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Package integrity testing has become more complex as pharmaceutical, medical device, and nutritional products continue to advance in formulation, format, and distribution pathways. Modern packages are expected to maintain barrier performance across extended shelf lives, varied transportation conditions, and increasingly demanding storage environments. At the same time, packaging designs now include multilayer films, advanced polymers, combination systems, and reduced headspace configurations. These changes have increased the difficulty of identifying very small defects that may compromise barrier performance. As expectations around quality, safety, and consistency continue to rise, integrity testing approaches must adapt to address both technical and operational pressures.

Key Challenges in Package Integrity Testing

Several factors continue to influence the effectiveness and reliability of integrity testing programs:

• Increasing use of flexible and semi-rigid materials that behave differently under pressure or vacuum conditions
• Presence of extremely small defects that allow slow ingress of gas or moisture rather than immediate failure
• Variability in seal quality due to changes in materials, equipment settings, or environmental conditions
• Difficulty in testing low-headspace or no-headspace packaging formats using traditional techniques
• Growing number of package formats within a single production environment, each requiring different test considerations
• Higher production volumes that place pressure on testing speed and throughput
• Need for repeatable and traceable data that supports quality reviews and audits

Limitations of Conventional Integrity Testing Methods

Conventional integrity testing methods have been widely used in quality programs for decades, yet they present several limitations when applied to modern packaging systems. Many traditional approaches rely on visual inspection or manual interpretation, which introduces subjectivity and variability between operators. Techniques such as bubble emission testing are often effective only for larger leaks and may not consistently identify very small defects that allow slow gas or moisture ingress over time. Dye ingress testing can be influenced by factors such as dye concentration, exposure duration, and material absorption, making results difficult to reproduce and compare.

In addition, many conventional methods are destructive, meaning tested samples cannot be retained for further evaluation, stability studies, or aging analysis. This limitation reduces flexibility during development and ongoing quality assessments. Some methods also require extended testing times, delaying feedback during process optimization or routine monitoring. As packaging materials become thinner, more flexible, and increasingly complex, traditional tests may struggle to accommodate low-headspace designs or multilayer structures. These constraints limit the ability of conventional integrity testing methods to provide consistent, sensitive, and data-driven insight into packaging performance across diverse modern applications.

Innovations Driving Modern Package Integrity Testing

Innovations in package integrity testing have focused on improving sensitivity, objectivity, and efficiency while accommodating a wide range of package designs. One notable shift is the increased adoption of deterministic testing approaches that rely on measurable physical parameters rather than probability-based outcomes. These methods generate numerical data that can be trended and compared across batches and time periods.

Vacuum decay technology has gained broad acceptance for its ability to detect small leaks by monitoring pressure changes within a sealed test chamber. It is applicable to rigid, semi-rigid, and flexible packages and is commonly used during development, validation, and routine quality testing.

Helium leak detection has also become more widely used, particularly for high-risk pharmaceutical applications. By using helium as a tracer gas and mass spectrometry for detection, this method identifies extremely fine leak paths that may not be detected by other techniques. It is often applied during package development as well as routine product quality monitoring.

High voltage leak detection (HVLD) is a non-destructive method used to identify defects in liquid-filled, non-conductive pharmaceutical containers such as glass or plastic vials, ampoules, and pre-filled syringes. These technologies enable detection of defects without damaging the package.

Automation has further transformed integrity testing workflows by reducing operator influence, improving repeatability, and supporting higher throughput. Modern systems can be integrated into production environments or used offline with consistent performance. Digital integration now allows test data to be captured automatically, stored securely, and analyzed in real time. This supports improved traceability and enables manufacturers to make informed decisions based on consistent datasets. Many modern systems also allow test parameters to be adjusted based on material properties, seal geometry, and expected defect types, creating testing conditions that more closely reflect real-world handling and storage scenarios.

Package integrity testing continues to evolve alongside advances in packaging materials, design complexity, and distribution demands. While traditional methods still offer value in certain scenarios, their limitations become more apparent as packaging systems grow more sophisticated. Modern testing technologies provide greater sensitivity, objective measurements, and improved operational efficiency, supporting more consistent evaluation across diverse applications. As innovation in packaging design progresses, integrity testing approaches will continue to adapt, aligning measurement capabilities with the realities of next-generation products and packaging systems.

