Major unit operations considered include feeders, milling, granulation and hot-melt extrusion based processing, as well as strategies such as staged powder addition in various operations such as mixing and twin-screw granulation.
Processes and Unit Operations for Bioavailability Enhancement
In this theme, center activities associated with addressing poorly water soluble drugs will be consolidated. Major activities include: (1) HME for amorphous materials, solid dispersions, as well as development of novel nano and micro composite materials through melt or wet granulation techniques, (2) Stripfilm based processing to develop unique products and their characterization. (3) Preparing engineered suspensions that are sterile filterable.
Processes Control and Information Management
This theme integrates various control strategies for all modes of continuous manufacturing of tablets, including direct compression, dry granulation and wet granulation, specifically, twin-screw granulation. Over-arching goal is to move towards a flexible and modular continuous pharmaceutical manufacturing plant that includes real-time sensing and control as well as incorporates various information and knowledge management strategies.
Sensor Development and Integration for PAT and RtR
In this theme, we address use and integration of traditional PAT techniques such as Near-IR, Raman, particle imagers (e.g., FBRM) as well as development of new sensing systems for process monitoring in continuous manufacturing and real-time-release of products. Novel sensing approaches such as ultrafast transmission NIR, infrared thermography, soft X-ray based on-line mass flow sensing, and microwave sensing for density measurements as well as testing and integration of single particle measurements. The project will use statistical approaches for analysis of data, for example, comparison of dissolution profiles.
Methodologies for Improved use of Measured Data
Facilities & Resources
The C-SOPS mission to be the national focal point for the science-based development of structured organic composite products and their manufacturing processes requires state-of-the-art laboratory facilities to conduct basic research and improve the pharmaceutical engineering knowledge-base. The Center has two main research laboratories located at the Rutgers New Brunswick campus and at the University of Puerto Rico at Mayaguez. In addition, Purdue University and the New Jersey Institute of Technology have well-equipped facilities which augment the research effort. These laboratories offer the latest equipment for performing an array of testing, simulations, analyses, and unit processing steps common in pharmaceutical manufacturing. See more details of our facilities below: RUTGERS The Pharmaceutical Engineering Laboratory at Rutgers-New Brunswick includes over 15,000 square feet of dedicated research and development space: 6,400 square feet specifically designed for pharmaceutical manufacturing research 1,100 square feet of space devoted to Test Bed 1, the continuous manufacturing commercialization project 8,400 square feet of laboratory space for nano-catalysis and reaction engineering activities 2,000 square feet of laboratory space for powder materials storage The pharmaceutical manufacturing research area, complete with GMP-quality, seamless epoxy flooring, has capabilities for controlling temperature and humidity, thereby enabling the maintenance of environmental conditions conducive to pharmaceutical manufacturing. The nano-catalysis research area is outfitted with over 13 laminar-flow hoods, and three of the lab rooms also have temperature and humidity controls. The two-story pilot plant area for continuous manufacturing is equipped with specialized equipment, controls, and safety interlocks designed to eliminate the safety hazards associated with the explosivity of powder/air mixtures often encountered in processing, and with the toxicological effects linked to APIs and inert dust particles. In addition, CSOPS at Rutgers also features the 2,000 sq. ft. Continuous Pharmaceutical Advanced Manufacturing Laboratory (CpAML), a fully integrated, control-enabled, commercial scale pilot plant for continuous manufacturing. This facility, which is the only one of its kind at a university anywhere in the world, is capable of manufacturing pharmaceutical products by any of the major modes (direct compression, wet granulation, roller compaction, and hot melt extrusion, as well as capsules). The equipment comprises a number of major units (three blenders, 10 feeders, two roller compactor, two tablet presses, a continuous granulator, a continuous drier) that