GMP Chemical-Pharmaceutical Big Bag Containers
Pharmaceutical-grade FIBCs dedicated to the fine chemical and pharmaceutical industries for the containment of active pharmaceutical ingredients (APIs) and intermediates. Manufactured in certified clean rooms with strict validated procedures, they guarantee absolute protection against cross-contamination.
Technical Features:
- Pure material: Pharmaceutical-grade virgin polypropylene (PP), free from additives, antioxidants, or slip agents that could migrate.
- Sterile production: Processed in a climate-controlled Class D (ISO 8) clean room, equipped with HEPA filters and sterile-clad personnel (upon specific request only).
- Absolute traceability: Full batch record, with detailed serialisation of batches and raw materials.
- Rigorous testing: Evaluations of extractables and leachables, and biocompatibility testing.
Specialised Configurations:
- Internal liner: Single-use pharmaceutical PE with ultra-high barrier effect.
- Double bag: Redundant system for maximum sterility assurance.
- Antistatic versions: Type B and Type C available for APIs or intermediates sensitive to electrostatic charges.
Key operational benefits:
- Absence of contamination: Total purity ensured by rigorously validated change-over procedures.
- Documented quality management: Change control according to GMP procedures and Certificate of Analysis (CoA) for every production batch.
- Audit success: Transparent and total compliance, ideal for easily passing GMP inspections and corporate audits.
