INSIGHTS ON PHARMACEUTICAL INSPECTION

• Implementing FDA Guidance: CCI Testing In Lieu Of Sterility Testing

  This application note details FDA released guidance titled “Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products."

• Label Mix-Up Prevention: Using Vision To Improve The Labeling Process

  This white paper explains how vision inspection systems help prevent recalls and protect brand reputations.

• Introduction To Laser-Based Headspace Inspection And The Application To 100% Container Closure Inspection

  Gain insight into the process, ensure the maintenance of sterility for finished product after capping, and meet current regulatory guidance using laser-based headspace inspection.

• CCI For Combination Products: Assembling The Package Integrity Profile For Autoinjectors

  Due to their complexity, combination products, specifically autoinjection systems, present unique challenges in implementing a container closure integrity (CCI) testing strategy. This is further complicated by a pervasive, though diminishing, tendency for companies to consider CCI only at the final product-package lifecycle stage, an approach where combination products will highlight the pitfalls.

• Determination Of Moisture Permeation During Product Shelf Life

  How non-destructive headspace analysis information can be critical for QC groups performing stability studies, or for packaging development groups responsible for choosing the optimal packaging.

• Understanding Sensitivity Principles For Industrial Metal Detectors

  This guide explains the concept of metal detector sensitivity, key factors that impact it, and why a small difference in spherical sensitivity performance can mean a big difference in contaminants detected.

• Experimental Design And Statistical Tools For Non-Destructive Package Integrity Testing Systems

  This short podcast focuses on experimental design and statistical tools we use with non-destructive package integrity test systems. PTI’s Veripac inspection systems are deterministic test methods for package integrity testing that produce reliable and robust quantitative test data.

• Effects Of X-Ray Inspection On Pharmaceutical Products

  Some manufacturers still have reservations about adopting x-ray inspection as a safe method of product inspection. This white paper examines the potential effects of x-ray inspection on pharma products.

• Container Closure Integrity Testing: Risks And Methods

  An overview of integrity tests where a high sensitivity are required to prevent the risks of stability failure of highly moisture sensitive drugs or the risk of biological ingress of sterile parenteral drugs.