"Ready-to-Fill"® Sterile Vials
Your specified vial will be processed and depyrogenated, then packaged in a Class 100 clean room so it arrives to you ready-to-fill.
We will:
- Inspect all vials upon arrival using ANSI/ASQC Z1.4-1993 Sampling plan for Acceptable Quality Levels (AQL’s);
- Wash and WFI-rinse all vials using a validated washing cycle;
- Package all vials in our standard trays OR
- Package all vials in your custom trays;
- Depyrogenate and sterilize vials using a process validated to provide 4-log endotoxin inactivation;
- Package all trays in a Grade A/Class 100 (ISO 5) clean room using sterile heat sealed plastic wraps (double- or triple-wrapping of trays at your discretion);
- Label all trays with contents, date of processing; and
- Provide finished product testing data for sterility, endotoxin level and other release tests as requested.