Pre-Washed Rupture Resistant “Ready to Sterilize” (RTS) 13 mm Stoppers
Aptar Pharma Pre-Washed Rupture Resistant “Ready to Sterilize” (RTS) 13 mm Stoppers, Quantity of 1000 per Bag
These represent the absolute pinnacle in quality for all Ready to Sterilize (RTS) stoppers in both construction and washing process, which produces the highest standards of particulate and microbiological cleanliness.
- Constructed of the highest grade bromobutyl material, made and processed in the U.S. by Aptar Pharma.
- Washing process employed is referred to as “Ultra Clean 6 Evolution Process”, which is Type V DMF registered with the U.S. FDA. The fine details of the 3-step washing process with “Water for Injection” and drying procedure with hot HEPA filtrated air is detailed in the available “Process Description”.
- Stoppers are double bagged and packaged in Tyvek “CleanSteam” autoclavable and steam sterilizable bags. Packaging operations are carried out in a class ISO 5 environment.
- Supporting documentation available for every product lot includes Particulate testing in compliance with ISO 8871-3 and, Endotoxin / Bioburden testing in compliance with ISO 11137 and letters of access to specific Type V DMF, detailed Ultra Clean 6 Process Description, and dimensional drawings.
Quick Reference Specifications:
COLOR
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Gray
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MATERIAL
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High Grade Bromobutyl
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VIAL CLOSURE SIZE
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13 mm
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STYLE
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Straight Plug
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TYPE
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Vial Stopper
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STERILE
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No
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Shop all 20mm Standard and Flip top Seals, Stoppers for Vials, Open Clear & Amber Glass Serum Vials & Bottles,Vial Crimpers and Decappers, and Complete Serum Vial Packaging. We also Sterile Empty Glass Mixing Vials.