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Contact lenses are invaluable visual correction devices that are a normal part of our daily life. Most contact lens solutions clean, disinfect, lubricate, and remove protein deposits from the lens while matching certain chemical properties of the ocular area. While these solutions may disinfect, similar properties to ocular fluids and increasing resilience of new bacterial and fungal strains make contamination a greater concern. Any breach or micro leak in the container closure greatly increases the risk of contamination of the contact lens solution.

Package defects are the primary cause of contaminated eye care solutions. While visual inspection and leak testing can detect many container failure modes in an uncapped container, minor inaccuracies or marks in the flange area allow bacteria and fungi to enter the product. This is the most common and difficult container defect to detect, since it remains hidden beneath the cap once applied.

Aside from visual inspection issues, liquid-filled packages present a variety of leak testing challenges, including low head space. PTI's Vacuum Decay leak testing technology capable of detecting defects as small as 5 microns in both liquid and air-filled containers. The method is ASTM certified and Food and Drug Administration (FDA) consensus standard, removing false positives and subjective results associated with manual visual inspection.

Testing Contact Lenses using VeriPac 410 Technology

The VeriPac 410 is a Container Closure Integrity Test (CCIT) that provides non-destructive seal and leak detection for low headspace blister packs, sachets, and pouches. To determine package integrity in multi-cavity blister packs and low head space packaging, a variety of test methods are used, the majority of which are destructive, subjective, and unreliable.

To detect defective packages, the VeriPac 410 employs a combination of Vacuum Decay technology and differential force measurement. The 410 can test multiple packages in a single test cycle, depending on the package specifications. The VeriPac 410 can also determine which package or blister cavity is faulty. The results of the tests are quantitative and provide operators with a clear pass/fail result.

Package quality assurance is achieved using precise, dependable, non-destructive inspection methods that eliminate subjectivity from the testing process. The VeriPac 410 enables tested products to be returned to the production line, reducing the cost and waste associated with destructive leak testing methods. VeriPac 410 covers all aspects of low volume flexible and semi-flexible package leak testing. The VeriPac 410's ROI makes it a powerful solution for the pharmaceutical industry.

Benefits of VeriPac 410 Technology

• Non-destructive, non-invasive, no sample preparation
• Non-subjective, accurate and repeatable results
• Capability to test multiple packages in a single test cycle
• Identifies which package is defective
• Simplifies the inspection and validation process
• Supports sustainable packaging initiatives
• ASTM test method and FDA standard
• Cost effective with rapid return on investment

The ability to evaluate the possibility of the container closure system to maintain a sterile barrier or to prevent leakage is a vital step in determining the safety and suitability of primary packaging. The United States Pharmacopeia (USP) and Food and Drug Administration (FDA) implement strict guidelines for container closure integrity testing (CCIT) as the driving factors behind safety examination of materials and closure systems in the US.

Historically, the two most common procedures for testing container closure integrity were dye immersion and microbial immersion (both probabilistic tests). In 2016, USP provided recommendations stating that deterministic methods are favored over probabilistic methods for CCIT because they produce reliable and predictable findings at low detection limits.

Non-Destructive CCI Test Methods Offered by PTI

1. Vacuum Decay Technology

Vacuum Decay has been substantiated as one of the most practical and sensitive vacuum-based leak detection methods. This test provides a quantitative result that is reliable, reproducible, and accurate, as well as a pass or fail judgement. PTI's VeriPac equipment was used to produce the ASTM F2338 standard vacuum decay test procedure. It is also recognized in the United States Pharmacopeia Chapter on CCI and is classified in ISO 11607. Using an absolute pressure or differential pressure transducer leak test device, VeriPac's non-destructive technology can detect package leaks and unseen defects.

2. Volumetric Imaging Technology

The OptiPac One-Touch Tool-less technology is intended for non-destructive leak detection in blister packages. To identify leaks, the OptiPac employs volumetric imaging technology to measure the motion of a blister package under vacuum. With new blister package formats, the interface is practical and straightforward to set up, requiring no tooling changeover or extensive parameter modifications as seen with previous non-destructive blister package inspection systems. The system collects volumetric data from each cavity, responding to variable cavity shapes, sizes, and configurations of various blister pack forms.

2. MicroCurrent HVLD Technology

PTI packaging and inspection systems transformed the traditional HVLD method and offered a game-changing new technology for assessing the integrity of all parenteral and biological products, including low conductivity liquids such as sterile water for injection (WFI). When compared to standard HVLD solutions, this innovative technology known as MicroCurrent HVLD uses approximately 50% less voltage and exposes the product and environment to less than 5% of the voltage. The Microcurrent HVLD test method may detect and locate pinholes, micro-cracks, stopper/plunger leaks, non-visible leaks under crimping, and a variety of other faults.

PTI provides package leak testing, seal integrity testing, and container closure integrity testing systems (CCIT). Our technologies eliminate subjectivity from package testing and employ ASTM-compliant test methodologies. The inspection technologies developed by PTI are deterministic test procedures that generate quantitative test result data.

