Rapid Sterility and Mycoplasma Solutions
Accelerate your pharmaceutical and biotechnology testing with Element's Rapid Sterility and Mycoplasma Solutions. Get results in as little as 1-7 days versus 14-28 days with traditional methods. Our cutting-edge PCR technology detects critical contaminants with smaller sample volumes, minimizing production delays and potential risks.
What is rapid sterility and mycoplasma testing at Element?
Rapid Sterility and Mycoplasma Testing is a critical quality control process for detecting microbial contamination in pharmaceutical and biotechnological products. At Element, we provide rapid PCR-based testing that goes beyond traditional methods, detecting both living and dead mycoplasma to ensure the highest standards of product safety and quality. Our advanced technologies significantly reduce testing timelines from the traditional 28 days to as little as same-day results for mycoplasma testing.
What can Element offer you for rapid sterility and mycoplasma solutions?
Products we test
Products we test
We deliver comprehensive testing for cell therapies, biotechnological products, pharmaceuticals, ATMPs, and compounded medications. With our Rapid Sterility testing, we can handle your materials and short shelf-life products at unrivalled speeds – we can test on the same day we receive the sample, with mycoplasma testing results available that same day and sterility testing results in as few as seven days.
Key tests offered
Key tests offered
We provide a comprehensive suite of tests for manufacturers of biotechnological products:
- Rapid Mycoplasma Testing
- Rapid Sterility Testing
- USP <71> Sterility Tests
- USP <63> Mycoplasma Tests
- PCR-based contamination detection
What is Rapid Mycoplasma Testing?
Rapid mycoplasma testing is essential for cell and gene therapy manufacturers to ensure product safety. Unlike traditional methods that take 28 days, Element's rapid PCR test delivers results within a day. It detects both living and dead mycoplasma by amplifying DNA, identifying contaminants that can cause cell line mutation, aberrant growth, and degraded products. This enables faster intervention and reduces production delays, particularly critical for time-sensitive and high-value products.
What is Rapid Sterility Testing?
For products requiring sterility testing, Element offers Rapid Sterility testing, cutting incubation time from 14-18 days to just 7 days for valid negative results, with positive results potentially available even sooner. Using an automated system that detects microbial contamination via CO2 produced during respiration, this method ensures faster, reliable results, especially for short shelf-life products and ATMPs.
Methods and solutions offered
Methods and solutions offered
We offer the fastest turnaround times in the industry without compromising on test reliability – our solutions include detecting contaminants that traditional methods might miss, with rigorous validation and comprehensive support.
Our experts deliver automated microbial detection through respiration, direct inoculation, and innovative PCR technologies, with testing available every day of the week -- even on weekends and holidays to accommodate irregular production schedules. By offering you faster results, we can help you to save time, money, and even lives.
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
- USP <1223> compliant comparability studies
Cutting-edge equipment we use
Cutting-edge equipment we use
Our expert testers use state-of-the-art technology, which for mycoplasma and sterility testing includes validated USP-recognized technologies and cutting-edge PCR equipment, that amplifies DNA to detect both living and dead mycoplasma. We use BacT/ALERT®, the first fully automated, growth-based, dual-temperature microbial detection system. with high sensitivity for microbial contamination through CO2 production during respiration.
Which labs offer this service
Which labs offer this service
Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.
Standards we test to and materials we test
- Pharmaceutical Products
- Biotechnological Materials
- Cell and Gene Therapy Products
- Advanced Therapy Medicinal Products (ATMPs)
- Compounded Medications
- Biological Samples
- Manufacturing Materials
- Pharmaceutical Water Systems
- Cell Lines
- Research and Development Materials
Your Challenges, Our Solutions
Prolonged Testing Timelines
Product Safety and Quality Risks Advanced Detection
High Sample Volume Requirements
Regulatory Compliance Challenges
Why Choose Element
Comprehensive and Customer-Centric
Time-sensitive solutions
Innovative technology
Extensive testing network
8,500+Global Experts
1-7Day Rapid Testing
10mL Sample Capacity
190+Years of Making Certain
Frequently asked questions
What makes your testing different from standard methods?
We use advanced PCR technology that amplifies DNA to detect both living and dead mycoplasma, and our sterility testing uses an automated system that detects microbial contamination through CO2 production during respiration. These methods offer more comprehensive and faster contamination screening than traditional approaches.
How quickly can Element provide test results?
Our Rapid Mycoplasma testing can provide results on the same day samples are submitted, while our Rapid Sterility testing delivers results in as few as seven days, with positive results potentially available even sooner. This is significantly faster than traditional 14-28 day testing methods.
Explore our global network of labs and find your nearest location
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