Sterile packaging components

The new European MDR EU 2017/745 lays down rules concerning med devices being placed on the market for human use. As part of a global harmonization effort, many aspects of the new MDR are aligned with requirements noted in the U.S. FDA CFR's, as well as the recent release of ISO 13485:2016, an international standard governing medical device quality management systems.

Hp 18916 M West
• Ready Pack system is appropriate for small-quantity filling of high-value drugs, pharmaceutical R&D and clinical work, and biopharmaceutical early-stage product development

• includes West VeriSure stoppers and
Flip-Off seals and Ready-to-Fill vials

• sterilized components are delivered in packaging appropriate for aseptic filling

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