Large Volume Parenterals (LVPs) are aqueous medicinal products with doses larger than 100 mL and are commonly supplied and administered using intravenous (IV) bags. These plastic containers are specialized medical devices used for the storage, transportation, and administration of intravenous fluids and medications and are specifically designed to safely hold sterile solutions and deliver them directly into a patient's bloodstream through an IV line.
Design, manufacturing, and testing of drug products packaged within plastic IV bags are subject to strict regulations and standards to ensure their quality, performance, and compatibility with medications. ISO 15747:2018 provides comprehensive guidelines for assessing the physical and performance characteristics of these containers.
Smithers is a trusted provider of comprehensive medical device testing services, offering expertise and support across various aspects of testing, including ISO 15747:2018 physical and chemical testing as follows:
Design, manufacturing, and testing of drug products packaged within plastic IV bags are subject to strict regulations and standards to ensure their quality, performance, and compatibility with medications. ISO 15747:2018 provides comprehensive guidelines for assessing the physical and performance characteristics of these containers.
Smithers is a trusted provider of comprehensive medical device testing services, offering expertise and support across various aspects of testing, including ISO 15747:2018 physical and chemical testing as follows:
- Physical tests
- Resistance to temperature, pressure, and leakage
- Resistance to dropping
- Transparency
- Water vapour permeability
- Particulate contamination
- Cover – Visual inspection
- Access port – Penetration ability of the insertion point
- Access port – Adhesion strength of the infusion device and impermeability of the insertion point
- Access port – Tightness of the injection point
- Hanger (tensile force)
- Identification (legibility)
- Chemical tests (Annex B)
