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GMP Annex 1 - How the Revision Impacts Pharmaceutical Manufacturers

Aug 21, 2023   |   19020

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   |   17112

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   |   15397

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.

A Closer Look at PTI's Advanced Testing Services

Jun 27, 2024   |   12962

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.

Understanding Pressure Decay Leak Testing

Jun 07, 2021   |   12934

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.
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Our technologies conform to ASTM and other regulatory standards.

Packaging Technologies & Inspection

PTI offers inspection systems for package leak testing, seal integrity and container closure integrity testing (CCIT). Our technologies exclude subjectivity from package testing, and use test methods that conform to ASTM standards. PTI's inspection technologies are deterministic test methods that produce quantitative test result data. We specialize in offering the entire solution including test method development and equipment validation.

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Packaging Technologies & Inspection

PTI offers inspection systems for package leak testing, seal integrity and container closure integrity testing (CCIT). Our technologies exclude subjectivity from package testing, and use test methods that conform to ASTM standards. PTI's inspection technologies are deterministic test methods that produce quantitative test result data. We specialize in offering the entire solution including test method development and equipment validation.

Sales Channel Partner Portal Login

ptiusa

Our technologies conform to ASTM and other regulatory standards.

Get in Touch

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