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.
PHARMACEUTICAL INSPECTION SOLUTIONS
Sentinel 5000 Multiscan Metal Detector
Multiscan is our new metal detection technology platform. Scan using five frequencies at a time for unmatched sensitivity and the highest probability of detection.
Blister Leak Tester
The VeriPac 410 utilizes a combination of vacuum decay technology and differential force measurement to identify defective packages. Multiple packages can be tested in a single test cycle, and the 410 identifies which package or cavity is defective.
Mass Extraction (Vacuum) Leak Testing Equipment
Pfeiffer Vacuum's Mass Extraction Technology takes advantage of the Micro-Flow phenomena and gas expansion, which occurs while the test is conducted in a vacuum.
Container Closure Integrity Testing
Successful drug product development should integrate formulation, manufacturing process, primary packaging, device and delivery to the patient. Lonza’s Drug Product Services (DPS) offering delivers a holistic approach to DP development that anticipates and prevents problems early, and ensures the result is a product that is fit for purpose.
Container Closure Integrity Testing Of Pharmaceutical Containers And Products
There is an increasing demand for CCIT (Container Closure Integrity Testing), in the pharmaceutical industry that are driven by strict FDA guidelines requiring a sterile barrier.