<th id="7b9he"><video id="7b9he"></video></th>
  • <nav id="7b9he"><video id="7b9he"></video></nav>
    <nav id="7b9he"></nav>
    <code id="7b9he"></code>
  • 成品預裝培養基平皿實用技術手冊 :培養基平皿生產與質量控制

    發布時間:

    2022-12-27

    作者:

    一次性平板TSA


    成品預裝培養基平皿實用技術手冊 :培養基平皿生產與質量控制
     
    培養基平皿生產與質量控制
     
     
     
    上一章節介紹了成品預裝培養基平皿的質量要求,那么我們如何能得到符合預期質量要求的成品預裝培養基平皿呢? 
     
    首先了解一下簡化的培養基平皿生產工藝。
     
    1
    配制:在制備培養基時,準確稱量質量符合要求的脫水培養基或按單獨配方組分進行配制,待脫水培養基或按單獨配方組分完全溶解后定容、調節PH值,再進行升溫滅菌。應記錄各稱量物的重量和水的使用量。
     
    2
    滅菌:培養基配制結束后,選擇經過驗證的滅菌程序,立即快速升溫至滅菌溫度進行滅菌,滅菌結束后必須快速冷卻到可分裝溫度。在工序中,溫度對培養基的質量影響非常敏感,所以要根據滅菌培養基的特性,進行全面的滅菌程序驗證,以保證在一定裝載方式下的正常熱分布。
     
    3
    分裝:將經滅菌、冷卻后的培養基分裝到無菌空皿中。在該工序中應避免產生氣泡,裝量均一、穩定,固體培養基表面不得產生裂縫或漣漪、不破損。分裝后冷卻過程應有層流保護,不得污染微生物。
     
     
    4
    包裝:分裝好的培養皿要及時包裝,用于環境監控的培養基須特別防護,需雙層包裝,若是用于A級區環境監測的培養基平皿,建議三層無菌包裝。
     
    5
    終端滅菌:將包裝后培養基平皿進行滅菌,確保其無菌性。特別是用于環境監測的培養基平皿,《中國藥典(2015版)》9203中明確規定“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”。
     
    6
    檢驗放行:培養基平皿生產結束后,在使用前必須對每一批次取樣檢驗。檢驗項目包括外觀、裝量、PH值、無菌性、微生物促生長試驗,確保在潔凈區使用的培養基平皿是符合預期質量要求的產品。
     
    培養基平皿生產工藝中工序并不多,但是在很多微生物實驗室自制用于環境監測的培養皿的過程中,比較容易忽略一些工序細節,例如使用單層包裝、非最終滅菌等。在使用前采取100%預培養雖然避免了“假陽性”,但同時還帶來了“假陰性”和培養基平皿因包裝保護不當而帶來的交叉污染。
     
    正因為培養基生產工序不多,一些院校微生物實驗室和部分制藥企業微生物實驗室所使用的培養基平皿還是根據培養基各組分自配自用,也有部分是使用按處方生產的符合規定的脫水培養基進行自行配制使用。但是根據《中華人民共和國藥典》通則9203“藥品微生物實驗室質量管理指導原則”中培養基制備的要求,手工配制培養基平皿難以滿足潔凈區環境監測的需要,所以在法規嚴格要求及質量意識普遍提高的時代背景下,用于潔凈區環境監測的培養基平皿基本上是采用商品化的成品預裝培養基平皿。
     
    每個產品的生產工藝都具有唯一性,成品預裝培養基平皿也如此,但是培養基的質量控制方面,有著共同的關鍵因素,如人員、培養基、菌種、驗證、設備、文件等。
     
    人員
    人員是生產活動中最關鍵的要素,既要管理物料、操控設備,又要制訂規程、治理環境,生產的每道工序都是靠人來把控。
    人員應依據所在崗位和職責接受相應的培訓,如在上崗前接受勝任工作所必需的設備操作、微生物檢驗技術等方面的培訓,包括無菌操作、培養基制備、消毒、滅菌、平皿分裝、菌落計數、菌種的轉種、傳代和保藏、微生物檢查方法等,經考核合格后方可上崗。
     
    培養基
    培養基作為成品培養平皿的原料,是微生物試驗的基礎,直接影響微生物試驗結果。適宜的貯藏條件和質量控制試驗是提供優質培養基的保證。所以在投產前必須要檢驗脫水培養基質量,如PH值、微生物促生長試驗等,這也是確保培養基平皿符合質量要求的首要條件。
     
    菌種
    根據《中國藥典》要求,實驗室應該有標準化的菌種處理和保藏的程序,盡可能減少菌種污染和生長特性的改變。規范操作程序制備的菌株是微生物試驗結果一致性的重要保證。
     
