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Ready-to-Fill™ 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.
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