Extensive wastewater testing for AMR-free antibiotic manufacturing
Centrient Pharmaceuticals has been a long-standing advocate for the sustainable manufacturing of antibiotics. We are an industry leader in enzymatic production and we continuously innovate to adopt the best wastewater treatment and testing measures. The global threat of Antimicrobial Resistance (AMR) to public health continues to grow; as a result, the need for sustainably produced antibiotics is more critical than ever. We at Centrient make it our responsibility to safeguard the efficacy of antibiotics for generations to come.
In 2016, Centrient began using the ‘Delvo’ test to assess antibiotic residues in wastewater streams. Developed in-house by our scientists, this test can detect the presence of antibiotic waste greater than 50 ppb (50 microgram/kg). Centrient was one of the first global manufacturers to conduct this regular testing on all our wastewater streams.
The PNEC discharge targets, developed by the AMR Industry Alliance, are stringent scientific limits on antibiotic concentrations in manufacturing wastewater. These values are increasingly being recognized as the standard for antibiotic discharge concentrations in water and are expanding beyond leading companies and their supply chains. Centrient achieved 100% compliance with PNEC discharge targets for clean and AMR-proof manufacturing of its full oral antibiotics product range.
For PNEC standards, the tolerance limit for antimicrobial residue is dramatically lower than our former test could measure. With targets as low as one ppb for amoxicillin and 0.25 ppb for ampicillin, the Delvo test became obsolete as it could not detect these small values. The need to test wastewater as per new tolerance limits triggered Centrient’s search for new sophisticated quantitative testing methods.
In 2018, Centrient collaborated with DSM Biologics in Delft to develop and validate an analytical method based on US EPA 1694 that can measure the concentration of residual antibiotics as per the PNEC values. The testing method runs on an advanced, costly instrument called HPLC/MS/MS. The development of this testing method came with challenges as the scientists needed a matrix to detect these minute antibiotic residues without interference from other impurities in the wastewater. The work continued for almost six months to achieve acceptable detection of antibiotic concentration, with the method finally being validated in the third quarter of 2019.
Centrient has implemented the methodology at all manufacturing sites and continues to enhance the sensitivity and precision of the test. With state-of-the-art wastewater treatment facilities and PNEC-compliant testing methodology, Centrient ensures that its manufacturing is unlikely to contribute to the spread of AMR.