In the in vitro diagnostic (IVD) industry, the quality of in vitro diagnostic reagent raw materials directly affects the performance of finished diagnostic reagents and the accuracy of test results. As a key link in ensuring the quality of these raw materials, the importance of cold chain management is self-evident. From the production, storage to transportation of raw materials, every link cannot be separated from the accurate control of cold chain technology.

(Glucose dehydrogenase)

The Importance of Cold Chain Management

1. Ensure raw material activity: Many IVD reagent raw materials, enzymes, antibodies, antigens and other bioactive substances are extremely sensitive to temperature. Enzymes may undergo denaturation and lose catalytic activity in high-temperature environments, resulting in inaccurate catalytic reactions of subsequent diagnostic reagents during the detection process, which affects the accuracy of the detection results. At inappropriate temperatures, the structure and immune activity of antibodies and antigens can also be disrupted, reducing their specific binding ability to target substances and increasing the false positive or false negative rate of detection. Through strict cold chain management and temperature control within an appropriate range, the biological activity of these raw materials can be maintained, ensuring their normal function in the production of diagnostic reagents.

2. Extending the shelf life of raw materials: A suitable low-temperature environment can slow down the chemical reaction rate of raw materials, inhibit the growth and reproduction of microorganisms, and thus extend the shelf life of raw materials. Some chemical raw materials are prone to oxidation, decomposition, and other reactions at room temperature, leading to a decrease in quality. Under cold chain conditions, the progress of these reactions will be greatly slowed down, allowing the raw materials to maintain a stable quality state for a longer period of time. This helps reduce the waste of raw materials and ensures that downstream enterprises always meet production requirements when using raw materials, improving production efficiency and product quality.

Key links in cold chain management

Transportation is one of the challenging links in cold chain management. During the transportation of raw materials, professional cold chain transportation equipment such as refrigerated trucks and insulated boxes should be used. Refrigerated trucks or refrigerated packaging must have good insulation performance and stable refrigeration to ensure that the temperature remains within the specified range during long-distance transportation. The insulated box needs to be reasonably equipped with refrigeration media such as ice packs based on transportation time and ambient temperature.

Problems and Countermeasures Faced by Cold Chain Management

Every aspect of cold chain management relies on the operation and management of professional personnel. If the staff have insufficient knowledge of cold chain and operate improperly, it is also easy to cause cold chain accidents. Enterprises should strengthen training for employees, enhance their awareness and professional skills in cold chain management. The training content includes operating methods, temperature anomaly handling procedures, storage and transportation requirements for raw materials, etc. Through regular assessments and supervision, ensure that employees can strictly operate in accordance with cold chain management standards, reducing the impact of human factors on raw material quality.

(Acridine salt NSP-SA-NHS)

In the cold chain transportation of IVD in vitro diagnostic reagent raw materials, such as enzyme substrates and luminescent reagent substrates, Xindesheng adopts professional cold chain transportation to avoid temperature interference with the products, which is highly favored by customers. With a sound cold chain management system and a persistent pursuit of product quality, Hubei Xindesheng provides high-quality and stable in vitro diagnostic reagent raw materials for the IVD industry, and is also a trusted partner for many IVD enterprises. If you have purchasing needs, please feel free to click on the website to inquire about details at any time!