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HOME|PRODUCTS|Clean ProcessingIRFU–Ready for Use UNISTAR
RFU–Ready for Use UNISTAR

“Unistar RFU” (Ready For Use) Gamma Sterilized & Low Residual Moisture Rubber Stoppers

  • These stoppers come pre-siliconised, pre-washed and pre-sterilized by Gamma radiation at our own state-of-the-art gamma irradiation facility “Universal Iso-Med”.
  • 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 processed stoppers are packed in a clean polyethylene bag under 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.
  • The primary pack is further protected by two more layers of covering bags. This triple layer pack is labeled with batch details and Gamma radiation indicator and finally packed in corrugated box.
  • The stoppers are sterilized in their final packing by a completely validated Gamma radiation process in our own Gamma Irradiation facility.
  • The consignment of such RFU stoppers is also provided with a Certificate Of Analysis (COA).
  • Control / Retain samples are maintained from each batch.
  • The bag containing the sterile stoppers can be directly cut open on the filling line and used.

Advantages of RFU stoppers:

  • Using RFU (Sterile) stoppers will completely eliminate the complex washing, siliconising, sterilization and drying steps at customer end, resulting in saving of a lot of time, energy and manpower involved in processing the stoppers.
  • It eliminates a lot of Validations required at customers end, resulting is substantial savings.
  • No overnight / advance preparation of rubber stoppers for urgent production schedules.
  • Stoppers with Low Residual Moisture NMT 0.1% especially for the critical dry powder and lyophilized injectable are available upon request.
  • Customized pack size available on request to suit customers batch size.

Each batch of RFU stoppers are duly certified for the following parameters :

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. Regular moisture content - NMT  0.4%
4.

Low moisture content

- NMT  0.1%
5. Sterility Test Sterile NMT 0.1%