PP Color Masterbatch for Pharmaceutical Packaging: Comprehensive Solutions for Oral/Topical Drug Packaging
We understand the exceptionally stringent requirements for materials and color masterbatch used in PP 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, REACH, and other international pharmaceutical standards.
Stringent Hexane Content Control Measures
Our white masterbatch maintains strict control over hexane and various other volatile compounds. According to FDA 21 CFR 177.1240 standards, hexane extractables are controlled below 0.0021 mg/in². We provide customized formulations for different regional regulatory requirements: U.S. FDA standards require bottle hexane residue ≤20μg/g, while EU standards require bottle cap residue ≤10μg/g and bottle body residue ≤2μg/g. Through optimized material selection and low-temperature production processes, we ensure no interference with the complex systems of oral/topical liquid medications, meeting global market access requirements.
Hazardous Substance Limit Control
We implement strict controls on masterbatch raw materials, with heavy metal content (lead, mercury, cadmium, hexavalent chromium) complying with EU REACH regulation limits (total ≤100ppm), including lead ≤50ppm, mercury ≤0.5ppm, and cadmium ≤0.5ppm. We simultaneously control PAHs, PAAs, and solvent residues, ensuring values remain below pharmacopeial standards (USP, EP, ChP). We utilize high-sensitivity detection technologies such as GC-MS and ICP-MS, ensuring accurate identification and quantification of 18 high-risk PAHs with detection limits reduced to μg/kg levels, far exceeding conventional testing capabilities.
Exceptional Resistance to Drug Contents
Our white masterbatch withstands the chemical properties of specific pharmaceuticals (acids, alkalis, alcohols, oils, etc.), with corrosion depth ≤0.05mm and weight change rate ≤3% after 72-hour immersion within pH 1-14. Contact with ethanol and acetone for 24 hours results in swelling rate ≤5% with no surface cracking. Accelerated aging tests verify that throughout the entire drug shelf life (2-3 years), the white color remains unchanged without yellowing, fading, or bottle wall peeling, ensuring packaging material maintains stable performance under long-term storage conditions.
Global Market Compliance Assurance
For European and American markets, we provide complete compliance documentation meeting EU REACH regulations (screening of 233 SVHC substances) and FDA 21 CFR standards. For Middle Eastern markets, we comply with Saudi Vision 2030 localization requirements (≥60% localization rate effective 2026) and align with UAE GulfPlastics Association’s “Green Healthcare 2030” initiative (30% bio-based content target by 2028). For Southeast Asian markets, we support ASEAN’s “Unified Standard for Medical Plastic Products” (heavy metal migration limits reaching 90% of EU REACH standards) and provide local language labeling services including Malay and Thai.
Technical Advantages & Service Commitments
Raw Material Systems: Use FDA-approved high molecular weight polymer carriers to prevent harmful substance introduction from source materials.
Strict adherence to FDA, EU 10/2011, and other international regulations.
- Process Control: Low-temperature production processes inhibit byproduct formation and ensure batch-to-batch consistency.
- Testing Capabilities: Each batch undergoes hexane residue verification through headspace gas chromatography, PAH detection via GC-MS, and heavy metal analysis using ICP-MS.
- Technical Support: Comprehensive support from concept development to production implementation with customized solutions.
- Certification Assistance: Support for completing FDA, CE, Halal certifications and other global market access requirements.
