Validation of Disinfectants in Pharmaceutics based on European Standard Test Methods

Rubrik: GMP / GLP / GCP

(Treffer aus pharmind, Nr. 04, Seite 489 (2022))

Steinhauer K | Grütters M

Validation of Disinfectants in Pharmaceutics based on European Standard Test Methods / Steinhauer and Grütters • Validation of disinfectants · Steinhauer K^1,2, Grütters M³ · ¹bactologicum GmbH, Itzehoe und Faculty of Mechanical Engineering, Kiel University of Applied Sciences, Kiel und Schülke & Mayr GmbH, Norderstedt
Good production hygiene is key when it comes to delivering safe and effective medicinal products to patients, which in many cases – due to their medical condition – are especially vulnerable. However, many reports on microbially contaminated pharmaceutical products exist. In his survey of the U.S. Food and Drug Administration (FDA) database for product recalls Jimenez [ 1 ] reported that from 134 cases of recalls for non-sterile pharmaceutical products 60 % were associated with Gram-negative bacteria. Dominating species were Burkholderia cepacia , Pseudomonas spp., and Ralstonia pickettii . When looking at sterile and non-sterile product recalls Jimenez [ 1 ] reported ...