Views:734 Author:Site Editor Publish Time: 2019-05-17 Origin:Site
This text is intended to complement TR-43 Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing. This text lists examples of the frequently found visual nonconformance attributes for Tubular Glass Vials. It lists the nonconformance name, its location, classification, definition and a photo or drawing. The photos or drawings are shown for illustration purposed only.
We classify defects into the following categories: Critical>Major A>Major B>Minor>N/A.
1. Crack: Fracture that penetrates completely through tha glass wall.
--Location: General
--Class: Critical
2. Spiticule: Bead or string of glass that is adhered to the interior surface.
--Location: General
--Class: Critical
3. Broken Finish: Afinish that has actual pieces of glass broken out of it
--Location: Finish
--Class: Critical if seal is compromised; Major B if seal is intact.
4. Ring Off: A container that has separated into two pieces
--Location: Body
--Class: Major A
5. Bent: The finish of the container is distorted to the extent that the plane of the seal surface is not perpendicular to axis of the body
--Location: Finish
--Class: Major B
6. Check: A discontinuity in the glass surface that does not penetrate through the glass wall
--Location: General
--Class: Major B
7. Chipped: Container with a section or fragment broken out(other that sealing surface)
--Location: General
--Class: Major B
8. Crizzle: A finish or neck that has several fine surface marks
--Location: Finish/Neck
--Class: Major B
9. Flared: Diameter just above the heel is greater that the body diameter
--Location: Bottom
--Class: Major B
10. Leaner: Plane of the container bottom that is not perpendicular to the axis of the body
--Location: Bottom
--Class: Major B
11. Lensing: Glass Container bottom that is completely separated from the body
--Location: Bottom
Class: Major B
12. Offset: Finish not concentric with the body
--Location: Finish
--Class: Major B
13. Rocker: Acenter bottom that protrudes beyond the plane of the outer rim or bearing surface resulting in an unstable container that rocks when placed on a flat surface
--Location: Bottom
--Class: Major B
14. Sunken Neck: The base of the container neck is recessed into the shoulder
--Location: Neck
--Class: Major B