What does the described OSH 250 ml supply chain cover?
The page outlines the relationship between container configuration, production control, documentation and traceability through placing the device on the market.
OSH OSH 250 ml
OSH 250 ml · REF OSH-200
OSH Vacuum Citrate Bottle | European Pharmaceutical Supply Chain
European pharmaceutical supply chain for the OSH 250 ml vacuum citrate bottle: aseptic assembly, quality control and medical-device traceability.
At a glance
The supply chain brings together container configuration, applicable controls, documentation and traceability through placing the device on the market. This page focuses on the link between the stated specifications and the quality-management system.
STATED TECHNICAL DATA
Supply chain and control
Stated elements of configuration, assembly and traceability.
| Configuration | Type II glass, borosilicate dip tube, qualified elastomeric closure |
|---|---|
| Assembly | In an aseptic chamber, according to the stated process |
| Control | Certified quality-management system |
| Traceability | Documentation and lot reference through placing the device on the market |
Informational technical summary; the label, IFU and official documentation prevail.
Information for healthcare professionals
Technical information publicly available for documentary transparency, to be read together with the official documentation.
Technical questions
How is configuration control presented?
The configuration brings together Type II glass, a borosilicate internal dip tube and a qualified elastomeric closure; applicable controls and documents are part of the described quality-management system.
What is the role of the borosilicate glass dip tube?
The borosilicate internal dip tube is a component of the bottle configuration and is described as a material with high chemical inertness under the intended conditions of use.
Where are the declared specifications available?
Capacity, citrate formulation, declared vacuum and materials are collected on the standalone technical specifications page.