Pharma glass defects - Part 32. Spiticule

Hello everyone – welcome to Part 32 of my ongoing series concerning visual defects that may be observed in pharmaceutical glass vials.? Today we’ll be briefly discussing the “Spiticule”, a defect defined by PDA TR 43 as a “bead or string of glass caused during the container forming process that is adhered to the interior surface”.? Refer to Figure 1 for an example.? The formation mechanism of a Spiticule is identical to the “Glass Stringer ” defect – i.e., a stray mass of molten material spins out from the vial surface during the converting process.? Just recall that the Glass Stringer is instead attached to the exterior surface of the vial.

The difference in location between a Spiticule and Glass Stringer makes a difference in defect classification.? A Glass Stringer is classified as a Major B defect while a Spiticule is classified as a more severe Major A defect. ?A Spiticule defect on the interior surface of the vial can fracture at some point after the initial washing process (see Footnote 1), thereby creating glass particulate in the drug product and presenting a potential safety hazard to the patient.

Questions or comments? – please leave them below or contact me directly.

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Footnotes

1.?????? ?Why do I specify “after the initial washing process”?? Interior washing should presumably remove loose glass particulate created by a Spiticule that fractured at some earlier point in the supply chain.