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Biological drug products are complex, large-molecule drugs that are derived from living organisms or their components. They are designed to mimic, augment or replace the function of naturally occurring molecules in the body. These drugs are often produced through biotechnology, which involves manipulating living cells to produce specific proteins or other molecules.

Examples of biological drug products include monoclonal antibodies, recombinant proteins, vaccines, and gene therapies. These drugs are used to treat a wide range of diseases, including cancer, autoimmune disorders, and genetic diseases.

Biological drug products are often more expensive than traditional small-molecule drugs because they are more complex to manufacture, require specialized facilities, and are subject to rigorous testing and regulatory requirements. However, they can also provide more targeted and effective treatments for certain conditions.

Package integrity testing is an essential part of ensuring the safety and efficacy of biologics. Any damage or compromise to the packaging of biologics can lead to degradation or contamination, which can impact their efficacy and safety. The choice of method depends on the specific biologic being packaged, the type of packaging used, and the regulatory requirements. It is important to perform Container Closure Integrity tests (CCIT) solutions. at multiple stages of the manufacturing process to ensure that the biologic remains safe and effective from production to patient use.

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. The E-Scan 655 technology is a MicroCurrent conductivity test method, HVLDmc, that is completely non-destructive to the container and product; exposing the package and product to lower voltage than other conductivity-based solutions.

The E-Scan MicroCurrent HVLD technology is often used in the pharmaceutical industry for detecting leaks in parenteral drug products, such as vials and syringes. E-Scan MicroCurrent HVLD technology is considered to be a reliable and efficient method for leak detection, ensuring the integrity of the drug product and patient safety.

The technology uses a non-contact and non-invasive test method that requires no sample preparation. The E-Scan 655 features a fast test cycle and simple operation. Additional benefits include quick changeover and easy recipe setup to accommodate a wide range of products and applications. E-Scan MicroCurrent HVLD technology can be migrated from laboratory to 100% inline production applications.

• Non-destructive, non-invasive, no sample preparation.
• High level of repeatability and accuracy
• Effective across all parenteral products, including extremely low conductivity liquids (WFI).
• Lower voltage exposure produces no ozone, eliminating risk to the product and environment
• Listed in USP Chapter <1207> as recommended method for parenteral liquid package inspection.
• Robust method and approximate 3x Signal-Noise-Ratio for a wide range of product classes and package formats.
• Simplifies the inspection and validation process.

Pouch seal inspection refers to the process of evaluating the quality of the seals on a pouch or bag. This can be done visually or through mechanical testing to ensure the seals are strong enough to maintain the integrity of the contents within the pouch. This is an important step in the packaging process to guarantee the integrity of the contents and to prevent product contamination or spoilage. The purpose of pouch seal inspection is to ensure that the seals will not break or leak, thereby preserving the quality and safety of the product.

Traditional seal integrity testing methods are unreliable because they miss unseen defects and mistakenly qualify pouches that have visual flaws. One of the most efficient techniques for non-destructive testing of flexible pouch packaging seals is Airborne Ultrasound technology. Seal-Sensor PQX is a non-contact Airborne Ultrasound technology technology to test package seals 100% online.

The Seal-Sensor PQX is a fully automated pouch seal inspection and handling technology. It comes with an integrated conveyor that can be readily connected into a production line. PTI's Seal-Sensor Airborne Ultrasonic technology is used to automatically scan the final pouch seal online at high speed. Seal-Sensor technology is an ASTM Test Method F3004 and an FDA consensus standard for inspecting seal quality.

Seal-SensorTM is an Airborne Ultrasonic Technology that inspects the final pouch seal 100% online and non-destructively. Seal-Sensor is a deterministic, quantitative, quick, and dependable approach for inspecting pouch seals for defects. Seal-Sensor detects incomplete seals, partial or weak areas in seals, and a variety of frequent defects in seals that appear visually acceptable but contain problems that impact product quality, value, and shelf-life. In less than one second, a single linear scan (L-Scan) of the pouch seal delivers a pass/fail result as well as quantitative, traceable data. At high outputs, a quick linear scan of the pouch seal allows immediate seal check/verification of seal quality. Data from tests is generated in seconds.

The Seal-Sensor PQX is a plug-and-play system for checking the quality of pouch seals inline. This simple-to-install system has a modest footprint and a full-screen HMI for displaying test result data as pouches are scanned. Inspection speeds can reach 350 mm/sec. A built-in reject chute swiftly removes flaws from the line, and a built-in stack light makes determining pass/rail outcomes simple.

• 100% pouch seal inspection
• Easy integration into production lines
• Adjustable for different size pouches
• Manual load or robotic pick & place
• Built-in reject chute