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3.清潔和維護腔室

Cleaning and maintaining the chamber

3.1清潔殘余（Cleaning residues）

  在清洗滅菌室時，必須遵循特定滅菌器制造商提供的用戶手冊和維護說明。不應使用滅菌器制造商未明確推薦或批準的清潔劑和方法。

    When cleaning a sterilization chamber, it is important to follow the user manual and maintenance instructions provided by the manufacturer of the specific sterilizer. Cleaning agents and methods that are not explicitly recommended or approved by the sterilizer's manufacturer should not be used.

  其原因是，在表面清潔過程中，可能會發(fā)生復雜的相互作用，這可能會損壞個別消毒器、其配件或其外圍設備。

     The reason for this is that, among other things, complex interactions which may damage the individual sterilizer, its fittings or its peripheral equipment, can occur during the surface-cleaning process.

3.2定期腔室維護（Regular chamber maintenance）

  實際經驗表明，在化學或電化學清洗的裸露金屬內表面區(qū)域，通過用符合DIN EN 285（給水）規(guī)格的水每周擦拭冷室，能顯著抑制甚至防止不良的表面變色/薄層，不用添加任何清洗劑。

    Practical experience has shown that, on chemically or electrochemically cleaned bare metal interior surface regions of sterilizers, undesirable surface discolourations/films can be significantly inhibited, or even prevented, by wiping out a cold chamber on a weekly bases with water that meets the specifications of DIN EN 285 (feed water), without adding any cleaning agents.

  頑固地附著在腔體前表面的任何殘留物（例如，來自標簽等）。必須盡快使用適當?shù)墓?/span>刀工具（塑料刮刀或其他類似物品，不能使用金屬工具）。然而，當這樣做時，必須注意不要損壞（抓撓或其他的損壞形式）腔體的內表面。

     Any residues stubbornly adhering to the interior surface of the chamber (e.g. from labels, etc.) must be manually removed as soon as possible with the use of appropriate scraping tools (plastic scraper or other similar items, do not use metal tools). However, when doing so, one must take care not to damage (scratching or other forms of da- mage) the chamber's interior surface.

  使用化學物質去除腔內表面的殘留物應首先得到腔體制造商的批準。

     The use of chemical substances to remove residues on the interior surface of the cham- ber should first be approved by the chamber's manufacturer.

  一旦任何可以容易去除的薄層從腔室的內表面擦除掉，作為定期腔室維護的一部分不銹鋼表面也可以選擇性地重新鈍化。這可以使用濕化學酸性鈍化溶液精準可靠的進行。根據(jù)特定的制造商，不同的水溶液提供了表面護理和再鈍化能力的最佳組合。

    Once any films that can easily be wiped away are removed from the chamber's interior surfaces, the stainless steel surface can also be selectively repassivated as part of regular chamber maintenance. This can be carried out in an accurate and reliable man- ner with the use of wet-chemical acidic passivation solutions. Depending on the specific manufacturer, different aqueous solutions offer the optimal combination of surface care and repassivation capacity.

4.去除管道薄層或腐蝕產物

Removing rouging films or corrosion products

  在受這一現(xiàn)象直接影響的專家（設備制造商和用戶）中，目前對起因、導致的問題和經常需要進行與滅菌室中的膜層相關的修復有廣泛的不同意見。

     Among the specialists directly impacted by this phenomenon (equipment manufacturers and users), there is presently a wide range of different opinions on the cause, resulting problems and recurring need for restoration related to films in sterilization chambers.

  一些參與其中的人主要將這些薄層描述為“僅僅是視覺上的麻煩”，而另一些人則要求定期的無殘留去除。對這些觀點的態(tài)度差異清楚地表明，這一現(xiàn)象在如今的專家中是多么有爭議。

     A number of those involved describe these films mainly as 'merely visually bothersome', whilst others demand a periodic residue-free removal. The marked difference in attitude towards these issues makes it clear just how controversial the phenomenon is among experts today.

  為了實際應用，這意味著，在風險分析的幫助下，每個負責任的中央無菌服務室(MPPU/CSSD)最終必須決定其自身的短期和中期政策來消除其直接的影響范圍。

     For the purposes of practical application, this means that, with the aid of a risk analysis, every responsible central sterile services department (MPPU/CSSD) must ultimately decide on its own shortand medium-term policy for its immediate sphere of influence.

