CompletePAK™ is a range of primary packaging components that are stocked ready-to-use and are customisable for most drug applications.
- Off the shelf, ready to use products
- One source for total packaging solutions
- Variety of different sterile components; a kit for any application
- Complete manufacturing traceability
Each kit component is particulate cleaned, depyrogenated, and sterilised, arriving in the lab ready to use. Vials are packed in a sterile PP tray which can be used as a filling aid. Kit packaging is sized to compliment manual aseptic filling processes.
The CompletePAK™ 'single source' focus can reduce customer's supply chain and time to market.
Certifications: Certificates of Analysis in each kit shows compliance with:
1. USP <788>/EP 2.9.19 Particulate Matter in Injections
2. USP <85>/EP 2.6.1 The Bacterial Endotoxins Test
3. USP <71>/ EP 2.6.14 The Sterility Test
4. USP <660>/EP 3.2.1 Glass Containers for Pharmaceutical Use
5. USP <381>/EP 3.2.9 Elastomeric Closures used in Parenteral Preparations
Delivery information: Batch-specific Certificates of Analysis showing compliance with relevant USP/EP standards are included in each kit.