PROCESS
RSF
“Unistar RFU” (Ready For Use) Gamma Sterilized & Low Residual Moisture Rubber Stoppers
Unisure RFS Rubber Stoppers
"Unisure RFS" rubber stoppers are meticulously processed through a validated cycle, incorporating automated washing, drying, and sterilization steps. Supplied in a steam-sterilizable Tyvek bag within a cGMP compliant plant, these stoppers meet international norms for particulate matter, bacterial endotoxin, bio-burden, and residual moisture. Each batch is accompanied by COA and sample packs for rigorous Q.C./Microbiology testing.
Advantages of RFS Stoppers
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.
-
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.
-
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.
-
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.
Advantages of Unistar RFU stoppers
STEP 01
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.
STEP 02
Streamlined Processes
Reduces validations required at the customer’s end, streamlining processes for substantial savings.
STEP 03
Urgent Production Ready
No need for overnight preparation, making it ideal for urgent production schedules.
STEP 04
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.
STEP 05
Customised Solutions
Offers customized pack sizes to meet individual customer requirements, providing flexibility in packaging.