Bluepharma Industria Farmaceutica S.A. sell "Complex Sterile Formulations Contract Development"
Basic Information
565
29
9
4.9(7)
Category
Subcategory & Sub-subcategory
Trade Type
Sell
Service Name
Complex Sterile Formulations Contract Development
Service Provider(s)
Specifications
- Sterility: Sterile, manufactured by aseptic processing or terminal sterilization and confirmed sterile per compendial test
- Bacterial Endotoxins: Meets pharmacopeial bacterial endotoxin limit (LAL test) for the parenteral route of administration
- Particulate Matter: Complies with compendial limits for sub-visible and visible particulate matter in injections
- Container Closure Integrity: Container closure integrity validated (e.g. dye ingress/vacuum decay/headspace analysis) to maintain sterility through shelf life
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Other
CE
FDA
GMP
ISO
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