Welcome to Pharma Troubleshooting!

Pharma Troubleshooting is your ultimate destination for all things pharmaceutical, biopharmaceuticals and gene therapy industries. Whether you're a professional in the industry or simply curious about the world of pharmaceuticals, biopharmaceuticals and gene therapy, you'll find valuable insights, tips, and solutions here.

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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About us

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. 

I want share my learnings and expertise to compile as a notebook and hope it might help you as a reader to learn and grow.