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  • 預裝培養基平皿的使用說明

    發布時間:

    2022-12-27

    作者:

    國內做培養基廠家


    成品預裝培養基平皿是用于獲得微生物純培養的最常用的固體培養基,它是冷卻凝固后的固體培養基在無菌培養皿中形成的平面。培養基平皿常用于單孢分離、測定菌絲生長速度、觀察菌落的形態、拮抗實驗、測定潔凈空間及表面的污染水平。
     
    潔凈區沉降菌的監測依據《醫藥工業潔凈室(區)沉降菌的測試方法》現行國家標準進行;浮游菌的監測依據《醫藥工業潔凈室(區)浮游菌的測試方法》現行國家標準進行。下文著重介紹平板在潔凈環境中的使用。
     
    培養基平皿進出潔凈區
    1將從倉庫領入的預裝培養基平皿在脫外包間脫去外包,若是真空包裝,需仔細檢查包裝是否漲袋,若漲袋請勿傳進潔凈區使用;
    2用消毒劑消毒外表面,放入傳遞窗或傳入物流緩沖間,接著紫外燈照射10~15min或根據公司文件規定操作;
    3消毒完后,從潔凈區(D級或C級區)一側小心拿出培養基平皿;
    4如果需要在B級區使用,再脫一層包裝傳入B級區;
    5如果需要在A級區使用,再脫一層包裝傳入A級區;
    6收集取樣后的培養基平皿,做好取樣信息標記,傳出潔凈區,及時放進培養箱培養,保證檢測結果準確;
    7打開包裝后未使用的培養基平皿用備用呼吸袋(一般培養皿廠家提供)包裝好,做好標識,存放在潔凈區,下次取樣可以使用。
     
    從平板進入潔凈區的流程可以看出,實驗室自制培養皿如果沒有特別的保護,不能用于潔凈區環境監控。這也是2015版《中國藥典》的要求:用于環境監控的培養基須特別防護,最好要雙層包裝和終端滅菌,如果不能采用終端滅菌的培養基,那么在使用前應進行100%的預培養,以防止外來的污染物帶到環境中及避免出現假陽性結果。
     
    2最少采樣點數目:浮游菌測試和沉降菌監測最少采樣點數目可參考GB/T16292-2010  如下表:
    浮游菌測試和沉降菌監測最少采樣點數目圖
    用于浮游菌采樣
    3.1培養皿在浮游菌采樣中的使用
    3.2浮游菌采樣注意事項
    一般采用Ø90mm規格的培養基平皿,可根據所選用的采樣器選擇合適培養基平皿;
    培養基需為TSA或SDA或其他用戶認可并經過驗證;
    培養基平皿在使用前應仔細檢查每一個皿的質量,有變質、污染或破損的平皿不得使用;
    在采樣過程中,不要將任何物體(包括操作人員的手和頭)置于板皿上方,避免在取樣點附近活動。
    用于沉降菌監測
    4.1采樣點布置
    參考GB/T16294-2010附錄A潔凈區采樣點布置。
    4.2最少培養基平皿數參考GB/T16294-2010
    4.3注意事項
    使用前必須檢查平板,若平板包裝破損或超過有效期不得使用。
    取樣后必須盡快培養,以保證結果準確。
     
    用于表面微生物測定
    表面微生物測定是對環境、設備和人員的表面微生物進行監測,方法是檢測人員打開平皿后,用培養基表面輕輕接觸取樣點表面,注意不要旋轉,取樣完畢后立即蓋上平皿蓋,完全接觸過程大約5s,取樣結束后用消毒劑消毒取樣點或用消毒劑浸濕的無菌潔凈布擦拭取樣點。
    表面微生物測定圖
    以上所用樣品及其培養廢棄物應視為污染性的物質,應蒸汽滅菌后處理或委托有資質的第三方處理。
     
    目前國內各制藥企業環境監測中微生物的監測方法大多依據GB/T16293-2010醫藥工業潔凈室(區)浮游菌的測試方法和GB/T16294-2010醫藥工業潔凈室(區)沉降菌的測試方法進行。潔凈區環境浮游菌、沉降菌及表面微生物監測用培養基一般采用胰酪大豆胨瓊脂培養基(TSA),當監測結果有疑似真菌或考慮季節因素影響時,可增加沙氏葡萄糖瓊脂培養基(SDA),但是對于抗生素企業和部分制劑廠家來說,僅僅按照這兩個國標推薦的兩種培養基(TSA和SDA)來監測潔凈區的微生物是不夠全面的,必要時可以加入適宜的中和劑。
     