    標準菌株的復蘇、復壯或培養物的制備應按供應商提供的說明或按已驗證的方法進行。從國內或國外菌種保藏機構獲得的標準菌株經過復活并在適宜的培養基中生長后,即為標準貯備菌株。標準貯備菌株應進行純度和特性確認。標準貯備菌株保存時,可將培養物等份懸浮于抗冷凍的培養基中,并分裝于小瓶中,建議采用低溫冷凍干燥、液氮貯存、超低溫冷凍(低于-30℃)等方法保存。低于-70℃或低溫冷凍干燥方法可以延長菌種保存時間。標準貯備菌株可用于制備每月或每周1次轉種的工作菌株。冷凍菌種一旦解凍轉種制備工作菌株后,不得重新冷凍和再次使用。
     
    工作菌株的傳代次數應嚴格控制,不得超過5代(從菌種保藏機構獲得的標準菌株為第0代),以防止過度的傳代增加菌種變異的風險。1代是指將活的培養物接種到微生物生長的新鮮培養基中培養,任何形式的轉種均被認為是傳代1次。必要時,實驗室應對工作菌株的特性和純度進行確認。
     
    工作菌株不可替代標準菌株,標準菌株的商業衍生物僅可用作工作菌株。標準菌株如果經過確認試驗證明已經老化、退化、變異、污染等或該菌株已無使用需要時,應及時滅菌銷毀。
     
    實驗室必須建立和保存其所有菌種的進出、收集、貯藏、確認試驗以及銷毀的記錄,應有菌種管理的程序文件(從標準菌株到工作菌株),該程序包括:標準菌種的申購記錄;從標準菌株到工作菌株操作及記錄;菌種必須定期轉種傳代,并做純度、特性等實驗室所需關鍵指標的確認,并記錄;每支菌種都應注明其名稱、標準號、接種日期、傳代數;菌種生長的培養基和培養條件;菌種保藏的位置和條件;其他需要的程序。
     
    驗證
    無論是自行制備還是商品化生產成品預裝培養基平皿,首先都必須要有滅菌程序的驗證,即培養基應采用通過驗證的滅菌程序進行滅菌,培養基滅菌方法和條件,應通過無菌性試驗和促生長試驗進行驗證。其次對高壓滅菌器的蒸汽循環系統也要加以驗證,以保證在一定裝載方式下的正常熱分布。第三,瓊脂平板最好現配現用,如置冰箱保存,一般不超過1周,且應密閉包裝,若延長保存期限,保存期需經驗證確定,即產品的穩定性考察。第四,產品的工藝驗證。在實驗室中,若采用已驗證的配制和滅菌程序制備培養基且過程受控,那么同一批脫水培養基的適用性檢查試驗可只進行1次。如果培養基的制備過程未經驗證,那么每一滅菌批培養基均要進行適用性檢查試驗。
     
    設備
    微生物實驗室應配備與檢驗能力和工作量相適應的儀器設備,其類型、測量范圍和準確度等級應滿足檢驗所采用標準的要求。設備的安裝和布局應便于操作,易于維護、清潔和校準,并保持清潔和良好的工作狀態。用于試驗的每臺儀器、設備應該有唯一標識。
     
    儀器設備應有合格證書,實驗室在儀器設備完成相應的檢定、校準、驗證、確認其性能,并形成相應的操作、維護和保養的標準操作規程后方可正式使用,儀器設備使用和日常監控要有記錄。
     
    文件
    對實驗室自行配制培養皿而言,文件應當充分表明試驗是在實驗室里按可控的檢查法進行的,一般包括以下方面:人員培訓與資格確認;設備驗收、驗證、檢定(或校準期間核查)和維修;設備使用中的運行狀態(設備的關鍵參數);培養基制備、貯藏和質量控制;菌種管理;檢驗規程中的關鍵步驟;數據記錄與結果計算的確認;數據偏離的調査。
     
    由于培養基平皿作為醫療器械類產品,其生產企業必須嚴格按照《醫療器械生產質量管理規范》來制訂相關指導文件指導生產,如工藝規程、質量標準、各操作規程等。
     
    總之,成品預裝培養基平皿的質量是生產出來的,所以在生產過程中要嚴格控制生產工序中每一個環節,著眼于整個質量體系,比如人員的規范操作、物料的質量控制、嚴格規范的生產過程、科學的質量控制等。
      •  

       

    •  
     
    http://www.tongliang818.com/products_list/pmcId=23.html
     
     
     
     
     
     
     

    Practical technical manual for finished preloaded culture medium plate (serial no.5) : production and quality control of culture medium plate
     
    Culture plate production and quality control
     
     
     
    In the previous chapter, the quality requirements of the finished prepared medium plate were introduced. How can we get the finished prepared medium plate that meets the expected quality requirements?
     