have been received (mostly as in-kind contributions of ERC industrial members), and a seamless floor and air handling equipment. In addition, CpAML is also equipped with specialized equipment, controls, and safety interlocks designed to eliminate the safety hazards associated with the explosivity of powder/air mixtures often encountered in processing. The Rutgers facility served as the model for the INSPIRE facility by Janssen in Gurabo, Puerto Rico, and has been also the starting design point of numerous other facilities at companies around the world. List of Equipment: Combined, the laboratories contain a wide spectrum of measurement devices and solids-processing equipment typically found in most major pharmaceutical companies for the formulation of new products: Schenck Accurate Powder Feeders, Model # ModPharma Fitz Mill Roller Compactor, Model # IR520 Quadro Conical Screen Mill, Model # 197-S Glatt Conical Screen Mill, Model # GCF-60 Readco Continuous Mixer Granulator Rheoscientific Rheometer, Model # SP 200n Thermo Fischer Near IR Analyzer Pharma Laser Pharma LIBS 250 Pharmatron Tablet Hardness Tester, Model # 6D Van De Graaf Generator TREK Amplifier/Controller 610E & TEKTRONIX Digital Storage Oscilloscope, DS 03062A Quantchrome AutoTap Resodyn Acoustic Mixers LABRAM Fisher Convection Oven, Model # 250F Feund Hi-Coater (Tablet Coater), Model # HCT-30 Innopharma Lab Eyecon Bruker MPA Handpress Octagon Sieve Shaker, Model #2000 Glatt Twin Axial Mixer, Model # TAM 40 MCC Shear Rheometer Patterson Kelly V-Blender Blend Master, 4, 8 and 16 qrt shells Zanazi Capsule Filling Machine, Model # Zanazi 2 Lab Mill Drum Rollers, Model # 8000 Glatt Fluid Bed Coater Granulator, Model # Mini Glatt -5 Glatt Fluid Bed Coater Granulator, Model # GPCG1 Gravitational Displacement Rheometer Freeman Technology Powder Rheometer, Model # FT – 4 X-Rite Colorimeter, Model # VS450 KTRON Feeders, KT-20 KTRON Feeder, KT-35 KTRON Feeder, MT-12 Glatt Continuous Mixer Granulator, Model # GCG 70 Quadro Conical Screen Mill, Model # 197-S Lodige Continuous Mixer Granulator, Model # CM-5 Agillent HPLC, 1100 series Patterson-Kelley Liquid Solids Blender, Model # LIB-6919 Kikusui Tablet Press, Model # Libra 2 Varian UV-Visible Spectrophotometer, Model # Carry 50 Agilent Dissolution Apparatus, Model # 708 DS Agilent Fraction Collector, Model # 8000 Dissolution Sampling Station Agilent Peristaltic Pump, Model # 810 Shimadzu HPLC System MCC Compaction Simulator Textronix TDS digital oscilloscope, 3052 C & Olympus Square Pulse Receiver, 5077PR Pharmatron Tablet Hardness Tester, Model # 6D Bohle Roller Compactor, Model # BRC25 --- PURDUE UNIVERSITY The CSOPS facilities at Purdue University comprises of the new pilot plant, an 1800 sq. ft. of flexible high bay space that is designed to handle particulate material with minimal exposure to operators by virtue of the dust containment system installed. The solid dosage form manufacturing line includes continuous dry and wet granulation equipment, thereby providing additional versatility in processing raw materials that are not amenable to direct compression. The different unit operations are housed in negative-pressure containment modules, which are directly connected to the dust collector to minimize operator exposure. The pilot facility is also equipped with a clean room maintained under negative pressure to be used for powder preparation prior to processing. The integrated manufacturing line are interfaced with different sensors along the production line to provide an eye into the process for enhancement of process understanding. The real-time sensors include instruments for measuring particle size, density, moisture content and blend uniformity. In addition, Purdue also houses a dedicated Test Bed 3 facility which is a 641 sq. ft. of lab space fully equipped to make drug products by solvent deposition and melt deposition (also called melt extrusion) with real-time monitoring and closed-loop process control. Additional 2000 sq. ft. of particle characterization laboratory is also available at Purdue that contains a wide selection of instruments for measuring raw material attributes and properties of intermediate and final products. List of Equipment: Shimadzu MCT-510, Micro-compression tester Bruker MultiMode 8 AFM Retsch PT100 sample divider Humboldt H-3985 sample splitter Gilson SP-1 sample splitter Malvern Mastersizer 2000S particle size analyzer Malvern Morphologi G3-ID Tyler Ro-tap Model E sieve shaker ASTM E-11 sieves Nikon SMZ1500 microscope Nikon Optiphot-2 microscope Innopharmlabs Eyecon in-line/at-line image analysis system Micromeritics AccuPyc II 1340 pycnometer