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As pharmaceutical manufacturing becomes increasingly automated, package inspection needs to keep pace with production demands. Container closure integrity testing (CCIT) and seal inspection are important parts of pharmaceutical packaging quality, particularly for products where package integrity is critical.

Automated inspection can help manufacturers increase testing capacity, reduce manual intervention, and create a more consistent and traceable inspection workflow.

PTI provides automated inspection solutions designed for different package formats and applications, including VeriPac LPX, E-Scan RTX, and Seal-Sensor PQX.

Why Is Automated Inspection Important for Pharmaceutical Manufacturing?

Manual inspection can require operators to handle samples, initiate tests, record results, and move products through different stages of the inspection process. As production volumes increase, these activities can limit testing capacity and introduce additional opportunities for operator-dependent variability.

Automated inspection can streamline these repetitive activities by combining testing with automated sample handling and result collection.

Depending on the application, automation can help manufacturers:

• Increase testing capacity
• Reduce manual sample handling
• Improve consistency
• Reduce operator-dependent variability
• Automate result collection
• Improve data traceability
• Support production-line inspection

The goal is not simply to make testing faster. It is to create a controlled and scalable inspection process that can support modern manufacturing requirements.

What Are PTI's Automated Inspection Solutions?

PTI's automated inspection portfolio includes three key solutions:

• VeriPac LPX – automated package and container closure integrity testing
• E-Scan RTX – automated CCI testing for parenteral products (pre-filled syringes)
• Seal-Sensor PQX – automated pouch seal inspection with built-in conveyor for easy handling

Each solution combines automation with a specific PTI inspection technology to address different package and application requirements.

How Does VeriPac LPX Support Automated CCIT?

VeriPac LPX is an automated package integrity testing solution based on PTI's Vacuum Decay technology. The system is designed to automate package integrity testing while reducing manual sample handling. For suitable applications, automated handling can move samples through testing and separate accepted and rejected products.

VeriPac LPX can support applications ranging from laboratory and batch release testing to production environments, helping manufacturers increase inspection capacity while maintaining quantitative, non-destructive testing.

How Does E-Scan RTX Support Automated CCI Testing?

E-Scan RTX is a fully automated container closure integrity testing solution designed for pre-filled syringes. The system uses PTI's HVLD technology together with automated robotic handling. Syringes can be automatically moved through the testing process and directed to the appropriate pass or reject location.

E-Scan RTX is designed for applications ranging from laboratory testing and batch release to high-volume production. Its automated workflow can reduce manual handling while providing rapid test results.

How Does Seal-Sensor PQX Support Automated Seal Inspection?

Seal-Sensor PQX is a fully automated pouch seal inspection and handling system. It uses PTI's Seal-Sensor Airborne Ultrasonic technology to inspect pouch seals online. The system incorporates automated handling and can identify defective seals and remove rejected pouches from the production process.

For manufacturers requiring high-volume pouch inspection, this provides an alternative to relying solely on manual or sampling-based seal inspection.

How Can Automated Inspection Support Batch Release?

Batch release involves the review of multiple quality attributes before a product can be released. Package integrity testing can become part of this workflow, particularly when large numbers of samples need to be tested and reviewed.

Automated inspection can support the process by:

• Increasing testing capacity
• Reducing manual handling
• Providing consistent test execution
• Generating clear test results
• Capturing test data electronically
• Improving traceability and data availability

PTI's VeriPac LPX and E-Scan RTX can support batch release applications where appropriate.

However, automated inspection does not independently determine whether a batch can be released. The final release decision remains subject to the manufacturer's quality system, procedures, acceptance criteria, and applicable regulatory requirements.

The benefit of automation is that it can make the inspection portion of the quality workflow more efficient and scalable.

What Should Manufacturers Consider When Selecting an Automated Inspection Solution?

The appropriate automated solution depends on the package, product, inspection objective, and production environment.

Manufacturers should consider:

• Package format: Size, shape, materials, and closure design can influence solution selection.
• Product characteristics: Product properties can affect the suitability of a particular inspection technology.
• Inspection objective: Requirements may include package leak detection, CCIT, or pouch seal inspection.
• Production requirements: Testing volume, throughput, handling, and line integration should be considered.
• Data requirements: Electronic data collection and traceability may be important for quality operations.
• Validation: The selected inspection method and automated system must be demonstrated to be suitable for the intended application.

