Pharmaceutical market moves with booming technology for sterile drug production.

Published in the Official Gazette of August 12, 2020, 2 more clients of LAS received the approval by ANVISA (National Health Surveillance Agency) for the release of medicines by the Rapid Microbiological Method BD BACTEC. ANVISA grants through the code 10207 Specific – the Update of Specifications and Analytical Methods.

The BD BACTEC is the only alternative microbiological method approved by ANVISA for releasing sterile pharmaceutical products and is being tested by other industrial segments, which have sterile processes. Its technology consists of fluorescence sensitive detectors that react with the biochemical production of CO2.

In order to bring to its customers technological innovation, safety and quality in analytical processes, LAS has experts in Microbiology and Filtration who are responsible for technical and scientific advice, commercial agreements, and logistical management of supplies that ensure success in validation protocols submitted to regulatory agencies.

Buy-In Project

It is a BACTEC’s Validation Period Incentive Program for LAS clients in Brazil. For the implementation of an alternative methodology in Quality Control laboratories, an analytical validation of the new methodology is required. The regulatory agencies, both ANVISA and MAPA, adopt the Brazilian Pharmacopeia (FB), American Pharmacopeia (USP) among others, as guidelines to validate the analytical tests. In these compendia, we find the tests that companies must adopt to have scientific evidence that the alternative methodology adopted should be safer than the traditional one.

By purchasing BD BACTEC equipment, LAS also offers, in its broad portfolio, the necessary supplies for analytical tests:

• DIFCO Culture Media
• PALL filtration systems
• Membranes
• Sanitizers
• Steris Detergents (contribution to Environmental Monitoring Analyses),
• Fisher Scientific laboratory supplies.

Contact LAS to know the excellence of BD BACTEC and other important solutions in Microbiology!