Micromeritics GeoPyc 1360 envelope & T.A.P. density analyzer Agilent Technologies 350 tapped bulk density tester Freeman FT-4 rheometer Schulze RTS-XS ring shear tester PerkinElmer Thermogravimetric Analyzer (TGA) Mettler Toledo HG63 moisture analyzer Binder FED115 drying oven Krüss K100MKII goniometer Photron FASTCAM-X 1024 PCI 100K high-speed video camera NovaStrobe DA115 strobe lamp Carver Press Auto Series 3888 Instron ElectroPuls E1000 mechanical testing frame Mechanical Testing Systems (MTS Model C43.504 testing frame Fike explosion suppression system. Negative pressure clean room equipped with HEPA filters Tote blender Chute riffler (powder splitter) Schenck AccuRate AP feeders with Gericke GCM 350 mixer Emerson DeltaV distributed control system 10-Station Riva Piccola Rotary Tablet Press Alexanderwerk WP-120V Roller Compactor with Gericke GCM 250 mixer 16-Station Natoli Rotary Tablet Press Drucker-Prager Cap powder parameter & powder-surface adhesion instrumented punch-die set UAS 5,000 cfm dust collector Test Bed 3 equipment: IVEK Digispense 10 temperature-controlled positive displacement pump Newport ESP301 three-axis motion controller for substrate movement Manta G146B machine vision camera for imaging drops Banner D10 high-speed photoelectric sensor for imaging drops Advanced Illumination collimated backlight for imaging drops Omega temperature controllers and heating elements for melt temperature maintenance TETech Peltier devices with TC-48-20 temperature controller for substrate temperature maintenance LabVIEW 2012 with Vision for full-fledged integration and control --- NJIT Center facilities at NJIT comprise of the 1,500 sq. ft. of laboratory space with full ventilation and wet lab facilities for housing novel particle processing instruments. The main space is dedicated to Test Bed 2, a closed-loop continuous oral film manufacturing facility that focuses on thin-film drug delivery systems that offer many advantages such as ease of delivery and patient compliance. Research focuses on techniques for forming precisely controlled release profiles that exploit particle engineering for direct incorporation of API particles into three-dimensional edible substrates which are about 100 microns thick. In addition, NJIT partner faculties have access to the New Jersey Center for Engineered Particulates (NJCEP) laboratories, the Particle Engineering Laboratory as well as NJIT’s Material Characterization Laboratory (MCL). Processing and testing equipment at the PI’s NJCEP includes SEA inverse gas chromatography (IGC), various dissolution testers, disintegration tester, Rodos/Helos dry powder sizer, Delsa Nano C particle size and zeta potential analyzer, several powder characterization equipment for powder flowability measurements, Carver press, fluid energy mill, magnetically assisted impaction coater, a comil high-speed delumping system, V-blender, near infrared spectrometer, a rotating fluidized bed coater, and a Hosakawa Micron Mechanofusion device, Netzsch wet stirred media mill, Procept spray dryer, Brookfield viscometer, Mettler Toledo thermogravimetric analyzer and polymer differential scanning calorimeter, Coulter LS13320 particle size analyzer, Sigma force tensiometer, and a Karl Fisher titrator for moisture content measurements. MCL is a common facility located in the same building with the PI’s laboratory, which makes it convenient to use. MCL includes scanning electron microscope with electron dispersive X-ray spectroscope (SEM-EDS), atomic force microscopy (AFM), Brunauer-Emmett-Teller (BET) surface area analyzer, X-ray diffractometer, high pressure liquid chromatography (HPLC), and Fourier transform infrared spectrophotometer (FTIR). Additionally PI also has no-fee access to EZ Raman coupled to a near-infrared laser emitting at 785 nm and a goniometer with a high speed camera. List of Equipment: 1. Fisher Vortex Mixer 2. Microclimate 3. IKA RO 15 Magnetic stirrer 4. Branson B1510 5. SP-230 Gilson Spinning Riffler 6. THINKY Mixer 7. Mettler Compact Karl Fisher Coulometer, C30 8. EvolutionTM 60S 9. Waters 2695 Separation Module 10. DT2 Manual Disintegration Tester 11. MAIC 12. Quadro Comil 13. Fluid Energy Mill 14. LabRam 15. Sirius SDI (Surface Dissolution Imager) 16. Netzsch Microcer Recicrulation Mill 17. Micros Batch Mill 18. Sonication Probes 19. Procept Spray Dryer 20. Thermo Twin Screw Extruder 21. Mini Glatt FB Coater 22. Buchi Mini Spray Dryer 23. HED Film Casting Line 24. Convective/Microwave Drier 25. Patterson Kelley V-Blender 26. Supercritical Fluid System 27. Carver Tablet Press 28. Sieve Shaker 29. Hybridizer 30. Sonication Probes 31. Beckman-LS13320 