BioSpectra Launches Class 6 Manufacturing Suite for Sterile filtered, GMP bulk Solutions, utilizing sterile, SUT packaging. First product launch: 5M NaCl solution made with WFI and multi-compendial salt.
BioSpectra, Inc. has announced the successful launch of its new ISO Class 6 manufacturing suite for the production of Sodium Chloride Solutions. The first product manufactured and shipped was a 5M NaCl solution made with multi-compendial salt and water for injection, sterile filtered and filled into a sterile, custom bio processing compatible 1000 liter container with satellite samples. The Sodium Chloride Production Suite is capable of manufacturing various molarities of NaCl and custom NaCl solutions. It is the first of four new ISO Class 6 manufacturing suites being built at its Bangor, PA, 150,000-ft2, GMP facility. BioSpectra is a US manufacturer of Premium Pharmaceutical Ingredients.