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Medical device quality control inspection is considered to be highly significant in ensuring safe delivery of medical devices from their place of origin to the market. However, tremendous development in medical technologies have challenged the medical device packaging industry to ensure quality and reliability in packaging

Adding to that, drug contamination is a serious concern in any medical industry- specifically for Class III medical devices. Class III medical devices are understood as devices that sustain or support life and are implanted, or present potential unreasonable risk of illness or injury. Since these devices are directly placed into human bodies, proper packaging is required to ensure quality of the product until it reaches the patient. Any breach in the packaging can cause contaminants to enter the device, causing major health risks. Hence, appropriate package integrity testing and seal quality inspection of Class III medical devices are required so as to ensure seal quality and sterile barrier integrity are maintained.

Initially, manufacturers heavily relied on visual inspection or other probabilistic test methods to inspect seal quality and integrity. However, such methods lacked accuracy and reliability in terms of test results. Hence, manufacturers are now shifting towards non-destructive method for evaluating seal quality and inspecting physical properties of a seal. One such technique that is increasingly becoming popular among medical device manufacturers is Airborne Ultrasound technology. It is an ASTM test method F3004 and FDA recognized standard for seal quality integrity testing. These tests are primarily conducted to provide advanced seal quality inspection of pouches, flexible packages and tray seals. The test is conducted by transmitting high frequency sound waves through the pouch seal area, providing a simple pass or fail result of seal quality. A linear scan analysis of the seal area will detect channel defects, misaligned seals, incomplete and missing seals immediately after the package has been sealed. If the system detects a package defect, the product can immediately be removed from the packaging and reworked. Process related defects can also be addressed and corrected immediately, which significantly reduces the quantity of defective packages produced

Airborne Ultrasound technology variants, namely Seal-Scan® and Seal-Sensor provide both, offline and online inspection of packages and accommodate various package specifications, test sensitivity and package handling requirements. Seal-Scan® offline systems offer in-depth seal quality analysis and seal characterization. Seal-Sensor online inspection systems for automated 100% inline scanning of pouch seals can be integrated into pouch production or pouch handling line. They provide a quick analysis of the seal area without tampering with the packaging to identify defects, such as incomplete or missing seals, wrinkles, channel defects and so on.

Advantages of Seal Scan and Seal Sensor method

• Deterministic seal quality inspection method that produces quantitative results.
• This method works for any material type and combinations regardless of color, transparency, print, surface finish or porosity.
• Non-destructive and non-subjective test method that requires no sample preparation.
• Technology can be integrated for 100% online defect detection of the final pouch seal.
• Repeatable, reproducible and reliable results for seal quality inspection.
• Cost-effective solution for seal integrity testing and seal analysis that characterizes overall quality and uniformity of the seal.

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

The pharmaceutical industry is the backbone of our health care system. As the industry is continuously progressing, the requirement for package integrity while being stored and shipped across the world is also increasing. Pharma package testing now has become an integral part of pharmaceutical industry especially when it comes to high-risk pharmaceuticals.

High-risk pharmaceutical products are usually filled and sealed in combination devices. As the design and distribution parameters are critical to both the drug and container, it is highly important for the manufacturers to ensure that the components function well together. Often manufacturing discrepancies in combination packages that contain multiple components primarily contribute to container closure failure causing distribution & shipment issues. It can cause aftereffect not only down the supply chain but also for patient safety. Hence accurate pharma package testing is highly essential for high-risk pharmaceuticals. High-risk pharmaceutical products are usually filled and sealed in combination devices. As the design and distribution parameters are critical to both the drug and container, it is highly important for the manufacturers to ensure that the components function well together. Often manufacturing discrepancies in combination packages that contain multiple components primarily contribute to container closure failure causing distribution & shipment issues. It can cause aftereffect not only down the supply chain but also for patient safety. Hence accurate pharma package testing is highly essential for high-risk pharmaceuticals?

Container Closure Integrity of Pharmaceuticals

The United States Food and Drug Administration recommends container closure integrity testing as part of the stability protocol for sterile biological products, human and animal drugs and medical devices. Traditionally, dye immersion, bubble test and other probabilistic and destructive test methods were used. In 2016, United Stated Pharmacopeia (USP) released a guidance stating that deterministic methods are preferred over the probabilistic methods.

The container closure integrity testing landscape has advances drastically. The USP Chapter <1207> on integrity testing have recommended different deterministic and non-destructive container closure integrity technologies throughout their specific product package life cycle.

The different deterministic pharma package testing technologies include the following:

Vacuum Decay Technology

Vacuum decay is considered as one of the most sensitive, practical and reliable vacuum-based leak detection method. This method gives repeatable and accurate quantitative data result with a pass or fail determination and can be used effectively for different kinds of nonporous, rigid or flexible packages. Vacuum decay technology is referenced in USP 1207 chapter guidance and is also listed in 11607. The vacuum decay method developed by PTI’s VeriPac instruments is capable of detecting microleaks in the range of single digit micron. In this method, the package to be tested is placed inside the test chamber to which vacuum is applied. The changes in absolute and differential vacuum is monitored over period of predetermined test time & is used to detect the presence of leaks within the package.

Benefits of Vacuum Decay Technology:

• Non-destructive & no sample preparation
• Deterministic test method
• Repeatable and quantitative test results
• Can be deployed in a robotic automated platform
• Highly sensitive & non- subjective

Microcurrent HVLD

Microcurrent HVLD Technology, the new breakthrough in the field of pharmaceutical package testing & highly effective for all parenteral and biological products. The microcurrent HVLD exposes the product and environment to less voltage and has transformed the conventional HVLD technology. It capable of detecting small pinholes, micro cracks and seal defects in applications that include liquid-based products ranging from extremely low conductivity sterile water for injection (WFI) to large molecule-based proteinaceous products with suspensions.

Benefits of MicroCurrent HVLD technology:

• Non-destructive & requires no sample preparation
• Deterministic & non-invasive
• Higher levels of accuracy, reliability & sensitivity in test results
• Offline and 100% online inspection at high production speeds
• Can be deployed in a robotic automated platform