What is it?
Microbial analysis is essential for ensuring that pharmaceutical products are safe and that they meet rigorous quality and regulatory specifications. We support clinical manufacturing and quality control for both non-sterile and sterile products.
How does it work?
Arcinova’s on-site microbiologists can assist manufacture through microbial monitoring and simulation tests. An advantage of having specialists close at hand during process testing is that samples can be taken as close to the source as possible. Quality control for sterile product release testing involves sterility, endotoxin and in-process testing. Microbiological enumeration and tests for specified microorganisms are also supplied for the quality control testing of non-sterile products.
Why choose Arcinova?
Our skilled microbiologists excel at method development through their extensive experience working with difficult products that have not previously been analysed. For extemporaneous injectable products, we offer same day turnaround for endotoxin testing. We are specialists in the microbial analysis of radiolabelled compounds and are able to handle cytotoxic and high potency compounds.