Rapid Sterility and Mycoplasma Solutions

Element understands the importance of providing results expeditiously and with priority - and we have the Rapid Microbial solutions you need. Whether you require rapid mycoplasma testing, rapid sterility testing, or both, we provide the timely services needed to ensure the safety and quality of your product. 

What is rapid mycoplasma testing? 

If you are a cell and gene therapy manufacturer, you are aware of the critical role mycoplasma testing has on the quality and safety of a product. Mycoplasma are difficult to detect but have dire consequences for a product. USP guidelines require that manufacturers of biotechnological products, and materials used to generate those products, are tested for mycoplasma. The use of cell lines also requires this crucial testing. Although the testing is necessary, regulations dictate a minimum total incubation time of at least 14-28 days. This timeline requirement can cause production to halt, and worse – jeopardize lives. 

The Rapid Mycoplasma testing Element employs presents several advantages. With Rapid Mycoplasma testing, results are sent to you as soon as the same day the sample is submitted. In addition to the speed of testing being reduced, the volume of product needed for testing is also typically less. Although this may seem too good to be true, the use of rapid PCR makes this testing possible. With rapid PCR, the DNA of any mycoplasma contaminant is amplified and detected in a product. This method is especially sensitive, detecting living and/or dead mycoplasma – a feature that the standard USP <63> Mycoplasma Tests method lacks. The sum of these advantages can be critical to intervention and remediation of contamination.

What is rapid sterility testing? 

There are many products that require both mycoplasma and sterility testing, and many that only require sterility testing. If you require USP <71> Sterility Tests, Rapid Sterility may be a solution for you. Sterility testing per USP <71> has a standard incubation time of 14 days, and 18 days if a sample requires subculture. With Short Shelf-Life products, ATMPs, and compounding pharmacies, this amount of time can be costly and present risk to the end-user. Element has a solution to this problem.

With Rapid Sterility, we can test your product the same day, and have valid negative results in as few as 7 days. Positive results may be available much sooner – critical to intervention . Element can test your material or short shelf-life product, up to 10mL, with speed and reliability. If you require sterility testing for your ATMP, or simply sterility results quickly – Element can provide those results with a Turn Around Time the same day that results become available – 7 days from testing.

Element utilizes an automated system that detects microbial contamination through respiration. The method utilizes direct inoculation, and samples incubate at the temperatures outlined in the USP <71> Sterility Tests method. Not only is this system advantageous to timelines, its automated system ensures detection at 7 days when visual inspection via the standard method may not be possible.

Key benefits of using Element for Rapid testing needs

• Time sensitive solutions - You can rely on Element to meet the demands of your time sensitive testing as well as important deadlines. We understand that your production timelines may be irregular and therefore offer Rapid Testing – available even on weekends and holidays. With faster results, you may save time, money, and even lives.
• Innovative technology - The methods and equipment we utilize are innovative technologies, and more importantly, validated. Timelines are met through rigorous testing, using state of the art, USP recognized technology. Outstanding customer service - Element understands the importance of customer service and communication. We handle each sample and each test with quality and care. You can count on us to be timely and communicative in our correspondence and in delivering your results to you. We are willing and happy to meet and chat online and in person, with tours of our lab available to you as well. 
• Extensive testing network - Element offers several GMP services outside of rapid testing. You can rely on us to perform your quality and analytical testing, all with Element's dedication to quality and service – without having to go to multiple providers. We can perform testing for most, if not all, parts of your process. 

Our range of related services:

• Microbiology - GMP Services
• Endotoxin Testing
• Media Fill Sterility Testing / Growth Promotion
• Non-sterile product testing (bioburden, absence of organism)
• Water for pharmaceuticals testing (USP <1231>)
• Incubation and enumeration
• Microbial ID
• Custom Methods
• Virology
• Disinfection Qualification

Environmental Monitoring

• GMP (ISO 4 - ISO 8) and Compounding (air, surfaces, non-viables)
• Utility testing (for gases: particles, moisture content, for water systems: microbial and chemical)
• Isolator, equipment, glove and personnel monitoring

Why Choose Element

Element offers rapid microbial testing solutions that deliver results when you need them most. Our cutting-edge technology, including rapid mycoplasma and sterility testing, provides accurate results in days, not weeks. Don't let testing delays hinder your progress.

Let Element be your partner in ensuring product safety and quality. Reach out and connect with us to learn more about our rapid microbial services, or additional pharmaceutical testing services.