The particulate contamination in products for injections and infusion liquids is defined as foreign, spontaneously present in solutions, insoluble particles other than the bubbles of air, which are able to move in accordance with the current of the liquid.
We carry out the examinations of particulate contamination within the full scope, as required by pharmacopoeia (USP, Ph. Eur., FP) within the range of:
- visible particles,
- sub-visible particles – determination of the particulate contamination in medicinal products (infusion liquids and preparations for injections) by means of the PAMAS counter.
We ensure that performed examinations and the prepared documentation are done in accordance with the requirements of pharmacopoeia (USP, Ph. Eur., FP), recommendations of the International Conference on Harmonisation (ICH), the requirements of the European Medicines Agency (EMA) and the American Food and Drug Administration (FDA).