Datwyler sell "Datwyler's solutions for Prefilled Syringe applications"
Basic Information
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4.2(35)
Category
Subcategory & Sub-subcategory
Trade Type
Sell
Product Name
Datwyler's solutions for Prefilled Syringe applications
Specifications
- Sterility: Manufactured and tested to comply with USP <71>/Ph.Eur. 2.6.1 sterility requirements for parenteral products.
- Bacterial Endotoxins: Bacterial endotoxin levels controlled below USP <85>/Ph.Eur. 2.6.14 limits appropriate to the route of administration.
- Particulate Matter: Particulate matter controlled per USP <788>/Ph.Eur. 2.9.19 limits for injections and parenteral infusions.
- Container Closure Integrity: Container closure system validated to maintain integrity and prevent microbial/contaminant ingress throughout shelf life.
Other Information
Additional Description:
A broad portfolio of high-quality sealing solutions for syringe systems, including elastomeric plunger stoppers, needle shields and tip caps to seal prefilled syringes, along with plungers and rubber-lined aluminum seals that maintain system integrity.
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