No single automated inspection solution is appropriate for every package.

What Are the Benefits of Automated Inspection?

When appropriately implemented, automated inspection can provide manufacturers with:

• Increased inspection capacity
• Reduced manual handling
• More consistent testing
• Automated product handling
• Integration with production workflows
• Reduced operator-dependent variability

These capabilities can be particularly valuable for manufacturers managing high production volumes or seeking to reduce testing-related bottlenecks.

Conclusion

Automated inspection can help pharmaceutical manufacturers improve package testing efficiency by increasing inspection capacity, reducing manual intervention, and providing more consistent and traceable results.

By combining these automated solutions with PTI's inspection technologies, manufacturers can create scalable workflows for laboratory testing, batch release, at-line inspection, and production environments.

Automation does not replace quality controls or the manufacturer's batch release process. Instead, it provides a way to make package inspection more efficient while maintaining the testing and quality requirements of the specific application.

Frequently Asked Questions

1.What are PTI's automated inspection solutions?

PTI's key automated inspection solutions include VeriPac LPX, E-Scan RTX, and Seal-Sensor PQX. Each is designed for specific package inspection requirements.

2. What is VeriPac LPX?

VeriPac LPX is an automated package integrity testing solution based on PTI's Vacuum Decay technology.

3. What is E-Scan RTX?

E-Scan RTX is an automated CCI testing solution designed for pre-filled syringes using PTI's MicroCurrent HVLD technology.

Parenteral products, such as pre-filled syringes, vials, and cartridges require stringent quality control to ensure sterility and product integrity. A compromised container closure can lead to contamination, posing severe risks to patient safety. To address this, automated Container Closure Integrity Testing (CCIT) solutions like the E-Scan RTX offer a highly reliable and efficient approach.

Understanding Parenteral Products

Parenteral products are sterile pharmaceuticals, mainly liquid form, administered via injection, including pre-filled syringes, vials, cartridges, and ampoules. These products bypass the body's natural defense mechanisms, making sterility and container closure integrity critical to patient safety.

Ensuring their container closure integrity (CCI) is critical to maintaining sterility and preventing microbial contamination, oxidation, or loss of potency. Given the delicate nature of biologic drugs, traditional destructive test methods like dye ingress are inadequate. Instead, non-destructive methods such as HVLDmc technology provide reliable and repeatable testing.

Automated Container Closure Integrity Testing (CCIT) is a non-destructive method used to test the integrity of pharmaceutical packaging, ensuring it remains sealed and free from contamination. Unlike traditional probabilistic methods such as dye ingress or microbial ingress tests, automated CCIT provides precise, repeatable, and high-throughput testing, making it ideal for large-scale production. It eliminates human error, increases sensitivity to micro leaks, and complies with regulatory guidelines such as USP Chapter 1207, which recommends deterministic testing methods. By integrating advanced technologies like MicroCurrent High Voltage Leak Detection (HVLDmc), automated CCIT ensures that parenteral products, including pre-filled syringes and vials, meet the highest quality and safety standards while maintaining efficiency in manufacturing.

Automated CCI Testing Using E-Scan RTX

The E-Scan RTX platform is PTI’s fully automated, modular container closure integrity (CCI) testing solution designed specifically for pre-filled syringes. Engineered with a dynamic robotic system, the RTX delivers a practical, reliable, and adaptable approach to CCI testing, seamlessly integrating with your production requirements.

This advanced platform features MicroCurrent HVLD technology, an innovative form of high-voltage leak detection (HVLD) optimized for high-risk, delicate biologic liquids. The RTX ensures fast and accurate PASS/FAIL results within seconds, making it ideal for batch release testing, inline production environments, or laboratory applications.

Unlike conventional HVLD methods, PTI’s MicroCurrent HVLD operates with a unique DC voltage mode, using no more than 50% of the voltage typically applied in traditional high-voltage testing. This enables precise leak detection even in low-conductivity liquids, such as sterile water. Additionally, the reduced voltage minimizes product exposure to high electrical stress, making it the preferred CCI solution for parenteral and biologic products.

