PHARMACEUTICAL DEVELOPMENT AND INNOVATION SERVICE
IUCT's Pharmaceutical Development and Innovation Service (PDI-S) was conceived with a view to developing internal projects, in addition to lending support to the pharmaceutical and chemical industry. The PDI-S promotes galenic development, in addition to the development and creation of new drugs, and the manufacture of batches used in research and clinical trials.
These facilities were designed with -a view to meeting current guidelines regarding the manufacture of pharmaceutical and pharmaceutical-related products, according to GMPs. For this purpose, air conditioning and treatment facilities have been designed, with a structure that is compartmentalised into Classes C and D according to the needs of the different divisions which make up the pilot plant. Temperature, Humidity, Pressure, Particle Density and Microbiological Checks are all run.
The pilot plant occupies a large area which is divided into 2 zones: the first is the solid zone, Class D (100,000) and the second, Class C (10,000), the liquid and semi-solid zone.
The Class D Zone comprises 5 rooms devoted to research, development and manufacture of capsules, tablets and powders. This zone also includes a conditioning room, two warehouses (one for raw materials, the other for end products), a class D changing room, a material cleaning room and a weighing room with a vertical laminar flow bell which delimits a Class 100 area.
The Class C zone is reached via a corridor-distributor, which includes a changing room (SAS) of the same class and two rooms devoted to the production of semi-solid and liquid forms.
PDI-S Activities and Services
- Galenic Development.
- Pre-formulation Studies.
- Medicine Design and Development.
- Manufacture of batches for clinical trials.
- Short and Long Term Medicine Stability Studies, according to ICH guidelines.
- Quality Control of Raw Materials, semi-manufactured products and end products.
- Determination of strengths and impurities of drugs.
- Development and Validation of analytical methods for drugs.
- Dissolution Studies of pharmaceutical forms, according to pharmacopoeia.
- All IUCT trials and analysis are accompanied by a specialist report.
These services are provided thanks to the equipment and techniques available, which include:
- High Performance Liquid Chromatography (HPLC) with an automatic programmable injector, a quaternary pump system, a column oven and a UV/VIS-DAD detector.
- GC-FID Gas Chromatography, GC-ECD, GC-MS quadrupole, with a direct injection probe.
- UV/VIS-DAD.
- FT-IR.
- NMR 60 MHz.
- Screen, mixer, churner, granulating mill, drying chamber and compression machine.
- Manual Encapsulating machines.
- Reactor for the production of semi-solid and liquid pharmaceutical forms.
- Ultraturrax Homogeniser.
- Equipment used in the quality control of pharmaceutical forms (durometer, brittleness gauge, equipment used to carry out disgregation tests, dissolution speed tests, volumeter, viscometer, etc.).
- Stability tests using Climatic Chambers and suitable analytic instrumentation.
The global operation of the pilot plant is achieved thanks to the combined efforts of the departments of Control and Analysis, Microbiology, Quality Assurance and Pharmaceutical and Fine Chemical Industry, in conjunction with General Management and the Programme Co-ordination department.
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