Qualification and Validation of HVAC Systems in Pharmaceutical Facilities According to cGMP

Heating, Ventilation, and Air Conditioning (HVAC) systems are critical components in pharmaceutical manufacturing environments. These systems directly influence product quality, regulatory compliance, and environmental control, especially in cleanrooms and classified areas. Adhering to Current Good Manufacturing Practices (cGMP), as outlined by regulatory authorities such as the FDA, EMA, and WHO, is essential to ensure that HVAC systems are properly designed, validated, and maintained to prevent contamination and ensure product safety.

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Qualification and Validation of Controlled Temperature Units (CTUs) i.e. Fridges, Freezers, Incubators, coldroom used in Pharmaceuticals and Bio Phamraceticals Industries

Controlled Temperature Units i.e. Fridges, Freezers, Incubators or Coldroom are most commonly used in pharmaceutical or biopharmaceutical  industries to store medicinal products, intermediates or raw materials as per the recommended storage conditions and also for the manufacturing process.  Highly regulated industries require to qualify and validate these units to verify their capability of storing products  or running process that do not compromise products quality or shelf life. The purpose of this article is to summarize the general industry practices and regulatory requirements/guidelines for the qualification or validation activities performed that ensure that CTUs can be used routinely to meet the user requirements and to maintain product integrity and quality. 

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Qualification and Validation of Bio Welders used in Biopharmceutical and Gene Therapy Manufacturing

The Biowelder® TC is an automated device for making sterile connections between thermoplastic elastomer (TPE) tubing elements. This proven technology uses unique rotating tube holders to connect dry- or liquid-filled TPE tubing and ensures total containment of process fluids by reconnecting discarded tube ends. The TPE tubing are typically used for safe fluid transfer during pharmaceutical manufacturing process.  These tubings are weldable and sealable which simplifies operations without the need for extra connectors.

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