Calibration & Validation Services
Validation Services
Validation is a systematic approach, where data is collected and analyzed to confirm that a process will operate within the specified parameters, whenever required and that it will produce consistent results within the predetermined specifications. The process verifies, if the compliance and quality standards are being met by a product in real time. In short, Validation is defined as a documented program that provides a high degree of assurance that a specific process, method, instrument or system will consistently produce a result meeting pre-determined acceptance criteria.
In a pharmaceutical facility, the validation program establishes that a company is meeting Current Good Manufacturing Process (cGMP) guidelines that are set for the industry by concerned regulatory bodies.
Validation is concerned mainly with processes. When the same approach is applied to a machine or any equipment instead of a process, it is referred to as Qualification instead. Qualification is not limited to a Validation process, but it is a part of it. It can be further divided into Installation Qualification (IQ), Operation Qualification (OQ) or Performance Qualification (PQ).
EIE Instruments offers a wide variety of Validation Services that meet FDA, ICH, and many European standards. We are well equipped with necessary Validation Accessories & SOP to carry out On-site Validation Process for following list of Instruments in any Pharmaceutical Industries:
Horizontal Steam Sterilizer (Horizontal Autoclave)
Vertical Steam Sterilizer (Vertical Autoclave)
Hot air oven
Dry Heat Sterilizer
Stability Chamber
Cooling chamber
Cold Room
Walk-In Stability chamber
Refrigerator
Freezer
SIP System
CIP System
Waterbath
Heating block
Validation Documents Include:
Diagram Procedures
Door Opening Studies
Result & Conclusion
Graphical Representation
Power Failure Studies
Hot & Cold Point
Recovery Studies
Why EIE's Validation Services?
- Well Trained and Qualified Engineer / Technician Team
- 3 decades Manufacturing experience according to GMP Guidelines
- Separate QA and Documentation Department to fulfill complicated activities on priority basis
- All Reporting work complies to National / International and Major Regulatory bodies like USFDA, MHRA, MCC, TGA, WHO, FDA, ISO etc
- Prompt Services and Fast Reporting
- On-Site Calibration & Validation Facility
- Remind Customers for due date of Instrument Calibration & Equipment Validation activity by Mail/Telephonic
Calibration Services
Calibration facilities are given the highest priorities at our organization. We hold excellent technical know-how to calibrate versatile calibration parameters with National & International Traceability. EIE’s in-house Calibration Lab is accredited by NABL Authorities as per IEC/ISO : 17025 Guidelines. The Laboratory at Precise is very well equipped with the most modern and sophisticated Master Instruments / Equipment & Reference Standards, which are employed for providing precise & accurate calibration services to the prestigious clients. We provide following 2 kinds of calibration services to our esteemed clients.
- In-house Calibration Service
- On-Site Calibration Service
Calibration Scope as per ISO/IEC 17025
Thermal Scope
Sensors, Thermometers, Switches, Recorders, Transmitters and Analytical Instruments such as Freezers, Refrigerators, Stability Chambers (Humidity chambers), Incubators, Ovens, Furnace, Waterbath Hygrometers etc
Mass Scope
Laboratory balances, F1 Class weights, F2 Class weights, M1 Class weights, M2 Class weights etc
Pressure/Vacuum Scope
Pressure Sensors, Pressure Gages, Pressure Transducers, Pressure Switches, Vacuum Gauges, Magnehelic Gauges, Compound gauges, Recorders and more
Dimension Lab Scope
Vernier Calipers, Rulers, Micrometers, Thickness Gauges, Dial Gauges, Depth Gauges, Level and more
System Calibrations
Autoclave, Lyophilizer, Centrifuge
Force Lab Scope
CBR Testing machine, Marshall Stability testing machine, Compression testing machine, Tensile testing machine, Universal tensile testing machine, Load cells, Proving Rings etc
Volume Scope
Beakers, Funnels, Pipettes, Burettes, etc
Electro-Technical
Shakers, Mixers, RPM, Timer, pH meter, Conductivity meter, ORP Meter, TDS Meter
NABL Accredited Calibration Laboratory(ISO/IEC 17025: 2017)
