The pharmaceutical freeze dryer is a technology that uses the principle of travel to perform monotony. It freezes the monotonous substances quickly at low temperature, and then in a suitable vacuum environment, the frozen water molecules travel directly to become water vapor and escape. The process. The resulting product is called lyophilisate, and the process is called lyophilization.
The quality requirements for freeze-dried products are: unchanged biological activity, uniform appearance and color, full shape, strong structure, fast dissolution rate, and low residual moisture.
To obtain high-quality products, one should have a more comprehensive understanding of the theory and process of freeze-drying. The lyophilization process consists of three stages: pre-freeze, travel, and re-lyophilization. Reasonably and effectively shortening the freeze-drying cycle has significant economic value in industrial production.
The pharmaceutical freeze dryer has a set of standardized processes when cleaning, let's take a look:
1. Cleaning preparation
1. Cleaning tools: sterilized cloths that do not shed fibers and particles, sterilized tweezers, brushes, pegs, cleaning cloths.
2. Preparation of cleaners and disinfectants:
Detergent preparation: Measure 10,000 ml of purified water in a bucket rinsed with purified water, add an appropriate amount of detergent, stir evenly, filter through a 0.22m filter membrane into a sterilization container, and seal it for later use.
Preparation of 75% ethanol solution: Take 4000 ml of 95% ethanol and add it to 5066 ml with water for injection, then filter it with a 0.22m filter membrane into a sterilized light-mouth bottle for later use.
Cleaning water: water for injection.
Second, the cleaning process
1. Daily cleaning and disinfection
The operator wipes the surface of the rear box with a cleaning cloth every day, and wipes the place with oil stains with detergent;
The door of the front box is in a sterile room, and the potting personnel should clean it. Use tweezers and brushes to put the missing ampoule on the freeze-drying box board into the tweezers, and dispose of them according to the production waste disposal procedures;
Wet the ultra-fine cloth with 75% ethanol solution, wipe the surface of the front box, the shelf in the box, and the surrounding of the box, and spray, leave it for 10-20 minutes, close the box door and stand by.
2. Cleaning and disinfection during weekly cleaning or maintenance
Disinfect the front box of the freeze dryer according to the ozone disinfection and sterilization procedures in the clean area;
After the ozone disinfection is completed, first remove the residues on the surface of the box, and then clean and disinfect the freeze-drying box according to the above regulations.
3. Evaluation of cleaning and disinfection
The surface is required to be free of grease, foreign matter, clean and bright.
4. After the inspector confirms that it is qualified, sign the record and put the freeze dryer on the status mark.
5. Cleaning and storage of cleaning tools
Thoroughly clean the sterilizing cloth, tweezers, and brushes used for cleaning with detergent, rinse with purified water, sterilize them, and store them in the clean room in the clean area. After the pinch is rinsed with water, wipe it with a detergent, and then disinfect it with a disinfectant.