1 隔膜閥的基本原理和應(yīng)用隔膜閥是大家常常會接觸到一個部件，基本原理是通過彈性隔膜（常用 EPDM/PTFE 材質(zhì)）將流體（液體、氣/汽體）與閥門閥體、驅(qū)動部件徹底分隔，有效避免金屬離子溶出、部件腐蝕對產(chǎn)品造成的污染；同時隔膜閥平滑無凹陷的流道設(shè)計可消除死體積，防止物料殘留滋生微生物。此外隔膜片（常見 EPDM+PTFE 材質(zhì)）除具備常規(guī)耐腐蝕性外，在在線滅菌（SIP）系統(tǒng)中，還能耐受高溫蒸汽滅菌，且無需拆卸閥門即可完成清潔、滅菌等操作。一句話概括：隔膜閥在生物制造行業(yè)中，憑借其介質(zhì)與閥體完全隔離、零死體積無衛(wèi)生死角、易清潔滅菌、極低剪切力等核心結(jié)構(gòu)特點，從源頭控制污染風(fēng)險、保障無菌環(huán)境、提升生產(chǎn)合規(guī)性，已經(jīng)成為生物制造控制領(lǐng)域不可或缺的關(guān)鍵設(shè)備部件！圖1 隔膜閥和膜片實拍本文聊的隔膜閥以如上圖所示這種堰式，膜片也是常見的EPDM+PTFE材質(zhì)的膜片為主，其他特殊形式的隔膜閥和其他材質(zhì)的膜片不在本文探討范圍內(nèi)。

　　The basic principle and application of diaphragm valve: Diaphragm valve is a component that people often come into contact with. The basic principle is to completely separate the fluid (liquid, gas/vapor) from the valve body and driving components through an elastic diaphragm (commonly made of EPDM/PTFE material), effectively avoiding the contamination of the product caused by metal ion leaching and component corrosion; The smooth and non concave flow channel design of the diaphragm valve can eliminate dead volume and prevent the growth of microorganisms due to material residue. In addition, diaphragm sheets (commonly made of EPDM+PTFE material) not only have conventional corrosion resistance, but also can withstand high-temperature steam sterilization in online sterilization (SIP) systems, and can complete cleaning, sterilization, and other operations without disassembling valves. In summary, diaphragm valves have become an indispensable key equipment component in the field of biomanufacturing control, thanks to their core structural characteristics such as complete isolation between the medium and the valve body, zero dead volume, no hygiene dead corners, easy cleaning and sterilization, and extremely low shear force. They control pollution risks from the source, ensure sterile environments, and improve production compliance! The diaphragm valve discussed in this article is of the weir type as shown in the above figure, and the diaphragm is mainly made of EPDM+PTFE material. Other special forms of diaphragm valves and diaphragms made of other materials are not within the scope of this article.

　　2 隔膜閥多久拆檢一次？首先：膜片屬于易損件，必須定期對其進行檢測和更換。對于閥門多久拆檢一次，沒有一個固定的說法，但科學(xué)的做法是罐子叔叔個人建議如下：

　　How often is the diaphragm valve disassembled and inspected? Firstly, the diaphragm is a vulnerable component and must be regularly inspected and replaced. There is no fixed rule on how often valves should be disassembled and inspected, but the scientific approach is as follows:

　　2.1 常規(guī)周期性拆檢策略1.梳理清單，起草風(fēng)險評估報告，不限于評估部件關(guān)鍵度分級、然后基于部件差異生產(chǎn)工藝等等完成風(fēng)險評估。2.基于風(fēng)險評估報告制定設(shè)備操作維護標(biāo)準(zhǔn)化文件/SOP3.再就是寫你所做，做你所寫補充分享：特別是在合規(guī)環(huán)境中，質(zhì)量風(fēng)險管理應(yīng)貫穿產(chǎn)品全生命周期，一定要深入領(lǐng)會其意思，一個很大的方面就是咱們生產(chǎn)各項參數(shù)、指標(biāo)、頻次等等好好梳理下，有沒有直接定的（甚至拍腦袋的）？這個是不太合適的哦，建議都要有一個風(fēng)險評估（文件）支撐過程，哪怕一個頻次是供應(yīng)商給的，但是也要結(jié)合實際生產(chǎn)和工藝情況進行評估。要科學(xué)的思維去做事。也是合規(guī)檢查特別是國外檢查容易被提出的問題。對于2.1項落地建議，這個確實要基于實際實驗和生產(chǎn)情況，以下僅做參考：

