The guidelines for the sterile/aseptic manufacture of medicinal products in clean rooms increasingly stipulate quality assurance and control measures (Annex 1 EU GMP Guidelines). As a GMP certified quality control laboratory, BioChem Labor für biologische und chemische Analytik GmbH, Karlsruhe, offers manufacturers a variety of analytical laboratory services for their product release.

These include in particular:

• Validation and testing for sterility
  Test for sterility acc. to Ph. Eur. 2.6.1 and USP <71>, performed in an isolator
• Validation and testing for bacterial endotoxins
  LAL test acc. to Ph. Eur. 2.6.14/5.1.10 and USP <85>
  rFC test acc. to Ph. Eur. 2.6.32
• Validation and microbiological examination of of non-sterile products (raw material)
  Test acc. to Ph. Eur. 2.6.12/2.6.13 and USP <61>/<62>
• Further tests acc. to pharmacopoeial methods as well as chemical analyses, e.g. to determine the identity and concentration of active substances

Als unabhängiges, GMP-zertifiziertes Qualitätskontrolllabor liefern wir Ihnen schnelle und zuverlässige Ergebnisse. Somit können herstellende Betriebe die Sicherheit ihrer selbst hergestellten Arzneimittel gegenüber ihren Kunden und den Behörden jederzeit nachweisen. Zu unseren Kunden in diesem Bereich zählen u. a. Hersteller steriler/aseptischer Parenteralia ebenso wie steriler und unsteriler Defekturarzneimittel von individuellen Apotheken bis hin zu internationalen Pharmaherstellern. Unsere Mitarbeitenden sind qualifiziert im Umgang mit hochwirksamen und toxischen Substanzen wie Zytostatika, BTMs, KMR-Substanzen, Hormone und Antibiotika.

As an independent, GMP certified quality control laboratory, we provide you with fast and reliable results. Thus, manufacturers can prove the safety of their manufactured medicinal products to their customers and the authorities at any time. Our customers in this area include manufacturers of sterile/aseptic parenterals as well as sterile and non-sterile pharmaceuticals from individual pharmacies to international pharmaceutical manufacturers. Our employees are qualified in handling highly effective and/or toxic substances e.g. narcotics, cytostatic drugs, hormones, antibiotics and CMR substances (carcinogenic, mutagenic, reproductive toxicity).

Please contact us if you are interested in our analyses. The experts of our microbiological department will be pleased to provide you with further information.