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Antibody & Antigen

Large-scale Production of in Vitro Diagnostic Reagents

1. What does the large-scale production of in vitro diagnostic reagents mean?

Large-scale production refers to the fact that factories are organized and orderly, and mass production is carried out according to a fixed pattern. The general process of large-scale production includes the preparation of resources, manufacturing, quality control and other main processes.

The preparation of materials includes the preparation of human resources, production sites, equipment and utensils, and the relevant documents of the products to be produced, that is, the preparation of materials (raw materials, auxiliary materials, packaging materials, instructions, purified water) used in production; the manufacturing process mainly includes processing, assembly and other processes Process, different types and different dosage forms have different product processes; the quality control process includes production process control and sampling inspection of intermediate products, semi-finished products and finished products.

The quality inspection of raw and auxiliary materials is the basis to ensure the production quality of the whole in vitro diagnostic reagents. Common indicators of raw and auxiliary materials inspection are appearance, purity and impurity content, molecular weight, protein concentration, antibody titer, enzyme specific activity, solubility, pH, etc.

In formal production, it is necessary to issue production instructions and issue standard operating procedures. The production order is a form issued by the planning department to the production site, purchasing, and warehouse to guide the on-site production arrangement. It is the basis for its action and the basis for assessment and inspection. Standard Operating Procedures, or SOPs, are used to refine, quantify, and optimize job quality and efficiency.

2. R&D of in vitro diagnostic reagents to large-scale production

Before R&D to large-scale production, there is still a process of trial production, that is, the pilot test. The purpose is to verify the performance of the formula and production process after the samples are qualified. It is also the training of R&D personnel for production and inspection personnel. and guidance.

Before large-scale production, at least three batches of pilot tests must be carried out, and production can be carried out only after passing the test.

The control of the production process of in vitro diagnostic reagents is the guarantee of the quality of the final product, mainly including material control, traceability and identification, equipment control and maintenance, production key process control management, document control, process change control, verification status control, Control of non-conforming products.

It is also crucial for the inspection of semi-finished products and finished products. The main indicators of semi-finished products inspection include appearance, pH, conductivity, reagent uniformity, stability, difference between bottles, moisture and other indicators. Finished product inspection includes appearance, linear range of loading, precision, accuracy, stability, etc.

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