VIALEX is able to reverse the surface effects from the vial converting process,
resulting in a minimized risk of interaction between drug product and vial surface !

Benefits

Unparalleled Surface Quality

  • Decreased risk of delamination
  • Reduction of extractables
  • Minimized pH shift

Easy Replacement

  • No revalidation work required
  • No sophisticated coatings
  • No changes to glass formulation

Unique Compliance

  • No risk associated with statistical sampling
  • Every single vial 100% All-Points-In compliant
Proven Technology:  Successfully passed over 100 challenging tests !

Category

Reagent

Cycle

USP <1660>

0.9% KCl pH 8.0

1 hr @ 121 °C
(1 and 2 cycles)

3% Sodium Citrate pH 8.0

24 hr @ 80 °C

20 mM Glycine pH 10.0

24 hr @ 50°C

 

Accelerated

Citrate @ 7.0 pH

1 hr @ 121°C
and 
6 hr @ 121°C

WFI @ 5-7 pH range

0.9% NaCl @ 5.8 pH

Acetate @ 5 pH

Phosphate @ 7 pH

20 mM Glycine pH 10.0

 

pH Rise

0.075% KCl @ 5.9 pH for 30 min

Varied based on customers’ specific protocols

0.4% NaCl for 13 min

0.4% NaCl for 26 min

pH over time (KCl)

pH over time (NaCl)

 

Test Results
  • Surface hydrolytic resistance (USP <660> EP 3.2.1 - 2 ml)

NPI Vialex

  • NaCl with Terminal Sterilization at 121 °C (0.9% NaCl – pH at start 5.2 – with TS – 2 ml) - pH shift

         NPI Vialex - chart

  • NaCl with Terminal Sterilization at 121 °C (0.9% NaCl – pH at start 5.2 – with TS – 2 ml) - Extractables

        NPI - Vialex - Chart - Extractables