1. The preparation of raw material and container
Prepare for sterile raw powders through sterile crystallization and spray drying, and then use the crushing machine to reduce the big rocks into powder which can be used for injection.
Flask and sealing plastics should be disinfected as the requirements of injection. Flask need to be sterilized at 180℃ for 1.5 hours in dry and heat circumstance, while sealing plastics should be cleaned and dealt with poly and sterilized at 125℃ for 2.5 hours in dry and heat circumstance, they need to be stored in clean air at less than 24 hours after sterilization.
2. Sub-package of sterile powder
Sub-package should be taken through artificial or machine process in a high quality bio-clean room. Packing machinery should be provided with partial laminar flow devices. Every vial must be covered with complete stopper and sealed by aluminum cap immediately after packing.
3. Sterilization and examination of foreign matter
For heat-resistant varieties, suitable supplement sterilization methods are usually preferred to guarantee the safety, while for heat-sensitive varieties, the products won’t be sterilized again so every process should be strictly taken with the requirement of aseptic technique. Foreign matter is generally reviewed by visual inspection on a conveyor belt.