Vials with Stopper & Seal, Sterile – 5 mL to 100 mL, Chlorobutyl Stopper
Prior to vial assembly, vials are dry-heat sterilized and stoppers are steam-sterilized. The vials/stoppers are assembled on an automated line located in a Class 100 suite. The vials are subsequently capped in a Class 100,000 environment. Lot release sterility testing conforms to requirements set forth in USP <71>.
- Sterile and depyrogenated
- Chlorobutyl stopper
- Ready to use
- Neutral Type I glass tubing
- CE Marked (upon request)
- ISO 13485:2016 Certified
- DMFs filed with US FDA
- Manufactured per cGMP standards