  如果一個部門決定實施定期的機械、化學或電化學恢復措施，它有一系列不同的選擇可供選擇——然而，所有這些都必須由專業(yè)公司與設備制造商和用戶合作執(zhí)行。

     If a department decides to implement periodic mechanical, chemical or electrochemical restorative measures, it has an array of different options to choose from – all of which, however, must be performed by specialist companies in cooperation with both the equipment manufacturer and the user.

所需所有要求如下：

?操作人員、滅菌器制造商和專門從事敏感不銹鋼表面的修復公司必須共同合作

?裝置的管接頭必須被單獨拆卸和處理

?必須計劃并遵守職業(yè)安全措施

?操作員必須考慮到消毒器的停機時間

?如適用，必須安裝防塵墻，并采取某些針對操作人員的安全預防措施

?必須執(zhí)行質量控制，包括恢復措施的文件

All measures require the following:

? The operator, sterilizer manufacturer and rehabilitation company specialising in sensitive stainless steel surfaces must all work together

? Fittings must be removed and treated separately

? Occupational-safety measures must be planned and adhered to

? Operator must account for sterilizer downtime

? Where applicable, dust protection walls must be put up and certain operator-specific safety precautions taken

? Quality control, including documentation of rehabilitation measures, must be carried out

本手冊中的圖10和圖11旨在說明現(xiàn)場在滅菌室中去除表面薄層所涉及的必要工作。

Figures 10 and 11 in this brochure are intended to illustrate the necessary work involved in the on-site removal of surface films in sterilization chambers.

  一般來說，可以使用不同的技術選擇或組合來有效地去除表面薄層。這些選擇應始終在與所有有關各方協(xié)商后再作出決定。這些決定應同時考慮到紅銹層的嚴重程度，最重要的是，現(xiàn)場的條件。

     In general, different options or combinations of techniques are available for effectively removing surface films. These options should always be decided on in consultation with all of parties involved. These decisions should take into account both the severity of the rouging film and, above all, the local conditions.

機械去除（Mechanical removal）

圖10：創(chuàng)建工作區(qū)域（防塵墻）

Creating a work area (dust protection wall)

圖11:質量保證（腔室內表面的表面粗糙度測量）

Quality assurance (surface roughness measurement on the chamber's interior surface)

  如果腔體的內部表面已被紅銹嚴重變色，則可以通過進行徹底的機械清潔（使用磨料機械工藝）來清潔受影響的區(qū)域以獲得更美觀的外觀

       If a chamber's interior surface has been severely discoloured by rouging, the affected regions can be cleaned-up for a more sightly appearance by performing a thorough mechanical cleaning (using abrasive mechanical processes).

      應該記住，在該技術過程中，很大一部分富含氧化鐵的顆粒不可避免地被嵌入不銹鋼表面并因此保存在那里，這意味著因為設備繼續(xù)使用，腐蝕在不久的將來會再次形成。因此，在大多數(shù)情況下，紅銹/腐蝕層不久就會重新出現(xiàn)。

      It should be kept in mind that, during this technical procedure, a significant portion of the iron-oxide-rich particles will inevitably be compacted into the stainless steel surface and thus stored there, which means that corrosion is bound to form again in the near future as the apparatus continues to be used. In most cases, the rouging/corrosion film thus reappears before long.

      出于這個原因，應該以批判性的眼光看待純機械表面修復。

       For this reason, a purely mechanical surface rehabilitation should be viewed in an critical light.

  在某些情況下，也會產生頑固的污漬，例如，從標簽粘合劑，可以在滅菌中使用的溫度條件下很好地并且確切地烘烤到表面上。除了將受影響的區(qū)域浸泡在水或化學溶劑中然后使用塑料刮刀進行去除之外，在這些情況下除了機械清理之外別無其他選擇。當產生這種類型的污漬時，作為可能使用的其他化學或電解處理選項的預處理，機械清潔也是必要的。

     In some cases, stubborn soiling also occurs, e.g. from adhesive labels which can be well and truly baked onto the surface at the temperatures used in sterilization. Aside from soaking the affected area in water or chemical solvents and then using plastic spatulas for removal, there is no other alternative to a mechanical cleaning in these situations. When soiling of this type occurs, mechanical cleaning is also necessary as a pre-treatment for other chemical or electrolytic treatment options that may be used.

