INSIGHTS ON PHARMACEUTICAL INSPECTION

PHARMACEUTICAL INSPECTION SOLUTIONS

  • Ensure compliance and flexibility for your laboratory by discovering a system that is designed for non-destructive sample inspection and meets ANNEX 1 and 21 CFR Part 11 standards.

  • Aggregation is an important step to make the pharmaceutical supply chain safer and more secure by adding traceability and insight to your logistic process, therefore, ensuring the safety of patients worldwide and maintaining trust in the pharmaceutical industry. However, the implementation of aggregation can be challenging as it adds steps to the packaging process. It is therefore important to integrate a solution that is flexible and tailored-made to your production processes to maximize the potential gains.

  • Discover a program designed to comply with Annex 1 CCI requirements, focusing on vials, syringes, and cartridges. This holistic, science-based approach generates robust data throughout the product life cycle.

  • Parenteral products, specifically vials, both glass and, increasingly, polymeric vials, represent one of the most common package systems historically tested by helium leak detection, largely due to their continued dominance as a package system for high-potency drugs requiring utmost protection. The primary sealing interface of a traditional vial system is between the elastomeric closure and land seal of a vial, physically compressed together by a crimped aluminum seal.

  • Not only can a feasibility study determine if a headspace measurement on your product container is possible, learn how it can also help guide the development of a future study plan.