Package Integrity Testing
Scientific equipment supplies
The pharmaceutical industry continues to bring breakthroughs in the field of new drugs and drug delivery systems amidst the increased scrutiny of the regulators. The packaging acts as the primary sterile barrier in drug delivery systems that safeguard the drug product through its life cycle. The efficiency of the primary sterile barrier and the functional components are of utmost importance to patient safety.
Container closure integrity is over and above a quality feature. Container closure integrity is over and above a quality feature. Container closure integrity determines the safeness of the drug product at the time of use.
The selection of the right CCI inspection methodology holds up to the quality standards endorsed by the pharmaceutical manufacturers. Any negligence of CCI is taken seriously by the regulatory bodies. The guidance documents stand by the deterministic, reliable test methods for measuring the industry-wide quality standards.
PTI checks the container closure integrity of pharmaceutical packaging formats that include parenteral products (vials, ampoules, syringes, autoinjectors) to blister packaging, induction sealed bottles and flexible packaging (pouches, sachets and suture packaging). The United States pharmacopeia released guidance in 2016 stating that deterministic methods are preferred over probabilistic test methods. Test methods offered by PTI are all deterministic and quantitative test methods that ensure the integrity of the supreme level.
Medical Device Industry
The medical device industry is fueled with an ongoing quest for providing better treatment and diagnostic methods to the healthcare sector. A wide range of packaging and delivery systems that vary from porous flexible packaging to non-porous rigid containers are used in the medical devices industry while being stored and shipped across the globe.
Devices like pacemakers, cardiovascular stents, respiratory ventilators, breast implants come under the category of class III medical devices. Class III medical devices are mostly implanted and present the highest level of risk associated with maintaining the sterile barrier of a package.
The quality testing of medical device packaging is highly significant in ensuring the safe delivery of medical devices from its place of origin to the market. Guidance documents such as ISO 11607 provide a list of methods that have the capability to improve the package quality testing of today’s capability. PTI offers inspection methods that provide more reliable, sensitive and traceable data. We offer in-depth feasibility studies, test method development and test equipment to bring the supreme level of quality to the high-value medical device applications.
Food & Beverage
Food and beverage package inspection can be challenging and complex. Packaging affects consumer perception of a product, quality, brand, safety and value. Food and beverages are packed in such a way that it is correctly assembled, tamper-proof, defect-free and complete so that manufacturers are assured that the products reach the consumers safely As food and beverage packaging trend toward lighter weight packaging formats the containers and closures get more challenging, the technology to inspect the containers has been adapting.
Food and beverage package inspection technologies keep quality in check, identifying manufacturing and process defects that affect package quality and shelf life.
PTI technology platforms include Vacuum Decay, Airborne ultrasound and HVLDmc. PTI’s VeriPac Series utilizes vacuum decay technology, a proven reliable solution for many food packaging formats
The nutritional market is progressive and dynamic and nutritional packages play a vital role in delivering the product safely. Most of the nutritional products are shelf-stable in nature and this is often the function of package performance. All nutritional products are subject to innate chemical reactions. Any discontinuity in the nutritional packaging can cause the products to deteriorate with the exposure to oxygen, moisture and bacteria. Fats and other infant nutrients can go rancid and inert. Nutritional packaging defines the quality and safety of the contents that reach the consumer.
Bottles and Containers
Preserving the integrity of the product from its manufacturing to dispatch from the warehouses for the shelves is a major concern. Testing empty beverage or household bottles before filling is a critical step in assuring container integrity.
VeriCon inspection systems are a complete line of leak testers for bottle and container leak testing. To accommodate various container specifications, line speed, handling and test sensitivity requirements, VeriCon systems are available in configurations including linear leak testing, continuous motion leak testing, and trimmer units for indexing installations. All VeriCon systems utilize high resolution non-drifting transducers (either pressure transducers or vacuum transducers) for consistent leak detection. Real time inspection data includes reject statistics and
test result trends,allowing for on demand analysis of bottle and container quality testing.
The most reliable and robust Trimmer Mount Leak Testers that operate 24/7 without loss of sensitivity and are versatile - single and dual station units.
Linear and Continuous Motion Leak Testers – single and multi-station testers with inspection speeds up to 150 bottles/minute. VeriCon linear and continuous motion container leak testing system offers the flexibility to work with different types of conveyor systems and container sizes.