    First of all, I want to know the simplified medium plate production process.
     
    1
    Make up: in the preparation of culture medium, accurate weighing dehydrated medium quality to meet the requirements or preparation according to separate formula components, or be dehydrated medium according to the formula composition alone completely dissolved after the capacity, adjust PH value, and then to heat sterilization. The weight of each weighing object and the amount of water used shall be recorded.
     
    2
    Sterilization: after the preparation of culture medium, select the sterilization procedure that has been verified, and immediately heat up rapidly to the sterilization temperature for sterilization. After sterilization, the sterilization must be quickly cooled to the separable temperature. In the process, the temperature impact on the quality of medium is very sensitive, so be according to the characteristics of sterilization medium, thorough sterilization process validation, to ensure the normal heat distribution under certain loading way.
     
    3
    Separation: the sterilized and cooled medium is separated into a sterile empty dish. Bubbles should be avoided in this process, and the loading quantity should be uniform and stable. Cracks or ripples on the surface of solid medium should not be produced or damaged. The cooling process after installation should be protected by laminar flow and should not contaminate microorganism.
    -- -- -- -- -- --
    4
    Packing: packing good dishes are to be packed in A timely manner, medium must be special protection for environmental monitoring, need to double packing, if it is used for A level area environmental monitoring of medium plate, suggested that three layers of aseptic packaging.
     
    5
    Terminal sterilization: sterilization is carried out on the flat plate of the packaged medium to ensure its sterility. Especially for environmental monitoring of medium plate, "the Chinese pharmacopoeia (2015 edition) 2015 clearly stipulated in the" medium must be special protection for environmental monitoring, best to double packing and terminal sterilization ".
     
    6
    Inspection and release: after the end of the production of petri dishes, each batch of samples must be inspected before use. The inspection items include appearance, loading, PH value, asepsis, and microbial growth promotion test to ensure that the culture medium plate used in the clean area meets the expected quality requirements.
     
    Process in medium plate production process is not much, but in many microbiology laboratory used for environmental monitoring in the process of a dish, it's easy to ignore some process details, such as using single packing, the final sterilization. Although 100% preculture before use avoids "false positive", it also brings cross contamination caused by improper packaging protection of "false negative" and culture plate.
     
    Because of media production process is not much, some colleges microbiology laboratory and part of the pharmaceutical enterprise microbiology laboratory used by medium plate or according to the culture medium components from the match for private use, also has a part is used according to the prescription of dehydrated medium production preparation used on its own. But according to the general principles of the "pharmacopoeia of the People's Republic of China" 9203 "pharmaceutical microbiology laboratory quality management guidelines" in the culture medium preparation requirements, manual preparation medium plate is difficult to meet the demand of clean area environment monitoring and so on laws and regulations strictly, and general improvement in the quality consciousness of era background, the culture medium for clean area environment monitoring AGAR is basically the commercialization of the products with culture medium plate.
     
    Each product the production process has uniqueness, finished with medium plate, but the medium quality control, common key factors, such as personnel, media, strains, validation, equipment, documents, etc.
     
    personnel
    Personnel is the most important factor in production activities. We should not only manage materials and control equipment, but also formulate rules and control environment.
    Personnel should be based on the position and responsibility to accept the corresponding training, such as necessary to accept the job before mount guard operation of the device, microbial inspection technology and other aspects of training, including aseptic operation, medium preparation, disinfection and sterilization, AGAR, colony counting, the switched to, extend the cultivation and preservation of species, microbiological examination method and so on, after the inspection qualified rear can mount guard.
     
    medium
    As the raw material of finished product culture plate, culture medium is the basis of microorganism test, which directly affects the result of microorganism test. Suitable storage condition and quality control test are the guarantee of providing high quality medium. Therefore, the quality of dehydrated medium must be tested before it is put into production, such as PH value, microorganism growth promotion test, etc., which is also the primary condition to ensure that the medium plate meets the quality requirements.
     
    Bacterial species
    According to the requirements of the Chinese pharmacopoeia, the laboratory should have standardized procedures for the treatment and storage of strains, so as to minimize the change of bacterial contamination and growth characteristics. The strain prepared by standard operating procedure is an important guarantee for the consistency of microbial test results.
     
