AEMTEK is your trusted partner in microbial challenge testing services for Medical Device and Pharmaceutical Packaging companies. Our expertise lies in helping our clients ensure the integrity and quality of their products through comprehensive microbial challenge testing.
AEMTEK offers two main types of microbial challenge testing: aerosolized microbial challenge testing and liquid immersion microbial challenge testing. These methods allow us to thoroughly evaluate the microbial barrier properties of various devices and package types, ensuring the highest standards of product protection.
Microbial challenge testing plays a crucial role in the assessment of pharmaceutical packaging and medical devices. Its primary objective is to determine the packaging’s ability to prevent the entry of microorganisms, thereby maintaining the sterility and integrity of the products throughout their lifecycle.
Formerly known as the Container/Closure Integrity Test (CCIT), our microbial challenge testing services are applicable to any non-porous barrier system that safeguards pharmaceutical products from environmental contamination.
By choosing AEMTEK for your microbial challenge testing needs, you can trust in our commitment to delivering accurate and reliable results, enabling you to meet regulatory requirements and ensure the safety and efficacy of your products.
Contact us today to learn more about how our microbial challenge testing services can support your pharmaceutical packaging and medical device quality assurance efforts.
Microbial challenge testing is needed for pharmaceutical packaging and medical devices in various scenarios:
Testing is necessary during the development phase of a product and when significant changes occur in the package system that could impact its integrity. This includes modifications to package design, materials, and manufacturing processes. Through microbial challenge testing, manufacturers can verify the ongoing efficacy of their package system.
In situations where physical test methods are impractical or lack the required sensitivity, microbial challenge testing becomes essential. For instance, certain closures or packages that rely solely on complex pathways to prevent airborne microbial ingress may not be adequately evaluated using physical methods like vacuum decay or tracer gas techniques.
Manufacturers may opt for microbial challenge testing if they lack the resources or expertise to develop and validate an alternate physical test method. Microbial challenge testing provides a reliable and standardized approach without requiring extensive resources for method validation.
For products intended for limited distribution, where a comprehensive physical test method validation program may not be warranted, microbial challenge testing provides a suitable approach. It enables the assessment of the packaging's microbial barrier qualities in a practical and effective manner.
Aerosolized microbial challenge testing involves placing product-filled or media-filled packages into a specially designed aerosolization chamber. The chamber is then filled with a nebulized cloud (or aerosol) of microorganisms for a specific amount of time. During the challenge test, the package may be subjected to different challenges to simulate real-world conditions. After being exposed to the challenge conditions, the media is incubated and subsequently examined for microbial growth. If the packages were filled with product, the package contents are exposed to media, which is then incubated and examined for microbial growth.
Aerosolized microbial challenge testing is particularly suitable for sterile pharmaceutical packages that rely on tortuous paths or barrier seals to maintain package integrity and cannot tolerate liquid immersion testing.
Aerosolized microbial challenge testing is particularly suitable for sterile pharmaceutical packages that rely on tortuous paths or barrier seals to maintain package integrity and cannot tolerate liquid immersion testing.
To guarantee consistent and precise results, our aerosolization chamber is equipped with fine adjustments and advanced monitoring systems, including pressure gauges and flow meters. It maintains strict humidity and temperature ranges, ensuring optimal air circulation and minimizing any potential variations between testing runs.
In addition, we incorporate positive controls as an integral part of our testing methodology. These controls are included to validate the sensitivity of the test and demonstrate the expected growth response, further ensuring the accuracy and reliability of our results.
Aerosolized microbial challenge testing is a qualitative evaluation, specifically focusing on detecting the presence or absence of microbial growth.
The time needed to complete this testing varies depending on the specific microbial challenge and incubation conditions. Usually, the exposure time lasts a few hours, followed by an incubation period of several days. These timeframes are carefully planned to ensure a thorough assessment of the results, providing accurate and reliable findings.
Liquid immersion microbial challenge testing involves submerging filled package units in a liquid containing microorganisms for a specific period. Then, the units are removed, rinsed, and incubated to examine microbial growth. Nutritive growth media is typically used, but in some cases, the product itself can be used if it doesn’t impede microbial growth. During immersion, the package may experience high-pressure conditions to simulate real-world situations during product processing or distribution.
Our liquid immersion microbial challenge testing is suitable for sterile pharmaceutical packages that can withstand being immersed in a liquid containing microorganisms.
At AEMTEK, our comprehensive testing process involves assessing the concentration of microorganisms in the challenge suspension and determining the compatibility of the media or product inside the container with microbial growth.
To ensure the reliability and sensitivity of our test, we also incorporate positive controls. These controls are included to clearly demonstrate expected growth as a point of comparison.
Through our rigorous approach, we are able to effectively identify and assess any potential microbial ingress, providing you with dependable results for the assessment of your product’s microbial barrier.
Liquid immersion microbial challenge testing is a qualitative evaluation, specifically focusing on detecting the presence or absence of microbial growth. Our commitment to precision means that we meticulously ensure sufficient bacterial growth, evident through the media becoming visibly turbid or detectable via analytical methods.
The duration of exposure during testing can vary, ranging from a few minutes to several hours. Following the exposure, the typical incubation period lasts between 7 and 14 days.
At AEMTEK, we have the necessary equipment, knowledge, and experience to conduct both aerosolized microbial challenge testing and liquid immersion microbial challenge testing. Our team of experts is committed to helping our clients develop and execute integrity assessment strategies throughout the different phases of a product’s life.
When it comes to evaluating the microbial barrier qualities of medical devices and pharmaceutical packaging, AEMTEK is your go-to partner. Contact us today to discuss your testing needs and ensure the integrity and quality of your medical devices and pharmaceutical products.
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Analyses are performed using various rapid and classical methods, including the FDA Bacteriological Analytical Manual (BAM), the Compendium of Methods for the Microbiological Examination of Foods, the APHA Standard Methods for the Examination of Dairy Products, and the AOAC International Official Methods of Analysis. We employ rigid quality assurance guidelines in all testing. We offer modern rapid methods of analysis for reliable, timely results. Reports are electronically generated in a user-friendly language and format. In addition, our scientists are always ready to answer your questions and address your concerns.
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