Sterile

Sterile

© Photo by courtesy of Sartorius Stedim Biotech

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A pioneer in sterile components, we provide the industry with a broad selection of products for immediate use, further reducing risks of contamination and providing you with greater flexibility in your fill and finish process. As the innovator in ready-to-use stoppers,we have specifically designed our manufacturing process to deliver gamma sterilized products compliant with the most demanding quality assurance standards. Benefits include:

  • Proven validation and re-validation (ISO 11137 and 11607)
  • The highest level of particulate cleanliness
  • Packaging for direct introduction into aseptic areas
  • Regulatory compliance (FDA, EMA)
  • Supporting documentation, including a type V DMF and a specific CoC for sterile products