Particle Size Analyzer 32. Malvern Spraytec Laser Diffraction System 33. Delsa Nano C 34. Hosokawa Powder Tester 35. IGC SEA surface energy analysis 36. FT4 Powder Tester 37. Sotax Td1 38. TGA/DSC1/SF Stare system 39. TA-XT Plus Texture Analyzer 40. Polymer DSC , TGA/DSC1/SF Stare system 41. Keyence VH -2500 42. SOTAX AT7 Smart Dissolution System 43. Distek 2100C USP II Apparatus 44. Sotax CE7 smart 45. Brookfield viscometer 46. Micron Air Jet Sieve 47. Sympatec Rodos-Helos 48. Flowdex 49. Attension optical tensiometer --- UNIVERSITY OF PUERTO RICO AT MAYAGUEZ In Mayaguez, C-SOPS and the University of Puerto Rico built a dedicated 7,000 sq. ft. laboratory and office space devoted to training and industry-based research. This facility, named "C-SOPS-UPR", has now been completed and supports research by five faculty members from three different campuses. The facility has 2,000 sq. feet for pharmaceutical operations (mixing, drying, compaction, etc.), 700 sq. ft. for analytical testing and another 1,200 sq. ft. for computer simulation and process control. List of Equipment: Combined, the laboratories contain a wide spectrum of measurement devices and solids-processing equipment typically found in most major pharmaceutical companies for the formulation of new products: MALVERN SyNIRgy NIR-Chemical Imaging Kaiser Raman RXN-1 RAMAN Spectrometer (Phat Probe – MR Probe) Micromeritics AccuPyc II 1340 Karl Fischer Volumetric Titrator, Model: Metrohm 870 KF Titrino Plus Thermo Scientific Evolution 60S UV-VIS Spectrometer Bruker Optiks Multi-Purpose Analyzer FT-NIR Spectrometer Matrix-F FT-NIR Online Analyzer Patterson-Kelly Blendmaster C438008 Fette 3090 Tablet Press Feed frame VanKel Varian TAP density Tester BINDER ED-115 Drying Oven With Natural Convection RiceLake TA-120 Analytical Balance (120g – 0.0001g) OHAUS Analytical Plus 250D Balance (210g – 0.0001g) VWR Vacuum Oven 1400E Controlled Humidity Environments Olympus CX31 Polarized light Microscope with Infinity 2 Camera.
Partner Organizations
Rutgers University
Purdue University
New Jersey Institute of Technology
University of Puerto Rico at Mayaguez
Abbreviation |
C-SOPS
|
Country |
United States
|
Region |
Americas
|
Primary Language |
English
|
Evidence of Intl Collaboration? |
|
Industry engagement required? |
Associated Funding Agencies |
Contact Name |
Fernando J. Muzzio
|
Contact Title |
Director
|
Contact E-Mail |
Website |
|
General E-mail |
|
Phone |
(848) 445-6750
|
Address |
Rutgers University - New Brunswick, School of Engineering
98 Brett Road
Piscataway
NJ
8854
|
[an NSF Graduated Center] Founded in 2006, the Center for Structured Organic Particulate Systems (C-SOPS) brings together a cross-disciplinary team of researchers from major universities to work closely with industry leaders and regulatory authorities to improve the way pharmaceuticals, foods and agriculture products are manufactured. C-SOPS focuses on advancing the scientific foundation for the optimal design of SOPS with advanced functionality while developing the methodologies for their active control and manufacturing. Headquartered at Rutgers University, C-SOPS partners include the New Jersey Institute of Technology, Purdue University, the University of Puerto Rico at Mayaguez, and more than 40 industrial consortium member companies. C-SOPS is committed to modernizing pharmaceutical manufacturing by developing the science and engineering methods for designing, scaling, optimizing and controlling dosage forms and relevant manufacturing processes. Teams of qualified engineers and scientists at C-SOPS use cutting-edge technology to address fundamental scientific challenges and to apply this knowledge to develop and optimize new manufacturing methods. C-SOPS aims to support manufacturing development from concept to qualification.
Abbreviation |
C-SOPS
|
Country |
United States
|
Region |
Americas
|
Primary Language |
English
|
Evidence of Intl Collaboration? |
|
Industry engagement required? |
Associated Funding Agencies |
Contact Name |
Fernando J. Muzzio
|
Contact Title |
Director
|
Contact E-Mail |
Website |
|
General E-mail |
|
Phone |
(848) 445-6750
|
Address |
Rutgers University - New Brunswick, School of Engineering
98 Brett Road
Piscataway
NJ
8854
|
Research Areas
From day one, our emphasis has been on the science-based development of pharmaceutical products and processes through high impact research, to enable efficient and effective manufacturing. We remain committed to this goal and, in our next phase, we will optimize our efforts to maximize impact, progress, and pathways to adoption for emerging advanced pharmaceutical manufacturing technology.
