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In the pharmaceutical industry, ensuring the integrity of vial is paramount for maintaining the sterility, efficacy, and safety of drug products. Traditional methods such as bubble emission, dye ingress, and microbial ingress have been used for years to test vial integrity. However, these methods often fall short in sensitivity, efficiency, and reliability. Vacuum decay testing has emerged as a superior alternative, offering numerous advantages that make it the preferred choice for container closure integrity testing. This method not only meets stringent regulatory requirements but also provides enhanced sensitivity, non-destructive testing capabilities, and operational efficiency, making it a vital tool in the pharmaceutical quality assurance process.

Vial Integrity Importance in Pharmaceuticals

Vial integrity is crucial in the pharmaceutical industry for several reasons:

• Product Safety: Ensuring the vial's integrity means the contents remain sterile and uncontaminated. Any breach can lead to contamination, which poses significant health risks to patients.
• Efficacy: The integrity of a vial ensures that the medication remains effective. Contaminants can degrade the drug, reducing its efficacy and making it less effective or even harmful.
• Regulatory Compliance: Regulatory bodies like the FDA have strict guidelines regarding the packaging and integrity of pharmaceutical products. Non-compliance can lead to recalls, legal issues, and loss of consumer trust.
• Shelf Life: A properly sealed vial protects the drug from environmental factors such as light, air, and moisture, which can affect its stability and shelf life.
• Cost Efficiency: Maintaining vial integrity reduces the risk of product loss due to contamination or degradation, which can be costly for pharmaceutical companies.

Why is Vacuum Decay Preferred Over Traditional Methods?

Vacuum decay is a non-destructive container closure integrity testing (CCIT) method used to detect leak and ensure package integrity. The test method is simple in principle and challenges container integrity based on fundamental physical properties. It provides accurate, repeatable, reproducible, and reliable quantitative results with a clear pass/fail determination. Referenced in the United States Pharmacopeia Chapter on CCI and listed in ISO 11607 (USP Chapter 1207), this test is conducted by drawing a vacuum on a package inside a test chamber and checking for any decay in the vacuum level, which would indicate a leak. This technique has become a preferred non-destructive alternative to the dye ingress test, preventing product waste and offering significant cost savings. For many products, it achieves a return on investment in less than six months.

Benefits of Vacuum Decay Technology

• Non-destructive, non-subjective, no sample preparation
• Defect detection down to 0.01 cc/min
• Results have proven superior to dye ingress
• Deterministic, quantitative test method
• Supports sustainable packaging and zero waste initiatives
• ASTM test method and FDA standard

Vacuum decay leak testing stands out as a premier method for ensuring vial integrity in the pharmaceutical industry. Its non-destructive nature preserves product viability while providing highly sensitive and accurate leak detection. The method’s ability to deliver consistent and repeatable results enhances quality assurance processes and regulatory compliance. Moreover, the efficiency and speed of Vacuum decay testing contribute to cost savings and operational efficiency, offering a rapid return on investment. By integrating Vacuum decay technology into their quality control systems, pharmaceutical companies can achieve superior product safety, efficacy, and reliability, ultimately ensuring the highest standards of patient care.

Container Closure Integrity Testing is a leak detection test conducted using non-destructive package inspection systems, to evaluate whether container closure systems can maintain sterile barriers against potential damages. CCIT plays a vital role in ensuring that the products are free from any possible contamination. Container closure systems are made up of primary packaging components and secondary packaging components. Components like glass, vials or syringes that are in direct contact with the product are called primary packaging components. Secondary packaging components include aluminum caps, cardboard boxes etc. that are not in direct contact with the product.

While there are multiple ways to conduct a Container Closure Integrity test, these methods can be broadly classified into probabilistic and deterministic test methods. Traditional methods like bubble tests, dye ingress and microbial challenge by immersion come under probabilistic test methods. Since it was found that such test results lacked accuracy and reliability, the United States pharmacopeia released guidance in 2016 stating that deterministic methods are preferred over probabilistic test methods. Let us now understand how Microcurrent HVLD technology ensures sensitive CCI testing across different industries and applications.

MicroCurent HVLD technology is a non-destructive test method capable of achieving high levels of CCI assurance across the entire range of parenteral products. It is an FDA recognized ASTM test method capable of detecting the presence and location of pinholes, micro-cracks, stopper/plunger leaks, non-visible leaks under crimping and many other defects. Additionally, MicroCurent HVLD technology is found to be effective in detecting leaks in a wide range of liquid- filled products including extremely low conductivity sterile water for injection (WFI) and proteinaceous products with suspensions. A unique feature of Microcurrent HVLD technology is that it does not require mass to pass through a defect site, requiring only the passage of electricity through a crack.

