New York, USA - December 7, 2022 - STEMart, a U.S.-based provider of comprehensive services for all stages of medical device development, has recently introduced Microbial Strain Typing services to fully characterize isolates by utilizing the latest identification and typing strategies without additional capital investment or staff training and performed following the bioburden, environmental monitoring, tissue testing, microbial limits, and on sterility or BI.
During medical device manufacturing, microbial contamination can be derived from many different locations and sources, including human handling, air/particulate matter, water, contact with surfaces, raw materials, and even final products. Since medical devices are risky, comprehensive microbial contamination testing throughout the product lifecycle of medical devices is a critical step in turning innovative designs into reliable and marketable products.
With years of experience in various testing services for Class I, Class II and Class III medical devices, STEMart now offers new Microbial Strain Typing services to customers with unrivaled data from the most relevant reference libraries of bacteria, filamentous fungi, and yeasts. These microbial strain typing services enable laboratories to fully characterize isolates using the latest identification and typing strategies without the need for additional capital investment and staff training.
Some of the identification methods include the Gram Staining and Genetic Identification. Gram staining is usually the first and most important test required in bacterial identification. Meanwhile, this procedure examines isolated colonies in terms of colony morphology, Gram response, and cell morphology. It utilized a purple stain based on crystal violet dye named after the inventor, the Danish bacteriologist Hans Christian Gram. Typical Gram-positive bacteria include Bacillus, Staphylococcus, Streptococcus, and Clostridium, while Escherichia coli, Helicobacter, and Salmonella are Gram-negative. It should be noted that since some bacteria are Gram-variant, they are not suitable for Gram staining.
Meanwhile, Genetic Identification is usually performed along with Gram Staining to ensure a pure culture and to further determine whether the unknown organism is a bacteria or yeast. This technique also provides information regarding phenotypic components, making this identification more comprehensive.
Genetic Identification applies DNA instead of traditional biochemical reactions. To further elucidate, DNA is isolated from the culture for 16S rDNA gene fragment amplification utilizing PCR, and PCR amplicons are purified to remove contaminants. The unknown sequence is then sequenced and compared to the MicroSeq library. In addition, public databases can be searched if no matched sequences are found in the MicroSeq library. Meanwhile, the top ten sequences are selected based on the maximum identity score.
STEMart focuses on delivering the most accurate results in accordance with the relevant microbial database and trending data solutions for the medical device industry. If you have additional questions about Microbial Strain Typing services for medical devices or would like to know more about STEMart's medical device development service, please visit https://www.ste-mart.com.
STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage upward to the manufacturing process. STEMart is dedicated to making research and biotech production simpler and safer in order to enhance access to better health worldwide.