Last spring a lot of 18,000 crimped 2 mL vials sat on a dock in New Jersey waiting for a release decision. The customer’s incoming inspector had already pulled 50 pieces and found two with septum push-through, which put the lot at roughly 4% defective on a visual attribute. Under a 2ml vial AQL sampling plan at General Inspection Level II, AQL 1.0, the accept number for n=125 is 3. Two defects in 50 tells you almost nothing. The question was whether the outgoing inspection record from...

A customer audit in 2023 turned up a calibration certificate for a batch of 2 mL vials that cited a balance serial number, a calibration date, and nothing else. No statement of what the balance measured. No uncertainty. No link to the mass of an empty vial as opposed to the mass of the water used to check the balance. The certificate looked official. It was also worthless as evidence, because it proved a balance was calibrated, not that the fill volume in those vials was traceable to a nati...

A 20 µL injection from a water blank came back with seven peaks between 4.1 and 9.8 minutes, the largest at 0.8 mAU·s, and the same blank run off a fresh lot of vials was clean. Nothing on the instrument had changed. The autosampler was the same, the column was the same, the mobile phase was the same bottle. The only variable was a case of 2 mL vials that had arrived two days earlier, and the ghost peaks traced back to extractables that had been in the glass and the septum since the day the...

We lost a 96-position sequence last March because the septa in a lot of 2 mL vials were silicone, and the autosampler was running 100% ethyl acetate. By injection 40 the peak areas for the internal standard had dropped 18% against the bracketing calibrators, and the GC-MS source was reading siloxane fragments at m/z 73, 147, 207, 281. The vials were fine. The closures were wrong. That is what this guide is about: which polymer belongs in which method, and what happens when you get it wrong....