In the whole process of biomedicine, the packaging is the final stage of the finished product and the external contact. The sterility detection of the laminar flow hood of the working environment can directly play a fundamental role in the quality of the drug product. The sterility testing of the packaging environment is a key step to ensure that the packaging products meet the sterility testing production and manufacturing regulations, and the various sterilization procedures implemented in the packaging room are the key to ensure the environmental sterility testing. This test evaluates the actual effects of the three sterilization countermeasures implemented in the sub-assembly room to clarify whether the implementation of this kind of implementation can meet the relevant requirements and to provide a strong guarantee for the production of sterility testing.
1 Raw materials and methods
1.1 Raw materials test Raw materials: salt water, indoor formaldehyde, potassium permanganate solution, 84 disinfectant, ethanol. Experimental equipment: floating dust particle detector, constant temperature incubator, petri dish, cotton ball, open basin.
1.2.1 Indoor formaldehyde sterilization:
(1) Disinfection method: Divide the average value in the sub-packaging workshop into 10 sterilization dosing points, put an open pot at each dosing point, turn off natural ventilation and add a 1:3 potassium permanganate solution to the pot And indoor formaldehyde, then closed production workshop to carry out sterilization; the sterilization time is respectively controlled at 6 hours and 12 hours, and the closed type achieves a specific time after natural ventilation, and the sterilization is completed.
(2) Detection method: After indoor formaldehyde sterilization, it is evenly proportioned in the sub-packaging production workshop. Place 10 beef extract peptone culture medium plates, and then open it for 30 minutes. Place the plate in a constant temperature incubator for 24 hours, observe and record the number of bacterial colonies in the plate, repeat 3 times.
Laminar flow hood
1.2.2 Ultraviolet sterilization of stainless steel transmission window:
(1) Sterilization method: The external transmission objects are placed in the stainless steel transmission window and the doors and windows are closed. The ultraviolet sterilization lamp can be passed on to the aseptic workshop after 30 minutes of sterilization.
(2) Detection method: After closing the stainless steel transfer window that has been opened from the outside, the ultraviolet sterilization lamp sterilizes separately for 15min and 30min;; Place beef extract peptone culture in the stainless steel transfer window after the ultraviolet sterilization lamp sterilization Liquid level for I30min, then put the plate in a constant temperature incubator for 24 hours, observe and record the number of bacterial colonies in the plate, repeat 3 times each.
1.2.3 Gas laminar flow hood:
(1) Operation method: Before entering the aseptic workshop. Before working, the gas laminar flow hood in the working area should be opened 1h earlier to start air filtration.
(2) Detection method: Open the air flow hood for 30min and 1h before the inspection, and use the floating dust particle detector to test the number of floating dust particles under the gas laminar flow hood, and repeat 3 times each.
2 Results and analysis
2.1 Indoor formaldehyde sterilization test results of bacterial cell counts. After 6 hours of indoor formaldehyde sterilization, several sampling points can still detect ultra-standard sedimentation bacteria, indicating that the actual effect of ideal sterilization cannot be achieved when the sterilization time is insufficient. Indoor formaldehyde sterilization should be carried out 12h sterilization according to specifications.
2.2 The actual effect of ultraviolet sterilization of stainless steel transfer window. It can be seen that no sedimentation bacteria are detected in the stainless steel transfer window after 30 minutes of ultraviolet sterilization, and there are more sedimentation bacteria in 15 minutes of ultraviolet sterilization. According to the information displayed on the material, ultraviolet sterilization can ensure sterility detection continuously for 5 hours, so objects can be removed in the aseptic workshop after sterilization 30 minutes without air pollution.
2.3 The test results of the number of floating dust particles under the gas laminar flow hood are based on relevant specifications. The number of 0.5μm floating dust particles in thousand-level areas cannot exceed 3,500, and 5μm floating dust particles cannot appear. Most of the microbial species in the air adhere to dust particles ≥0.5μm, and most of the bacteria have a diameter of 0.5~5μm, which is basically all in the air. It adheres to the floating dust and produces a potential of 5~10μm in size. Sexual particles are floating.
Under the condition that the laminar flow hood is opened for 30 minutes, the floating dust particles in the thousand-level area cannot be completely discharged, which cannot meet the specified specifications; the discharge of the floating dust particles in the thousand-level area after the laminar flow hood is opened for 1 hour meets the regulations.