PET Color Masterbatch for Pharmaceutical Packaging: Advanced Solutions for Oral & Topical Applications
Regulatory-Compliant Safety First Approach
We understand the exceptionally stringent requirements for materials and color masterbatch used in PET plastic bottles manufactured through injection blow molding and one-step processes for oral/topical liquid formulations and oral solid drugs. At Runpacet, we prioritize safety and reliability above all, providing complete raw material lists, safety data sheets, and compliance declaration documents for our masterbatch products. Our solutions ensure full compliance with USP <87> <88> biocompatibility testing and relevant regulations including FDA, EU 10/2011, and other international pharmaceutical standards.
Enhanced Light Protection for Extended Shelf Life
PET oral liquid bottles typically utilize amber (brown) coloration to effectively absorb ultraviolet and blue-violet light below 450nm wavelength. Our specialized formulations significantly reduce harmful light penetration that can compromise product quality, extending the consumption cycle and maintaining drug efficacy throughout the product lifecycle.
Low Migration Formulation Design
Migration control is the lifeline for ensuring the safety, efficacy, and stability of PET oral solid bottles. Our masterbatch incorporates a comprehensive migration testing system during formulation design, with rigorous evaluation protocols to prevent any potential interaction with drug contents. Additionally, our formulations demonstrate excellent resistance to alcohol immersion without color bleeding or migration.
Stringent Formaldehyde Control
For oral and topical medications requiring long-term storage, preventing drug component degradation is critical. Our masterbatch maintains formaldehyde content below 2 parts per million (0.0002%), ensuring the integrity of sensitive pharmaceutical formulations and protecting against component breakdown over extended storage periods.
- Raw Material Selection ：Uses high molecular weight polymer carriers to prevent formaldehyde introduction at the source.
- Process Optimization ：Implements low-temperature production processes to inhibit formaldehyde byproduct formation.
- Quality Verification ：Validates formaldehyde residue levels through headspace gas chromatography for every production batch.
- Complies with FDA 21 CFR §177.1520 formaldehyde residue limits.
- Demonstrates full compatibility with common drug components (phenols, amines, etc.).
- Accelerated aging tests show no significant change in formaldehyde release over 36 months.
- Supports pharmaceutical stability throughout product shelf life.
Comprehensive Quality Assurance
- Full regulatory compliance documentation for global markets.
- Batch-to-batch consistency with complete traceability.
- Technical support from concept development to production scale-up.
- Customized solutions for specific drug formulations and packaging requirements.
- Compatibility with various sterilization methods including gamma, ETO, and autoclave.