    The finished product preloaded medium plate is the most commonly used solid medium for obtaining the pure culture of microbes. It is the solid medium formed by the solidified solid medium in the aseptic culture dish after the cooling and solidification. The culture dishes are commonly used for single spore isolation, determination of mycelial growth rate, colony morphology, antagonistic experiment, determination of clean space and surface contamination level.
    The monitoring of the bacteria in the clean area was carried out according to the current national standard of the testing method of the settling bacteria in the clean room (area) of the pharmaceutical industry; the monitoring of the zooplankton was carried out according to the current national standard of the testing method of the zooplankton in the clean room (area) of the pharmaceutical industry. The following is a brief introduction to the use of Petri dishes in a clean environment.
    Culture base plate in and out of clean area
    1 the pre installed base plate from the warehouse is outsourced in the outer compartment. If vacuum packing is used, it is necessary to check the packing of the package carefully. If the bag is raised, please do not use it in the clean area.
    2 disinfect the external surface with disinfectant and put it into the transfer window or the incoming logistics buffer room. Then the ultraviolet lamp will irradiate 10~15min or operate according to the company's documents.
    3 after disinfection, remove the culture dish from the clean area (level D or C level).
    4 if you need to use it in the B level area, remove another layer of package into the B level area.
    5 if you need to use it in Grade A, remove another layer of package into Grade A.
    6 collect the dishes after sampling, mark the sampling information, send out the clean area, and put them into the incubator in time to ensure the accuracy of the test results.
    7 the unused culture base plate after opening packing is packed in a spare breathing bag (provided by the general Petri dish manufacturer). It is marked and stored in the clean area. The next sampling can be used.
    It can be seen from the flow of culture plate into the clean area that laboratory self-made Petri dishes can not be used for environmental monitoring in clean areas without special protection. This is also the requirement of the 2015 edition of the Chinese Pharmacopoeia: the medium for environmental monitoring must be specially protected, preferably double layer packing and terminal sterilization. If a terminal sterilization medium is not used, a 100% pre culture should be carried out before use in order to prevent external contaminants from being brought to the environment and avoid false positive results.
    2 the minimum number of sampling points: the minimum number of sampling points for planktonic bacteria testing and settlement monitoring can be referred to GB/T16292-2010 as follows:
    Minimum number of sampling points for planktonic bacteria test and settlement monitoring
    Sampling for planktonic bacteria
    The use of 3.1 Petri dishes in the sampling of zooplankton
    3.2 points for attention to sampling of planktonic bacteria
    In general, the medium plate of the 90mm specification can be selected according to the selected sampler.
    The culture medium should be TSA or SDA or other user approved and validated culture medium.
    The quality of each dish should be carefully inspected before using the Petri dish.
    During sampling, do not place any object (including the hands and head of the operator) on the top of the culture plate, and avoid moving near the sampling point.
    Used for monitoring of the bacteria
    4.1 sampling point layout
    Refer to GB/T16294-2010 appendix A sampling points for clean area.
    4.2 reference GB/T16294-2010 for the minimum culture base plate number
    4.3 matters of attention
    The flat must be inspected before use. If the flat packing is damaged or exceeded the validity period, it must not be used.
    After sampling, it must be trained as soon as possible to ensure the accuracy of the results.
    Determination of surface microbes
    The surface microorganism measurement is to monitor the surface microorganism of the environment, equipment and personnel. The method is that the inspector opens the plate and gently contacts the surface of the sampling point on the surface of the medium, and pays attention to not rotation. The plate cover is covered immediately after the sampling is finished. The complete contact process is about 5S, and the sample is sterilized with disinfectant after the end of sampling. Wipe the sampling point with the dot or the sterile clean cloth soaked with disinfectant.
    Surface microorganism determination diagram
    The above samples and their waste should be regarded as contaminating substances. They should be treated after steam sterilization or entrusted by qualified third party.
    At present, the monitoring methods of microorganism in the environmental monitoring of various pharmaceutical enterprises in China are mostly based on the testing method of the GB/T16293-2010 pharmaceutical industry clean room (area) and the test method of the settling bacteria in the clean room (area) of the GB/T16294-2010 pharmaceutical industry. The culture medium of bacterial soybean Peptone Agar Medium (TSA) is used in the culture medium of environmental plankton, settling bacteria and surface microorganism in the clean area. When the monitoring results have the influence of suspected fungi or considering the seasonal factors, the glucosose agar medium (SDA) can be increased, but for the antivegetate Enterprises and some pharmaceutical manufacturers, It is not comprehensive to monitor the microbes in the clean area only according to the two medium (TSA and SDA) recommended by the two national standards, and the appropriate neutralizer can be added when necessary.
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