Grifols International | Murcia Plant

Grifols International | Murcia Plant

Sterile manufacturing solutions (small molecules) in flexible bags

About the plant

Production of intravenous solutions in flexible PP bags:

• Fully automated plant with 4 form-fill-seal lines (PP bags)
• Extrusion area to manufacture plastic components for IV solutions
• Large volume parenteral solutions in IV Fleboflex® PP bags (50, 100, 250, 500 and 1000 mL)

Parametric Release for Sterility

Terminal sterilization autoclaves

EMA, FDA and GMP approved

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Certifications

• ISO
• EMA (EU GMP)
• FDA (cGMP)
• Health Canada (Canada GMP)
• ECOVADIS
• World Health Organization (GMP / HACCP)
• TGA (Australia GMP)
• ANVISA (Brazil B-GMP)
• ANMAT (Argentina nueva GMP)
• MFDS/KFDA (Republic of Korea GMP)
• ISP (Chile BPM)
• INVIMA
• MHRA (UK GMP)

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Activity

• Injectables, Terminal sterilization, Flexible bags / Infusion systems, FDF / DRUG PRODUCTS manufacturing

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Features

• Uses: Commercial (Phase IV), Human, Veterinary
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
• DEA: Schedule III (lower potential for abuse), Schedule IV (low potential for abuse), Schedule V (lowest potential for abuse)
• BSL:
• Therapeutic areas: (A) Digestive tract and metabolism, (C) Cardiovascular system, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system
• Markets: FDA (USA), EMA (EU), TGA (Australia), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea)

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Batch Size / Reactor

• Small, Medium, Large

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Services

• Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Scale-up, Parametric release, Primary packaging, Secondary packaging, Labeling, Storage, Distribution

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