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Overview

Capsule Seam Analysis is a key part of quality control in soft gel capsule production. It focuses on evaluating the seal where the two capsule halves are joined. Any imperfection in this area—whether a gap, misalignment, or inconsistency—can compromise the capsule's strength, leak resistance, or dissolution behavior.

Description

Importance of Morphology and Composition

Several seam characteristics must be monitored closely: coating thickness, width, and angle. If the seal is too shallow or too deep, too wide or too narrow, or shows sharp or blunt edges, it may lead to mechanical failure. A uniform, well-formed seam helps protect the contents and maintain capsule durability through storage and use.

Broader Physical Parameters

A properly sealed capsule dissolves as expected and delivers the intended dose. Uneven sealing can result in incomplete dissolution, delayed release, or reduced bioavailability. Reliable seam quality also contributes to consistent performance across production batches.

Relevance to Pharmaceutical Applications

Visual inspection remains a widely used technique in Capsule Seam Analysis. It helps identify visible flaws quickly, allowing technicians to catch defects in the early stages of manufacturing. This form of assessment establishes the baseline before proceeding to more detailed automated checks.

Risk Mitigation in Drug Development

By closely monitoring seam properties, manufacturers can reduce the chances of product rejection, leakage, or breakage. Early identification of sealing issues improves operational efficiency and lowers the risk of disruption during scale-up or market release.A dependable Capsule Seam Analysis process supports smoother approvals and strengthens production reliability.

Analytical Techniques and Challenges

The ipvPSA system from ImageProVision automates Capsule Seam Analysis, capturing primary, secondary, and maximum thickness measurements. This level of precision helps eliminate variability, streamlines reporting, and supports audit readiness. The ipvPSA seam software is 21 CFR Part 11 compliant, making it suitable for regulated pharmaceutical environments.

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