　　2.1 Conventional Periodic Inspection Strategy: 1. Sort out the checklist, draft a risk assessment report, including but not limited to assessing component criticality classification, and then complete the risk assessment based on component differences in production processes, etc. 2. Based on the risk assessment report, develop standardized documents for equipment operation and maintenance/SOP. 3. Then, write about what you have done and provide supplementary sharing. Especially in a compliant environment, quality risk management should run through the entire product lifecycle, and it is important to have a deep understanding of its meaning. One major aspect is to carefully sort out our production parameters, indicators, frequency, and so on. Is there any direct (or even brainstorming)? This is not very suitable. It is recommended to have a risk assessment (document) to support the process, even if the frequency is given by the supplier, it should be evaluated based on the actual production and process situation. We need scientific thinking to do things. This is also a problem that is easily raised in compliance inspections, especially in foreign inspections. For the implementation suggestion of item 2.1, it should indeed be based on actual experiments and production situations. The following is for reference only:

　　1.總體通常發(fā)酵建議至少半年拆檢一次，發(fā)酵上游因為罐體定期要空消、批批要實消會經(jīng)常在高溫蒸汽環(huán)境下使用，清洗也有高溫堿煮、相比其他工序，使用環(huán)境要惡劣一些，因此要縮短。

　　1. Generally, fermentation is recommended to be disassembled and inspected at least once every six months. The upstream fermentation process is often used in high-temperature steam environments due to the regular emptying of the tank body and the need for batch to batch sterilization. Cleaning also involves high-temperature alkali boiling. Compared to other processes, the usage environment is more harsh, so it needs to be shortened.

　　2.但建議以批次來定，有的實驗或者生產(chǎn)可能半年不生產(chǎn)一次，也就沒必要半年拆檢了，比如10批次后，集中拆檢一次。如果有條件，自控系統(tǒng)配置了自動閥門開關(guān)計數(shù)次數(shù)，基于開關(guān)次數(shù)也是一個好的方式（但批次其實也差不多能涵蓋）。

　　2. However, it is recommended to determine by batch. Some experiments or production may not be conducted every six months, so there is no need to dismantle and inspect every six months. For example, after 10 batches, they should be dismantled and inspected once in a centralized manner. If conditions permit, the self-control system is equipped with an automatic valve switch counting system, and based on the number of switches, it is also a good way (but batches can actually cover more or less).

　　4.自動閥門和手動閥門策略要有所不一，特別是手動的閥門，人員操作的不確定性太大，容易加快損壞，因此也是一個考量點。

　　4. The strategies for automatic valves and manual valves should be different, especially for manual valves. The uncertainty of personnel operation is too high, which can accelerate damage, so it is also a consideration point.

　　4.核心的還是基于工藝和閥門所處的定位，核心還是基于風(fēng)險評估，自己定，如果產(chǎn)品附加值高，每批使用前對關(guān)鍵閥門進行拆檢，也常有使用。

　　4. The core is still based on the positioning of the process and valves, and the core is still based on risk assessment, which can be determined by oneself. If the product has high added value, key valves should be disassembled and inspected before each batch of use, and they are often used.

　　5.也要基于閥門膜片的質(zhì)量和綜合考量。比如在很多年前罐子叔叔當(dāng)時的發(fā)酵車間，隔膜膜片也便宜，當(dāng)時的策略：補料的隔膜閥膜片不管好壞就是一批一換。消毒班組每批搞完了，很大一部分活就是拿著內(nèi)六角，站在補料管架邊，拆半天閥門~~2.2 特殊情況下拆檢策略上面是正常的，但是如果出現(xiàn)異常情況不限于：

　　5. It should also be based on the quality and comprehensive consideration of the valve diaphragm. For example, many years ago in Uncle Jar's fermentation workshop, diaphragm membranes were also cheap. The strategy at that time was to replace the diaphragm valve membranes for replenishment one by one, regardless of their quality. After each batch of disinfection work is completed, a large part of the work is to hold the inner hexagon and stand by the feeding pipe rack, dismantling the valve for half a day~~2.2 In special circumstances, the dismantling and inspection strategy is normal, but if abnormal situations occur, it is not limited to:

　　2.2.1 生產(chǎn)跑冒滴漏這個時候沒啥好說的，哪里不對拆哪里，定向拆檢。

　　2.2.1 There is nothing to say about production leaks and leaks at this time. Wherever it goes wrong, it should be dismantled and inspected in a targeted manner.

