Media Storage培養(yǎng)基存儲(chǔ)

It is prudent to consider how the manufacturer or supplier transports and stores media before distribution to the end user.Manufacturers of media should use transport and storage conditions that minimize the loss of moisture, control the temperature, prevent microbial contamination, and provide mechanical protection to the prepared media.

培養(yǎng)基的生產(chǎn)商或供應(yīng)商在培養(yǎng)基銷售給最終用戶前的運(yùn)輸和存儲(chǔ)方式是需要慎重考慮的。培養(yǎng)基生產(chǎn)商所采用的運(yùn)輸和存儲(chǔ)條件應(yīng)最大程度降低水份損失、保證溫度的控制、防止微生物污染，提供對(duì)已制備培養(yǎng)基的物理保護(hù)。

Media should be labeled properly with batch or lot numbers, preparation and expiration dates, and media identification.Media should be stored according to the manufacturer's instructions. Media prepared in house should be stored under validated conditions. Do not store agar at or below 0°, as freezing could damage the gel structure. Protect stored media from exposure to light and excessive temperature. Before prolonged storage, agar plates should be placed into a sealed package or container to retard moisture loss.

培養(yǎng)基應(yīng)標(biāo)記批號(hào)，制備時(shí)間和有效期，以及培養(yǎng)基識(shí)別信息。培養(yǎng)基應(yīng)根據(jù)生產(chǎn)商說(shuō)明進(jìn)行存儲(chǔ)。公司自己制備的培養(yǎng)基應(yīng)在經(jīng)過(guò)驗(yàn)證的條件下存儲(chǔ)，不要將瓊脂培養(yǎng)基存儲(chǔ)在等于或低于0℃條件下，因?yàn)榻Y(jié)凍可能對(duì)膠質(zhì)結(jié)構(gòu)造成損傷。存儲(chǔ)期間培養(yǎng)基應(yīng)避光，避免超溫。如果需要長(zhǎng)期存儲(chǔ)，瓊脂平板應(yīng)放在密封的包裝或容器中以減少水份損失。

Remelting of an original container of solid media should be performed only once to avoid media whose quality is compromised by overheating or potential contamination. It is recommended that remelting be performed in a heated water bath or by using free-flowing steam. The use of microwave ovens and heating plates is common, but care should be taken to avoid damaging media by overheating and to avoid the potential injury to laboratory personnel from glass breakage and burns. The molten agar medium should be held in a monitored water bath at a temperature of 45° to 50° for not more than 8 hours. Caution should be taken when pouring the media from a container immersed in a water bath to prevent water from the bath commingling with the poured sterile media. Wiping the exterior of the container dry before pouring may be advisable.

固體培養(yǎng)基只能再融化一次，以避免培養(yǎng)基由于過(guò)熱或潛在污染造成質(zhì)量問(wèn)題。建議在熱水浴中或使用自由流動(dòng)蒸汽融化培養(yǎng)基。使用微波爐和加熱盤(pán)也是常見(jiàn)的，但需要注意避免因?yàn)檫^(guò)熱造成培養(yǎng)基損傷，避免因玻璃儀器破裂和燒傷引起化驗(yàn)室人員受傷。熔化的培養(yǎng)基在40~45℃水浴中存放不超過(guò)8h。將培養(yǎng)基從浸在水浴中的容器中倒出時(shí)要特別注意，避免水浴用水混入倒出的無(wú)菌培養(yǎng)基中。最好在將容器從水浴中取出后、傾倒前，將容器外表面擦干。

Disposal of used cultured media (as well as expired media) should follow local biological hazard safety procedures.

使用過(guò)的培養(yǎng)基處理（和過(guò)期的培養(yǎng)基）需要按照生物危害安全程序處理。

Quality Control Testing質(zhì)量控制檢測(cè)

Although growth media can be prepared in a laboratory from individual components, many laboratories, for ease of use, use dehydrated media or purchase commercially prepared media in plastic plates or glass containers. Manufacturers of media attempt to standardize raw materials from biological sources, but must constantly deal with unavoidable differences in raw materials obtained from natural sources, and therefore, lot-to-lot variability of media must be considered. In addition, the performance of media prepared in a laboratory or by a manufacturer is highly dependent on preparation and storage conditions.Improper media preparation can cause unsatisfactory conditions for microbial growth or recovery and unreliable results.

雖然培養(yǎng)基可以采用各組份配制而成，但許多化驗(yàn)室為了方便，采用培養(yǎng)基干粉或采購(gòu)商業(yè)制備的成品培養(yǎng)基。培養(yǎng)基生產(chǎn)商會(huì)盡量采用同一生物來(lái)源的原料，但這些原料不可避免會(huì)有差異，因此需要考慮到培養(yǎng)基批次之間的差異。另外化驗(yàn)室制備的或者生產(chǎn)商制備的培養(yǎng)基的性能很大程度上取決于制備條件和存儲(chǔ)條件。培養(yǎng)基制備不當(dāng)會(huì)導(dǎo)致微生物生長(zhǎng)或恢復(fù)不理想，從而導(dǎo)致不可靠的結(jié)果。

Therefore, quality control tests should be performed on all prepared media, including media associated with swabs or media in strips and other nontraditional formats. Tests routinely performed on in-house prepared media should include pH, growth promotion, inhibition, and indicative properties (as appropriate), and periodic stability checks to confirm the expiration dating.