Benefits of E-Scan RTX

• MicroCurrent HVLD technology is effective across all parenteral products, including biologics and extremely low conductivity liquids including sterile water (WFI).
• Robust CCI technology, MicroCurrent HVLD offers bi-lateral scalability from the lab to production line.
• Listed in USP Chapter 1207 as the recommended method for parenteral liquid package inspection.
• Robust method and good Signal-Noise-Ratio between good and defective products. Low voltage exposure reduces production of ozone.

In today's world, product quality and safety are paramount. This holds especially true for the packaging industry, where ensuring the integrity of a package is crucial for protecting the product within. Package integrity testing plays a vital role in safeguarding product quality and preventing contamination throughout the supply chain.

Package integrity testing encompasses a variety of methods used to assess the ability of a package to withstand the rigors of the supply chain and protect its contents. These tests evaluate factors like strength, seal integrity, and resistance to external elements like moisture, oxygen, and physical impact. Package leaks can compromise product sterility, potency, and overall quality, leading to recalls and potentially harming consumers.

Why is Automated Package Leak Detection Gaining Importance?

Traditional, manual package integrity testing methods often involve destructive testing or rely on statistical sampling. These methods can be time-consuming, labor-intensive, and may not provide a complete picture of package quality across an entire production run.

Automated leak detection systems address these limitations. They offer several advantages:

• Automated In-Line Testing: VeriPac LPX enables real-time, in-line leak detection for every single package, ensuring comprehensive quality control.
• Increased Efficiency: Automation streamlines the testing process, significantly reducing labor costs and production downtime.
• Enhanced Accuracy: VeriPac LPX utilizes standardized testing methods, minimizing human error and ensuring consistent, reliable results.
• Improved Data Tracking: Automated systems can integrate with production line controls, facilitating data collection and analysis for better quality control practices.

Automated Package Leak Detection using VeriPac LPX

The VeriPac LPX series comprises fully automated systems for inspecting package quality, offering 100% inline testing. The LPX enhances automated testing, ensuring a high level of confidence in packaging line performance. It's a dependable solution for issues related to infrequent testing and addressing process-related quality concerns.

When it comes to Container Closure Integrity testing (CCIT ), sensitivity and reliability are crucial. The VeriPac LPX 430.8S represents the latest generation in automated inspection systems for testing the integrity of parenteral product containers. It offers automated testing for 100% of batches or batch release, featuring an eight-station dual chamber design with a robotic testing platform suitable for various products, including pre-filled syringes, vials, lyophilized products, small molecule liquids, and Water for Injection (WFI).

The VeriPac LPX boasts a dynamic robotic design tailored to diverse production requirements. It's scalable and modular, ensuring it can meet the demands of different production lines. This adaptable platform facilitates reliable automated handling of various packaging formats, from flexible to rigid containers, and parenteral products. Moreover, the VeriPac LPX allows for easy changeover to test different package sizes on the same system.

Benefits of VeriPac Flex

• Deterministic, quantitative test method
• Non-destructive, non-subjective, no sample preparation
• Test multiple packages in a single test cycle
• Cost effective with rapid return on investment
• Supports sustainable packaging and zero waste initiatives
• Simplifies the inspection and validation process
• Accurate and repeatable results
• ASTM test method and FDA standard
• USP < 1207> compliant

In the dynamic landscape of pharmaceuticals, ensuring the integrity of parenteral products is paramount. Container closure integrity testing is a critical part of the quality control process for parenteral products. Parenteral products, such as vials, ampoules, syringes, and cartridges, are sterile and must be protected from contamination. CCI testing ensures that the container closure system is intact until it reaches the patient.

PTI's automated CCI solutions for parenterals provide a fast, reliable, and efficient way to test CCI. These solutions are designed to meet the needs of a variety of parenteral product manufacturers, from small-scale production to large-scale manufacturing.

Why Parenteral Product CCI Testing Is Important?

Parenteral products are particularly vulnerable to contamination, as they are directly injected into the bloodstream or body tissues. Even a small leak in the packaging can allow bacteria or other contaminants to enter the product, potentially causing serious infections or other health problems. CCI testing helps to ensure that the product is sterile and free from contamination. CCI testing also helps to protect patients from infections and other adverse reactions. Automated CCIT is a reliable and precise way to test the integrity of pharmaceutical packaging, reducing the risk of human error and ensuring compliance with regulatory standards.

