Pharmaceutical drugs are the backbone for the pharmaceutical industry as it brings new solutions that help patients to live longer and healthier. These pharmaceutical drugs usually biological & parenteral products like blood components, cells, vaccines, tissues and recombinant proteins. These products contain large complex molecules that are derived from human, animal or microorganisms through biotechnology. The evolution of these complex products has also increased challenges in terms of packaging and transportation.
Owing to the highly sensitive nature of these drugs to various external factors like oxygen, moisture, chemicals, and bacteria, any containment to the drugs is a concern in the health care industry. Poor package performance can cause even chemical alterations to the remedial property of these products. Therefore, parenteral product leak testing has an important role to meet the packaging challenges associated with biological products and to assure the safety of the products during the product life cycle.
Package integrity of parenteral & biologic products
PTI’s Microcurrent is patent-pending unique CCI technology that has revolutionized the conventional high voltage leak detection method. It is a non-invasive and deterministic container closure integrity testing method that is effectual across all parenteral and biologic products including low conductivity liquids such as sterile water for injection. The Microcurrent HVLD test method is highly effective in detecting the presence and location of pinholes, micro-cracks, stopper/plunger leaks, non-visible leaks under crimping and many other defects across applications like pre-filled syringes, vials, cartridges, ampoules, BFS, bottles and pouches. A unique mode of Microcurrent HVLD uses about 50% less voltage and reduces the exposure of product and environment to less than 5% of the voltage when compared to conventional HVLD solutions. The E-scan HVLD series have joined the line of sturdy packaging integrity equipment.
Benefits of MicroCurrent HVLD technology
- Non-destructive & requires no sample preparation
- Deterministic & non-invasive
- Highly effective across all parenteral products
- High levels of sensitivity, accuracy and reliability in results
- Offline and 100% online inspection at high production speeds
- Simplifies the inspection and validation process
- Referenced in Chapter Guidance for CCIT
We, being the think tank of Europe’s container closure integrity always aim to achieve a high-level of package integrity across the entire range of parenteral products
Parenteral Product Leak Testing, container closure integrity testing methods, CCI