Thermal /Equipment Validation

Temperature / Humidity Mapping are Very Critical Step in the Validation of any Pharmaceutical Process. To ensure the Safety and Efficacy of Life Science Products, all Storage and Manufacturing Facilities ( From Raw Material to Finished Goods) must be Temperature / Humidity Mapped to show that Storage and Transportation conditions are good for your Products & meeting all Regulatory Requirements.

We provide high quality Qualification Services for Equipment & Facilities. Our experience in Temperature / Humidity Mapping allows us to offer our customers a wide range of services. We can help our customers to established methods & Protocol based on current GMP Trends and best practices followed in Industry.

We have proper Documentation methods meeting Current Regulatory requirements. Our Documents consist of Basic Temperature Mapping Data, Calculations like F0, Fh, Min. & Max. Temperature, Standard Deviation, Lag Time Calculation, Identification of Hot & Cold spots, we also provide Graphical Presentation of Temperature V/s Time, Diagram Indicating Sensor location & Validation Summary / Certificate etc.

Our range of Services in Thermal Validations,

• Autoclave, DHS, Depyrogenation Tunnels, Ovens

• Warehouse , RM Stores, Labs, Production Area 

• Stability Chambers, Refrigerators, Freezers, Incubators, Cold Chambers

• Vessels, Tanks, Filters, Fermentors

• Water Baths, Muffle Furnace, Vacuum & LOD Oven, Other QC Equipments.

We offer Special Validation Services for the following:
Lab Equipments.

BMS Systems.

PLC / SCADA / DCS Systems.

Through Regulatory compliance services we help our clients assess and define their compliance and validation requirements.

Technovision offers specialized assistance involving consultation or validation services for a single system, a unit operation or an entire facility.

Our range of services encompasses the entire product life cycle and includes GAMP compliance services, validation services and projects requiring the integration of both these services.

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Calibration

Quality of Final Product is depending on the Proper & Efficient Working of Instruments used at different stages in the Manufacturing Process. The accuracy of the electronic components used in all Instruments naturally drifts over time. Time in service as well as environmental conditions also add to this drift. As time progresses, changes in component properties will cause grater uncertainty in your measurements. Eventually, the drift causes the Instruments uncertainty to become undefined, meaning the manufacturer can no longer predict the uncertainty and guarantee measurement results. To resolve the issue, Instruments must be calibrated at regular intervals as defined by the manufacturer.

In fact out of tolerance (OOT) Instruments may give false information leading to unreliable product customer dissatisfaction and increased warranty costs. In addition, out of tolerance (OOT) conditions may cause good products to fail tests, which ultimately results in unnecessary rework costs and production delays. A regular cycle of checks with traceable calibration equipment is essential. Calibration ensures that your quality and the customer’s.

All our Masters Instruments are of Reputed Manufacturer, Very Accurate & Reliable. We are doing periodic Calibration of our Master Instruments from NABL Accredited Labs. We are carried out Calibration at Client’s Site also. We are following all standard norms while carrying out the Calibration Activity. Our Calibration Services are already audited by various reputed Pharmaceutical Companies. We maintain proper documentation of the calibration activity like SOP, Raw Data Sheets, and Calibration Certificate. We are giving NABL Traceability for our Calibration Certificates.

We are doing calibration of following Instruments.

• Temperature Sensor / Element / Gauge / Psycronesmeter

• Transmitter / Indicator / Controller

• Pressure / Vaccum Gauge, Transmitter & Switch

• Pressure Safety Valve, Control Valve, I/P Converter

• Magnetic Differential Pressure Gauge

• Data Logger / Recorder / Temp. Scanner

• Level Transmitter

• pH , & Conductivity Sensor & Transmitter

• Timer, RPM Indicator, Anemometer, Lux Meter

• Humidity Sensor , Meter & Data Logger ( Hygrometer )

• We provided support to calibrate Other Instruments from Outside Calibration Lab.