Quality control activities within pharmaceutical manufacturing are designed to confirm that every unit released meets predefined expectations for safety and performance. Among these activities, verification of container closure integrity has gained increasing attention as product formulations become more complex and shelf-life expectations extend. Modern parenteral drugs, biologics, and combination products are often sensitive to moisture, oxygen, and microbial ingress, making container performance a continual focus throughout production. Integrating container closure integrity testing into routine QC workflows allows manufacturers to evaluate seal performance at defined stages, supporting consistent outcomes without disrupting established operations. When implemented thoughtfully, integrity verification becomes a repeatable, data-driven process aligned with daily quality practices rather than a standalone investigation tool.

The Role of CCI Testing in Quality Control

Container closure integrity testing supports quality control by providing direct evidence that packaging systems maintain their barrier properties during manufacturing and handling. Defects such as microcracks, incomplete seals, or compromised stopper-fit conditions may not be visible through visual inspection alone, yet they can allow pathways for contamination or gas exchange. CCI testing introduces a quantitative layer of evaluation that complements sterility assurance, stability studies, and in-process checks.

Within QC environments, integrity testing also supports batch release decisions by offering objective measurements instead of subjective observations. When applied at appropriate checkpoints, it helps detect process variability linked to equipment wear, material inconsistencies, or environmental factors. Over time, trending CCI data can highlight subtle shifts in packaging performance, enabling proactive adjustments before deviations escalate. This structured use of integrity verification aligns with risk-based quality strategies and supports regulatory expectations for container system evaluation.

Selecting CCI Methods for Routine QC Use

1. Vacuum Decay Technology

Vacuum decay is a non-destructive, quantitative method widely used for routine QC of rigid, semi-rigid, and flexible packaging. It detects leaks by monitoring pressure changes under vacuum conditions and is well suited for high-throughput environments. Since the results are quantitative, vacuum decay enables statistical process control and trending in routine QC programs. It is well suited for offline QC and at-line inspection where repeatability and data integrity are required. Vacuum decay systems are scalable and adaptable to different container sizes and materials, making them widely used in pharmaceutical and medical device manufacturing environments.

2. High Voltage Leak Detection (HVLD)

High Voltage Leak Detection (HVLD) is a non-destructive, deterministic container closure integrity testing method designed for liquid-filled pharmaceutical containers. It works by applying a high-voltage signal to the container while monitoring changes in electrical resistance or current flow. A defect allows current to pass through the container wall or closure area, triggering detection. HVLD is widely used for inspecting vials, ampoules, prefilled syringes, and blow-fill-seal containers containing aqueous or conductive formulations. The method supports fast test cycles and is suitable for both QC sampling and 100% inspection strategies in inline, at-line, or offline configurations. It provides objective pass/fail results that can be trended over time, supporting consistent quality monitoring in regulated manufacturing environments.

3. Helium Leak Detection

Helium leak detection is a tracer gas–based method that measures the movement of helium through defects in the container closure system. Packages are either filled with helium or exposed to helium under controlled conditions, and a mass spectrometer detects any escaping gas. This technology delivers very high sensitivity, allowing detection of extremely small leaks that may not be identified by other methods. Helium leak detection is commonly applied during package development, method feasibility studies, and stability testing. In routine QC, it is typically used for high-risk products or applications where extremely low leak rate thresholds must be monitored. The method generates quantitative leak rate data and supports correlation to microbial ingress studies.

Overcoming Common Integration Challenges

Integrating container closure integrity testing into established QC workflows can present practical challenges, particularly in facilities with legacy systems or limited floor space. One common concern involves aligning test throughput with production schedules. Selecting automated or semi-automated systems can help maintain pace without creating bottlenecks. Another challenge lies in method transfer from development or validation teams to routine QC staff. Clear standard operating procedures, supported by hands-on training, reduce variability and build operator confidence.

Data management can also require careful planning. QC environments rely on traceable, audit-ready records, so integrity testing systems must generate clear, reproducible outputs that align with quality documentation practices. Integration with laboratory information management systems further streamlines record handling and trend analysis. Resistance to change is another factor, particularly when introducing new testing concepts. Demonstrating how integrity testing complements existing checks—rather than replacing them—helps encourage broader acceptance across quality teams.