　　2.2.2 常見的發(fā)酵染菌后制定對應(yīng)閥門的拆檢策略，這個也基于染菌的實際情況來決定深度和廣度，不要一刀切。序號場景場景個人建議策略1偶發(fā)染菌首選核心補料管線閥門進階補料、進氣、罐底、取樣等2連續(xù)染菌首選所有無菌界限內(nèi)的所有閥門全部拆檢進階擴展到無菌界限外到公用工程連接處這里引用了一個無菌界限的概念，這個在ASME-BPE里面有描述，索引如下：圖2 發(fā)酵罐和反應(yīng)器無菌界限（來源ASME-BPE2022）

　　2.2.2 Common strategies for dismantling and inspecting valves after fermentation and bacterial contamination should be developed based on the actual situation of the contamination, and the depth and breadth should not be a one size fits all approach. Number Scenario Personal Suggestions Strategy 1: For occasional bacterial infections, the preferred core feeding pipeline valve is advanced for feeding, air intake, tank bottom, sampling, etc. 2. For continuous bacterial infections, all valves within the sterile boundary are dismantled and inspected, and advanced to extend beyond the sterile boundary to the utility connection. Here is a reference to the concept of sterile boundary, which is described in ASME-BPE and indexed as follows: Figure 2 Fermentation tank and reactor sterile boundary (source ASME-BPE2022)

　　2.2.3 ?其他一些偏差比如清潔偏差，懷疑這一條線閥門有問題，基于實際評估結(jié)果拆檢。2.2.4 膜片的存放期限長期庫存未使用，膜片的存放期間也是有時間限制的，不能無限制存放，這個主要在做備件策略請購的時候要給予考量參考。

　　2.2.3 ? Other deviations, such as cleaning deviation, are suspected to be related to the valve on this line. Based on the actual evaluation results, the valve will be dismantled and inspected. 2.2.4 Storage period of membrane: If the long-term inventory has not been used, the storage period of membrane is also limited by time and cannot be stored without restrictions. This should be considered and referenced when making spare parts strategy procurement.

　　3 膜片怎樣就該換了？這個也是本文想主要闡述的，在分享前罐子叔叔也嘗試在各路資料上找一點關(guān)于膜片表面更換鑒別的比較直觀的資料圖譜啥的，發(fā)現(xiàn)除了常見的描述，圖片資料比較少（也可能是罐子叔叔沒找到或者沒公開），也咨詢了專業(yè)的隔膜閥廠家詢問是否有膜片鑒別的圖片之類的指導(dǎo)文件反饋是這一塊暫時還沒得，主要還是基于經(jīng)驗為主。但現(xiàn)實這一塊確實是大家在實驗和生產(chǎn)過程中會面臨的一個問題，特別是對于消毒班組設(shè)備拆檢的人員。那么罐子叔叔就拋磚引玉，基于個人的一點見解，拋磚分享一下，不一定完全對！大家結(jié)合實際情況考量。更希望大家在評論區(qū)多多分享細節(jié)經(jīng)驗。首先常規(guī)的膜片新的差不多是這樣的圖3 實拍和官網(wǎng)公開圖片索引過一段時間之后，你拆開后就會發(fā)現(xiàn)發(fā)生了變化：

　　How should the 3 membranes be replaced? This is also the main point that this article wants to elaborate on. Before sharing, Uncle Can also tried to find some more intuitive information maps about membrane surface replacement identification from various sources. He found that besides common descriptions, there are relatively few image materials (which may also be because Uncle Can has not found or made public). He also consulted a professional membrane valve manufacturer to inquire if there are any guidance documents such as membrane identification pictures. The feedback is that this is not yet available, mainly based on experience. But in reality, this is indeed a problem that everyone will face in the experiment and production process, especially for the personnel in the disinfection team who dismantle and inspect the equipment. So Uncle Jar would like to share his personal insights with others, which may not be entirely accurate! Everyone should consider the actual situation. I hope everyone can share more details and experiences in the comment section. First of all, the regular membrane is like this. After a period of time, you will find that there have been changes when you open it, as shown in Figure 3 and the official website's public image index

