Facilities
The Centre’s distinctive infrastructure not only facilitates clinical testing support, spanning from prototype to finished product, but also provides access to an extensive and diverse network of experts in manufacturing and regulatory affairs.
The DDIC complies with current Good Manufacturing Practices (cGMP) set by Health Canada and provides stability testing in accordance with the protocols established by the International Conference on Harmonization (ICH). Having secured a Health Canada Site License for manufacturing, processing, and packaging in 2009, the DDIC consistently renews this license, and has added a Drug Establishment License to its activities attesting to its commitment to maintaining the highest regulatory standards.
GMP Compliant Classified Cleanrooms Facility: ISO 6 (Class 1000) and ISO 7 (Class 10,000): for production and packaging, includes a clean room gowning area, clean room formulation facility, clean room filling area.
Quality Control Laboratory: For testing of active pharmaceutical ingredients, NHPs and drug products, including disintegration and dissolution.
Prototype Laboratory: For executing project designs and performing proof of concept studies.
Services
The DDIC provides a wide range of services for industry, researchers, students, and more, in its state-of-the-art clean room facilities, prototype labs, and quality control lab.
Due to its different Health Canada licenses, the DDIC is able to engage with a wide range of activities including controlled substances.
For Researchers: Novel delivery systems, Nano formulations, Design and proof of concept studies, and Regulatory pathway design.
For the Pharmaceutical Industry: Product research and design, Quality control, Regulatory affairs, Analytical testing, Drug release testing, Performance testing, Product life cycle management, Production of liquid, semi solid, and solid oral dosage forms.
For Clinical Investigators: Clinical trial material production, packaging, labeling, and randomization. Customized dosage form development including matching placebos. Customized package designs; e.g. blister packs.
For Students and Trainees: Hands-on training in GMP environment and pharmaceutical production and testing including batch release.
Equipment
The DDIC’s state-of-the-art equipment is capable of processing small to medium quantities of active pharmaceutical ingredients and clinical trial materials packed and labeled.
Product Development Equipment: Analytical and manufacturing balances, Blister packaging, Capsule filling equipment (000, 00, 0, 1), Comill, Containment chamber, Customized labeling, Double cone blender, Emulsification equipment, Fluid bed granulator, Freeze dryer, Wet-granulators, Grinders, Mixers and Blenders, Ointment maker and dispenser, Rotary tablet press with instrumentation, Screw capping machine, Spray dryer, Suppository maker, Tablet counting machine and De-duster, Tube filler, Automatic and semi automatic capsule filler, Capsule bander, Coating pan.
Quality + Performance Characterization Equipment: Disintegration and dissolution testing apparatuses (1, 2), Flow through cell (for performance testing of special dosage forms), Franz cell (for performance testing of special dosage forms), Friability tester, HPLC /UPLC systems for chemical analysis, LCMS/MS and NMR, ICH conform stability chambers (25°C, 60% RH/30°C, 65% RH/40°C, 75% RH), Tablet hardness tester, Thermal conductivity tester, Weight checker, Water system, Micro balance, Tap density, Liquid density measurements, Brookfield rheometer, Spectrophotometer.
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