Integrating container closure integrity testing into QC workflows strengthens packaging oversight through repeatable, measurable verification of seal performance. By selecting methods suited to routine use and addressing operational challenges early, manufacturers can embed integrity evaluation into daily quality activities with minimal disruption. This approach supports consistent batch outcomes, enhances process understanding, and aligns packaging verification with modern quality expectations. As pharmaceutical products and packaging formats continue to evolve, structured integration of integrity testing within QC environments provides a forward-looking pathway for maintaining high standards across production lifecycles.

Ensuring the integrity of container closures is a critical aspect of pharmaceutical and medical product safety. Container Closure Integrity Testing (CCIT) is essential to confirm that containers such as vials, syringes, and ampoules maintain their seal and protect the contents from contamination throughout their shelf life.

E-Scan MicroCurrent High Voltage Leak Detection (HVLD) technology has emerged as the optimal solution in advancing CCIT methodologies. E-Scan MicroCurrent HVLD technology significantly enhances container closure integrity testing by providing accurate, non-destructive, and efficient solutions. Its integration into CCIT processes helps ensure that pharmaceutical and medical products are safe, reliable, and of the highest quality.

MicroCurrent HVLD for Pharmaceutical Package Testing

MicroCurrent HVLD is a non-destructive method for evaluating the integrity of container closures in non-porous pharmaceutical and parenteral products. This technique utilizes low electrical current to detect leaks in various liquid-filled products, including those with extremely low conductivity such as sterile water for injection (WFI) and products containing proteins or suspensions. Unlike conventional HVLD technology, MicroCurrent HVLD reduces product voltage exposure to less than 5%, eliminating any potential risk to the product and reducing ozone formation during testing.

In this method, high voltage probes scan the container. One side is subjected to high voltage, while a ground probe is attached to the other side. If the container is intact, both sides offer complete electrical resistance, and no significant current passes through. However, if a micro-leak or fracture is present, resistance breaks down, allowing current to flow through the defect. HVLD is unique among leak detection methods as it does not require mass to pass through the defect site; instead, it transmits electricity through the crack.

E-Scan Technologies: E-Scan 605, E-Scan 615, E-Scan 655, E-Scan RTX

E-Scan 605: E-Scan 605 is designed for non-destructive evaluation of container closure integrity in pharmaceutical and parenteral products. Its rapid testing capabilities make it a cost-effective and efficient solution for ensuring the integrity of parenterals.

E-Scan 615: E-Scan 615 is designed to handle a wider range of product types and configurations, making it suitable for more complex testing scenarios. It ensures accurate detection of leaks, providing high levels of safety and quality assurance for pharmaceutical packaging. With its easy operator HMI screen, the E-Scan 615 enhances workflow efficiency.

E-Scan 655: E-Scan 655 is the advanced analytical version in the E-Scan series, offering enhanced capabilities for container closure integrity testing. It uses state-of-the-art MicroCurrent HVLD technology to provide highly accurate leak detection across a broad spectrum of pharmaceutical and parenteral products. The E-Scan 655 is equipped with advanced features for handling diverse product sizes and shapes, ensuring comprehensive testing coverage.

E-Scan RTX: E-Scan RTX represents the latest innovation in the E-Scan product line, offering a comprehensive technology for automated container closure integrity testing. It incorporates advanced MicroCurrent HVLD techniques with automated pick & place of pre-filled syringes. Its intuitive interface and automated testing capabilities make it a powerful tool for ensuring the highest standards of product integrity and safety of pre-filled syringes.

E-Scan MicroCurrent HVLD Series offers a powerful solution for parenteral container closure integrity testing. Its advanced technology, combined with its non-destructive nature, reduced voltage exposure, and automation features, ensures high-quality, reliable testing results. By integrating these systems into CCIT processes, pharmaceutical and medical industries can uphold the highest standards of product safety and efficacy.

High-risk pharmaceutical products refer to medications and substances that, due to their nature or intended use, pose a higher level of risk to patients and the public. These products often include injectable drugs, biologics, vaccines, and other sensitive formulations that require stringent quality control measures to ensure patient safety and regulatory compliance.

The packaging of high-risk pharmaceutical products presents unique challenges due to the need for exceptional product protection, stability, and, most importantly, containment of the product to prevent contamination. As these products are often administered directly into the body, maintaining the integrity of the container closure system is critical to prevent microbial ingress, oxygen exposure, and other factors that could compromise the drug's efficacy and safety.

