Accreditation
Rigel S.p.A. obtained the certification n. 305 as an Accredited Calibration Laboratory (LAT) – in compliance with the requirements of the ISO / IEC 17025: 2017 ‘General requirements for the competence of testing and calibration laboratories‘ – from ACCREDIA, the Italian Accreditation Body.
The accreditation certifies the Lab’s competence, impartiality, constant and consistent activity in operating as an ACCREDIA Calibration Center, in the field of calibration of optical particle counters for the metrological “Quantity of substance” area, and in the fields and the uncertainties as reported in the Accreditation Table attached to the Accreditation Certificate.
Both of these documents are available in the Data Banks section of the website www.accredia.it
As detailed in the Accreditation Table, the calibration method used by Rigel is in accordance with the ISO 21501-4:2018 for the following measurands:
- particle size
- counting efficiency
- size resolution
- sampling flow rate
and consequently, the Company can officially issue Calibration Certificates containing the results of the calibration activities.
Expertise and know how
Rigel has become an Accredited Laboratory for the calibration of particle counters, thus accepting the inspiring principles set out in the 2018 revision of the ISO 215014 standard, which in sect. 6.10 states: “Calibration certificates issued by ISO / IEC 17025 accredited laboratories and covering all results for the parameters 1 to 5 are considered to comply with the requirements above“.
As a result, Rigel is now able to ensure the best possible service for the Climet particle counters, as it brings together both an accredited laboratory and the official assistance center in one single player.
Accredited Calibration Service
The Company’s current dual identity, both as an accredited laboratory and as an official service center, allows it to provide a complete service for the Climet particle counters including activities such as: accredited “as-found” calibration (i.e. a calibration of the instrument as it was received) and accredited “as-left” calibration thanks to the presence of an internal accredited Calibration Center, tuning and other contextual activities due to the existence of an internal official Climet Assistance Center.
COMPLETE DOCUMENTATION
The calibration and maintenance service provides a thorough analysis with comprehensive documentation.
To ensure verification and standards compliance, a Calibration Certificate is issued and can be used as part of an effective overall service and maintenance regime that can track the long-term reliability of equipment, meeting both technical and GMP requirements.
WHAT CHANGES
One could think that the tuning has to be performed only if the as-found calibration reveals that the instrument is out of tolerance, while it could be omitted if the instrument is within tolerance – thus limiting the service to the as-found calibration only.
Such an approach is not conceptually wrong, but has a weak point, as it omits a precious activity aimed at preventing “out of specification” cases. As a matter of fact, particle counters are instruments inevitably subject to drift. For this reason, in the usage period between two different calibrations, parameters will inevitably get decentralized, even if they may have remained within the limits of the acceptance criteria.
As a result of tuning, parameters are re-centered, and are set as far as possible from the limits of the acceptance criteria. This activity is of extraordinary importance, as it makes it possible to drastically reduce the probability of future out-of-specification cases.