Achieve right the first time
Used in top pharmaceutical companies worldwide, the MicroSEQ™ Rapid Microbial Identification System is ideal for environmental monitoring, contamination investigation, root cause analysis, raw materials testing, and microbial identification in small molecule and biopharmaceutical manufacturing, and service laboratories. It can also be used in public health laboratories, cosmetics and personal care products manufacturing, food testing laboratories, and academic and research centers.
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Why is Microbial Identification Important?
Harmful bacteria and fungi can contaminate raw materials, production facilities, and branded products. Regulatory expectations include accurate identification of environmental isolates to support active environmental monitoring programs within pharmaceutical manufacturing environments as part of cGMP, and to implement accurate Corrective and Preventive Actions (CAPAs) for products and processes to reduce the risk of contamination. The US, European, and Japanese Pharmacopeia guidelines recommend genotypic microbial identification of bacteria and fungi at the species level. The comparative gene sequence analysis of ribosomal DNA (rDNA) has been shown to have the highest accuracy of microbial identification system technologies and has been considered the gold standard for microbial identification for over a decade.
Where to test for Bacteria & Fungi?
MicroSEQ Rapid Microbial Identification System Featuring the 3500 Genetic Analyzer
Go Molecular. The Answer Is in the DNA
It's time to take microbial identification to the next level. It's time to partner with the proven leader in rapid molecular methods. It's time for the MicroSEQ Rapid Microbial Identification System in your QC Microbiology lab. Built on years of molecular expertise, this system delivers unparalleled accuracy and time to results for bacterial and fungal identifications in one easy-to-use platform.
- Accurate genotypic bacterial identification based on the 16S rRNA gene
- Accurate genotypic fungal identification based on the D2 region of the 26S rRNA gene
- Easy workflow, high throughput, accurate results typically in less than five hours
- Fully validated and implemented in as few as four months
- Enables 21 CFR Part 11 compliance
Step-by-Step Guide to Microbial Identification & Detection Products
Extract DNA from bacteria or fungi using the PrepMan™ Ultra sample preparation reagent. Your sample can be a single colony or a pure culture. The ideal colony size is 1-2 mm for bacteria and 3 mm for fungi. The DNA you extract in this step will be your template for the PCR step.
Use the MicroSEQ ® Microbial PCR Kit that matches .your needs. Each kit contains reagents for amplification (PCR) reactions. Run the reactions on the Veriti 96-Well thermal cycler. Clean up the PCR products for the subsequent step using the MicroSEQ® clean-up kits.
Use the MicroSEQ ® Microbial Sequencing Kit that matches .your needs. Each kit contains reagents for cycle sequencing reactions. Run the reactions on the Veriti 96-Well thermal cycler. Clean up the products for the subsequent steps using the MicroSEQ® Clean-up kits. Next, sequence your sample automatically by running it on a genetic analyzer (DNA seqeuncer). Choose the system configuration that meets your throughput needs.
Overcome critical implementation challenges in the qualification of instrument and operation quality (IQ/OQ) through a collaborative partnership with Applied Biosystems.
- Consultation with client to determine needs
- Statement of work to define project
- Detailed verification test plan and documentation
- System installation verification
- Sequence of system operations qualification
- Microbial identification verification
- Accuracy report
- System software installation and security verification
- Software exporting, importing, archiving and verification
- Phylogenetic tree and custom library verifications
- Detailed data analysis and review
- Consultation on experimental process and results
- Performance Qualification (PQ) recommended guidelines
Customize laboratory design and training to the specific needs of your lab, with the aim of completing Performance Qualification (PQ) within the six-month timeframe of the program.
- MicroSEQ® Microbial Identification System
- MicroSEQ ID IQ/OQ Service, Implementation & Training
- MicroSEQ® ID 2.2 500 BP Library
- MicroSEQ® ID 2.2 500 BP Library Validation Statement
- Solutions for the Biopharmaceutical Industry
- MicroSEQ® Rapid Microbial Identification System
- MicroSEQ® ID - Own Your Own Data Tech Note
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