GREAT competence in classification, development, registration and production of “Borderline” Medical Devices
facility is authorized to develop & manufacture under ISO 13485 invasive oral, nasal & vaginal Medical Devices class I,II III in solids & liquid forms.
Medical Device is any instrument, apparatus, appliance, material or other article, whether used alone or in combination, ……for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease. (no pharmacological, metabolic, or Immunological action ).
Problems with correct demarcation between medical devices, medicinal products, cosmetics, food supplements and general use products remain frequently unsolved. “Borderline products” doesn’t clearly belongs to a specific category.
When these product are classified as Medical Devices SIIT has strong competences in development & production.
up to now more than 50 product has been registered by SIIT’s regulatory staff.
Medical Devices Department: solid oral dosage forms technologies:
- Dry blending
- Granulates: dry, fluid bed, traditional drying and under vacuum
- Tablet, micro tablet, mono layer, bi and tri-layer, chewable, effervescent and modified release tablets
- Film and sugar coated tablets, candies,
- Chewingum mono, multilayer uncoated & sugar coated
- Capsules filled with powders, granulates, pellets, tabs or combinations
- Stick pack
- Thermo-sealed sachets for powder, granulates
- Blister in PVC/PVDC, in Alu/Alu
- Bottles in PVC, PV, glass
- Tubes for effervescent tablets (10-20 tablets
Medical Devices Department: Liquid oral dosage forms technologies:
- Blending, emulsions, homogenisation, liposome
- Filling bottle for spry (10-50 ml), drops (5-50 ml) and syrup (100-1000 ml)
- Filling monodose and 2 phase vials (5-20 ml)
- Stick pack & sachet for liquid