Since 2004, the use of more sensitive and specific methods has been endorsed by the European Pharmacopoeia (E.P. chapter 5.1.6 and chapter 2.6.1) and by the FDA Aseptic guidelines. Thereby, molecular biological methods are recommended as a faster and more reliable alternative to conventional methods.
To meet this need, BIOTECON Diagnostics introduced the microproof® product line in 2005. The microproof® brand includes all BIOTECON Diagnostics’ products used in the pharmaceutical and clinical areas. In addition to the foodproof® product line for food safety, which has been widely used for years, BIOTECON Diagnostics’ portfolio is thus complemented by specific products for the pharmaceutical industry.
Pharma Detection Kits
microproof® Pharma Detection Kits
The microproof Hygiene Screening System allows the rapid and highly specific detection of the three genera Staphylococcus, Micrococcus and Corynebacterium. It is in use by several international manufacturers of pharmaceutical products, mainly for hygiene monitoring prior to sterile production processes in the different clean room classes. Additionally, the most important species, like Micrococcus luteus or Staphylococcus aureus, can be identified within the same reaction through melting curve analysis.
The microproof Hygiene Screening System allows efficient hygiene monitoring in the pharmaceutical environment, and is used worldwide by many pharmaceutical companies. It is one of the few commercially available so-called NAT methods (Nucleic Acid Amplification Techniques), which have been successful in this industry
The microproof Streptococcus pneumoniae Detection Kit was developed for rapid detection of Streptococcus pneumoniae by real-time PCR.
Streptococcus pneumoniae, or pneumococcus, is a Gram-positive, alpha-hemolytic, aero-tolerant, anaerobic member of the genus Streptococcus. As an important human pathogen, S. pneumoniae was identified as a major cause of pneumonia in the late 19th century.
Streptococcus pneumoniae, or pneumococcus, is a Gram-positive, alpha-hemolytic, aero-tolerant, anaerobic member of the genus Streptococcus. As an important human pathogen, S. pneumoniae was identified as a major cause of pneumonia in the late 19th century.