    The preparation of the resuscitation, rejuvenation or culture of the standard strain shall be carried out according to the instructions provided by the supplier or in accordance with the proven method. The standard strains obtained from domestic or foreign mycelia preservation institutions are the standard reserve strains after being resurrected and growing in suitable medium. Standard strains should be identified for purity and characterization. Standard supply strains preserved, cultures can be equal parts suspended in resistance to freezing medium, and packing in small bottle, the proposal USES low temperature freeze drying, liquid nitrogen storage, ultra-low temperature freezing method such as save (less than 30 ℃). Lower than 70 ℃ or freeze drying method can prolong strains preserved in low temperature. The standard strains can be used to prepare the working strains which are transferred once a month or once a week. Once the refrigerated strains are thawed and transferred to prepare the working strains, they shall not be re-frozen and reused.
     
    The number of generations of the working strains should be strictly controlled, no more than 5 generations (the standard strain obtained from the seed preservation mechanism is the 10th generation), so as to prevent the excessive propagation from increasing the risk of strain variation. Generation 1 refers to the inoculation of live culture materials into the fresh medium for microbial growth, and any type of transgenic species is considered to be transmitted once. If necessary, the laboratory should confirm the characteristics and purity of the working strains.
     
    The working strains can not replace the standard strains, and the commercial derivatives of the standard strains can only be used as working strains. The standard strain shall be sterilized and destroyed in time if it has been confirmed that it has aged, degraded, mutated, contaminated, etc.
     
    Laboratory must establish and maintain its all strains of pass in and out, collection, storage, validation test as well as the destruction of records, should have a diversity management program files (from the standard strains to job strain), the program include: the standard strains of purchase records; Operation and recording from standard strain to working strain; The bacteria must be transfected and transmitted on a regular basis, and the identification of key laboratory indicators such as purity and characteristics should be made and recorded. Each strain should have its name, standard number, date of inoculation, and algebra indicated. Culture medium and culture conditions for bacterial growth; The location and conditions of bacterial species preservation; Other required procedures.
     
    validation
    Preparation on their own, or whether it is commercialized products with medium plate, first is must have the sterilization process validation, the medium should be used through the validation of the sterilization procedures of sterilization, medium sterilization methods and conditions, should be validated aseptic test and the growth test. Secondly, the steam circulation system of high pressure sterilizer should be verified to ensure the normal heat distribution under certain loading mode. Third, AGAR plate is best matched with now, such as refrigerator, generally no more than 1 week, and should be sealed packaging, if extended shelf life, shelf life should be verified and determined, the stability of the product. Fourth, product process validation. In the laboratory, if the culture medium is prepared by a proven preparation and sterilization procedure and the process is controlled, the suitability test of the same batch of dehydrated media can be conducted only once. If the preparation of the culture medium is not verified, the applicability test of each sterilized batch medium shall be conducted.
     
    equipment
    The microbiological laboratory shall be equipped with instruments and equipment suitable for the inspection capability and workload, whose types, measuring ranges and accuracy levels shall meet the requirements of the standards used in the inspection. The installation and layout of the equipment should be easy to operate, easy to maintain, clean and calibrate, and keep clean and in good working condition. Each instrument and equipment used for testing shall be uniquely identified.
     
    Instruments and equipment shall have the certificate of quality and laboratory in the instruments and equipment to complete the corresponding verification and calibration, verification, confirm its performance, and to form the corresponding behind the operation, maintenance, and maintenance of standard operating procedures can be used formally, the equipment use and daily monitoring records.
     
    file
    For the preparation of the laboratory's own petri dishes, the documents shall fully demonstrate that the tests are conducted in the laboratory under controlled inspection methods, generally including the following aspects: personnel training and qualification confirmation; Equipment acceptance, verification, verification (or verification during calibration) and maintenance; Operating status (key parameters of the equipment) in use; Preparation, storage and quality control of culture media; Germ management; Key steps in the inspection procedures; Confirmation of data records and results calculation; Survey of data deviation.
     
    Because culture medium plate as a class of medical equipment products, the production enterprise must be in strict accordance with the "medical equipment production and the quality control standard to make the relevant guidance documents to guide the production, such as process planning, quality standards, the operation procedures, etc.
     
    In a word, the quality of the finished product with culture medium plate is produced, so in the process of production to strictly control the production process each link, look at the entire quality system, such as personnel, material quality control, strict norms of standard operation of the production process, scientific quality control, etc.
    久久产精品一区二区三区,欧美 国产 在线 一区,亚洲中文字幕熟女久久

    <th id="7b9he"><video id="7b9he"></video></th>
  • <nav id="7b9he"><video id="7b9he"></video></nav>
    <nav id="7b9he"></nav>
    <code id="7b9he"></code>