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."
Lyo Chamber Moisture Mapping
Rapid non-destructive headspace moisture analysis from LIGHTHOUSE enables fast moisture determination of statistical numbers of lyo samples.
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.
Sterile Production Process Studies Using 100% Headspace Inspection Of Finished Product
This app note describes the application of the PULSAR inspection platform to perform 100% headspace oxygen monitoring during the filling of oxygen-sensitive formulations, 100% container closure inspection of suspect batches, moisture inspection of freeze dried product, and automated media fill inspection.
Inline Weighing Technology Offers Additional Quality Check Features
Protina Pharmazeutische GmbH produces high-quality preparations, such as medicine, food supplements and cosmetics. Alongside weight monitoring, the checkweigher used at Protina offers other important functions that support the company's system of strict quality management.
Seal-Sensor Airborne Ultrasonic Technology
Seal-Sensor™ is an Airborne Ultrasonic Technology that inspects pouch seals non-destructively 100% online for defects. Seal-Sensor detects incomplete seals, partial or weak areas in seals, and common seal defects that affect product quality and shelf-life.
Contract Pharmacal Corporation Installs X-Ray Inspection And Checkweighers For Brand Protection And Quality
CPC develops, manufacturers and packages premium pharmaceuticals, over-the-counter drugs and dietary supplements. Since five of their lines package product in a foil-laminated film, which disrupts traditional metal detector, they need to implement x-ray systems for those lines.
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.
How To Maximize The Performance Of Your Metal Detector
To get the most out of your metal detection program, it’s important to understand the factors that affect metal detector sensitivity and the ability to find different types of metal. This guide explains the various elements.
PHARMACEUTICAL INSPECTION SOLUTIONS
21 CFR Part 11 Data Integrity Software for Container Closure Integrity Testing Systems
PTI has developed a new standard for protecting, storing and presenting data generated from its line of non-destructive leak testers in the form of a software package called PTI Ethos.
Used Mettler Toledo Safeline Pharmaceutical Metal Detector
Used Safeline metal detector, model PHARMXSR4V1/26X22, module serial# 32625, serial# 13123.
Determine Feasibility Of Headspace Analysis On Your Product Samples
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.
CCIT For Moisture Ingress & General Protection
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. Whether you are testing sterile barrier, a moisture barrier or general protection packaging we can offer nondestructive container closure integrity test equipment.
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.