Streamlines user-end processes by eliminating complex washing and siliconization steps.
Significantly reduces validation activities, leading to substantial time and cost savings.
Enables prompt production schedules without the need for overnight or advance preparation of rubber stoppers.
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.
Eliminates complex washing, siliconizing, sterilization, and drying steps at the customer’s end, leading to significant time, energy, and manpower savings.
Reduces validations required at the customer’s end, streamlining processes for substantial savings.
No need for overnight preparation, making it ideal for urgent production schedules.
Especially for critical dry powder and lyophilized injectables, Unistar RFU stoppers with low residual moisture (NMT 0.1%) are available upon request.