- Piramal Pharma Solutions (PPS) has opened a new microbiology laboratory at its sterile injectable facility in Lexington, Kentucky, as part of its $85 million site expansion.
- The laboratory more than triples existing microbiology testing space and includes a sterility testing suite that doubles the site’s sterility testing capacity.
Piramal Pharma Solutions (PPS) has opened a new microbiology laboratory at its sterile injectable facility in Lexington, Kentucky, as part of its ongoing $85 million expansion. The laboratory was released for routine GMP use on September 11, 2026, and its new sterility testing suite was subsequently conditionally approved. The full manufacturing expansion is expected to be operational in late 2027.
The new laboratory more than triples the site’s existing microbiology testing space and adds three biosafety cabinets, allowing concurrent testing and supporting shorter sample queue times. PPS has also consolidated all incubators within the new laboratory to streamline workflow and improve monitoring and accessibility.
A dedicated sterility testing suite features a Grade C background environment and a fully integrated Grade A sterility testing isolator. The isolator doubles the site’s sterility testing capacity and can process multiple samples simultaneously. The suite supports both open and closed filtration methods and includes pass-throughs for moving samples directly from the manufacturing floor to the laboratory.
PPS said the new infrastructure is expected to reduce testing times by up to 50%, supporting faster batch releases and reducing bottlenecks as programs transition from clinical to commercial stages. The company said the added capacity also strengthens contamination control and sterility assurance capabilities and prepares the Lexington facility for commercial-scale demand.
“The new microbiology laboratory represents an important milestone in our Lexington expansion journey. The investment strengthens the site’s ability to support clients with microbiology quality and sterility testing services across the product life cycle.”
Nathan Richardson, VP and Site Head at Piramal Pharma Solutions Lexington
