VIALEX™ – PREMIUM TECHNOLOGY FOR SURFACE Durability

The VIALEX™ technology is able to reverse the effects from the converting operation on the vial surface.

Vialex vial

Benefits

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

 

EASY REPLACEMENT
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

 

UNIQUE COMPLIANCE
VIALEX™ offers inline 100 % API compliance on every vial manufactured.

  • No risk associated with statistical sampling
  • 100 % API Compliance

Proven technology

VIALEX™ processed vials have passed severe testing.

Nipro PharmaPackging - VILAEX - Testing excerpt #1
Nipro PharmaPackging - VILAEX - Testing excerpt #3
Nipro PharmaPackging - VILAEX - Testing excerpt #2

Test
Surface hydrolytic resistance testing | USP<660> and EP 3.2.1.

Result
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 

Test
NaCl with Terminal Sterilization | Depyrogenation cycle at 355 °C | Vials are filled with 0.9 % NaCl | Terminal sterilization at 121 °C

Result
VIALEX™ exhibits lowest level of pH shift
Low level of extractables supports low pH shift

Test
Glycine 10 pH – 24 hr at 50 °C | Test run as per USP<1660>

Result
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

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