TABLE IV

Sample Count for One-Year Study for a Stopper/Vial Systema

Time (months)RSF/He-LeakOHSTotal
03612
Compression 12020202030110
Compression 22020202030110
Compression 32020202030110
330
  • a Three compressions are considered. RSF is measured before He-leak; samples are discarded after measurements. OHS samples are reused. Sample sizes for RSF/He-leak are those employed typically at West; sample sizes for OHS are those recommended by Lighthouse Instruments, LLC.