Tag: cleanroom HVAC systems

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

Poor reproducibility in HVAC validation data for cleanroom environments.

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Poor reproducibility in HVAC validation data for cleanroom environments. Poor reproducibility in HVAC validation data for cleanroom environments. Introduction: In the pharmaceutical industry, maintaining the integrity of cleanroom environments is critical to ensuring the quality and safety of products. Heating, Ventilation, and Air Conditioning (HVAC) systems play a pivotal role in controlling the cleanroom environment…

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

Ensuring Adequacy of Cleanroom Pressure Differentials During Validation

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Ensuring Adequacy of Cleanroom Pressure Differentials During Validation Ensuring Adequacy of Cleanroom Pressure Differentials During Validation Introduction: In the pharmaceutical industry, maintaining a contamination-free environment is crucial for ensuring the safety and efficacy of products. Cleanrooms, with their controlled environments, are critical in achieving this objective. One of the key aspects of cleanroom management is…

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Solid Dosage form, Tablets