The entire production system is bound to compliance with regulations and procedures, defined in detail by the various UNI EN ISOs that establishes the parameters that must be respected by both the instruments and the production processes in a rigid and timely manner.
Specifically, the instruments must be calibrated, the processes must be validated. The Calibration and Validation Division of Tecno Electric performs those activities counting on over 50 specialized technicians and a Metrological Laboratory.
Tecno Electric can guarantee safety and conformity of instruments and processes by offering services related to calibration and validation.
Let’s see them in detail.
Here you will find some Case Histories useful to illustrate the problems faced and the solutions implemented.
VALIDATION AND CALIBRATION
CALIBRATION
The calibration of a measuring instrument is a fundamental activity in order to be able to work in compliance with UNI EN ISO 9001.
The Validation and Calibration division of Tecno Electric has been calibrating measuring instruments for over 30 years and guarantees the measurements’ traceability to the standards of the International System.
Over 50 Specialized Technicians can perform measurements and calibrations in a Metrological Laboratory equipped with more than 150 sample instruments, all with Accredia certification or equivalent, such as UKAS, COFRAC, DKD, FINAS.
All sample instrumentation is constantly identified, traced, updated, stored and controlled so that its efficiency is always guaranteed during the calibration activities, as established by the UNI EN ISO 10012 standard.
The following are the main physical quantities for which we can guarantee traceability to International System standards:
– Temperature
– Absolute, relative and differential pressure
– Vacuum
– Electrical quantities
– Relative and absolute humidity
– Mass and volume
– Liquid and gas flow
– Conductivity, pH and Redox
– Time
– Linear and angular velocity
VALIDATION AND CALIBRATION
VALIDATION
The production processes must be compliant with regulations, often very strict, whose main purpose is guaranteeing safety and quality. The main objective of Validation activities consists in verifying that production processes are compliant to those regulations. Validation of a process is a documented verification that ensures that the process (including machinery, components, utilities, procedures) meets stakeholders’ needs and expectations, is safe and compliant with the current cGMP (current Good Manufacturing Practice).
Tecno Electric offers the following services:
– Clean Rooms, c-Rabs and LAF qualifications
– Biological Hoods qualifications
– Chemical hoods qualifications
– Process qualifications
– Software qualifications
– Thermal Validation of Machines and Devices
– FAT and SAT
– Bio-decontamination of environments with hydrogen peroxide vapour
– Preparation of Validation Protocols
– Consulting (Qualifications, Risk Assessment, SOPs, Supervision)
– Documentation review
Our specialized technicians provide documented evidences of the activities performed by reviewing the documentation prepared, verified and approved by the personnel who are responsible for ensuring their authenticity and usability.
Tecno Electric has a Metrological Laboratory with state of art SIT certified instruments that allow to perform calibration and validation activities.
