Informații despre marcă
LyondellBasell has developed a dedicated Purell service concept for customers in the healthcare industry. Purell resins offer excellent aesthetic characteristics (clarity and gloss), outstanding organoleptic properties (low taste and odor), inertia to most chemicals and a full range of stiffness and mechanical resistance (even at low temperatures).
Customers regard these positive properties as the basis for the use of polyolefins in healthcare applications. Due to the complexity and tediousness of the approval processes (including e.g., expensive toxicological studies), pre-testing of material, pharmacopoeia compliance certificates, security of supply and consistency of formulation are also necessary preconditions for any raw material used.
As the original healthcare concept in the polyolefins industry, the Purell Service Concept addresses all these requirements. All products within the Purell range are compliant with European (Ph.Eur 3.1.4, 5, 6) and / or United States pharmacopoeia regulations and Drug Master Files (DMF) are filed with the US Food and Drug Administration (FDA). The Purell Service Concept exemplifies the spirit of pharmaceutical GMP – awareness, change control and documentation and provides a series of benefits:
Manufacturing and logistics
- Consistency of formulation
- Dedicated manufacturing and quality management procedures
- Dedicated cleaning procedures for silos, trucks, railcars and containers
- Customer-specific supply solutions
- Pest control and sanitation procedures
Regulations
- Meet EU and/or USP pharmacopeia, with a Drug Master File (DMF) listing
- Reference to ISO 10993 compliance available in regulatory documents
- Reference to ICH Harmonized Guideline Q3D covered in regulatory documentation
- Extractable profile available
- Long-term sample and documentation retention
Support
- Effective risk management procedures
- Minimum 2-year Notification of change
- Global asset base
- Dedicated Local sales and technical service teams in all regions of the world
- Access to over 40 years of application innovation in the industry
- Plant audits
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