The VIALEX™ technology is able to reverse the effects from the converting operation on the vial surface.
UNPRECEDENTED SURFACE QUALITY
The inner glass surface durability generated by VIALEX™ greatly reduces interaction opportunity in glass tubular vials.
- Significant reduction of pH shift versus industry standard vials
- Elimination of the boron deposits which occur during the converting process
- Test of surface resistance indicates a surface that is even more chemically durable than tubing
- ICP extractables indicate lower values upon stress testing of the glass
- The improvements in glass surface durability greatly reduces the risk of delamination
VIALEX™ allows an easy and cost effective replacement of industry standard vials.
- No sophisticated coatings
- No changes to glass formulation
- No revalidation work required
- Easily scalable to meet any capacity requirements
- Full design liberty
VIALEX™ offers inline 100 % API compliance on every vial manufactured.
- No risk associated with statistical sampling
- 100 % API Compliance
VIALEX™ processed vials have passed severe testing.
Surface hydrolytic resistance testing | USP<660> and EP 3.2.1.
Surface hydrolytic resistance testing reveals surface durability on par with the original glass tube raw material or that of a molded vial. VIALEX™ vials consistently perform ≤25 % of the maximum limit as set forth by
NaCl with Terminal Sterilization | Depyrogenation cycle at 355 °C | Vials are filled with 0.9 % NaCl | Terminal sterilization at 121 °C
VIALEX™ exhibits lowest level of pH shift
Low level of extractables supports low pH shift
Glycine 10 pH – 24 hr at 50 °C | Test run as per USP<1660>
VIALEX™ exhibits a strong, stable surface indicating it’s enhanced chemical durability to even the most aggressive buffers (11 cycles).
Lower level of extractables supports the observed surface condition via SEM
- Silicon – 30 % Reduction
- Boron – 60 % Reduction