【正文】 Article 33 It shoul。必要時，生產(chǎn)操作的設(shè)備及該 區(qū)域的排風(fēng)應(yīng)當(dāng)作去污染處理（如排風(fēng)口安裝過濾器）。 應(yīng)當(dāng)特別保護(hù)已清潔的與產(chǎn)品直接接觸的包裝材料和器具及產(chǎn)品直接暴露的操作區(qū)域?？刹捎眠B鎖系統(tǒng)或光學(xué)或（和）聲學(xué)的報警系統(tǒng)防止兩側(cè)的門同時打開。一般情況下，洗手設(shè)施只能安裝在更衣的第一階 段。更衣室后段的靜態(tài)級別應(yīng)當(dāng)與其相應(yīng)潔凈區(qū)的級別相同。 Article 29 Sinks and drains should be prohibited in grade A/B areas used for aseptic manufacture. In other areas, sinks and drains should have proper design, layout and maintainance. Cleanable facilities with air break function should be fitted to prevent backflow. The connection with outside drain system should be designed to prevent microbial contamination. 第三十條 應(yīng)當(dāng)按照氣鎖方式設(shè)計更衣室，使更衣的不同階段分開，盡可能避免工作服被微生物和微粒污染。在其它潔凈區(qū)內(nèi)，水池或地漏應(yīng)當(dāng)有適當(dāng)?shù)脑O(shè)計、布局和維護(hù)，并安裝易于清潔且?guī)в锌諝庾钄喙δ艿难b置以防倒灌。門的設(shè)計應(yīng)當(dāng)便于清潔。 B級潔凈區(qū)的設(shè)計應(yīng)當(dāng)能夠使管理或監(jiān)控人員從外部觀察到內(nèi)部的操作。應(yīng)當(dāng)按照相關(guān)操作規(guī)程進(jìn)行工作服的清洗、滅菌，洗衣間最好單獨設(shè)置。 Article 25 Outdoor clothing should not be brought into changing rooms leading to grade B and C rooms. Every worker should change clean sterile protective garments at every time when he enters a grade A/B area。每位員工每次進(jìn)入 A/B級潔凈區(qū)，應(yīng)當(dāng)更換無菌工作服；或每班至少更換一次，但應(yīng)當(dāng)用監(jiān)測結(jié)果證明這種方法的可行性。 safety goggles should be worn。 ??Grade A/B: Headgear should totally enclose hair and, where relevant, beard and moustache。應(yīng)當(dāng)戴經(jīng)滅菌且無顆粒物（如滑石粉）散發(fā)的橡 膠或塑料手套，穿經(jīng)滅菌或消毒的腳套，褲腿應(yīng)當(dāng)塞進(jìn)腳套內(nèi)，袖口應(yīng)當(dāng)塞進(jìn)手套內(nèi)。工作服應(yīng)當(dāng)不脫落 纖維或微粒。 ??Grade D: Hair and, where relevant, beard should be covered. A general protective suit and appropriate shoes or overshoes should be worn. Appropriate measures should be taken to avoid any contamination ing from outside the clean area. C級潔凈區(qū)：應(yīng)當(dāng)將頭發(fā)、胡須等相關(guān)部位遮蓋，應(yīng)當(dāng)戴口罩。應(yīng)當(dāng)穿合適的工作服和鞋子或鞋套。 Article 23 Changing and washing should follow a written procedure designed to minimize contamination of clean area or carrythrough of contaminants to the clean areas. 第二十四條 工作服及其質(zhì)量應(yīng)當(dāng)與生產(chǎn)操作的要求及操作區(qū)的潔凈度級別相適應(yīng)，其式樣和穿著方式應(yīng)當(dāng)能夠滿足保護(hù)產(chǎn)品和人員的要求。當(dāng)員工由于健康狀況可能導(dǎo)致微生物污染風(fēng)險增大時，應(yīng)當(dāng)由指定的人員采取適當(dāng)?shù)拇胧? Article 20 All personnel (including those concerned with cleaning and maintenance) employed in such areas should receive regular training in disciplines relevant to the correct manufacture of sterile products. This training should include reference to hygiene and to the basic elements of microbiology. When outside staff who have not received such training (. building or maintenance contractors) need to be brought in, particular care should be taken over their instruction and supervision. 第二十一條 從事動物組織加工處理的人員或者從事與當(dāng)前生產(chǎn)無關(guān)的微生物培養(yǎng)的工作人員通常不得進(jìn)入無菌藥品生產(chǎn)區(qū)，不可避免時，應(yīng)當(dāng)嚴(yán)格執(zhí)行相關(guān)的人員凈化操作規(guī)程。培訓(xùn)的內(nèi)容應(yīng)當(dāng)包括衛(wèi)生和微生物方面的基礎(chǔ)知識。 Article 18 Because of this special technology particular attention should be paid to, at least the following: ??equipment design and qualification ??validation and reproducibility of cleaninginplace and sterilisationinplace ??background clean room environment in which the equipment is located ??operator training and gowning operations in the critical zone of the equipment including any aseptic assembly or setup? prior to the mencement of filling. 