issues at crimp vials

Our "inhouse" analyst Kevin Triglia shows you how to properly crimp a cap onto a vial using Aijiren's electronic crimper. Manual Vial Crimpers can lead to contaminated samples, vial

Based on the dimensions in ISO 8362, 13mm 2R, 3R, and 4R vials have between 1.1 and 1.4mm of available space to crimp aluminum onto, while 20mm 6R, 8R, 10R, and 15R vials have between 1.6 and 1.9mm. Exceeding the available neck to crown distance results in crimping onto the neck, which typically manifests as a fold in the metal near the neck.

Container closure integrity (CCI) plays an important role in maintaining the sterility and stability of sterile injectable products. The defects which cause a sterile vial to leak are not necessarily defects that will be detected by a visual inspection process. Examples of such defects are defects that are hidden by the crimp, microscopic

Factors which are critical to such a package’s integrity are described including package specifications, the absence of critical defects, the physical location at which the seal must occur, and the impact of environmental forces exerted on the assembled package.

Most cracks are introduced in the body, heel, and footprint regions of a vial as a result of bump checks, while less frequent high-risk cracks (because detection is difficult), such as neck cracks and bottom lensing, are introduced in the neck and footprint. Three Methods for Replicating Stable Cracks in Parenteral Containers

Jul 15, 2021 · Temperature and Head Space Volume in Vial High levels of filled liquid drug inside a vial leave less available gas headspace. If a cold liquid drug would warm quickly, the gas phase is expected to expand, which may increase the vial system interior pressure.

LAY ABSTRACT: Pharmaceutical vials are typically closed off with an elastomeric stopper that is secured onto the vial with an aluminum crimp cap (or seal) such that the entire assembly is meant to protect the vial's contents from external contamination. Therefore, the capping process is critical for ensuring container closure integrity.

The starting position of the vial crimper percussion pin is usually the best for most crimping applications but can be lowered if you’re having difficulty crimping flip cap vial seals. Step One – Loosen the Crimper Percussion Pin Bolt. In the picture above (BEFORE ADJUSTMENT), you will see the vial crimper percussion pin in its standard

Oct 2, 2015 · The electronic crimpers do rely on the opposing force of the crimping to come to a complete stop, however, so repeatedly crimping the same cap on a vial should not be attempted. (It can also lead to interference between the jaws and the vial sides in some cases).

Land Seal Dimensions. The land seal of a vial is typically considered the primary final seal for maintenance of container closure integrity. Like the valve seal, it is largely impacted by dimensional overlap. However, unlike the valve seal, the land seal is formed by application of mechanical compression during the crimping process.

Jun 22, 2020 · Over-crimping may cause coring or poor septum re-sealing. Under-crimping can cause evaporation problems. Correct crimping results in a cap that should not be able to rotate and a septum that appears smooth and level. This can be achieved with the proper adjustment of the vial crimpers.

The strength and challenges of methods to control the capping process are discussed. The residual seal force method can characterize the capping process independent of the used capping equipment or CCS. We analyze the root causes of several cosmetic defects associated with the vial capping process.

Dec 1, 2017 · Historically, issues can arise due to unoptimized crimping processes or equipment. Often the use of jaw-type crimping devices can generate defects due to the dimensions of the jaw head not being appropriate for the vial, stopper or seal. Also, if the downward pressure onto the vial is not appropriate or uniform, a defect can result from the

Oct 24, 2020 · 3) Fill vial with homebrew 4) Crimp vial Which problem am I encountering? After dry heating the vial, there are water stains left on the vial. Looks like they are dried up. Second problem, after filling my vial with my homebrew and crimping there appears humid above the homebrew, supposedly water because of the water stains.