undergoes a meticulously validated cycle, including a final rinse with water for injection. This process ensures the effective removal/reduction of particulate matter, bacterial endotoxin, and bio-burden loads, aligning with international standards.
cutting-edge facility, Universal ISO-MED, Unistar RFU is packed in a cleanroom environment within our cGMP compliant plant. Our state-of-the-art facility, equipped with a microbiology lab, HVAC system, water system, and other essential amenities, ensures the highest quality standards in the pharmaceutical industry.
gamma radiation indicators, provides an added layer of protection. Stoppers are sterilized in their final shipper pack through a validated Gamma Irradiation process, with retained samples from each batch for quality assurance. A Certificate of Analysis (COA) and a sample pack for Q.C/Microbiology testing accompany each batch supplied.