Industrial Technology Systems Ltd (ITS) has extensive experience in the provision of equipment, facility and process validation services to medical device and pharmaceutical manufacturers.
ITS’ expertise includes 21 CFR Part 211, 21 CFR Part 11, the FDA’s regulation for Electronic Records and Signatures, and 21 CFR Part 820, the Quality System Regulation for Medical Device and Invitro Diagnostic Products. With a quality management system developed around GAMP®, ITS’ engineers are also experts in working to GAMP® guidelines.
Using a risk-based approach with rigorous IQ, OQ and PQ testing procedures, ITS' validation team is dedicated to demonstrating that equipment, facilities and manufacturing processes meet both quality and regulatory requirements.
ITS' validation experience varies from equipment, machinery and processes through to entire plants. This experience includes but is not limited to the following:
| • Autoclaves |
• Laboratory Instruments |
| • Automated Device Assembly Lines |
• Material Testers |
| • Batch Weighing & Dispensing Equipment |
• Metronic Prometers |
| • Binder Preparation Vessels |
• Microbiology Incubators |
| • Bin Washers |
• Micronisers |
| • Blenders |
• Microwave Dryers |
| • Capsule Fillers |
• Mixers |
| • Cartoning & Packaging Equipment |
• Moisture Balances |
| • Chromatography Units |
• Moulding Machines |
| • Coaters |
• Particle Counters |
| • Co-ordinate Measuring Machines |
• Particle Detection Systems |
| • Dispensary Systems |
• Particle Size Analysers |
| • Dry Granulation Rigs |
• Printers |
| • Drying Ovens |
• Printing Labelling Equipment |
| • Effluent Treatment System |
• Purified Water Systems |
| • Extruders |
• Robot Arms |
| • Environmental Monitoring Systems |
• Sterilisers |
| • Form-Fill-Seal Machine |
• Syringe Crack Detectors |
| • Freeze Dryers |
• Tablet Checkweighers |
| • Granulators |
• Tablet Presses |
| • Heat Sealers |
• Tensile Testers |
| • Incubators |
• Tray Dryers |
| • In-Process Checkweighers |
• Vial / Syringe Filling Equipment |
ISPE owns the GAMP® trademark http://www.ispe.org/