Quality Certification Services

At LAMBDA-ELAN Ltd., we offer comprehensive quality certification services for electroanalytical devices. Our team is dedicated to ensuring the highest standards of performance and reliability for your equipments.

Our Services:

1. Electronic and Mechanical Specification & Function Check (OQ Test):
   • Conducted according to SOPs from METROHM or our own SOPs inspired by METROHM and manufacturer’s specifications.
   • Includes electronic and mechanical parameter checks to ensure they fall within prescribed ranges.
2. Chemical Conformity Assessment (PQ Test):
   • Performed according to METROHM SOPs or our own SOPs inspired by METROHM and manufacturer’s specifications.
   • Assesses the chemical conformity of devices through a series of measurements on certified reference materials.
3. Analytical Method Validation:
   • Chemical conformity assessment of electroanalytical methodologies using METROHM SOPs or our SOPs inspired by METROHM, using certified reference materials.
4. Electrode Validation:
   • Chemical conformity assessment of electroanalytical sensors according to METROHM SOPs or our SOPs inspired by METROHM and manufacturer’s specifications, using certified reference materials.
5. Calibration of Volumetric Titrator Dispensing Units:
   • Calibration of burettes or peristaltic pumps according to METROHM SOPs or our SOPs inspired by METROHM and manufacturer’s specifications.
6. Pipette Calibration:
   • Volumetric conformity assessment of automatic pipettes following SOPs from Biohit.
7. Dispenser Calibration:
   • Volumetric conformity assessment of dispensers according to SOPs from Hirschmann.
8. Syringe Calibration:
   • Volumetric conformity assessment of precision injection syringes based on SOPs from Hamilton.

Required Documents:

Auditors may request records of IQ, OQ and PQ tests for analytical instruments or complex measuring configurations used for quality control of ingredients, semi-manufactured, and final products. Regular check-ups, commonly at least once a year, are required for ISO-qualified companies and their instruments such as pH meters, conductivity meters, salinity meters, dissolved oxygen meters, chlorine meters, ozone meters, gas analyzers, automatic titrators, polarographic, and ion-chromatographic systems.

OQ Test Details:

• Specification Check: Inspects electronic and mechanical parameters specified by the manufacturer to ensure they are within the prescribed ranges. Instruments are tested as “black-boxes” with signal inputs and outputs, checking if responses meet manufacturer SOPs.
• Function Check: Controls the operation of front-end elements like the keyboard, display, and all electronic interfaces. Immediate detection of faults is crucial to avoid product waste and potential damage to the company’s reputation.

PQ Test Details:

• Chemical Conformity Assessment: Involves a series of measurements with the analytical instrument on certified reference materials. The results are compared with the manufacturer’s specifications.
• Electrode Validation: Conducts chemical conformity assessments of sensors using certified reference materials, ensuring they meet specified requirements.