"Ready-to-Fill"® Sterile Stoppers
To complement the Ready-to-Fill® sterile vials, let us process your specified stopper and send them to you ready for use.
We will:
- Inspect all stoppers upon arrival using ANSI/ASQC Z1.4-1993 Acceptable Quality Levels (AQL’s);
- Wash and WFI-rinse all stoppers using a validated washing cycle;
- Package stoppers in sterilizable breather pouches (you decide how many stoppers per breather pouch);
- Sterilize stoppers using a process validated to give a minimum Sterility Assurance Level (SAL) of 10-6;
- Wrap all breather pouches in a Grade A/Class 100 (ISO 5) clean room, using sterile heat sealed plastic wraps (double- or triple-wrapping of packages at your discretion);
- Label all packages with contents, date of processing; and
- Provide finished product testing data for sterility, endotoxin level and other release tests as requested.