Unexpected contamination can lead to rejected batches, expensive investigations, unnecessary cleaning cycles and lost ...

This is especially relevant given the recent revision to EU Annex 1 – Manufacture of Sterile Medicinal Products (2022). The Technical Report (TR) outlines how particle counters are used to monitor and ...

Some professionals working with particle counters believe it to be necessary to divide the particle counts of non-volumetric particle counters by the counting efficiency (CE) at the lower limit when ...