　　3.1 ?壓痕&變色之類外觀的反復(fù)的開啟，中間和接觸面的地方就會有壓痕。圖4 實際膜片拆件檢修示意個人建議：

　　3.1 ? Repeated opening of appearance such as indentation and discoloration will result in indentations in the middle and contact surfaces. Figure 4: Schematic diagram of disassembly and maintenance of actual membrane. Personal suggestion:

　　1.這個有壓痕正常，但對于壓痕彈性如果永久變形（手捏折痕不回彈）則是判定失效（已經(jīng)失去了良好的彈性恢復(fù)能力，無法正常發(fā)揮其密封、傳動等功能），需要更換。但比如上圖4的膜片，雖然有壓痕，但是彈性還可以，以前筆者策略判定是可以用的。

　　1. It is normal to have an indentation, but if the indentation elasticity is permanently deformed (the crease does not rebound when pinched by hand), it is considered invalid (it has lost its good elasticity recovery ability and cannot function properly in sealing, transmission, etc.), and needs to be replaced. But for example, the membrane in Figure 4, although it has indentation, its elasticity is still good. Previously, the author's strategy determined that it can be used.

　　2.壓痕出現(xiàn)明顯變色，比如變白，可能隔膜材料已發(fā)生化學(xué)老化、物理損傷或結(jié)構(gòu)劣化，其密封性能和使用壽命會大幅下降，如下圖，以前我們策略是換掉。

　　2. If the indentation shows obvious discoloration, such as whitening, it may indicate that the diaphragm material has undergone chemical aging, physical damage, or structural degradation, which will significantly reduce its sealing performance and service life. As shown in the figure below, our previous strategy was to replace it.

　　3.肉眼可見裂紋、分層（PTEF和EPDM分開了）、氣泡、類似燒蝕、魚鱗紋建議換掉

　　3. Visible cracks, delamination (PTEF and EPDM separated), bubbles, similar erosion, and fish scale patterns suggest replacement

　　4.?拆開膜片含顆粒時，密封邊緣磨損嚴(yán)重，導(dǎo)致無法貼合閥門密封面，也應(yīng)該換掉

　　When disassembling the diaphragm containing particles, the sealing edge is severely worn, resulting in the inability to fit the valve sealing surface, and it should also be replaced

　　5.腐蝕 / 溶脹：接觸強腐蝕性介質(zhì)后，表面出現(xiàn) 鼓泡、軟化、體積膨脹，也應(yīng)該更換4&5 條個人見得少，主要是中間部分。

　　5. Corrosion/swelling: After coming into contact with highly corrosive media, the surface may develop bubbles, soften, and expand in volume. It is also recommended to replace 4-5 of them, mainly in the middle part.

　　3.2 還沒破（減薄）如下圖所示，原因判定過程就是安裝問題膜片閥桿沒完全裝進去，這個已經(jīng)快破了，但是還沒破（下面還有一層EPDM），總體這建議還是換掉。（這個要基于實際情況判斷，看位置，以前有的批次是換到其他地方，還能用....開放討論）

　　3.2 Not yet broken (thinned) as shown in the figure below. The reason for this is that the installation problem is that the diaphragm valve stem has not been fully installed. This is almost broken, but it has not yet broken (there is still a layer of EPDM below). Overall, it is recommended to replace it. (This should be judged based on the actual situation, depending on the location. Some batches in the past were moved to other places, but they can still be used... Open discussion)

　　3.3 破了如果出現(xiàn)破損，沒啥好說的，還是換掉。下面是以前某批次染菌調(diào)查的一個最有可能的原因：為補料管道上一個去疏水的排污隔膜閥膜片出現(xiàn)了破損（懷疑在補料的時候排污端和無菌側(cè)發(fā)生了交叉污染）。圖8 某批次膜片破損示意（實拍）圖9 閥門所處的位置（僅圖解示意）

　　3.3 If there is damage, there's nothing to say, it's better to replace it. The following is the most likely reason for a previous batch of bacterial contamination investigation: a damaged drainage diaphragm valve membrane on the feeding pipeline (suspected to have cross contamination between the drainage end and the sterile side during feeding). Figure 8 Schematic diagram of membrane damage in a certain batch (actual photo) Figure 9 Position of valve (only illustrative)

　　3.4 罐子叔叔需要補充的是

　　What Uncle Jar needs to add is

　　1.閥門膜片異常是一個因素，但是不要發(fā)現(xiàn)一個膜片異常，就下結(jié)論染菌原因就是它，其他原因該調(diào)查的還是要調(diào)查，其他閥門沒拆完的還是要拆。目的是為了調(diào)查出最有可能得原因，不是為了應(yīng)付報告，結(jié)案了事。

　　1. Abnormal valve diaphragm is a factor, but do not conclude that the cause of bacterial infection is just one diaphragm abnormality. Other reasons that should be investigated should still be investigated, and other valves that have not been fully disassembled should still be disassembled. The purpose is to investigate the most likely cause, not to deal with the report or close the case.