As we reach our 10th year anniversary and “graduate” from NSF support, C-SOPS is in an excellent position to continue to drive innovation in pharmaceutical manufacturing. As a strong partner both for Industry and for the FDA, C-SOPS is in a unique position to facilitate the integration and implementation of new manufacturing technologies. Strong support from our members, growing partnerships with leading adopters of continuous technology and with the FDA, and a number of new and exciting initiatives are coming together to enable success in the next phase of our center.
Moving forward, C-SOPS’ core research program will focus increasingly on continuous manufacturing technologies, emphasizing the key aspects needed to make them reliable, easy to implement, and easy to operate.
In addition, in recent months, working directly with companies such as Janssen and government agencies such as the NSF and FDA, we have been able to launch several high-value/high-impact projects. In this mode of engagement, C-SOPS focus on the partner strategic interests and needs, achieving a much deeper level of collaboration. At the present time, several efforts are under way to expand these partnerships and developing new ones. Some of the new project areas are given below:
Material Characterization and Processibility for Continuous Tablet Manufacturing
This theme will address aspects of CM, including design, prediction, and optimization of formulation platforms based on materials property characterization and modification. It includes establishing relationships between key material properties of powder blends and “tabletability” of the blend and means to expand regimes of feasibility for direct compression (DC) as well as dry granulation (DG). Powder agglomeration, sticking and prevention/mitigation thereof will be also addressed with respect to CM platforms (both DC and DG). Expanded database of associated properties, including cohesion, flow, packing density, compactibility, and Drucker-Prager cap properties will be generated and continually updated on pharmaHUB.
Process and Unit Operations Modeling
This theme will be geared towards developing comprehensive process modeling tool-box consisting of unit operations, controller and sensor models together with a material property library, and executive system for assembling and executing integrated process simulations. It involves employing of the reduced order modeling methodologies to be used for flowsheet models, optimization and control. Major unit operations considered include feeders, milling, granulation and hot-melt extrusion based processing, as well as strategies such as staged powder addition in various operations such as mixing and twin-screw granulation.
Processes and Unit Operations for Bioavailability Enhancement
In this theme, center activities associated with addressing poorly water soluble drugs will be consolidated. Major activities include: (1) HME for amorphous materials, solid dispersions, as well as development of novel nano and micro composite materials through melt or wet granulation techniques, (2) Stripfilm based processing to develop unique products and their characterization. (3) Preparing engineered suspensions that are sterile filterable.
Processes Control and Information Management
This theme integrates various control strategies for all modes of continuous manufacturing of tablets, including direct compression, dry granulation and wet granulation, specifically, twin-screw granulation. Over-arching goal is to move towards a flexible and modular continuous pharmaceutical manufacturing plant that includes real-time sensing and control as well as incorporates various information and knowledge management strategies.
Sensor Development and Integration for PAT and RtR
In this theme, we address use and integration of traditional PAT techniques such as Near-IR, Raman, particle imagers (e.g., FBRM) as well as development of new sensing systems for process monitoring in continuous manufacturing and real-time-release of products. Novel sensing approaches such as ultrafast transmission NIR, infrared thermography, soft X-ray based on-line mass flow sensing, and microwave sensing for density measurements as well as testing and integration of single particle measurements. The project will use statistical approaches for analysis of data, for example, comparison of dissolution profiles.
