Hamilton was recently accredited as a manufacturer of certified reference materials in accordance with ISO 17034. The certification of the company’s pH buffer solutions and conductivity standards was granted by the Swiss Accreditation Service and highlights Hamilton’s consistent commitment to the highest standards of quality, reliability, and compliance in the field of process analytics. With 14 pH values in up to six sizes and eleven conductivity standards, Hamilton offers a broad product portfolio that has been measured in accredited laboratories. The most important of these products are certified reference materials produced in accordance with ISO 17034, and all are tested in accordance with ISO 17025.
For users in regulated environments, particularly in the pharmaceutical industry and biotechnology, the certification brings significant advantages. This is because it ensures metrological traceability and confirms long-term stability, and reduces the audit risk for GMP/GLP laboratories. Another aspect certified under ISO 17034 is compliance with legal regulations, as well as support for method validation, method verification, and instrument calibration in audit processes and qualification procedures.
“A sensor is only as good as its calibration. We have recognized that our customers need calibration solutions of the highest level, they can rely on and that deliver outstanding results”, explains Eric Hess, Product Manager at Hamilton Process Analytics.
Hamilton calibration solutions meet high demands
Hamilton’s ISO 17034-certified pH buffer solutions are characterized by proven stability of up to five years, even after the bottle has been opened. The solutions are available in package sizes ranging from 250 ml to 25 l. Sizes up to 500 ml come with an integrated calibration vessel that prevents contamination of the solution and reduces buffer consumption to just 15 ml per calibration. Due to the variety of sizes, they are used in both laboratory applications and large-scale production processes. The measured pH value is certified by accredited laboratories and is based on two international reference standards (NIST and PTB).
Hamilton also offers “best-in-class” products for conductivity standards. The company is the first manufacturer worldwide to offer these with values of 1.3 µS/cm and 5 µS/cm, featuring a certified accuracy of ± 1 % and documented shelf life. A patented glycerin matrix formulation effectively prevents CO2 absorption from the air and ensures a shelf life of up to three years after opening. The standards have also been tested by accredited laboratories and meet the requirements of the United States Pharmacopeia as well as other international pharmacopoeias.
All certificates and safety data sheets can be accessed digitally via a QR code on the bottle and are available for download. The homogeneity and stability studies were conducted in full compliance with the requirements of ISO 17034 and ISO 33405, respectively, and the reported measurement uncertainties were calculated in accordance with the GUM principle.
ISO 17034 certification proves that our certified reference materials are produced under the strictest quality requirements, with traceability and reliability as core principles.”
Eric Hess, Product Manager, Hamilton Process Analytics
The certified solutions are now available through the Hamilton web shop and the authorized dealer networks.
