In the in vitro diagnostics (IVD) industry, the stability of reagent raw material properties is key to ensuring diagnostic results. Whether it is chemiluminescence reagent raw materials used for clinical testing or molecular diagnostic reagent raw materials, small fluctuations in their performance may lead to deviations in test results. Therefore, how to improve the stability of IVD reagent raw material performance has become an important issue of concern for enterprises and researchers in the industry.

(Biological buffer CAPS)

Strictly control the procurement process of raw materials

1. Selecting reliable suppliers: The quality of IVD reagent raw materials needs to be strictly controlled from the source of procurement. Enterprises should establish a comprehensive supplier evaluation system to assess the qualifications, production capacity, technical level, quality management system, and other aspects of potential suppliers. When selecting a biological raw material supplier, focus on their cell culture technology, raw material extraction process, and biological properties; For chemical raw material suppliers, the stability of their synthesis process and the purity of the raw materials need to be examined. By conducting on-site inspections, sample testing, and other methods, we select suppliers with good reputation and reliable product quality to reduce raw material quality risks from the source.

2. Strengthen raw material acceptance management: Establish strict raw material acceptance standards and processes, and conduct sampling and testing on each batch of raw materials. The testing content includes key indicators such as appearance, purity, activity, acidity and alkalinity of the raw materials. For bioactive raw materials, it is also necessary to test whether their biological activity meets the standards. Utilize advanced detection equipment such as liquid chromatography (HPLC) and mass spectrometry (MS) to accurately detect raw materials.

Optimize production processes and equipment

Enterprises should continuously explore and optimize production processes, adopting advanced production technologies and methods. In the synthesis process of chemiluminescence reagent raw materials, accurately control parameters such as reaction temperature, time, reagent addition sequence and quantity to ensure consistency in the synthesis process of each batch of products. Introduce automated production equipment and control systems to reduce human interference in the production process, and improve the stability and controllability of the production process.

Strengthen quality control in the production process

Develop detailed and standardized production operating procedures, with clear regulations for every step of the production process, from raw material ratio, reaction control to product separation and purification. Strengthen training for production personnel to familiarize them with and strictly adhere to operating procedures. Establish a production process recording system to provide detailed records of key parameters and operational steps during the production process, facilitating traceability and analysis. By standardizing the operating procedures, we ensure that the production process of each batch of products is consistent and improve the stability of product quality.

Improve the quality inspection and traceability system

Establish a comprehensive quality inspection system to conduct multi-level and multi-dimensional testing on IVD reagent raw materials. Strict quality inspections are conducted before raw materials are stored, during the production process, and before finished products leave the factory. Using advanced testing technology and equipment, various performance indicators of the product are tested to ensure that the product quality meets the standards. For unqualified products, they will not be released and the reasons will be analyzed and dealt with to prevent unqualified products from entering the market.

(Luminescent reagent acridine ester)

In terms of improving the stability of IVD reagent raw material performance, Hubei Xindesheng Company has strictly controlled the raw material procurement process since its establishment, established long-term stable cooperative relationships with reliable suppliers, and ensured reliable raw material quality; Continuously optimizing production processes, introducing advanced production equipment and technology, and achieving automated control of the production process; Strengthen quality control in the production process, establish standardized operating procedures and a strict environmental monitoring system. With these measures, the IVD reagent raw materials produced by Xindesheng have stable performance and have won the trust of many customers in the market. At present, a full range of products including biological buffering agents, luminescent reagents, chromogenic reagents, enzyme raw materials, and blood collection tube additives are available for sale. If you have purchasing needs, please feel free to click for consultation at any time!