New options. Improved processes. Streamlined processing.
RESOMER® Sterile is the first and only sterile controlled release poly (lactic-co-glycolic) (PLGA) excipient that enables new options for the manufacturing of parenteral drugs, improved process controls and streamlined steps for aseptic processing. RESOMER® Sterile versions are available on a made to order basis for any controlled release RESOMER® catalogue product or RESOMER® Select custom-made product.
Key properties of Resomer® Sterile:
Proprietary manufacturing process for sterile RESOMER® polymers
White powder with a bulk density for easy handling during formulation
For solvent purified and vacuum distilled polymers
Allow for aseptic processing of solutions that cannot be filtered or powders
Avoids possible detrimental effects on polymer, API, and drug products from terminal sterilization
Minimized bioburden level of raw material for terminal sterilized process
High sterility assurance level - SAL 10-6
Applicable to all controlled release RESOMER® catalogue and RESOMER® Select products
Proven reliability, quality and supply chain security