We offer you a wide range of analyses in the production or clean room environment of the medical device and pharmaceutical industries. Proof of depyrogenation is subject to various guidelines and standards, depending on the specific industry.

Product integrity and patient safety

Endotoxins are pyrogens that originate from the cell wall of gram-negative bacteria. They can cause serious complications in the human organism. This is why testing for bacterial endotoxins is now mandatory on a large scale in the medical device and pharmaceutical industries.

However, endotoxins cannot always be avoided, especially if aseptic production is not possible for technical reasons. Therefore, there are several strategies to remove endotoxins from products or pharmaceuticals (depyrogenation). This includes, above all, dry heat over a longer period of time, as well as various cleaning processes using washing cycles.

At GfPS mbH, you have the option of carrying out the detection of depyrogenation together with our laboratory. For this purpose, you can provide us with samples that are contaminated with a high concentration of endotoxins. We then send these samples back to you so that the cleaning process you have chosen can be applied. After completion, the samples are sent back to GfPS, where the quantitative test for bacterial endotoxins is carried out using the kinetic-turbidimetric or rFC method in accordance with standards.

Evidence of depyrogenation is usually provided when a 3-log reduction in endotoxins has been achieved.

Guidelines:

  • European Pharmacopoeia (Ph. Eur.)
  • United States
  • ISO 11737-3 – Sterilization of health care products- Microbiological methods Part 3: Bacterial endotoxin testing
  • ANSI/AAMI:ST72 Bacterial endotoxins-Test methods, routine monitoring, and alternatives to batch testing
  • FDA Guidance for Industry, Pyrogen and Endotoxins Testing – Questions and Answers
  • International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) – e.g. ICH Q7A for GMP guidelines
  • Good Manufacturing Practice (GMP) Guidelines for biotechnological products

We will be happy to assist you with your questions about testing for growth-promoting properties at
freigabe@gfps.de
.