Search QUALITY CONTROL FOR VIALS
Every Vial from every production shift is tested in our internal laboratory We are primarily concerned by leak testing, internal air pressure testing, cap force and twist test.
Operational Information:
- Leak testing:
- Isopropyl alcohol and blue crystal dye - Identifies imperfections in the 3 layers of seal,
- Dye water testing (submerge vials into dye water bath and see it there is any ingress of dye water into the vials,
- Sugar testing (place sugar into vials and submerge vials into dye water bath and see it there is any ingress of water into the vials by seeing if the sugar clumps).
- Pressure testing:
- Milk test - submerge vials filled with milk in hot water bath and then place into cooler. See if any vials pop open due to the pressure build up of temperature change. PSI test - invert vial and submerge in water bath. Insert probe into side of vial and inject air into vial. Record when air bubbles start to form or when top pops open. (Vials must be able to hold greater than 3 pounds of internal PSI to withstand commercial air transport).
- Cap force:
- Samples are open once and closed and then the cap force is measured with a strengh gauge,
- Twist test is done at 3 positions on samples to check hinge resistance (child proof).
- Interval-based sampling plan:
- Samples are pulled every hour of every 2 hours and marked by the time of day,
- Any defects can be identified by the time they occurred and the production for that time period can be pulled from the holding area and placed into quarantine.
Key points:
- Samples are pulled using a interval based sampling plan,
- Leak tests utilize fluids that will be stored in the vials as well as more a viscous fluid to serve as a diagnostic tool,
- Vials are tested to ensure that they can withstand commercial air transport and child handling.