Companies that manufacture pharmaceutical products for the American market and others are audited by US Authorities such as the Food and Drug Administration and are obligated to meet the requirements of USP drug standards. These standards are used in more than 140 countries.
The current USP describes in Chapter 31 that the Class A error limits specified in the ASTM standards are required for glass volumetric instruments.
BLAUBRAND® USP volumetric instruments comply with the Class A error limits required by United States Pharmacopeia.
BRAND glass volumetric instruments are manufactured according to current DIN EN ISO standards. Since the construction requirements defined in the DIN EN ISO standards differ from those in the ASTM standards, different error limits result for the individual measuring instruments. BRAND confirms with the enclosed USP certificates for all USP measuring instruments delivered that the Class A error limits corresponding to the ASTM standards are observed.
Every glass volumetric instrument is individually calibrated. For measuring instruments with scales, such as graduated pipettes, burettes and graduated cylinders, flexible screen stencils are used. These stencils can be stretched to match the calibration marks accurately, so that the measuring precision is maintained for all intermediate volumes. Computer-controlled systems ensure maximum precision in a fully automated production line.
Thermal stress in the glass blanks are eliminated prior to adjustment. Therefore, BLAUBRAND® volumetric instruments can be heated up to 250 °C in a drying cabinet or sterilizer without any permanent volume changes. Specially developed quality printing inks burned in at about 500 °C also ensure a long service life for BLAUBRAND® USP volumetric instruments.
The quality management system applied at BRAND and certified to DIN EN ISO 9001 is a combination of process monitoring and random checks. The accepted quality level (AQL) is less than or equal to 0.4.
The reference temperature of 20 °C applies to our volumetric instruments, which are produced according to DIN EN ISO standards. If a volumetric instrument calibrated at 20 °C is used at 27 °C, the volumetric expansion of the instrument results in an additional measurement variation that, at 0.007% (borosilicate glass 3.3) or 0.02% (soda lime glass) is significantly smaller than the error limits for the volumetric instrument. As a result, the reference temperature is of little importance for practical applications. However, if an adjustment or calibration is carried out at a different temperature, the measured values must be corrected accordingly (see DIN EN ISO 4787).
The testing of volumetric instruments is done gravimetrically according to DIN EN ISO 4787. So that calibration can be done rapidly and easily, while minimizing sources of error, BRAND provides detailed testing instructions (SOP) for every type of volumetric instrument, free of charge.
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