Bangs Laboratories

Global pharmacopoeia standards for pharmaceutical, ophthalmic, parenteral, and therapeutic protein injections and/or solutions require that these solutions be tested for contaminating particles. To demonstrate that these tests meet the standards, the machines need to be calibrated to ensure that they are meeting the required levels of detection. The provision of standard solutions that can be used for these instrument calibration checks and evaluating the cleaning procedures of the single-use consumables is therefore of critical importance to Quality Control departments.

Bang’s Laboratories has recently launched SureCount™ PCS-Contamination beads for customers needing to meet  USP<787>, USP<788>, USP<789>, ASTM E3230-20, European Pharmacopoeia 2.9.19 and more international standards. The 15.0 ± 0.2 µm beads are supplied at 3800 particles/mL ± 15% in water. Each lot is sized using a NIST-calibrated stage micrometer with digital processing. Particle counts are verified using the Coulter method. 

Bang’s Labs are an original manufacturer of these standards, which offers an advantage to established QC departments in surety that their supply is not dependent on a single manufacturer of their current standards, as well as the option of a price advantage for new QC protocols written.

Bang’s Labs SureCount PCS can be supplied with or without the SureCount™ buffer solution (blanks).