　　2.一般液體接觸的比如核心補料系統(tǒng)是高風(fēng)險。

　　2. Contact with general liquids, such as core feeding systems, is high-risk.

　　3.不管膜片判定原則，如果如果保壓沒合格，跟這個閥門膜片有關(guān)，那么這個膜片就得替換。

　　3. Regardless of the principle of membrane determination, if the pressure holding is not qualified and is related to the valve membrane, then the membrane must be replaced.

　　4 預(yù)防大于維護--淺談膜片的拆卸和安裝

　　Prevention is greater than maintenance - A brief discussion on the disassembly and installation of membranes

　　a.注意拆的過程有掉落的風(fēng)險，不要拆到最后一個螺絲，閥頭掉下來，砸到人了，做好保護措施，特別是大的閥門~

　　a. Pay attention to the risk of falling during the dismantling process. Do not dismantle until the last screw, or if the valve head falls off and hits someone, take protective measures, especially for large valves~

　　b.閥門拆卸前確保管道內(nèi)務(wù)必沒有壓力，沒有殘液等等。1&2條，是這些都是出現(xiàn)過的真實教訓(xùn)啊，一定要注意~

　　b. Before disassembling the valve, ensure that there is no pressure or residual liquid inside the pipeline. 1&2, these are all real lessons that have occurred before, so be sure to pay attention to them~

　　c.拆卸前，關(guān)閉氣源。d.閥頭的螺絲對角擰松動，一步步來。e.安裝的時候，常見的幾點注意：方向要正確，膜片中間有凸起，和閥體堰體凸起對準(zhǔn) 膜片擰緊到連接件中，要剛好適中！如果膜片未充分?jǐn)Q入連接件中，則關(guān)閉力會直接作用在膜片螺釘而非整個壓塊上！這會導(dǎo)致膜片損壞以及提前失效，進而造成產(chǎn)品泄漏。如果膜片擰入過深，過度拉扯，則閥門座上的密封件功能也會會受到影響，這個很關(guān)鍵！

　　c. Before disassembly, turn off the air source. d. Loosen the screws of the valve head diagonally, step by step. e. When installing, there are several common points to note: the direction should be correct, there is a protrusion in the middle of the diaphragm, align it with the protrusion of the valve body, and tighten the diaphragm into the connecting piece, which should be just right! If the diaphragm is not fully screwed into the connector, the closing force will directly act on the diaphragm screw rather than the entire press block! This can lead to membrane damage and premature failure, resulting in product leakage. If the diaphragm is screwed too deeply or pulled excessively, the sealing function on the valve seat will also be affected, which is crucial!

　　備注：關(guān)于膜片的安裝，可以去專業(yè)的膜片廠家官網(wǎng)去檢索相關(guān)資料，具有詳細的圖示步驟資料和標(biāo)準(zhǔn)。不要擠壓膜片，不要過度變形如下圖所示

　　Note: Regarding the installation of the membrane, you can go to the official website of a professional membrane manufacturer to search for relevant information, which includes detailed diagram steps and standards. Do not squeeze the membrane, do not deform excessively as shown in the following figure

　　5 膜片其他補充幾點清潔驗證擦拭取樣點，需要考慮到不同材質(zhì)的，因此隔膜片是需要選取擦拭的部分轉(zhuǎn)產(chǎn)需要考慮膜片的更換

　　5. Additional points for cleaning, verification, wiping, and sampling points of the diaphragm need to be considered for different materials. Therefore, the diaphragm needs to be selected for wiping and the replacement of the diaphragm needs to be considered for production

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　　This article is a friendly contribution from Lianggong Valve Shandong Sales Office For more related knowledge, please click http://m.nikecsb.com/ Sincere attitude To provide you with comprehensive services We will gradually contribute more relevant knowledge to everyone Coming soon.v