BrandTech - blaubrand class a usp glass volumetric pipettes

BLAUBRAND® USP Volumetric Pipettes

Class A, USP, certified single-volume bulb pipette. High contrast blue enamel print represents the optimum combination of resistance and readability. These volumetric pipettes are available in all ISO sizes from 5mL to 100mL. Made of AR-GLAS®.

The optimized flow of geometry in the tip ensures reliable liquid dispensing from the pipette. The mechanical resilience of the tip and its fire-polished edges ensures a long service life.

All BLAUBRAND® USP volumetric pipettes are supplied with a batch number and an accompanying USP batch certificate in the original packaging.

Volumetric Pipettes according to USP error limits:

• Companies producing pharmaceutical products for the US market are supervised by US authorities, e.g. the FDA (Food and Drug Administration), and must meet the requirements of the USP (United States Pharmacopeia).
• The current USP prescribes in section 31 the use of volumetric pipettes with accuracy in accordance to class A of the ASTM standards and list those for volumetric flasks, transfer pipettes and burettes in tables.
• For graduated pipettes up to and including 10 mL size the error limits are mentioned in the text. BRAND volumetric pipettes are manufactured according to the current DIN EN ISO standards. As the construction specifications are differently defined in the DIN EN ISO and ASTM standards, the error limits differ as well. With included USP certificates BRAND confirms for the delivered USP volumetric pipettes that the class A error limits according to the USP or, rather, ASTM standards are met.

Every glass volumetric pipette is individually calibrated:

• Computer-controlled systems ensure maximum precision in a fully automated production line.
• The final step of this Statistical Process Control is random sampling of finished product according to DIN ISO 3951.
• The quality management system applied at BRAND, which is certified according to DIN EN ISO 9001, is a combination of process monitoring and random checks with an accepted quality level (AQL) of approximately 0.4.

The batch certificate of the volumetric pipettes confirms that ASTM class A error limits required by USP are met. The certificate records the mean value, the standard deviation of the batch and the date of issue (batch number: year of manufacture/batch).