Rapid microbiological methods in pandemics
Producers of sterile and biotechnological products: be prepared to face emergency situations and optimize processes more safely!
– ANVISA (National Health Surveillance Agency) has exceptionally and temporarily authorized – through Deliberative Resolution 243 – that shipments of sterile drugs be transported to distributors and health institutions before the completion of Quality Control tests. However, the drugs can only be used after the manufacturer communicates the approval of the products in sterility tests within 7 (seven) days of incubation.
ANVISA’s incubation period of 7 (seven) days is a rapid methodology release protocol, realizing higher sensitivity compared to the traditional membrane filtration protocol.
HOW DOES BACTEC WORK? FX POSITIVELY IMPACT YOUR ROUTINE?
- Significant reduction of media preparation and assay time;
- Simple procedure, step-by-step traceability of actions and definitive results independent of subsequent analysis;
- Detects in up to 5 hours and releases in up to 5 days, reducing inventory quarantine period;
- Robust assay in routine, no method interference, no need for specific materials or care in intensive environmental control.
This 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 Pharmacopoeia (FB), American Pharmacopoeia (USP) among others, as guidelines to validate the analytical assays. In these compendia, we find the tests that companies must adopt in order to have scientific proof that the alternative methodology adopted is safer than the traditional one.
By purchasing the BD BACTEC equipment, LAS also offers, in its wide portfolio, the necessary supplies for analytical assays:
- DIFCO CULTURE MEDIA;
- PALL FILTRATION SYSTEMS / MEMBRANES;
- STERIS SANITIZERS/ DETERGENTS (contribution to Environmental Monitoring Analyses);
- LABORATORY SUPPLIES FISHER SCIENTIFIC