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Seal integrity of pouches is examined to ensure that the packaging provides the necessary product protection. Seal integrity tests are commonly used to evaluate user-friendly sustainable packaging choices. With an increased interest in sustainable packaging, novel structures such as monolayer recyclable flexible packaging are being developed, making it vital to guarantee that the seals for these structures stay strong. Poorly sealed pouches can cause significant issues for pharmaceutical manufacturers. Incorrect seals may cause contamination or product spoilage in addition to product waste. Pouch seal integrity testing is also used to lower the possibility of product recalls. Product recalls can draw the attention of drug safety regulators, leading to fines and penalties. As a result, seal integrity testing is critical to ensuring that such scenarios do not occur. Thus, PTI have developed two effective testing methods for evaluating the integrity of pouch seals.

Automated Pouch Seal Inspection Techniques Offered by PTI:

1. VerPac LPX Technology

The VeriPac LPX series is PTI’s line of fully automated package quality inspection systems for 100% inline testing. VeriPac LPX systems utilize PTI's Vacuum Decay technology, an ASTM Test Method F2338, developed using the VeriPac platform. The Food and Drud Administration (FDA) recognizes the test technique as a consensus standard for package integrity testing, and it is listed in ISO 11607 and USP Chapter 1207> guidelines. The LPX provides a practical and dependable solution to the concerns associated with infrequent testing, allowing process-related quality issues to be identified and remedied sooner rather than later. The VeriPac LPX for flexible packaging allows for continuous testing of pouches, stick packs, sachets, and other flexible packaging types.

The VeriPac LPX has a dynamic robotic design tailored to fit your production requirements. The LPX series are scalable, modular systems designed to satisfy the needs of manufacturing lines.

VeriPac LPX Benefits

• Automated testing enables the highest level of container quality assurance.
• Deterministic, quantitative test method.
• ASTM Test Method F2338 and FDA standard, ISO 11607.
• Distinct PASS/FAIL results.
• Highly accurate test results - low false positives and false negatives.
• High Signal Noise Ratio (SNR) for peak sensitivity and reliability.
• Non-destructive, non-subjective, no sample preparation.
• Pick-and-Place option back into the production line.
• Auto reject option of defects removed from the production line.
• USP <1207> compliant.

2. Seal-Sensor Technology

Seal-Sensor 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. A single linear scan (L-Scan) of the pouch seal delivers a pass/fail result as well as quantitative, traceable data in less than one second.

Seal-sensor Benefits

• Deterministic inspection method producing quantitative results.
• Non-destructive, non-invasive, no sample preparation.
• Works for any material and combinations, regardless of color, transparency, print, surface finish and porosity.
• Can be integrated for 100% online defect detection of the final pouch seal.
• Repeatable and reliable results.
• Eliminates subjective, manual vision inspection methods.
• Economical, cost-effective solution for seal integrity testing the final pouch seal.

Parenteral product package systems are expected to provide barriers against drug contamination and ensure stability and sterility throughout the entire shelf life. Any defect in packaging can cause microbial contamination, exposure to gases and water vapor, resulting in product deterioration. Furthermore, the industry has seen a spike in demand for combination products and patient-centered drug delivery systems, that present a high level of technical risk for maintaining container closure integrity (CCI). Therefore, container closure integrity testing is an important stage in the sterile drug product lifecycle.

Automated package inspection with VeriPac LPX

As the pharmaceutical industry continues to grow, manufacturers require capable, consistent automated solutions for container closure integrity testing. Automated inspection systems improve package reliability, reduce chances of product recalls and packaging failure.

PTI's VeriPac LPX series are a line of fully automated package quality inspection systems for 100% inline testing. The LPX enables enhanced automated testing that provides a high level of confidence in packaging line performance. Veripac LPX is a practical and reliable solution for the problems associated with performing infrequent testing as well as for recognizing and correcting process-related quality issues.

Sensitivity and reliability go hand in hand with CCI testing. The VeriPac LPX 430.8S is the next generation automated inspection system for container closure integrity testing of parenteral products. Automated for 100% testing or batch release, the VeriPac PLX 430.8S is an eight-station dual chamber design, with robotic testing platform for pre-filled syringes and vials, products filled with lyophilized product, small molecule liquids and Water for Injection (WFI).

The VeriPac LPX features a dynamic robotic design, tailored to fit varied production requirements. LPX Series are scalable, modular solutions to meet production line demands. This adaptable platform provides reliable automated handling of a variety of packaging formats. Applications for LPX automation range from flexible packaging to rigid containers, and parenteral products. Additionally, VeriPac LPX allows easy changeover for testing different size packages on the same system.

Benefits of VeriPac LPX test systems

• Automated testing enables the highest level of container quality assurance
• Self-teach software
• Non-drift transducers for consistent leak detection
• Low false rejects
• Operator friendly
• Reject statistics & test result trends
• 24/7 operation
• Increased productivity
• Reduced downtime
• Low maintenance