How does MicroCurrent HVLD technology work?

MicroCurrent HVLD technology functions on the simple property of electrical current. The first step is to place container horizontally on the rotating stage. While rotating the container, high voltage is applied on one side of the container and a ground probe on the opposing side. In the presence of a micro-leak or crack in one of the container walls, break-down resistance is reached and the current passes through. On the other hand, if there is no leak, the two container walls (high voltage side and ground side) provide full electrical resistance and no significant current is measured passing through the package.

MicroCurrent HVLD reduces voltage exposure to the product to less than 5% of the voltage exposure experienced when testing with other HVLD solutions. Reduced voltage exposure has twin benefits- limits any risk that the voltage may cause to the product, and greatly reduces production of ozone during operation. In fact, experiments have shown that MicroCurrent HVLD produces essentially no Ozone

Benefits MicroCurrent HVLD technology

• 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 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.

Non-destructive testing (NDT) plays a pivotal role in ensuring the quality and reliability of various products across industries. In the realm of contact lens manufacturing, where precision and safety are paramount, the VeriPac system stands out as a game-changer. This innovative technology revolutionizes the quality control process by offering a non-invasive means to inspect and validate contact lenses without compromising their integrity.

The VeriPac system employs advanced inspection techniques that eliminate the need for destructive testing methods, preserving the integrity of each lens while providing comprehensive analysis. By utilizing non-destructive methods such as Vacuum Decay technology, the VeriPac system can detect even the slightest defects or irregularities in contact lenses, ensuring that only products meeting the highest standards are delivered to consumers.

Challenges in Contact Lens Manufacturing

Contact lens manufacturing involves intricate processes to ensure the production of high-quality lenses that are safe and comfortable for wearers. Here are some of the challenges faced in contact lens manufacturing:

• Material Selection: Choosing the right material is crucial. It needs to be biocompatible, allowing oxygen transmission to the cornea, and have appropriate mechanical properties to ensure comfort and durability.
• Sterilization: Ensuring lenses are free from contaminants and microorganisms is essential to prevent eye infections. Sterilization methods must be effective without altering the properties of the lens material.
• Quality Control: Maintaining consistent quality across batches is challenging. Quality control measures are necessary at every stage of production to identify and rectify any defects.
• Regulatory Compliance: Contact lenses are medical devices, so manufacturers must comply with strict regulatory standards set by organizations such as the FDA in the US and the CE in Europe.
• Cost-Efficiency: Balancing quality and cost is a constant challenge. Manufacturers need to invest in advanced technologies while keeping the production cost-effective to remain competitive.
• Environmental Impact: With increased awareness of sustainability, manufacturers face pressure to develop eco-friendly materials and reduce waste generated during production.

Role of VeriPac System in Enhancing Contact Lens Manufacturing

VeriPac 410 is an innovative Container Closure Integrity Testing (CCIT) method, that uses force decay technology for non-destructive seal and leak detection for contact lenses. VeriPac 410 inspection technology platform integrates Vacuum Decay technology with a new force-based measurement system for enhanced performance. This advanced force decay technology can measure force by detecting the surface deflection of a package during a standard vacuum test cycle. By measuring the surface force of the package, the VeriPac 410 can not only identify defective packages but also perform leak tests on packages with minimal headspace.

The ability to inspect multiple packages in a single test cycle is one of the key features of VeriPac 410 technology. This capability streamlines evaluations, facilitating a faster processing rate for products. Furthermore, the system is engineered to identify the exact defective package or blister cavity, offering precise data to operators and quality control teams. The test results are quantitative, delivering a definitive PASS/FAIL determination. This eliminates any subjective interpretation from the evaluation process, thereby improving the dependability and precision of quality control measures.

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
• ASTM test method and FDA standard
• Cost-effective with rapid return on investment

As contact lens manufacturing continues to evolve, the VeriPac system stands as a testament to the power of technology in driving progress and innovation. Its impact extends beyond the manufacturing floor, influencing the standards of quality assurance and setting new benchmarks for excellence in product inspection. With its proven track record of reliability and precision, the VeriPac system remains an indispensable tool for ensuring the quality and safety of contact lenses, ultimately enhancing the overall experience for consumers worldwide.