A contract development and manufacturing organization (CDMO) is a company that provides drug development and manufacturing services. Pharmaceutical companies collaborate with CDMOs to outsource drug development and manufacturing. CDMOs can handle the entire process of medication research and production, and they also deal with clients who want to outsource specific steps in their workflow and manufacturing.

Pharmaceutical businesses increasingly depend on CDMOs to handle the complicated requirements of drug research and production. Having a CDMO partner can be a great resource with many advantages for pharmaceutical companies to focus their efforts and resources on initiatives that move their company forward, whether it's navigating the highly regulated drug development framework required by the FDA or scaling production to meet deadlines and demand.

Quality assurance is a key concern for prospective clients when choosing a CDMO because strict quality control procedures are what makes the difference when it comes to protecting a product on its journey to the patient.

The packaging of a drug is a crucial element in preserving its quality since it protects both the product and the manufacturer's commitment to patient safety throughout the product's life cycle till delivery. Container closure integrity testing (CCIT), in accordance with USP 1207>, provides confirmation of a package's capacity to prevent loss and maintain product sterility. ¹ However, a lack of knowledge of CCIT could put a CDMO at a disadvantage when compared to rivals that have adopted advanced CCIT solutions that cater to the particular needs of the goods of their clients. As a result, it's critical that CDMOs have a thorough understanding of CCIT.

Container Closure Integrity Testing Methods Offered by PTI.

Pharmaceutical packaging innovation has paved the way for a diverse range of advanced technologies and materials that enable drug manufacturers to design container and closure systems based on the unique properties of their products.

Traditional leak testing methods, such as the dye ingress leak test and the water bath, have been commonly used methods, but their test results are highly subjective. Since some items, like cell and gene therapy treatments, are only produced in small amounts, manufacturers cannot take the chance of the dye ingress leak test being detrimental to the product itself.

Probabilistic methods rely on a series of sequential and/or simultaneous events, each associated with uncertainties, yielding random outcomes described by probability distributions. On the other hand, deterministic approaches produce objective quantitative data by following a predetermined course of events, and leakage is detected using physiochemical technologies that are simple to regulate and monitor. PTI offers a wide range of non-destructive container closure integrity test methods applicable across a wide range of industries.

PTI's goal is to help our clients succeed by delivering on the promise of science through exceptional CCIT solutions. Life-changing products rely on dependable, high-quality delivery systems that can withstand the rigors of the journey from the lab to the patient.

That is why our experts are committed to providing strong CCIT through exceptional engineering and an organizational drive to achieve our own purpose and mission. We recognize the importance of our role in delivering safe and effective products and are excited about the opportunity to collaborate with you to advance the future of medicine.

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.

Testing the integrity of blister packages is essential to guarantee that the packaging safeguards the contents from oxygen, moisture or contaminants. Packaging keeps the product safe and functional by preventing air ingress.

Probabilistic test methodologies have been widely used to conduct blister package integrity tests, such as the blue dye test method. These tests rely on a range of sequential or simultaneous events, each with random results that are characterized by probability distributions. In order to acquire relevant results, it is necessary to use large sample sizes and strict test condition controls because the findings are related to uncertainty. Studies have also revealed the unreliability of such testing, which frequently fails to detect leaks that could endanger the quality of a product.

As a result, it is preferable that the integrity test method be deterministic. The leakage event being detected or measured in this type of test method is based on phenomena that follow a predictable chain of events. Helium leak detection is an example of a deterministic, highly sensitive method.

What is Helium Leak Detection Technology?

Helium Leak Detection Technology is a Container Closure Integrity test (CCIT) method found to be highly effective in evaluating the integrity of a wide range of complex pharmaceutical and parenteral products. Helium leak detection can be understood as the process of identifying leaks in any closed or sealed system with the help of helium gas and measuring its concentration as it escapes due to leakage. Common applications of helium leak testing include pre-filled syringes, cold form blister packs, foil pouches and many other package formats. The technique uses helium as a tracer gas and its concentration is measured as it escapes through the leaks. Under this method, the package is helium filled and subjected to vacuum. The amount of helium escaping the package is quantitatively measured and stated as a leak rate.

Why is Helium used as a Tracer Gas?

Helium is used as a tracer gas because of certain unique qualities that make it ideal for leak testing.

• Non-toxic, non-condensable, non-flammable.
• Helium gas is inert, which means it does not interact with the components being tested.
• Since the atomic size of helium is small, it can easily breach through pathways reliably and easily.
• Compared to other tracer gases, helium is less expensive and readily available.
• Its presence in the atmosphere is not more than 5ppm.

Technology Overview

The procedure begins with filling the package with helium, after which vacuum is applied within a chamber. The amount of helium escaping from the package is then quantified using a helium leak detector. This is then referred to as the leak rate. Helium leak detection technology is also suitable for package design, failure analysis, tooling qualification, packaging line setup and validation, and product quality monitoring, in addition to leak testing. ASTM F2391 helium leak detection is a well-established method recognized and widely used in the pharmaceutical industry.

Applications of Helium Leak Testing

• Ensuring Container Closure Integrity.
• Selecting closure formulation and configuration.
• Seal integrity monitoring during stability studies.
• Extremely valuable in early-stage pharmaceutical product package system development.