EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 20688 testing. This standard specifies minimum requirements for the production and quality control of synthesized oligonucleotides (nominally up to 250 bases).
This standard also describes general quality characteristics for synthesized oligonucleotides, as well as common methods for evaluating quality characteristics.
The quality and consistency requirements of synthetic oligonucleotides depend on their intended use. For example, in a polymerase chain reaction (PCR) or a microarray or NGS, the quality requirements of primer and probe are significantly different. Generally, users are responsible for determining the quality requirements of the oligonucleotides for their particular application.
A quality policy and quality objectives will be established for the order taking process. Quality requirements for users may vary depending on their intended use, the design of their experimental method, and the potential for results to affect reproducibility and reproducibility. Based on the quality policy, quality objectives, and grades of synthetic oligonucleotides clearly stated in the order forms process, the manufacturer should monitor with tools such as process checklists whether production is carried out in accordance with appropriate processes. In addition, necessary actions should be taken in the production processes in order to reach the planned results with the measurement and analysis of the quality of the produced synthetic oligonucleotides.
The manufacturer should adopt a quality management system. The quality management system should establish the necessary procedures and ensure that production control is carried out based on the established procedures. The quality management system should regularly check that synthetic oligonucleotide production based on this standard is carried out correctly.
The acceptable degree of impurity or range of a given oligonucleotide for a particular intended use should be determined and agreed upon between the manufacturer and the user. In general, impurity is the amount of oligonucleotide that interferes with its intended use. The degree of impurity should be determined using an appropriate method.
EUROLAB assists manufacturers with ISO 20688 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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