Spain Europe
FDF / DRUG PRODUCTS in Europe
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
Compliance
- 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)
- 9001
- 13485 (Medical devices)
- 14001
- 45001
Activity
- Injectables, Terminal sterilization, Flexible bags / Infusion systems, FDF / DRUG PRODUCTS manufacturing
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)
- Controlled substance: Lower potential for abuse, Low potential for abuse, Lowest potential for abuse
- BSL: N/A
- 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)
Batch Size / Reactor
- Small, Medium, Large
Services
- Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Scale-up, Parametric release, Primary packaging, Secondary packaging, Labeling, Storage, Distribution
