Grifols International | Barcelona Plant

Grifols International | Barcelona Plant

Sterile manufacturing solutions (small molecules) in flexible bags and vials.

About the plant

Production of intravenous solutions in glass vials and in PP bags:

• Glass vials from 5 mL to 50 mL
• 3-L Bags for irrigation
• 3 lines (PP bags) for ready-to-use mixtures
• Diluents – WFI
• 10 - 300 L reactors
• Premixed solutions in IV Fleboflex® Luer PP bags (50 mL - 1000 mL) Needle-free access valve
• Premixed solutions in customized IV PP bags (50, 100, 250, 500 and 1000 mL) (One port, two ports, twist-off, luer valve)

Light and oxygen sensitive products

Drug product development

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, Small volume vials, Large volume vials / Bottles, Flexible bags / Infusion systems, FDF / DRUG PRODUCTS manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, 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, (M) Musculoskeletal system, (N) Nervous system
• Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), MHRA (UK), TGA (Australia), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea)

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Batch Size / Reactor

• Small, Medium, Large

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Tech transfer, Pilot plant, Formulation mixing, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of product, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Parametric release, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, Distribution, GDP, CMC regulatory support, IND (Investigational New Drug aplication) filing support, IMPD (Investigational Medicinal Product Dossier) submission support, NDA (New Drug Application) submission support, ANDA (Abbreviated New Drug Application) submission support

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