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HOME|PRODUCTS|Clean ProcessingIRFS-Ready for Sterilization UNISURE
RFS-Ready for Sterilization UNISURE

“Unisure RFS” (Ready For Sterilization) Rubber Stoppers

  • The RFS stoppers are supplied pre-siliconised and pre-washed, ready to be sterilized by autoclaving at the user’s end.
  • Sequential washing and drying operations are carried out in a fully automated PLC controlled Bung processor using a Validated Washing & Drying cycle i.e. with final rinse with Water For Injection for effective removal / reduction of particulate matter, Endotoxin & Bio-burden loads as per the internationally accepted norms / limits.
  • These stoppers are packed in a Steam Sterilizable Tyvek bag in Clean Room environment in the state-of-the-art cGMP compliant plant, equipped with a Microbiology lab, HVAC system, Water system and other necessary amenities as per the latest Pharma Industry requirements.
  • Control / Retain samples are maintained from each batch.
  • The intact Tyvek bag can be autoclaved and cut opened directly on the filling line and used.
  • This will eliminate the complex washing & siliconization steps at customer end resulting in saving of a lot time, energy and manpower involved. And it also eliminates lot of other Validations required at customers end.
  • No overnight / advance preparation of rubber stoppers for urgent production schedules.
  • Separate sample pack for Q.C / Microbiology testing provided for each batch supplied.
  • Each batch of RFS stoppers are supplied with Certificate Of Analysis ( COA ).

Each batch of RFS stoppers are duly certified for the following parameters in the COA :

Sr. No. Test International Norms / Limit UML’s benchmark
1. Endotoxin content NMT 0.25 EU NMT 0.125 EU
2. Clean level NMT 3.4 NMT  1
3. Bioburden - NMT  5 CFU