Tag: air flow validation

Difficulty in validating air exchange rates in encapsulation areas.

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Difficulty in validating air exchange rates in encapsulation areas. Difficulty in validating air exchange rates in encapsulation areas. Introduction: In pharmaceutical manufacturing, particularly in the production of solid oral dosage forms like capsules, maintaining optimal air quality is crucial. The encapsulation area, where hard and soft gelatin capsules are manufactured, demands stringent environmental controls to…

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Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Inadequate methods for validating air flow patterns in manufacturing areas.

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Inadequate methods for validating air flow patterns in manufacturing areas. Inadequate Methods for Validating Air Flow Patterns in Manufacturing Areas Introduction: In the pharmaceutical industry, ensuring the proper validation of air flow patterns in manufacturing areas is crucial. These environments, often referred to as cleanrooms, are critical for maintaining product integrity and safety. Air flow…

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Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Troubleshooting Failures in Compressed Air Distribution Validation

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Troubleshooting Failures in Compressed Air Distribution Validation Troubleshooting Failures in Compressed Air Distribution Validation Introduction: In the realm of pharmaceutical manufacturing, ensuring the quality and integrity of all input materials and processes is crucial. Among these, compressed air systems play a vital role in maintaining the sterility and safety of pharmaceutical products. Compressed air is…

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Solid Dosage form, Tablets

Inadequate systems for monitoring HVAC air flow patterns during validation.

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Inadequate systems for monitoring HVAC air flow patterns during validation. Inadequate Systems for Monitoring HVAC Air Flow Patterns During Validation Introduction: Heating, Ventilation, and Air Conditioning (HVAC) systems play a critical role in ensuring the quality and safety of pharmaceutical products. Proper air flow is essential for maintaining cleanroom standards, controlling contamination, and providing a…

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Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms