Implementation of equipment and Processes to use Presterilized Components such as Vials, Cartridges and Syringes
Examples of Services Provided:
- Syringe & component selection (manual, auto-injection,etc).
- Equipment selection, user requirements specifications, request for quotation, and equipment specification.
- Layout and equipment design.
- Secondary packaging applications including inspection (manual and automated), denesting and renesting technologies, component labeling, automated cartoning, and serialization requirements.
- Equipment qualification,(IQ,OQ, PQ) and process validation.
- Risk assessment & compliance.
- Contamination control.
- Media fill test for validation.
- Stability program management.
- Break loose & Gliding Force-Siliconization method – glass & rubber coating.
- Selection of the appropriate CMO for your presterilized component filling requirements.