Industry Solutions
Biopharmaceutical laboratories usually include physical and chemical laboratories and microbiology laboratories; The physical and chemical laboratory USES physical and chemical methods to identify raw and auxiliary materials, packaging materials, intermediates and finished products for production, analyze and test the content. Generally, the microbiology laboratory carries out the verification of microbial test methods, sterility test, microbial limit test, microbial test of antibiotic titer, penicillin enzyme and its activity test. Main testing items: 1. Drug composition testing; 2. 2. Routine physical and chemical testing; 3. Microbial detection; 4. Heavy metal detection; 5. Auxiliary materials testing; 6. Character detection; 7. Identification test; 8. Allergy test; 9. Hemolysis test; 1. The design should understand the inspection process, the nature of the process, and the provisions of relevant standards and specifications, etc., and reasonably arrange the corresponding microbial inspection functions according to the production varieties and inspection workload of the drug manufacturer. 2. Quality control laboratories should generally be separated from production. Laboratories for bioassay, microbiology and radioisotopes shall also be separated from each other. 3. To avoid cross contamination, sufficient area should be provided for sample disposal, sample retention, sample stability inspection and record preservation.