因此，需要對(duì)所有制備的培養(yǎng)基進(jìn)行質(zhì)量控制檢測(cè)，包括與擦拭棉簽相關(guān)的培養(yǎng)基、條狀培養(yǎng)基和其他非傳統(tǒng)方式培養(yǎng)基。一般公司自制培養(yǎng)基檢測(cè)應(yīng)包括pH值、促生長(zhǎng)試驗(yàn)、抑制試驗(yàn)和指示特性試驗(yàn)（如需要），并進(jìn)行定期穩(wěn)定性檢查以確認(rèn)有效期。

When in-house prepared microbiological media are properly prepared and sterilized using a validated method, the growthpromotion testing may be limited to each incoming lot of dehydrated media, unless otherwise instructed by the relevant compendial method. If the media preparation procedure was not validated, then every batch of media should be subjected to growth-promotion testing. Test organisms may be selected from the appropriate compendial test chapter. In addition, microorganisms used in growth-promotion testing may be based on the manufacturer's recommendation for a particular medium, or may include representative environmental isolates (but these latter are not to be construed as compendial requirements).

如果公司采用經(jīng)過(guò)驗(yàn)證的方法進(jìn)行培養(yǎng)基制備和滅菌，則促生長(zhǎng)試驗(yàn)可以是只針對(duì)購(gòu)入的每個(gè)培養(yǎng)基干粉批次，除非相關(guān)藥典方法另有要求。如果培養(yǎng)基制備程序未經(jīng)驗(yàn)證，則所制備的每批培養(yǎng)基均需要進(jìn)行促生長(zhǎng)試驗(yàn)。檢驗(yàn)用菌種可以從藥典相應(yīng)的檢測(cè)章節(jié)中選擇。另外，用于培養(yǎng)基促生長(zhǎng)試驗(yàn)的菌株可以采用生產(chǎn)商推薦的品種，或包括有代表性的環(huán)境隔離物（但后者不構(gòu)成藥典要求的內(nèi)容）。

Expiration dates on media should have supporting growth-promotion testing to indicate that the performance of the media still meets acceptance criteria up to and including the expiration date. The length of shelf life of a batch of media will depend on the stability of the ingredients and formulation under specified conditions, as well as the type of container and closure.

培養(yǎng)基的有效期應(yīng)有促生長(zhǎng)試驗(yàn)支持，在培養(yǎng)基有效期內(nèi)及到有效期時(shí)，該培養(yǎng)基應(yīng)仍符合可接受標(biāo)準(zhǔn)。一批培養(yǎng)基有效期的長(zhǎng)短取決于各成份和配方在規(guī)定條件下的穩(wěn)定性，以及容器和密封的形式。

When a batch of media does not meet the requirements of growth-promotion testing, an investigation should be initiated to identify the cause. This investigation should include a corrective action plan to prevent the recurrence of the problem. Any batch of media that fails growth-promotion testing is unsuitable for use. [NOTE—Failed growth-promotion test results may not be used to negate positive test results.]

如果培養(yǎng)基的促生長(zhǎng)試驗(yàn)失敗，則應(yīng)啟動(dòng)調(diào)查程序?qū)ふ以?。該調(diào)查程序應(yīng)包括糾正措施以防止相同問(wèn)題重復(fù)發(fā)生。所有促生長(zhǎng)試驗(yàn)失敗的培養(yǎng)基不得用于檢測(cè)。注：促生長(zhǎng)試驗(yàn)失敗可能會(huì)導(dǎo)致陽(yáng)性檢測(cè)為陰性。

Some reagents are used for diagnostic purposes to help support identification of microbial organisms, e.g., Gram stain and oxidase test reagents. These may have attributes that can be quality control tested similar to microbiological media. Select the correct quality control standard microorganisms, following the manufacturer's instructions, and perform the testing before unknown sample diagnostic testing. All relevant diagnostic reagents should be subjected to incoming quality confirmation before use.

有些試劑盒用于鑒別微生物種類，例如革蘭氏染色和氧化酶檢測(cè)試劑。這些試劑具有與微生物培養(yǎng)基類似的進(jìn)行質(zhì)量控制測(cè)試的特性。選擇正確的質(zhì)量控制標(biāo)準(zhǔn)微生物，按照生產(chǎn)商指示，在未知樣品診斷檢測(cè)前進(jìn)行測(cè)試。所有相關(guān)的試劑盒均進(jìn)行進(jìn)廠質(zhì)量確認(rèn)才可使用。

Special care should be taken with media that is used in sterility tests (see Sterility Tests á71ñ for requirements) and in environmental monitoring studies. Media used for environmental monitoring of critical areas should preferably be double-wrapped and terminally sterilized. If terminal sterilization is not performed, media should be subjected to 100% pre-incubation and inspection before use within a critical area. [NOTE—Growth-promotion testing for this media must be performed after the preincubation stage.] This will prevent extraneous contamination from being carried into controlled environments and will prevent false-positive results. A raised agar level for surface contact plates should be verified.

用于無(wú)菌檢測(cè)（見(jiàn)71無(wú)菌檢測(cè)）和環(huán)境監(jiān)控的培養(yǎng)基需要特別注意。用于關(guān)鍵區(qū)域環(huán)境監(jiān)控的培養(yǎng)基最好雙層2，并采用最終滅菌方式。如果無(wú)法進(jìn)行最終滅菌，則在使用前應(yīng)進(jìn)行100%預(yù)培養(yǎng)并檢查（注：該培養(yǎng)基的促生長(zhǎng)試驗(yàn)必須在預(yù)培養(yǎng)階段后進(jìn)行）。這樣能防止由于攜入受控制環(huán)境中所產(chǎn)生的額外污染，防止假陽(yáng)性結(jié)果。接觸碟培養(yǎng)基厚度應(yīng)進(jìn)行確認(rèn)。

原文鏈接：https://mp.weixin.qq.com/s/w0epoMAzc3IMpqFAtGV0vA

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