The maintenance of APIs mainly includes the following aspects:
Storage conditions: The storage conditions of APIs are crucial to their stability and quality. The storage environment should control temperature and humidity, usually between 10-30°C and 35%-75% relative humidity. For APIs with certain special properties, such as volatile liquids or solid preparations that are susceptible to humidity, lower temperatures and/or lower relative humidity may be required to maintain their stability. In addition, biological products, vaccines, and some specific antibiotics need to be stored in a cold place (2-8°C) to maintain the stability of their active ingredients and extend the shelf life.
Packaging and labeling: APIs should use packaging materials with good moisture-proof and oxidation-proof properties, and choose appropriate packaging specifications according to the properties and uses of the APIs, such as 25kg/bag, 1kg/bottle, etc. The storage conditions and expiration date should be clearly marked on the packaging to ensure that there is no damage or contamination.
Environmental monitoring and adjustment: Use high-precision temperature and humidity sensors to monitor the temperature and humidity changes in the API storage area in real time, and take measures to adjust them. In addition, air cleanliness maintenance and testing are also necessary.
Safety management: Set up a special hazardous goods storage area to ensure that hazardous goods are stored separately from other raw materials. Formulate fire prevention and emergency escape guidelines to ensure safety.
Maintenance technology and methods: For light-sensitive and perishable APIs, they should be kept away from light and placed in dark light-shielding containers. Drugs with special odors and odors should be stored in separate cabinets from drugs with strong adsorption to prevent mutual odor.
Maintenance of special drugs: Biological products, organ products, and vaccine serum products should be sealed and stored in a cool, dark place. If necessary, they can be stored in a refrigerator or cold storage.