Container Closure Integrity (CCI) testing is a vital process within the pharmaceutical industry to verify that the packaging of a product effectively prevents any leakage or contamination. This testing is crucial in ensuring that the pharmaceutical product maintains its integrity throughout its shelf life, safeguarding patient safety and therapeutic efficacy.

MicroCurrent HVLD Technolgy for Testing Integrity of High-Risk Pharma

PTI's MicroCurrent HVLD technology represents a non-destructive and non-invasive approach to testing the container closure integrity (CCI) of various liquid-filled products, including pre-filled syringes, vials, cartridges, ampoules, blow-fill-seal (BFS) containers, bottles, and pouches. This method has proven to be highly effective in ensuring the integrity of container closures in diverse applications.

The technology employs electrode probes to scan sealed containers, aiming to detect any potential leaks. By analyzing changes in the current flow, both the existence of defects in the container and their approximate locations can be identified with precision. This makes the MicroCurrent HVLD technology particularly versatile, capable of detecting leaks in a wide range of liquid-filled products, even those with extremely low conductivity, such as sterile water for injection (WFI) and proteinaceous products with suspensions.

One notable advantage of MicroCurrent HVLD is its efficiency in terms of voltage usage. It utilizes approximately 50% less voltage compared to conventional HVLD solutions, contributing to a more energy-efficient and environmentally friendly testing process. Moreover, the reduced voltage exposure (less than 5% compared to traditional methods) minimizes potential risks to both the product and the testing environment.

Benefits of MicroCurrent HVLD:

• Deterministic, non-destructive, non-invasive, non-subjective
• High level of repeatability and accuracy
• Ideal package integrity solution for liquid filled parenteral products
• Low voltage exposure to the product and environment
• Offline and automated online inspection
• Referenced in USP 1207 guideline

In the pharmaceutical industry, the integrity of packaging plays a pivotal role in ensuring the safety, efficacy, and quality of medications. Packaging serves as a barrier that protects pharmaceutical products from external factors, such as moisture, air, light, and contaminants, which could compromise their stability and effectiveness. Ensuring the integrity of pharmaceutical packaging is not only crucial for regulatory compliance but also for maintaining patient safety and confidence in the products.

Traditional methods of package testing often involve destructive techniques, where samples are opened, punctured, or otherwise altered for assessment. However, these methods come with inherent drawbacks, including product wastage, the need for additional samples, and prolonged testing times. To address these challenges, the pharmaceutical industry has increasingly turned to non-destructive methods for package integrity testing.

What are the Non-destructive Methods Used for Pharmaceutical Package Testing?

Vacuum Decay Technology

Vacuum decay is a non-destructive Container Closure Integrity Test (CCIT) that provides reliable, repeatable, reproducible, and accurate results along with clear pass/fail quantitative data. The basic idea of Vacuum decay technology is to question the integrity of containers based on their fundamental physical properties. Sample packages are initially placed within a tightly sealed evacuation test room with an external vacuum source. Based on the test sample and the needed level of sensitivity, a predetermined vacuum level is selected. The test chamber and test system dead space must be evacuated after that for a certain period of time. To monitor variations in vacuum level over time, differential pressure transducers are utilized. The container is leaking if the pressure rises over the designated pass/fail limit.

Volumetric Imaging Technology

Non-destructive leak detection of blister packages is done using OptiPac One-Touch Tool-less technology. The OptiPac uses volumetric imaging technology to monitor the movements of a blister package while it is under vacuum in order to identify leaks. The interface is practical and simple to set up with new blister package forms, necessitating no tooling changeover or significant parameter revisions as with previous non-destructive blister package inspection systems. In response to different cavity shapes, sizes, and combinations of various blister pack types, the system gathers volumetric data from each cavity.

Airborne Ultrasound Technology

Airborne ultrasound is a deterministic test technique for seal quality inspection in materials including aluminum, foil, paper, plastic, poly, film, and Tyvek. It has been proven to be one of the most effective non-destructive testing techniques for flexible package seals. According to studies, conventional seal inspection methods are ineffective because they miss undetectable defects and incorrectly reject pouches that are tightly sealed. On the other hand, Airborne ultrasound technology has been successful in both online and offline solution options. Airborne ultrasound is a typical test method for evaluating seal quality and integrity in accordance with ASTM F3004-13.

