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Jun 2024

Innovative Technologies Revolutionizing Quality Control in Biological Products

Innovative Technologies Revolutionizing Quality Control in Biological Products

The biopharmaceutical industry is witnessing a paradigm shift in quality control practices, driven by the emergence of innovative technologies. As the demand for biological products continues to rise, ensuring their safety, efficacy, and consistency has become increasingly complex. Traditional quality control methods are often inadequate in addressing the unique challenges posed by biologics manufacturing.

However, advancements in technology offer promising solutions to these challenges, revolutionizing the way quality control is conducted in the biopharmaceutical sector. From novel analytical tools to sophisticated data analytics and automation, these innovative technologies are reshaping the landscape of quality assurance.

This blog delves into the transformative impact of these advanced, cutting-edge technologies on quality control in biological products. By enhancing detection sensitivity, accelerating testing processes, and enabling real-time monitoring, these innovations are poised to elevate the standards of quality assurance and ensure the delivery of safe and effective biopharmaceuticals to patients worldwide.

CCI Techniques for Biological Products Quality Control

1. Vacuum Decay Technology

Vacuum Decay technology, being recognized by the FDA, is a leak detection method ideal for Container Closure Integrity (CCI) testing in high-risk package applications. This non-destructive technique enhances package analysis and minimizes waste. It is highly sensitive in detecting leaks in sealed packaging, whether rigid, semi-rigid, flexible, or made from non-porous or porous materials. The technology consistently delivers repeatable, reliable, and quantitative test results. Vacuum Decay technology is widely recognized as a non-destructive alternative to the water bath leak test and dye ingress test.

In this method, packages are placed in a well-fitted evacuation test chamber connected to an external vacuum source. Utilizing single or dual vacuum transducer technology, the vacuum level and changes in the vacuum are monitored over a predetermined test period. Variations in absolute and differential vacuum indicate leaks and defects within the package. If a package is defective, air escapes through the leak into the test chamber. Non-defective packages retain the air, maintaining a constant chamber vacuum level.

2. MicroCurrent HVLD Technology

MicroCurrent HVLD technology is a non-destructive method that sends high-voltage current signals through packages. This method is recognized in USP 1207 as a deterministic test method. It is a practical solution for a wide range of liquid-filled parenteral products, including vials, ampoules, drug product cartridges, and pre-filled syringes. HVLD is unique among leak detection technologies as it does not require mass to pass through a defect site; it only requires electricity to pass through a crack. This feature makes HVLD highly sensitive to leaks that other test solutions cannot detect.

The technology relies on the basic principle of quantitative electrical conductivity measurements. In this method, the container is placed horizontally on a rotating stage. During rotation, high voltage and ground probes are applied to opposite sides of the container. If the package is defect-free, the container walls offer complete electrical resistance, and no current is detected passing through. If the package is defective, the resistance breaks down, allowing current to pass through.

Innovative technologies have ushered in a new era of quality control for biological products, significantly transforming the landscape of the biopharmaceutical industry. Through advancements in analytical techniques, automation, and data analytics, these technologies have revolutionized how quality assurance is conducted, ensuring the safety, efficacy, and consistency of biological products.

Overall, the integration of innovative technologies into quality control processes for biological products holds great promise for improving healthcare outcomes and driving the development of novel therapies to benefit patients worldwide.

microcurrent hvld, vacuum decay technology, non-destructive methods
Jun 2024

An Overview of Comprehensive CCIT Services in the Pharmaceutical Product Lifecycle

An Overview of Comprehensive CCIT Services in the Pharmaceutical Product Lifecycle

From the early stages of development to commercial production and distribution, maintaining the integrity of container closures is paramount for preserving product sterility and stability. In this blog, we embark on an exploration of complete CCIT services within the pharmaceutical product lifecycle. By understanding the importance of CCIT throughout the lifecycle, we gain insight into its impact on product quality assurance, regulatory compliance, and ultimately, patient safety.

Services Offerings:

CCIT Testing Services

  • Feasibility Studies - Initial experimental feasibility studies are the first step in evaluating and selecting the most suitable inspection technology and test method for a specific application. These studies are supported by comprehensive reporting and analysis of test result data.
  • Test Method Development Support - Our services in test method development offer documentation and testing assistance, encompassing advanced initial recipe formulation, container qualification, and system suitability testing.
  • Stability Testing - This testing service ensures that products maintain container closure integrity either before stability testing or throughout the stability period.
  • Recall & Batch Release Testing - Tailored for recalled products, items on hold, and those slated for batch release, this testing service ensures compliance with quality standards.
  • Helium Testing Services - Helium Testing Services provides a range of testing solutions including Cold Storage Testing (-80°C to -160°C), Hard Vacuum Method, and 100% Helium Flow Method, all conducted in accordance with ASTM F2391 standards. We specialize in Parenteral Product CCI, blister packs and other applications, including Package Validation testing services.

CCIT Consulting Services

  • CCIT Consulting: Ideal for R&D or clinical purposes, PTI will design a plan to assist clients in navigating from component matching to production and manufacturing.
  • Sampling Plan Consulting: CCIT helps clients develop and assess their statistical sampling plans to ensure compliance with relevant regulations.
  • Package Development Consulting: Our service supports clients in crafting optimal package designs to ensure Container Closure Integrity (CCI). By providing real result data on leak rates of various components, we facilitate comparisons between different designs and package elements.

CCIT Training Services

  • Regulatory Requirement Training: General training about regulatory requirements relevant to CCIT. Obtain assistance in navigating USP 1207/Annex 1/ASTM/ISO and standards.
  • CCIT Training: Broad training course covering all aspects of general CCI including method comparisons, Maximum allowable leakage limit (MALL), and regulatory guidance.
  • Hands-on System Training for all operator levels: beginner and advanced levels.
  • Test Recipe Training for distinct applications.
  • Application Specific Training: Review the challenges of a particular package or container to find the optimal solution.

CCIT Test Method Development Support

PTI’s CCIT Center of Excellence offers extensive support in developing and validating container closure integrity testing (CCIT) solutions, ensuring clarity and justification within GMP environments. Leveraging scientific principles, PTI creates tailored experimental frameworks for method validation, producing clear reports that detail quantitative test methods, technology solutions, and acceptance criteria. PTI's non-destructive deterministic inspection technologies provide actionable insights, allowing clients to confidently ensure package integrity.

CCIT Helium Testing Services

  • Cost-Efficiency – Unlike some testing methods, we can generate leak rate data without the need for a full feasibility study. This not only saves significant time but also eliminates unnecessary expenses.
  • Reliable Data – With Helium Leak being a deterministic method, there are no questionable results, as would be the case with probabilistic methods. No operator subjectivity.
  • Time Savings – Compared to headspace analysis, helium leak testing can be performed in less than a day as opposed to many days.
  • Flexibility – We offer the flexibility to tailor our testing services to your specific needs without the added expense of operating under strict GMP guidelines.

CCIT services employ advanced testing methodologies and technologies to assess the effectiveness of seals and closures in maintaining a sterile barrier. By integrating CCIT into their quality assurance programs, pharmaceutical companies can safeguard product quality, ensure regulatory compliance, and enhance patient safety.

ccit services, pharmaceutical products, container closure integrity testing

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