16 第六章 人員 Chapter 6 Personnel 第十九條 潔凈區(qū)內(nèi)的人數(shù)應(yīng)當(dāng)嚴(yán)加控制，檢查和監(jiān)督應(yīng)當(dāng)盡可能在無菌生產(chǎn)的潔凈區(qū)外進(jìn)行。 用于生產(chǎn)最終滅菌產(chǎn)品的吹灌封設(shè)備至少應(yīng)當(dāng)安裝在 D級潔凈區(qū)環(huán)境中。 Article 16 Monitoring should be carried out routinely and should include frequent leak testing of the isolator and glove/sleeve system. 第五章 吹灌封技術(shù) Chapter 5 Blow/fill/seal technology 第十七條 用于生產(chǎn)非最終滅菌產(chǎn)品的吹灌封設(shè)備自身應(yīng)裝有 A級空氣風(fēng)淋裝置，人員著裝應(yīng)當(dāng)符合A/B級潔凈區(qū)的式樣，該設(shè)備至少應(yīng)當(dāng)安裝在 C級潔凈區(qū)環(huán)境中。確認(rèn)時應(yīng)當(dāng)考慮隔離技術(shù)的所有關(guān)鍵因素，如隔離系統(tǒng)內(nèi)部和外部所處環(huán)境的 空氣質(zhì)量、隔離操作器的消毒、傳遞操作以及隔離系統(tǒng)的完整性。 隔離操作器所處環(huán)境取決于其設(shè)計及應(yīng)用，無菌生產(chǎn)的隔離操作器所處的環(huán) 境至少應(yīng)為 D級潔凈區(qū)。傳輸裝置可設(shè)計成單門或雙門，也可是同滅菌設(shè)備相連的全密封系統(tǒng)。 Note: (1) The products before capping are deemed as not pletely sealed. (2)According to the sealing reliability, design of capping equipment, characteristics of aluminium caps etc, capping operation can be conducted in Grade A air supply environment with a Grade C or D background. The Grade A air supply environment should conform with at least the requirement of Grade A at rest. 14 第四章 隔離操作技術(shù) Chapter 4 Isolator technology 第十四條 高污染風(fēng)險的操作宜在隔離操作器中完成。 （ 2）根據(jù)已壓塞產(chǎn)品的密封性、軋蓋設(shè)備的設(shè)計、鋁蓋的特性等因素，軋蓋操作可選擇在 C級或 D級背景下的 A級送風(fēng)環(huán)境中進(jìn)行。 直接接觸藥品的包裝材料、器具的最終清洗、裝配或包裝、滅菌 D級 13 ClassificatioExamples of operations for aseptic preparations n 1. Operation and transfer of those products which are not pletely (1)sealed in process, such as filling/sealing, subpackaging, (2)stoppering capping of products etc. Grade A 2. Preparation of solutions or products which are not able to go environment through sterilefiltration before filling。 (1)全密封容器內(nèi)的轉(zhuǎn)運； B級 2直接接觸藥品的包裝材料、器具滅菌后處于密閉容器內(nèi)的轉(zhuǎn)運和存放。 and filtration of products(concentration or Grade D dilution in a closed system) and ,final washing of primary packaging material tools a which directly contact with medicinal products. 注： （ 1）此處的高污染風(fēng)險是指產(chǎn)品容易長菌、灌裝速度慢、灌裝用容器為廣口瓶、容器須暴露數(shù)秒后方可密封等狀況； （ 2）此處的高污染風(fēng)險是指產(chǎn)品容易長菌、配制后需等待較長時間方可滅菌或不在密閉系統(tǒng)中配制等狀況。 12 3. Preparation and filling(or sealing) of ophthalmic preparation, sterile ointment, sterile emulsion or suspension, etc. 4. Handling of primary packaging materials and tools after final washing, which are in direct contact with medicinal products 1. Capping。 Article 13 The selection of production operations environment for sterile medicinal products, refer to the examples in the following table. Classification Examples of operations for terminally sterilised products Grade A envFilling (or sealing)of products, when risk ironment of contamination is (1)with aGhigh rade C background 1. Filling (or sealing) of products。 潔凈度級別 最終滅菌產(chǎn)品生產(chǎn)操作示例 C級背景下的 (1)高污痙縵盞牟 飯嘧埃 ɑ蜆嚳猓 ?局部 A級 （或灌封）； (2) 染風(fēng)險產(chǎn)品的配制和過濾； C級 3.眼用制劑、無菌軟膏劑、無菌混懸劑等的配制、灌裝（或灌封）； 的包裝材料和器具最終清洗后的處理。操作規(guī)程中應(yīng)當(dāng)詳細(xì)說明結(jié)果超標(biāo)時需采取的糾偏措施。 11 （ 2）單個沉降碟的暴露時間可以少于 4小時，同一位置可使用多個沉降碟連續(xù)進(jìn)行監(jiān)測并累積計數(shù)。在正常的生產(chǎn)操作 監(jiān)測外，可在系統(tǒng)驗證、清潔或消毒等操作完成后增加微生物監(jiān)測。成品批記錄的審核應(yīng)當(dāng)包括環(huán)境監(jiān)測的結(jié)果。監(jiān)測方法有沉降菌法、定量空氣浮游菌采樣法和表面取樣法（如棉簽擦拭法和接觸碟法）等。 (8)The monitoring of Grade C and D areas in operation (when necessary) should be performed in accordance with the principles of quality risk management. The requirements and alert/action limits will depend on the nature of the operations carried o