I Investigation Reports

INVESTIGATION REPORT CAPSULE SHELL SOFTENING DUE TO HIGH HUMIDITY

PharmaGuide Hub

October 15, 2026

INVESTIGATION REPORT

Capsule Shell Softening Due to High Humidity During Pharmaceutical Manufacturing

Investigation Details

Company Name: XXYYZZ

Company Location: AABBCC

Product Name: Amoxicillin 500 mg

Batch Number: PGH/C/26-002

Date of Incident: DD/MM/YYYY

Manufacturing Stage: Capsule shell handling / filling

Nature of Deviation: Capsule shell softening

Observation: During the manufacturing of Amoxicillin 500 mg capsules, Batch No. PGH/C/26-002, softening of capsule shells was observed. The shells appeared softer than normal and may have become difficult to handle, separate, fill, or close properly.

High relative humidity can increase moisture absorption by gelatin capsule shells and may affect their mechanical properties. The extent of the effect depends on the capsule shell material, formulation, packaging, exposure time, and environmental conditions.

1. Objective

The objective of this investigation is to identify the root cause of capsule shell softening observed during the manufacturing of Amoxicillin 500 mg, Batch No. PGH/C/26-002.

The investigation aims to:

Determine whether high relative humidity contributed to the softening of capsule shells.
Review the temperature and relative humidity conditions during storage, dispensing, and capsule filling.
Assess capsule shell quality, packaging integrity, and material handling practices.
Evaluate the impact on capsule filling, shell closure, finished product quality, and batch integrity.
Identify corrective and preventive actions to prevent recurrence.
Ensure that the affected batch is assessed and handled according to approved pharmaceutical quality procedures.

2. Scope

This investigation covers the receipt, storage, dispensing, handling, and filling of capsule shells used for Amoxicillin 500 mg, Batch No. PGH/C/26-002, manufactured at XXYYZZ, location AABBCC.

The scope includes:

Physical inspection of the softened capsule shells and filled capsules.
Review of temperature and relative humidity records for the warehouse and manufacturing area.
Review of capsule shell supplier specifications and storage instructions.
Verification of packaging integrity and exposure time after opening.
Review of material dispensing and capsule filling records.

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INVESTIGATION REPORT CAPSULE SHELL SOFTENING DUE TO HIGH HUMIDITY

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