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

22 Feb 2025 16:28

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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At Pharma Troubleshooting, I am dedicated to providing accurate and reliable information to our readers. Here I bring my years of experiences in the pharmaceutical industry, biopharmaceutical industry ensuring that you get the best learning experiences with me. I have 11 years of working experiences in pharmaceutical, biopharmaceuticals or medical device companies with some renowned pharma giants i.e. Novartis, Regeneron, Johnson & Johnson, Beckman Coulter etc. in areas of Equipment & Facility Qualification and Validation, Cleaning Validation & Process Validation.

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