What can cause of too high percentage deviation for capsules?

21 July 2023 1 7K Report

I used a semi automatic capsule filling machine to filled the 300 mg capsules and there was about 1 capsules which had percentage deviation more than 7.5 following the BP 2013. What are the causes of a problem?

Thanks in advance

Mostak Ahamed

A high percentage deviation for capsules, also known as weight variation or content uniformity, can be caused by various factors related to the manufacturing process or the quality control of the capsules. Here are some possible causes:

Raw Material Variability: Inconsistent or poorly controlled raw materials, such as active pharmaceutical ingredients (APIs) or excipients, can lead to variations in the weight of the filled capsules.

Mixing Issues: Inadequate or improper mixing of the capsule contents can result in uneven distribution of the API and excipients, leading to weight variations among capsules.

Capsule Filling Machine Calibration: Improper calibration of the capsule filling machine can cause inaccurate dosing of the capsule contents, resulting in weight deviations.

Machine Malfunction: Mechanical issues with the capsule filling machine, such as uneven dosing mechanisms or clogged parts, can contribute to weight discrepancies.

Capsule Shell Variability: Variations in the quality or size of the capsule shells can affect the final weight of the filled capsules.

Environmental Factors: Changes in humidity and temperature during the manufacturing process can influence the flow properties of the capsule contents, leading to inconsistent filling.

Human Error: Manual handling of capsules or errors during the filling process can cause weight variations.

Inadequate Quality Control: Insufficient or ineffective quality control measures during production may fail to identify weight variations in capsules.

Improper Storage: Improper storage of filled capsules after production can lead to changes in their weight due to moisture absorption or evaporation.

Process Variability: Lack of process standardization or deviations from standard operating procedures can contribute to weight discrepancies.

Quality of Tamping: In hard gelatin capsule manufacturing, improper tamping can cause uneven compaction of the capsule contents, leading to weight variations.

Capsule Size Variation: If different capsule sizes are used during manufacturing, this can impact the weight deviation of the filled capsules.

To address high percentage deviation for capsules, manufacturers should implement rigorous quality control procedures, maintain consistent raw material sourcing, regularly calibrate equipment, and ensure proper training of personnel involved in the manufacturing process. Regular monitoring and adjustments to the production process can also help to minimize weight variations and ensure the content uniformity of capsules.

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