Overview of Container Closure Systems for Packaging Human Pharmaceuticals and Biological Products

Containers for biological product packaging are made of materials that are used to produce packaging components [eg, COP, glass, high-density ethylene (HDPE), metal.

5ml COP vial

100ml COP injection vial

Package refers to any component of the container closure system, including containers (such as ampoules, vials, bottles), container linings (such as tubes), sealing sheets (such as screw caps, chambers), rubber stoppers, etc. Top seal, container inner seal, infusion port [for example, large volume injection (LVP) outer packaging drug delivery accessories and container labels Primary packaging components refer to the packaging components that may be in direct contact with the agent, secondary packaging components Refers to packaging components that do not come into direct contact with the drug product.

RTU(ready to use) 2ml COP vial

The container closure system refers to the sum of all packaging components that contain and protect the preparation. If the secondary packaging component is equipped with the function of providing additional protection for the product, the container closure system includes the primary packaging component and the secondary packaging components. Packaging systems are equivalent to container closure systems. Packaging or marketing packaging refers to container closure systems and labels, associated accessories (e.g., measuring cups, droppers, ER medications) and outer packaging (e.g., carton or shrink wrap). Marketing packaging refers to packaging provided to pharmacists or retail and consumer The packaging of the buyer, excluding packaging specially used for transportation.

Disposable Intranasal Atomization Device

Quality refers to the physical, chemical, biological, biological, bioavailability, and stability attributes of a drug that are considered therapeutic or diagnostic. In this guideline, this term can also be understood as characteristics such as safety, identification, specification, quality and purity. Extractables full refers to the analytical characteristics of substances extracted from packaging components "usually using color language method". Extractables quantitative profile means that each detected component can be quantified.