Malvern’s Quality Audit Standards have been produced to provide users of Malvern’s laser diffraction and imaging-based particle size analyzers with a one-shot, polydisperse transfer standard that enables them to verify the performance of their systems on a regular basis.

If your particle size analyzer is used as a quality control tool, it is inevitable that an occasion will arise where a sample batch you are measuring will be reported to be out of specification. In such a situation, confirmation that the particle size analyzer is performing correctly will help to eliminate any concerns that the analytical system has led to the reported failure.

Malvern’s Quality Audit Standards are designed provide a reliable means of checking and documenting the correct operation of Malvern’s Mastersizer, Spraytec and Morphologi G3SE / G3SE-ID systems, supporting their use in quality control applications as part of FDA or other international laboratory accreditation schemes (e.g. ISO, NAMAS, and IAF).

Malvern’s Quality Audit Standards are:

  • Compliant with ISO13320:2009, USP<429> and EP 2.9.31 guidance relating to the verification of laser diffraction systems.
  • Single-shot samples, reducing the sampling errors associated with measurements.
  • Provided with detailed measurement procedures to aid their routine use within quality control laboratories.
  • Made of an inert material, ensuring a long shelf life.
  • Produced from the world’s largest particle size standard master batch, ensuring many years of consistent supply.

Datasheets

Quality Audit Standard Measurement Protocols for QAS3002
Datasheet providing the Quality Audit Standard measurement procedures and specifications for QAS3002.

Quality Audit Standard Measurement Protocols for QAS3001-B
Datasheet providing the Quality Audit Standard measurement procedures and specifications for QAS3001-B.

Quality Audit Standard Measurement Protocols for QAS3004
Datasheet providing the Quality Audit Standard measurement procedures and specifications for QAS3004. This standard is used for the verification of the Hydro 2000 Micro Precision sample dispersion unit.

Quality Audit Standard Measurement Protocols for QAS3006
Datasheet providing the Quality Audit Standard measurement procedures and specifications for QAS3006. This standard is used for the verification of the sample dispersion unit included in the Morphologi G3SE and Morphologi G3SE-ID systems.