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GMP Annex 1 - How the Revision Impacts Pharmaceutical Manufacturers

Aug 21, 2023   |   22730

Stay ahead in pharmaceutical manufacturing excellence! Explore the transformative changes brought by the revised Annex 1 of EU GMP guidelines. Enhance your understanding of contamination control, quality risk management, and sterile manufacturing techniques. Learn how to implement these changes effectively and ensure product quality, safety, and efficacy.

Decoding USP Standards - An In-Depth Look at USP <382>

Aug 02, 2024   |   20491

USP <382> sets new standards for assessing the functionality of elastomeric components in injectable drug packaging, emphasizing comprehensive container closure integrity testing to ensure safety and efficacy. Compliance by December 2025 is critical for pharmaceutical companies to maintain robust and reliable packaging systems.

How to Leak Test High Risk Medical Device Packages

Jan 25, 2022   |   18084

Medical device leak testing is considered a critical step in ensuring package integrity primarily due to its sensitive nature. Leaks in the device can cause serious health risks to the patients and result in huge financial losses to the manufacturer. PTI's Seal-Scan technology is a non-destructive seal quality inspection technique for high risk pharmaceuticals and medical devices.

Understanding Pressure Decay Leak Testing

Jun 07, 2021   |   17958

Pressure Decay leak test is a sensitive leak detection method particulary for testing small leaks. It is applicable across multiple industries like pharmaceutical, medical device and food and nutrition industries.

A Closer Look at PTI's Advanced Testing Services

Jun 27, 2024   |   16577

PTI offers advanced lab testing services across industries, safeguarding product integrity, safety, and regulatory adherence. Their expertise spans feasibility studies, test method development, stability testing, recall & batch release, and helium testing, all conducted by qualified professionals using advanced technologies.
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