Methodologies for Improved use of Measured Data
Facilities & Resources
The C-SOPS mission to be the national focal point for the science-based development of structured organic composite products and their manufacturing processes requires state-of-the-art laboratory facilities to conduct basic research and improve the pharmaceutical engineering knowledge-base. The Center has two main research laboratories located at the Rutgers New Brunswick campus and at the University of Puerto Rico at Mayaguez. In addition, Purdue University and the New Jersey Institute of Technology have well-equipped facilities which augment the research effort. These laboratories offer the latest equipment for performing an array of testing, simulations, analyses, and unit processing steps common in pharmaceutical manufacturing. See more details of our facilities below: RUTGERS The Pharmaceutical Engineering Laboratory at Rutgers-New Brunswick includes over 15,000 square feet of dedicated research and development space: 6,400 square feet specifically designed for pharmaceutical manufacturing research 1,100 square feet of space devoted to Test Bed 1, the continuous manufacturing commercialization project 8,400 square feet of laboratory space for nano-catalysis and reaction engineering activities 2,000 square feet of laboratory space for powder materials storage The pharmaceutical manufacturing research area, complete with GMP-quality, seamless epoxy flooring, has capabilities for controlling temperature and humidity, thereby enabling the maintenance of environmental conditions conducive to pharmaceutical manufacturing. The nano-catalysis research area is outfitted with over 13 laminar-flow hoods, and three of the lab rooms also have temperature and humidity controls. The two-story pilot plant area for continuous manufacturing is equipped with specialized equipment, controls, and safety interlocks designed to eliminate the safety hazards associated with the explosivity of powder/air mixtures often encountered in processing, and with the toxicological effects linked to APIs and inert dust particles. In addition, CSOPS at Rutgers also features the 2,000 sq. ft. Continuous Pharmaceutical Advanced Manufacturing Laboratory (CpAML), a fully integrated, control-enabled, commercial scale pilot plant for continuous manufacturing. This facility, which is the only one of its kind at a university anywhere in the world, is capable of manufacturing pharmaceutical products by any of the major modes (direct compression, wet granulation, roller compaction, and hot melt extrusion, as well as capsules). The equipment comprises a number of major units (three blenders, 10 feeders, two roller compactor, two tablet presses, a continuous granulator, a continuous drier) that have been received (mostly as in-kind contributions of ERC industrial members), and a seamless floor and air handling equipment. In addition, CpAML is also equipped with specialized equipment, controls, and safety interlocks designed to eliminate the safety hazards associated with the explosivity of powder/air mixtures often encountered in processing. The Rutgers facility served as the model for the INSPIRE facility by Janssen in Gurabo, Puerto Rico, and has been also the starting design point of numerous other facilities at companies around the world. List of Equipment: Combined, the laboratories contain a wide spectrum of measurement devices and solids-processing equipment typically found in most major pharmaceutical companies for the formulation of new products: Schenck Accurate Powder Feeders, Model # ModPharma Fitz Mill Roller Compactor, Model # IR520 Quadro Conical Screen Mill, Model # 197-S Glatt Conical Screen Mill, Model # GCF-60 Readco Continuous Mixer Granulator Rheoscientific Rheometer, Model # SP 200n Thermo Fischer Near IR Analyzer Pharma Laser Pharma LIBS 250 Pharmatron Tablet Hardness Tester, Model # 6D Van De Graaf Generator TREK Amplifier/Controller 610E & TEKTRONIX Digital Storage Oscilloscope, DS 03062A Quantchrome AutoTap Resodyn Acoustic Mixers LABRAM Fisher Convection Oven, Model # 250F Feund Hi-Coater (Tablet Coater), Model # HCT-30 Innopharma Lab Eyecon Bruker MPA Handpress Octagon Sieve Shaker, Model #2000 Glatt Twin Axial Mixer, Model # TAM 40 MCC Shear Rheometer Patterson Kelly V-Blender Blend Master, 4, 8 and 16 qrt shells Zanazi Capsule Filling Machine, Model # Zanazi 2 Lab Mill Drum Rollers, Model # 8000 Glatt Fluid Bed Coater Granulator, Model # Mini Glatt -5 Glatt Fluid Bed Coater Granulator, Model # GPCG1 Gravitational Displacement Rheometer Freeman Technology Powder Rheometer, Model # FT – 4 X-Rite Colorimeter, Model # VS450 KTRON Feeders, KT-20 KTRON Feeder, KT-35 KTRON Feeder, MT-12 Glatt Continuous Mixer