REMAFIN™ EP White Masterbatch Range for Pharmaceutical Containers
Meets Packaging Compliance
REMAFIN™ EP White Masterbatch range targeted for the use in production of pharmaceutical containers for parenteral, ocular, and nasal drugs. Masterbatch are available in PP PE (high and low density) and produced with ingredients tested to European Pharmacopeia 3.1.3 in addition to US Pharmacopeia 23 parts 87, 88. This helps avoid potential issues with interpretation of regulation. Increased regulatory support and change control supports leachable and extractable studies. Recent DMF is available as standard.
Impact
- Supports improved regulatory compliance for pharmaceutical packaging materials
- Ingredients used are TESTED to European Pharmacopeia 3.1. rather than relying on 'listed'
- Ingredients used are tested to USP 23 parts 87, 88 - considered an essential requirement for nasal and ocular solutions packaging.
- Drug Master File (DMF)
- Full Change Control standard
- Available as masterbatch or compound to fit your process
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