Microcurrent HVLD technology

High Voltage Leak Detection, often known as HVLD, is a deterministic, non-destructive leak detection technique used to evaluate the Container Closure Integrity of vials, cartridges, and other liquid-filled parenteral products. It is one of the most efficient approaches for online container closure testing. MicroCurrent HVLD uses around 50% less voltage and exposes the product and environment to less than 5% of the voltage when compared to standard HVLD systems. This technique doesn't require sample preparation and is non-invasive. Pre-filled syringe testing is one of the main uses of MicroCurrent HVLD, along with vial leak testing.

Non-destructive Package Integrity Testing Method Benefits

Non-destructive package integrity testing holds significant importance in the pharmaceutical industry due to the critical nature of pharmaceutical products and the strict regulatory requirements in place. Here are some key benefits of using non-destructive package integrity testing in the pharmaceutical industry:

• Product Safety: Ensuring the integrity of pharmaceutical packaging is paramount for product safety. Non-destructive testing methods can identify leaks, defects, or breaches in packaging that could lead to contamination, spoilage, or compromised efficacy of the medication.
• Regulatory Compliance: The pharmaceutical industry is heavily regulated to ensure patient safety and product quality. Non-destructive package integrity testing helps companies meet regulatory requirements outlined by agencies such as the FDA (U.S. Food and Drug Administration) and other international regulatory bodies.
• Reduced Risk of Contamination: Non-destructive testing methods can detect micro-leaks or breaches in packaging that may not be immediately visible to the naked eye. This reduces the risk of contamination from external factors like air, moisture, or pathogens.
• Preservation of Sterility: Many pharmaceutical products require a sterile environment to maintain their efficacy and safety. Non-destructive testing ensures that the packaging's sterile barrier is intact, preventing any potential breach of sterility.
• Enhanced Product Quality: Maintaining package integrity helps prevent degradation of pharmaceutical products caused by exposure to light, moisture, or air. This ensures that medications maintain their intended potency and effectiveness.
• Cost Efficiency: Non-destructive testing methods save costs by preventing the need for destructive testing, which would require additional samples for analysis. This also reduces the need for retesting, minimizing waste and resource consumption.

As the demand for stringent quality control and regulatory adherence in the pharmaceutical sector continues to grow, understanding the nuances of non-destructive package testing methods becomes essential. By adopting these innovative techniques, pharmaceutical manufacturers can uphold their commitment to patient safety, product efficacy, and overall excellence in the field.

Combination products are medical devices that combine two or more different types of medical products (e.g., a drug-device combination or a biologic-device combination) into a single entity. These products present unique challenges in terms of design, development, and regulatory approval due to the integration of different technologies and functionalities. Therefore, it is crucial to use appropriate techniques to evaluate combination product’s safety, efficacy, and overall performance.

The FDA's Center for Devices and Radiological Health (CDRH) and the Center for Drug Evaluation and Research (CDER) developed the "Guidance for Industry and FDA Staff - Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology" to help manufacturers evaluate combination products containing nanomaterials. While this guidance specifically addresses nanotechnology, many of the concepts and principles apply more broadly to evaluating combination products.

What are the three main categories of combination products?

Combination products are categorized into three main types based on their primary mode of action.

1.Drug-Device Combination Products: These products combine a drug and a medical device into one single entity. The drug and device components work together to achieve the intended therapeutic effect. An example of this type of combination product is an auto-injector that contains a drug and a delivery device.

2. Biologic-Device Combination Products:These products combine a biological product (such as a vaccine, cellular therapy, or tissue product) with a medical device. The device is integral to the administration or use of the biological product. An example of this type of combination product is a pre-filled syringe containing a biological medication.

3. Drug-Biologic Combination Products: These products combine a drug and a biological product. This category is less common than the others, but it involves combining a drug with a biologically sourced material. An example of this type of combination product is a drug formulated with a growth factor derived from human tissues.

