RUBBER STOPPER LEARNING SECTION - Universal Medicap
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Advantages of Unistar RFU stoppers
Time and Energy Savings
Eliminates complex washing, siliconizing, sterilization, and drying steps at the customer's end, leading to significant time, energy, and manpower savings.
Streamlined Processes
Reduces validations required at the customer's end, streamlining processes for substantial savings.
Urgent Production Ready
No need for overnight preparation, making it ideal for urgent production schedules.
Low Residual Moisture Option
Especially for critical dry powder and lyophilized injectables, Unistar RFU stoppers with low residual moisture (NMT 0.1%) are available upon request.
Customised Solutions
Offers customized pack sizes to meet individual customer requirements, providing flexibility in packaging.
FAQ
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Crafted through sequential washing and drying operations in our fully automated controlled bung processor, Unistar RFU...
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.
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Pre-siliconised, pre-washed, and pre-sterilized by Gamma radiation at our...
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.
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The triple-layer packaging, labeled with batch details and...
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.