Granulator, Model # GCG 70 Quadro Conical Screen Mill, Model # 197-S Lodige Continuous Mixer Granulator, Model # CM-5 Agillent HPLC, 1100 series Patterson-Kelley Liquid Solids Blender, Model # LIB-6919 Kikusui Tablet Press, Model # Libra 2 Varian UV-Visible Spectrophotometer, Model # Carry 50 Agilent Dissolution Apparatus, Model # 708 DS Agilent Fraction Collector, Model # 8000 Dissolution Sampling Station Agilent Peristaltic Pump, Model # 810 Shimadzu HPLC System MCC Compaction Simulator Textronix TDS digital oscilloscope, 3052 C & Olympus Square Pulse Receiver, 5077PR Pharmatron Tablet Hardness Tester, Model # 6D Bohle Roller Compactor, Model # BRC25 --- PURDUE UNIVERSITY The CSOPS facilities at Purdue University comprises of the new pilot plant, an 1800 sq. ft. of flexible high bay space that is designed to handle particulate material with minimal exposure to operators by virtue of the dust containment system installed. The solid dosage form manufacturing line includes continuous dry and wet granulation equipment, thereby providing additional versatility in processing raw materials that are not amenable to direct compression. The different unit operations are housed in negative-pressure containment modules, which are directly connected to the dust collector to minimize operator exposure. The pilot facility is also equipped with a clean room maintained under negative pressure to be used for powder preparation prior to processing. The integrated manufacturing line are interfaced with different sensors along the production line to provide an eye into the process for enhancement of process understanding. The real-time sensors include instruments for measuring particle size, density, moisture content and blend uniformity. In addition, Purdue also houses a dedicated Test Bed 3 facility which is a 641 sq. ft. of lab space fully equipped to make drug products by solvent deposition and melt deposition (also called melt extrusion) with real-time monitoring and closed-loop process control. Additional 2000 sq. ft. of particle characterization laboratory is also available at Purdue that contains a wide selection of instruments for measuring raw material attributes and properties of intermediate and final products. List of Equipment: Shimadzu MCT-510, Micro-compression tester Bruker MultiMode 8 AFM Retsch PT100 sample divider Humboldt H-3985 sample splitter Gilson SP-1 sample splitter Malvern Mastersizer 2000S particle size analyzer Malvern Morphologi G3-ID Tyler Ro-tap Model E sieve shaker ASTM E-11 sieves Nikon SMZ1500 microscope Nikon Optiphot-2 microscope Innopharmlabs Eyecon in-line/at-line image analysis system Micromeritics AccuPyc II 1340 pycnometer Micromeritics GeoPyc 1360 envelope & T.A.P. density analyzer Agilent Technologies 350 tapped bulk density tester Freeman FT-4 rheometer Schulze RTS-XS ring shear tester PerkinElmer Thermogravimetric Analyzer (TGA) Mettler Toledo HG63 moisture analyzer Binder FED115 drying oven Krüss K100MKII goniometer Photron FASTCAM-X 1024 PCI 100K high-speed video camera NovaStrobe DA115 strobe lamp Carver Press Auto Series 3888 Instron ElectroPuls E1000 mechanical testing frame Mechanical Testing Systems (MTS Model C43.504 testing frame Fike explosion suppression system. Negative pressure clean room equipped with HEPA filters Tote blender Chute riffler (powder splitter) Schenck AccuRate AP feeders with Gericke GCM 350 mixer Emerson DeltaV distributed control system 10-Station Riva Piccola Rotary Tablet Press Alexanderwerk WP-120V Roller Compactor with Gericke GCM 250 mixer 16-Station Natoli Rotary Tablet Press Drucker-Prager Cap powder parameter & powder-surface adhesion instrumented punch-die set UAS 5,000 cfm dust collector Test Bed 3 equipment: IVEK Digispense 10 temperature-controlled positive displacement pump Newport ESP301 three-axis motion controller for substrate movement Manta G146B machine vision camera for imaging drops Banner D10 high-speed photoelectric sensor for imaging drops Advanced Illumination collimated backlight for imaging drops Omega temperature controllers and heating elements for melt temperature maintenance TETech Peltier devices with TC-48-20 temperature controller for substrate temperature maintenance LabVIEW 2012 with Vision for full-fledged integration and control --- NJIT Center facilities at NJIT comprise of the 1,500 sq. ft. of laboratory space with full ventilation and wet lab facilities for housing novel particle processing instruments. The main space is dedicated to Test Bed 2, a closed-loop continuous oral film manufacturing facility that focuses on thin-film drug delivery systems that offer many advantages such as ease of delivery and patient compliance. Research focuses on techniques for