German plant gains three new state-of-the-art laboratories
NextPharma has extended the microbiology facilities at its site in Göttingen, Germany.
The European provider of product development, contract manufacturing and cold chain and logistics outsourcing services has added three laboratories equipped with modern air ventilation, laminar-flow benches and temperature-controlled incubators linked to a computerised monitoring system that helps to ensure a constant temperature throughout the incubation period. The microbiology department meets the highest GMP standards, is EU and FDA compliant.
The new laboratories will be used to develop and validate microbiological methods as well as to test non-sterile pharmaceutical products, medical devices and cosmetics for microbial purity and preservative efficiency.
Additionally, the new laboratories can work sequentially to process samples enabling a high throughput of testing. Overall, the microbiology department in Göttingen has the capacity to test some 40,000 samples a year. Microbiological testing of sterile products will continue to be undertaken at NextPharma’s facility in Belgium.
Sean Marett, managing director, NextPharma Technologies, Product Development Services, said the microbiology department would enable the company to add to its Product Development Services in this field of expertise.
‘We look forward to working with new and existing customers in the pharmaceutical, medical device and cosmetics markets,’ he said.
NextPharma Göttingen has many years of experience in the manufacture and packaging of solid dosage forms. In recent years, significant investments have been made in the manufacturing and packaging of conventional solid dosage forms, including the completion of a state-of-the-art tablet bottle filling line in July 2010.
In addition to tablets and hard gelatin capsules NextPharma Göttingen manufactures and packages effervescent tablets and sachets and provides Alu-Alu blister packaging. Additionally it undertakes formulation development and analytical testing of solid forms, microbiological testing, manufacture of investigational medicinal products and clinical trial labelling and equipping.
NextPharma also has a separately housed cephalosporins plant in Göttingen, which produces various cephalosporin dosage forms, while NextPharma Berlin has separate dedicated production facilities to produce penicillins and amoxicillin-clavulanic acid.