  與符合DIN EN 285（給水）規(guī)格的（非常簡單）定期護理/清潔的主要區(qū)別在于使用合適的不銹鋼清潔劑（不含氯化物?。┎⑶矣酶植诘睦w維羊毛來代替棉布。也可以通過機器（例如刷砂或拋光機）進行清潔。為此，（砂光/拋光）布或皮帶應適合機器，以便于機械去除薄層。 但是，這并不能最大限度地減少適用于機械清潔方法的基本技術注意事項。

     The main difference to (very simple) regular care/cleaning with water that meets the specifications of DIN EN 285 (feed water) is that suitable stainless steel cleaners (containing no chloride!) are used, and that rougher fiber fleeces are used in place of cotton cloths. Cleaning can also be performed by machines (e.g. brush-sanding or polishing machines). To do so, (sanding/polishing) cloths or belts are fit onto the machines to facilitate the mechanical removal of the films. However, this does not minimise the basic technical caveats that apply to mechanical cleaning methods.

 

圖12a:機械恢復措施（Mechanical rehabilitation measures）

圖12b:機械恢復措施（Mechanical rehabilitation measures）

      特別是在要進行磨砂/拋光或電拋光的表面，必須仔細考慮或采取用于進行機械修復的程序，因為表面的狀況（例如表面粗糙度）可能會因此而變差。當腔室的內表面進行電拋光時，機械工藝——包括使用纖維羊毛材料，甚至是刷子打磨/拋光措施——會對不銹鋼表面產生不利影響，至少在局部也有不利影響。

      Particularly where surfaces are to be mechanically sanded/polished or electropolished, the procedure used to perform mechanical rehabilitation must be carefully considered or adapted, as the condition of the surface (e.g. surface roughness) can be deteriorated as a result. When the interior surfaces of a chamber are electropolished, mechanical processes—including the use of fibre fleece materials or even brush-sanding/polishing measures—have an adverse effect, at least locally, on the stainless steel surfaces.

  徹底清潔通常會破壞鈍化層。 因此，在將系統(tǒng)恢復運行之前，建議等待一定時間（通常約48小時）同時允許空氣自由進入腔室，以便允許鈍化層再生（自然再鈍化）。活性（濕化學）鈍化劑也可用于優(yōu)化和大大加快再鈍化過程。該方法還改善了鈍化層的化學特性（例如厚度，Cr/Fe比率）。

     A thorough cleaning will usually destroy the passive layer. Waiting for a certain amount of time (normally about 48 hours) whilst also allowing air to freely enter the chamber is therefore recommended before putting the system back into operation, so as to allow the passive layer to regenerate (natural repassivation). Active (wet-chemical) passivating agents can also be used to optimise and greatly speed up the repassivation process. This approach also improves the passive layer's chemical characteristics (e.g. thickness, Cr/Fe ratio).

  然而，重要的是要記住，不銹鋼表面的機械研磨會導致鈍化層的永久破壞。經驗表明，這就消除了鈍化層完全自然自我再生的可能性，甚至是在電拋光后表面上觀察到了相似的再生。這意味著基于自然空氣的再鈍化將在有限的程度上或完全不發(fā)生，因為在機械拋光過程中改變（損壞）結構的不銹鋼表面不再具有完全的鈍化能力。然而，在這些情況下，濕化學再鈍化劑至少可以用來促進再鈍化。

     However, it is important to keep in mind that this mechanical grinding of stainless steel surfaces causes a permanent destruction of the passive layer. Experience has shown that this then eliminates the possibility of a complete natural self-regeneration of the passive layer, or even a regeneration that is equivalent to the results seen on electropolished surfaces. This means that a natural air-based repassivation will take place either to a limited extent or not at all, since stainless steel surfaces that have been structurally altered (damaged) by mechanical processes no longer possess their full passivation capacity. In these situations, however, wet-chemical repassivation agents can be used to at least promote a repassivation.

  一旦機械清洗完成，重要的是確保所有殘留物（如灰塵和任何磨砂/拋光材料）被完全清除。

     Once the mechanical cleaning is complete, it is important to ensure that all residues (e.g. dust and any sanding/polishing materials) are completely removed.

來自：德國的錢伯斯工作組(德語縮寫：AKK)的手冊