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13 September 2013

Calibration and Adjustment

Calibration (a procedure which highlights differences between measured values and actual values), adjustment (procedure by which the identified differences are rectified) and maintenance of instruments, devices and plants are essential procedures for companies working in compliance with FDA (Food and Drug Administration), GMP (Good Manufacturing Practice) or ISO 9001 (International Organization for Standardization of Quality) standards.

Such procedures can be connected to your company Quality Systems, in particular in compliance with ISO 17025 about management of calibrating and adjustment laboratories.

 

Our Consulting Services

  • Setting and management of planned calibration/adjustment/maintenance procedures of instruments used in production plants (cold-storage plants, laminar flow hoods, furnaces etc.), in storage areas (monitored condition warehouses and stands, etc.), in laboratories (measuring devices, etc.), in compliance with current regulations and national, European and international reference regulations
  • Creation of an adjustment logbook
  • Metrological chains* r(eferring to national SIT standards – Italian Adjustment Service) and international standards
  • Supervision, certification, trial, precautionary maintenance of analysis systems, for pharmaceutical, environmental and chemical laboratories
  • Survey on tolerances during processes and following analysis of uncertainty budgets

 

* Set of means and procedures which allow referability between in progress measurement and the physical sample

Keeping under control the physical parameters of the processes allows to acquire knowledge of the dynamics occurring during the production or preservation stages. Such knowledge allows to reduce check tests downline of the production chain, to reduce reprocessing due to products that turn out to be out of the expected specifications, to reduce waste and to optimize performances. The whole works result in an income raise, reducing loss.

 

Use cases

  • To ensure accuracy and reliability to surveys of targeted physical parameters, leading to an improvement in the product quality
  • To guarantee to equipment and plants a high efficiency level
  • To reduce substantially the event of unexpected malfunctions and of unproductive periods
  • At the time that process parameters have to be guaranteed and undergo a periodical calibration plan to produce to supervisory authorities such as ministries of health, ASL, customers, etc…
  • Routinely to ensure exactness of data produced by laboratory or used equipment
  • To meet regulation compliance
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