New injection-delivery systems have introduced new challenges to package validation and product development, particularly for container closures. Each component coming in contact with the critical product path must be validated to provide a reliable sterile barrier. Planning for container-closure integrity testing of the delivery system is crucial.
Investments are the building blocks of a company's future. Planning and implementing them requires strategy and system and decision-makers who know their goals and carry out the implementation according to plan are more successful than those who rely exclusively on their impulses.Meaningful information forms the basis of a good investment decision and it helps to protect the future prosperity of your company. This white paper will help you answer several question regarding the total cost of ownership (TCO) of production line equipment including “have you clarified the foundations of your investment decisions?” and “how do you determine and calculate the return on investment (ROI) time of an investment?”
Food manufacturers typically install an x-ray inspection system at the end of the production line, although it can be installed at any point during the production process. But, which are the best locations for x-ray inspection? Where are the critical control points to ensure the highest levels of product safety? Should x-ray inspection be at the beginning of the production line, where the raw materials arrive, at some intermediate stage, or at the end of the line before products are shipped out? Or would product safety and quality be better served by installing x-ray systems at more than one critical control point? This white paper addresses these questions to help you understand the most effective locations of critical control points.
In recent years, container closure integrity (CCI) testing has steadily moved up the pharmaceutical manufacturing agenda. Latest research has shown that not only ampoules are prone to CCI defects. Other primary packaging types such as vials, cartridges and syringes equally require thorough testing, especially when filled with lyophilized products. Consequently, the United States Pharmacopeia (USP) has been revising its General Chapter 1207, calling for more quantitative, validated CCI test methods. A significant shift is expected towards non-destructive technologies.
The Center for Regenerative Medicine (ZRM) in Zurich is part of the Center for Clinical Research (ZKF), which is supported by the University Hospital Zurich and the University of Zurich. The ZRM combines basic biomedical research and clinical applications in the field of regenerative medicine. Regenerative medicine uses cell-based technologies for the treatment of tissue and organ damage (e. g. growing skin for burn victims).
The generics market has taken off in recent years due to numerous patent expirations for brand-name companies. In light of this, pharmaceutical manufacturers, insurance companies and consumers, in search of significant cost savings, have turned towards the generics industry.
Multi-cavity blister packs and low head space packaging use a variety of test methods to determine package integrity, with most being destructive, subjective, and unreliable.
HVLD Technology Referenced in USP <1207> Chapter
Vacuum Decay Technology Referenced in USP <1207> Chapter
The VeriPac UBV Leak Detection System is a deterministic non-destructive technology designed specifically for multi-cavity blister packs. The VeriPac UBV utilizes volumetric imaging under vacuum to detect the presence and location of leaks. It’s a rapid test requiring no changeover or sample preparation. Operators simply input the number of blister cavities, place the blister pack on the inspection plate and press the START button. Within seconds, the operator sees a definitive pass/fail result, along with a volumetric measurement reading. The location of the defective cavity is presented to the operator with an image of the tested package.
MicroCurrent HVLD Technology is the Optimal Solution for all Parenteral and Biologic Products
The VeriPac 410 inspection system offers non-destructive seal and leak detection for blister packs, sachets, and pouches with low headspace including transdermal patch packaging
The E-Scan 655 is a revolutionary deterministic offline micro leak test instrument that utilizes a new class of HVLD technology to inspect vials, syringes, and other liquid filled parenteral products for container closure integrity.