Automated CCI Testing Solutions Offered by PTI

1.E-Scan RTX Technology

The E-Scan RTX is a fully automated container closure integrity (CCI) testing solution for pre-filled syringes. It uses MicroCurrent HVLD technology, a non-destructive testing method that is highly sensitive to even the smallest leaks and defects. MicroCurrent HVLD technology works by applying a high-voltage, low-current signal to the syringe. The signal creates an electric field around the syringe, which is disrupted by any leaks or defects in the packaging. The E-Scan RTX detects the disruption in the electric field and generates a signal that indicates whether the syringe has passed or failed the test. The E-Scan RTX is a highly efficient solution for automated testing in the laboratory to high-volume manufacturing.

Features of E-Scan RTX

• Fully automated CCI testing for pre-filled syringes
• MicroCurrent HVLD technology for high sensitivity and accuracy
• High throughput (hundreds of syringes per hour)
• Easy integration into existing production lines

2. VeriPac LPX Technology:

The VeriPac LPX is a fully automated CCI testing solution for a wide range of parenteral packaging formats, including vials, ampoules, and cartridges. It uses vacuum decay technology, a non-destructive testing method that is highly reliable and accurate. Vacuum decay technology works by creating a vacuum inside the packaging container and then measuring the rate at which the pressure increases over time. A leak in the packaging will cause the pressure to increase more quickly, indicating that the package has failed the test. The VeriPac LPX can be used for batch release testing or inline testing. It is highly versatile and can be configured to test a variety of packaging formats and sizes.

Features of VeriPac LPX

• Fully automated CCI testing for a wide range of parenteral packaging formats
• Vacuum decay technology for high reliability and accuracy
• High throughput
• Easy integration into existing production lines

Both the E-Scan RTX and the VeriPac LPX are valuable tools for pharmaceutical manufacturers who are looking to improve the safety and quality of their parenteral products. These automated CCI testing solutions can help manufacturers reduce risk, improve compliance, and increase profitability.

Automated Container Closure Integrity Testing (CCIT) of pre-filled syringes is a critical quality control process that ensures the product inside the syringe remains safe and effective during its shelf life. Pre-filled syringes are used to package and deliver various injectable drugs, such as vaccines, insulin, and other biologics.

The container closure integrity of pre-filled syringes can be compromised due to various factors such as: microcracks, defects in the rubber stopper, or improper sealing. To detect any potential defects in pre-filled syringes, automated CCI testing is done. This testing involves subjecting the pre-filled syringe to multiple conditions to check for any leakage or breakage in the container or closure.

Automated CCI testing of pre-filled syringes can be done utilizing techniques such as vacuum decay, high voltage leak detection, and tracer gas detection. These methods involve the use of specialized equipment to subject the pre-filled syringe to certain conditions including vacuum, high voltage, or exposure to a tracer gas. Any potential leaks or breakages in the container or closure can be detected by monitoring the pressure or electrical conductivity changes, or by the presence of the tracer gas

Automated CCI testing is crucial to ensure the safety and efficacy of pre-filled syringes. It is a reliable and efficient way of detecting potential defects in pre-filled syringes and ensuring that only products which meet the required quality standards are released to the market.

The E-Scan RTX platform is PTI’s fully automated, modular container closure integrity testing solution for pre-filled syringes. The RTX is a practical and reliable CCI solution that features a dynamic robotic design, tailored to fit your production requirements. This robust, adaptable platform utilizes MicroCurrent HVLD technology, a revolutionary form of HVLD that is the ideal CCI solution for high-risk, delicate biologic liquids. It provides a rapid PASS/FAIL result – its test cycle is only seconds – and is suitable for batch release testing, in line on production or in the lab.

PTI’s MicroCurrent HVLD technology uses a unique mode of DC voltage, applying no more than 50% of the voltage used on conventional high-voltage technologies. The nature of the PTI solution allows for the detection of leaks in packages with liquids of extreme low conductivities, including packages containing sterile water. The low voltage and current applied to the container also reduce the voltage the product is exposed to during the test. This technological advantage makes it the ideal solution for all parenteral and biologic solutions.

• MicroCurrent HVLD technology is effective across all parenteral products, including biologics and extremely low conductivity liquids including sterile water (WFI).
• Listed in USP Chapter 1207 as the recommended method for parenteral liquid package inspection.
• Robust method and good Signal-Noise-Ratio between good and defective products.
• Low voltage exposure reduces production of ozone.