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Dec 2021

Assuring CCI in Parenteral Products

Assuring CCI in Parenteral Products

Container closure integrity (CCI) testing requirements and regulatory guidelines have been rising steadily in the pharmaceutical industry in recent years. Parenteral products are often packaged in a variety of ways. The most common packaging formats are - vials, ampoules, syringes, BFS, and autoinjectors.

Microbial contamination, exposure to gases, water vapor, and solvent loss can all cause product degradation if the packaging is breached. As a result, container closure integrity is an important part of the sterile medicine product's lifespan. Patients may be at risk if the container closure integrity is compromised. Drugs that are meant to save lives might lose their effectiveness or cause catastrophic adverse effects. CCI defects might cause oxidation, hydrolysis, or a loss of vacuum, which would have a major influence on the drug's efficacy and shelf life.

MicroCurrent HVLD to assure CCI in parenteral products

The criteria and purpose of the test determine the optimal container closure integrity testing technique. The sensitivity and reliability of the test method, the material of the basic package, and the necessity for inline vs. offline testing are all considerations to consider when choosing the right CCI test method. CCI test procedures such as MicoCurrent HVLD can detect breaches before they become an issue with the product and ensure patient safety.

MicroCurrent HVLD is a non-destructive, highly sensitive technology for parenteral product leak testing. This test technique detects pinholes, microcracks, stopper/plunger leaks, non-visible leaks under crimping, and a variety of other defects by scanning a non-conductive container sealed with electrode probes. A change in current flow indicates the presence of a leak, along with the approximate location of the defect in the container. This is a patent-pending high voltage leak detection technique that has been found to be extremely effective in a variety of applications, including pre-filled syringes, vials, cartridges, ampoules, BFS, bottles, and pouches. Being one of the most effective online CCI testing methods, MicroCurrent HVLD requires very minor infrastructure modifications. This method is non-invasive and does not need sample preparation. It is one of the most effective CCI methods.

What sets MicroCurrent HVLD apart from traditional HVLD technology?

MicroCurrent HVLD, as referenced in USP 1207, is a unique High Voltage Leak Detection Technology for container closure integrity testing. When compared to traditional HVLD solutions, this method uses around 50% less voltage and exposes the product and environment to less than 5% of the voltage. MicroCurrent HVLD is a non-invasive CCI technique that does not require sample preparation, and has a high degree of reproducibility and accuracy throughout. This ground-breaking technique can be applied to a wide range of liquid-filled products including low conductivity sterile water for injection (WFI) and highly proteinaceous pharmaceutical products within suspensions.

Any breach in the sterile packaging systems can cause environmental pollutants to grow, turning a life-saving medicine into a potentially fatal microbial soup. This technology is highly effective across all parenteral and biologic products. At high production speeds, the MicroCurrent HVLD technique is scalable and can easily migrate from offline to 100% inline testing applications. It is a cost-effective online container closure testing solution.

The rapidly increasing preference towards parenteral products continues to fuel innovation, but it also faces distinct challenges in terms of implementing a container closure integrity testing strategy. Parenteral product packaging can be as complicated as the products themselves. To ensure package integrity, CCI testing in accordance with current USP 1207 guidance and regulation is required.

container closure integrity testing, container closure integrity, microcurrent hvld, parenteral product leak testing, cci technologies
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