Sterilization and leak detection in GMP workshop
Sterilization and leak detection in GMP workshop
Ampoule after filling and sealing in GMP workshop must be sterilized at high temperature to ensure internal quality; the inner wall of the ampoule is washed twice with purified water and water for injection, and then dried and sterilized, and the filling pipe, needle, etc. are washed with water for injection Clean and sterilized; the filling process of each ampoule opening is in a purified environment...
Text label: GMP workshop purification, GMP workshop sterilization, GMP workshop design and installation
GMP workshop sterilization leak detection
Ampoule after filling and sealing in GMP pharmaceutical cleanroom must be sterilized at high temperature to ensure internal quality; the inner wall of the ampoule is washed twice with purified water and water for injection, and then dried and sterilized, and the filling pipe, needle, etc. are washed with water for injection Clean and sterilized; the filling process of each ampoule opening is carried out in a purified environment, but it is impossible to achieve complete sterilization in the ampoule after filling and sealing, so sterilization is an indispensable link in the production of injections; commonly used injections are sterilized. The bacteria equipment is a cabinet-type autoclave sterilization box. The sterilization box has three functions: high temperature sterilization, leak detection, and color flushing.
In order to distinguish and detect unqualified ampoules such as loose glass sealing, cold explosion and capillary holes during the process of filling and sealing the ampoules, usually the water inlet pipe can be opened after the steam sterilization is completed in the ampoules sterilization box. The valve is filled with colored water into the box for leak detection; the ampoules after being sterilized by high temperature steam are hot, and when they meet with colored cold water, a vacuum is generated in the ampoules. Colored water in the sealed ampoules cannot enter the ampoules, thus completing the inspection function of distinguishing the sealing quality of the ampoules, and detecting the ampoules with loose sealing; the methods of adding colored water are: vacuum negative suction method, pumping method, which can be Choose according to the situation; after the ampoules are filled with colored water for leak detection, there will inevitably be colored stains on the surface. Therefore, after filling with colored water for leak detection, the water inlet valve of the water spray pipe must be opened again, and the ampoules should be cleaned and cleaned. Open the door to get out the bottle. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and clean workshops.
The ampoules that have been sterilized and leak-tested are irradiated with light with a certain degree of illumination, and manual or photoelectric equipment can be used to further determine whether there are problems such as rupture, air leakage, overfill or underfill, etc., empty bottles, focus, bubble heads or Unqualified ampoules such as colored spots, turbidity, precipitation and other foreign matter can be rejected. Manual visual inspection mainly relies on the movement of particles in the liquid medicine after the ampoule to be tested is shaken to achieve the purpose of detection. One lamp inspection room can only inspect one type of ampoule. Generally, a 40W cyan fluorescent lamp is used as the light source for inspection, and a baffle is used to cover it. To avoid direct light into the eyes; the background should be black or white to make it have obvious contrast and improve the detection efficiency; when testing, place the ampoule to be tested under the inspection light about 200mm away from the light source and gently turn the ampoule, artificial light inspection requirements The visual acuity of the inspector shall not be less than 0.9. The ampoule foreign body automatic inspection instrument uses the rotating ampoule to drive the liquid medicine to rotate together. When the ampoule suddenly stops rotating, the liquid medicine will continue to rotate for a period of time due to inertia. When the scattered light or projection is generated, the ampoule and liquid images appear on the fluorescent lamp behind; the photoelectric system is used to collect the signal of the size and number of particles in the moving image, and the static interference is eliminated, and then the circuit can be processed directly. The size and amount of the insoluble matter are displayed, and the unqualified ampoules are promptly and accurately removed by mechanical action.
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