EFHSS Questions and Answers - Question Q00526

What is the risk to articles posed by particles in the controlled enviroment.

Dear Deborah

Particles, also referred to as Particulate Matter (PM), aerosols or fine particles, consisting of organic or anorganic matter are usually of microscopic dimension.
Particles are mobile homes for microbes used as transport vehicle and as a shield from beeing killed by decontaminant.
For devices intended to penetrate the human skin, sterility alone is not enough; the article should also be free from all kind of particles. Particles on or in the product can act as "foreign bodies" causing adverse reaction in the patient.
To avoid accumulation of particles, clean room technology during controlling, assembling and packaging of medical devices, CSSD has to meet the specified guidelines and standards.

Kind regards
Josy Holdener