forming precisely controlled release profiles that exploit particle engineering for direct incorporation of API particles into three-dimensional edible substrates which are about 100 microns thick. In addition, NJIT partner faculties have access to the New Jersey Center for Engineered Particulates (NJCEP) laboratories, the Particle Engineering Laboratory as well as NJIT’s Material Characterization Laboratory (MCL). Processing and testing equipment at the PI’s NJCEP includes SEA inverse gas chromatography (IGC), various dissolution testers, disintegration tester, Rodos/Helos dry powder sizer, Delsa Nano C particle size and zeta potential analyzer, several powder characterization equipment for powder flowability measurements, Carver press, fluid energy mill, magnetically assisted impaction coater, a comil high-speed delumping system, V-blender, near infrared spectrometer, a rotating fluidized bed coater, and a Hosakawa Micron Mechanofusion device, Netzsch wet stirred media mill, Procept spray dryer, Brookfield viscometer, Mettler Toledo thermogravimetric analyzer and polymer differential scanning calorimeter, Coulter LS13320 particle size analyzer, Sigma force tensiometer, and a Karl Fisher titrator for moisture content measurements. MCL is a common facility located in the same building with the PI’s laboratory, which makes it convenient to use. MCL includes scanning electron microscope with electron dispersive X-ray spectroscope (SEM-EDS), atomic force microscopy (AFM), Brunauer-Emmett-Teller (BET) surface area analyzer, X-ray diffractometer, high pressure liquid chromatography (HPLC), and Fourier transform infrared spectrophotometer (FTIR). Additionally PI also has no-fee access to EZ Raman coupled to a near-infrared laser emitting at 785 nm and a goniometer with a high speed camera. List of Equipment: 1. Fisher Vortex Mixer 2. Microclimate 3. IKA RO 15 Magnetic stirrer 4. Branson B1510 5. SP-230 Gilson Spinning Riffler 6. THINKY Mixer 7. Mettler Compact Karl Fisher Coulometer, C30 8. EvolutionTM 60S 9. Waters 2695 Separation Module 10. DT2 Manual Disintegration Tester 11. MAIC 12. Quadro Comil 13. Fluid Energy Mill 14. LabRam 15. Sirius SDI (Surface Dissolution Imager) 16. Netzsch Microcer Recicrulation Mill 17. Micros Batch Mill 18. Sonication Probes 19. Procept Spray Dryer 20. Thermo Twin Screw Extruder 21. Mini Glatt FB Coater 22. Buchi Mini Spray Dryer 23. HED Film Casting Line 24. Convective/Microwave Drier 25. Patterson Kelley V-Blender 26. Supercritical Fluid System 27. Carver Tablet Press 28. Sieve Shaker 29. Hybridizer 30. Sonication Probes 31. Beckman-LS13320 Particle Size Analyzer 32. Malvern Spraytec Laser Diffraction System 33. Delsa Nano C 34. Hosokawa Powder Tester 35. IGC SEA surface energy analysis 36. FT4 Powder Tester 37. Sotax Td1 38. TGA/DSC1/SF Stare system 39. TA-XT Plus Texture Analyzer 40. Polymer DSC , TGA/DSC1/SF Stare system 41. Keyence VH -2500 42. SOTAX AT7 Smart Dissolution System 43. Distek 2100C USP II Apparatus 44. Sotax CE7 smart 45. Brookfield viscometer 46. Micron Air Jet Sieve 47. Sympatec Rodos-Helos 48. Flowdex 49. Attension optical tensiometer --- UNIVERSITY OF PUERTO RICO AT MAYAGUEZ In Mayaguez, C-SOPS and the University of Puerto Rico built a dedicated 7,000 sq. ft. laboratory and office space devoted to training and industry-based research. This facility, named "C-SOPS-UPR", has now been completed and supports research by five faculty members from three different campuses. The facility has 2,000 sq. feet for pharmaceutical operations (mixing, drying, compaction, etc.), 700 sq. ft. for analytical testing and another 1,200 sq. ft. for computer simulation and process control. List of Equipment: Combined, the laboratories contain a wide spectrum of measurement devices and solids-processing equipment typically found in most major pharmaceutical companies for the formulation of new products: MALVERN SyNIRgy NIR-Chemical Imaging Kaiser Raman RXN-1 RAMAN Spectrometer (Phat Probe – MR Probe) Micromeritics AccuPyc II 1340 Karl Fischer Volumetric Titrator, Model: Metrohm 870 KF Titrino Plus Thermo Scientific Evolution 60S UV-VIS Spectrometer Bruker Optiks Multi-Purpose Analyzer FT-NIR Spectrometer Matrix-F FT-NIR Online Analyzer Patterson-Kelly Blendmaster C438008 Fette 3090 Tablet Press Feed frame VanKel Varian TAP density Tester BINDER ED-115 Drying Oven With Natural Convection RiceLake TA-120 Analytical Balance (120g – 0.0001g) OHAUS Analytical Plus 250D Balance (210g – 0.0001g) VWR Vacuum Oven 1400E Controlled Humidity Environments Olympus CX31 Polarized light Microscope with Infinity 2 Camera.
Partner Organizations
Rutgers University
Purdue University
New Jersey Institute of Technology
University of Puerto Rico at Mayaguez