Microtech is a leading name in Calibration and Validation Services in India and across the globe. With a team of experts providing consultancy for ISO 13485, CE Marking, ISO Certifications, NABL Accreditation, and GMP Compliance, we bring deep technical and regulatory expertise to the pharmaceutical industry. Leveraging our vast experience, we assist pharmaceutical companies in calibration and validation processes that fully comply with US FDA and other international audit standards.
We offer complete calibration solutions for all types of instruments used in pharmaceutical manufacturing, along with validation services for any type of equipment. Our state-of-the-art facility has been NABL accredited since 2000 and is equipped with controlled temperature conditions and advanced systems for calibrating E2 class weights as well as performing comprehensive validation activities for pharmaceutical and process industries.
Our validation reports are generated using high-precision imported instruments designed to meet the stringent requirements of US FDA and other compliance audits. Over the years, we have proudly served leading pharmaceutical companies including Zydus, Alkem, IPCA, Qatar Pharma, Intas, McLeods Pharma, Gujarat Themis, United Phosphorus, India Gelatine, Amneal, and Rushan, among many others.
Our team of electronics and instrumentation engineers has extensive experience in software validation. With Microtech, many of India’s leading pharmaceutical companies have successfully conducted software validation for their PLC, HMI, SCADA, and APS-based automation systems used in auto-filling, packing, and other process control applications. Our calibration and validation reports have consistently helped our clients achieve successful US FDA, GMP, and other regulatory compliance audits for many consecutive years.
Validation
| Clean Room validation | HVAC Validation | AHU Validation |
| Laminar air Flow | Air flow Test & ACPH Calculations | Installed Filter System Leakage Test |
| Smoke test | Non-Viable Particle Count Test | Recovery Test |
| Air Flow Pattern Test (Using Water Fogger) | Air Flow Pattern Test (Using Water Fogger) | Light Intensity Measurement |
| Sound Level Measurement | Ventilation measurement | Air capture hood measurement |
Software Validation
Installation qualification, operational qualification and performance qualification of software based equipments based on the requirements of GAMP as per the requirements of US FDA.
| PLC and HMI validation | SCADA validation | BMS (Building Maintenance System) Validation |
| SAP Validation | ERP Validation | EMS Validation |
OSD
| Blender | Rapid Mixture granulator | Auto water |
| FBD Blister | packaging Machine | |
Injectable
| Vial washing | Vial feeling |
| Autoclave | Tunnel |
Utility
| RO + UV water | Purified water generation and siatillation |
Instrument Calibration
| Thermo-Hygrometer | Weight Box (E2 Class and coarser) | Temperature controller / Indicator |
| Autoclave Mapping | Micro pipettes | ORP Meter |
| Temperature Mapping | Weighing balance | Data Loggers |
| Humidity Mapping | Glass wares | Safety Valve |
| Incubator | Hydrometer | Magnahilic Gauge |
| Oven | Measuring scale | Manometer |
| Glass thermometer | Caliper | Pressure gauges |
| Thermocouples / Temperature Sensor | Wobble meter | Compound gauges |
| Muffle Furnace | Dial gauge | Pressure recorder |
| Anemometer | Lux Meter | Hot-Wire anemometer |
| Temperature recorder | Temperature transmitter | Pressure Transmitter |
| Humidity transmitter | Test sieve Dial | Gauge |