Combination Products Quality Control Techniques

Microcurrent HVLD technology

MicroCurrent High Voltage Leak Detection (HVLD mc) is a non-destructive container closure integrity testing method that has been proven to be significantly more effective in identifying leaks in various types of parenteral and pharmaceutical applications. It may be used to check for leaks in nonporous, rigid, or flexible packaging as well as packaging that contains liquids. Tests for high voltage leak detection are carried out using electrical conductivity and resistance theories. This method operates by transmitting high voltage, low current impulses through sample packages. When there is a leak, the electrical resistance of the sample falls, causing an increase in current. HVLD technology depends on the "flow" of current, compared to conventional leak detection methods that depend on the movement of gas or liquid.

MicroCurrent HVLD Applications

• Vials
• Ampoules
• Cartridges
• Pre-filled Syringes
• BFS

Helium Leak testing

Helium leak detection is a method for finding leaks in a variety of sealed or enclosed systems by utilizing helium as a "tracer" gas. It is a CCI technique used to evaluate the integrity of critical injectable or parenteral products. Since helium is non-toxic, non-flammable, and non-condensable, helium gas is a great option for tracer gas. Helium is present in the atmosphere in amounts of little more than 5 ppm, making minor leaks easy to pass through. Helium is also more readily available and less expensive than other tracer gases, available in a variety of cylinder sizes. The test is performed by attaching the test component to the leak detector, which is then filled with helium gas. Helium escapes from the test components when there is a leak, and this partial pressure is measured, with the results shown on the meter.

Benefits of Helium Leak Testing

• Practical and sensitive flow-based leak test method,
• Enables the discovery of extremely small microleaks.
• Detects leaks with sensitivity level as low as 1x10-10 mbar L/sec.
• Helium is a non-explosive, non-toxic and non-destructive tracer gas.
• Applicable across package design, failure analysis, packaging line setup and validation.
• A faster test cycle reduces cost and total processing time.

The specific techniques and requirements for evaluating combination products may vary depending on the nature of the product (e.g., drug-device vs. biologic-device) and the intended use. Manufacturers are encouraged to engage in early communication with regulatory authorities to clarify the requirements and expectations for their combination product. Additionally, seeking the expertise of professionals with experience in evaluating combination products can be beneficial throughout the development and approval processes.

High Voltage Leak Detection (HVLD) of pre-filled syringes, vials, cartridges, ampoules, BFS, bottles and liquid filled pouches detects pinholes, micro-cracks, stopper/plunger leaks, non-visible leaks under crimping and many other defects. The HVLD testing procedure also guarantees the security of the product seal by finding tiny pinholes, micro fractures and screen defects that are not visible. Eventual packing defects lead to resistance differential and changes of current flow in the container and the approximate position of the fault. It is also one of the most affordable methods for testing container closure that requires little adjustments to the infrastructure. This technology is not invasive and does not require preparation of the sample. It is one of the most powerful CCI technologies for all biological and parenteral goods

E-Scan HVLD has a high-speed test cycle, produces highly reproducible results and is easy to handle. Fast changeover and easy adjustments of test parameters for various goods and applications are further advantages. Another advantage of the HVLD technique is that it can readily be moved from the laboratory offline to 100% online testing applications at high production speeds. That is an enormous benefit and makes the inspection and validation procedure globally simpler. E-Scan employs a number of electrode probes to scan a sealed container which is not conductive. Glass, plastic or poly laminate might be the container material.

Working principle of MicroCurrent HVLD technology

In non conductive or semi-conductive packing materials, HVLD works by implementing high voltage potential for electrically conductive goods. When electrical discharges between goods and device electrodes are observed, the pinholes are determined. The two container walls (high voltage side and ground side) offer complete electric resistance when the package is not leaked, and no significant current is detected by flash. If one of the container walls has a microleak or fracture, the barrier to breakup is met and the current passes. HVLD is the only technique for leak detection that requires a crack site without mass, needing just the flow of electricity via a crack. This feature sensitises HVLD to leaks that are not identified by typical leak test systems.

Applications of MicroCurrent HVLD

• Pre-filled syringes
• Vials
• Cartridges
• Ampoules
• BFS
• Bottles
• Pouches

Advantages of MicroCurrent HVLD

• High level of repeatability and precision
• Deterministic, non-destructive, non-invasive
• Product and environmental low voltage exposure
• Offline and 100% online testing at high production speeds
• Simpler inspection and validation procedure
• Most powerful CCI technology for all parenteral and biologic products
• Robust method and approximate 3x Signal-Noise-Ratio for a wide range of product classes and package formats