European Pharmacopoeia
Microbiological monitoring and sterility testing in accordance with the European Pharmacopoeia
Normec provides organisations with analytical units to meet specific needs in terms of microbiological monitoring and sterility control, in accordance with the recommendations of the European Pharmacopoeia.
Our sterility testing services in accordance with the European Pharmacopoeia
Microbiological monitoring
Sterility testing
Our sterility testing services in accordance with the European Pharmacopoeia
Microbiological monitoring
Bulk purified water, highly purified water
Water for diluting concentrated solutions for hemodialysis
Implementation of new protocols for any other matrix
Filtration – culture – incubation for 5 days – enumeration
Interim results available after 5 days
Final results between 5 and 7 days
Sterility testing
This test applies to substances, preparations, and products that must be sterile according to the Pharmacopoeia guidelines
We offer you the possibility of designing and implementing specific protocols, adapted to the elements you wish to test, in accordance with the guidelines of the European Pharmacopoeia
Filtration – culture – incubation for 5 days – counting
Interim results possible after 5 days
Final results between 5 and 7 days
Regulations
European Pharmacopoeia: https://www.edqm.eu/fr/Pharmacopee_Europeenne_10e_Edition
These services might also be of interest to you
Hemodialysis water analysis
Particle counting
Leading companies in this service
Normec Abiolab
Montbonnot-Saint-Martin France
Curious to know what we can do for you?
FAQ
Frequently asked questions
Sterility testing according to the European Pharmacopoeia is a laboratory process that checks whether substances, preparations, or products comply with the strict sterility requirements.
Sterility and microbiological monitoring are essential for patient safety, regulatory compliance, and the quality assurance of water, solutions, and pharmaceutical products used in healthcare.
The process typically includes filtration, culture, and incubation for 5 to 7 days, with interim results available after 5 days. Tests can be adapted to different types of water, pharmaceutical preparations, or custom protocols as required.