The PCS conforms to the Dual-Dye Ratiometric Photometric Method described in ISO 8655-7:2022 and facilitates conformity to the Photometric Reference Measurement Procedure described in ISO 8655-8:2022. The PCS can be used to fulfill test and calibration requirements according to CLSI QMS23:2019, ISO 17025, cGMP, and cGLP. ArtelWare and PCS Software can be used in laboratories compliant to 21 CFR Part 11.

Artel has evolved our brand to better align with our values and the customers we serve, and to symbolize where we are today. But the Artel mission has remained the same – to help labs achieve their goals for quality, productivity, and compliance. One of the changes made during the transition was consolidating the array of verification solutions under the new QualAssure label. The QualAssure name describes the assurance of accurate, precise, and reproducible data that customers have come to expect from using Artel technology, products and services. The products themselves are the same proven formulations and volumes as users have come to depend on and customers do not need to change their ordering processes.

• Calibrate pipettes under the exact conditions in which they are used, in the lab where they are used.
• Perform operator competency assessments in the lab environment, in which pipette users work, with the actual pipettes used by the operators.
• Powerful PCS Software manages the entire pipette inventory and operator assessments.
• Audits become a breeze, as all pipette calibration and operator performance information is stored in one central, secure place.
• Fast operation: a full pipette calibration with 3 x 10 data points takes only about 7 minutes to complete, including furnishing a calibration report.
• User determines the schedule, test volumes, number of data points, and pass/fail tolerances – for pipette calibrations and operator assessments.
• Lean, paperless workflow: user can set email alerts for due calibrations and skills assessments and review and approve/reject results electronically.
• Excellent pipetting technique training tool.
• PCS instrument is essentially maintenance free.
• Ease of use: all calibration solutions are supplied ready-to-use, no need to prepare reagents or establish calibration curves.
• Calibrate pipettes from 0.1 µL (100 nL) to 5,000 µL (5 mL).
• System inaccuracy of 0.6%; system imprecision 0.3% CV.
• Instrument works in a wide range of environmental conditions:
  • Temperature range: 15 °C to 30 °C
  • Relative humidity: 10% to 90%, non-condensing

• Calibration method conforms to ISO 8655 part 7
• PCS measurement results are traceable to SI units through calibration standards maintained by NIST (USA) and NPL (UK).
• The PCS can be used in 21 CFR Part 11 compliant facilities.
• Makes regulatory compliance and audits easy.

Yes, a comprehensive Validation Guide is available to perform full IQ/OQ validations of the PCS instrument and ArtelWare Software.

Some types can be calibrated. Our team will need to evaluate individually.

No, we use specialized reagents in a custom photometer design; PCS QualAssure Solutions, the PCS instrument, and ArtelWare Software are created as a system to provide optimal ease-of-use, speed, accuracy and precision.

Yes, PCS measurement results are traceable to the International System of Units (SI) through calibration standards maintained by the National Institute of Standards and Technology (NIST, USA) and the National Physical Laboratory (NPL, UK). All PCS calibration solutions are tested in Artel’s ISO 17025 accredited laboratory.

0.1 μL (100 nL) to 5,000 μL (5 mL)

Yes, an Accredited Laboratory can use the PCS for both, pipette calibration and to demonstrate operator proficiency, by doing the following:

• Purchase an Artel PCS along with the ISO 17025 PCS Instrument Calibration Certificate (PCS-410).
• Purchase the PCS Calibrator Kit that includes the ISO 17025 Calibration Certificate (AW-605).
• Contact Artel for a detailed PCS Measurement Uncertainty Budget.
• Follow the ISO 17025 requirements to implement test and/or calibration procedures, and ensure operators are trained and qualified.
• Comply with any additional requirements imposed by your particular accreditation body.

Note 1: We suggest contacting your Accreditation Body early in the process, so they may advise of all particular requirements.
Note 2: The PCS employs a standard method, and as such is exempt from the method validation requirements of ISO 17025, section 5.4.5.