Follow the principle of aseptic technique to ensure the quality and safety of drugs

The particularity of aseptic drugs determines the high risk in the production process. How to control the quality risk is a problem that aseptic drug manufacturers must face. Therefore, the personnel concerned should maintain the principle of asepsis during the operation and technical process.





For operators, pay attention to appearance before formal operation, wear a hat, trim nails, wash hands, and evaluate the environment to see if it is clean, dry and spacious. Ventilation should be conducted 30 minutes before operation. Stop sweeping and reduce the movement of people to reduce dust in the air. The treatment room is disinfected by ultraviolet lamp irradiation once a day. In addition, wipe the counter, wash your hands and wear a mask.



During aseptic operation, the aseptic area and the non-aseptic area should be defined firstly. The operator should keep a certain distance (20cm) from the aseptic area and should not speak, cough or sneeze in the face of the aseptic area. Sterile holding forceps should be used when taking sterile articles, facing the sterile area. The arm should be kept above the waist or treatment table, and should not cross the sterile area, and should not touch the sterile items. -



Once sterile items are removed, they should not be put back into sterile bags or containers even if they are not used. It is worth mentioning that a set of sterile articles can only be used by one patient. If sterile items are contaminated or are suspected to be contaminated, they should be replaced and re-sterilized.



Industry insiders say there are many violations of aseptic practices in the production of aseptic drugs. For example, used gloves may be misplaced; When changing gloves, the hand that takes off gloves does not go through disinfection to open the door, polluted door handle, door handle became the medium of cross contamination.



Secondly, in the process of production operation, under the laminar flow, the sterilized vial falls down, and when lifted up with tweezers, the arm is stretched on the open vial, which is likely to cause contamination to the vial.



Third, clean area operator has developed intervals for a period of time or the habit of using alcohol to disinfect hands after touching objects, but in practice, such as adding glue plug, take after sterilization equipment, should be disinfected with alcohol hand before operation, but the operator is always used to disinfect with alcohol hand after operation, disinfecting hand grasp the correct time.



Fourth, there are other misdeeds, such as dressing incorrectly, which lead to the dispersal of body particles; Touch surfaces and materials with hands without gloves, and cross hands; Wipe your hair or other body parts with your fingers; Entering the clean room during a cold or other illness; Wear jewelry and watches in a clean room. Use the wrong cleaning material in the clean room.



There are two main reasons for the above illegal aseptic operation. On the one hand, there is no concept of aseptic zone and germ-free zone. Much of the aseptic training is in microbiology and procedures for entering and leaving the clean room. Since it is impossible to be exhaustive in the operating procedures, employees may encounter situations that are not specified in the actual production procedures, because there is no sterile area and the concept of germ-free area, which often violates the principles of aseptic operation.



On the other hand, in case of some minor faults in the equipment, in order to continue the production, the operators will make some abnormal operation actions, because there is no strong concept of asepsis or because of the thought of pressing the completion of the production task, the violation of aseptic operation will occur from time to time.



Clean, experts say, clean room personnel all the code of conduct, must conform to the principle of aseptic operation, any way shall not affect the product aseptic operation, repeated training to operators at the same time, once encounter violation of aseptic operation, should be timely analysis of reasons and in view of the specific reasons for employees to carry out the aseptic operation training.



To ensure the sterility of drugs, we should not only follow the relevant principles in operation, but also improve the relevant awareness of operators. We can establish a mechanism that the interests of operators are linked to the quality of products, so that drugs can be better guaranteed.