設(shè)備清潔驗證方案

1、PROCEDURES/INSTRUCTIONS設(shè)備清潔驗證方案Equipments Cleaning Qualification Protocol文件編號 Doc. No.:文件版本 Revision:修訂日期 Revision Date:擬案單位 Issued by:編輯 Author審核 Approved by校對 Reviewed by日期 EffectiveDate精品資料1. 概述 DescriptionDermasil OTC 產(chǎn)品生產(chǎn)設(shè)備組由真空乳化攪拌鍋組和液體自動填充機組成。主材采用不銹鋼，易清 洗，耐消毒。造型美觀大方，各系統(tǒng)轉(zhuǎn)動靈活、平穩(wěn)，溫度調(diào)節(jié)靈敏、易控制。該組設(shè)備主

2、要生產(chǎn)活 性成分相同的護膚產(chǎn)品。微生物控制尤為重要。Manufacturing equipment for Dermasil OTC skincare product includes vacuum emulsification mix tank group & Liquid Automatic Filling Machine. These equipments adopt stainless steel materials, and facilitate cleaning and resist disinfection. They are easy to control and ha

3、ve good design, flexible and stable system, sensitive temperature adjusting. These equipments are used to produce skin care products with same active ingredients. Control the microorganism is significant.2. 目的 Purpose檢查并確認 OTC 生產(chǎn)設(shè)備清潔規(guī)程制定是否具有可操作性和科學(xué)性，保證清洗后的設(shè)備能夠滿足工 藝要求。This is to check and verify if t

4、hese equipments for OTC products arescientific and designed tofacilitate operation.3. 范圍 Scope3.1. 本驗證方案主要適用于以下 Dermasil OTC 護膚產(chǎn)品生產(chǎn)設(shè)備的清潔驗證。This protocol is applied for cleaning qualification of these equipments for Demersil OTC Skincare products;項目 Project標準范圍 Limits物理外觀檢測 Physical test目測潔凈，干燥，無嗅 Cl

5、ean, dry, no scent殘留物濃度限度 Limits of residue目測潔凈無色 （說明見 5.5 ）Clean and chromaticity （see section 5.5）微生物限度 Microbial test細菌總數(shù) Total bacteria 100CFU mL （淋洗水 washing water ） 細菌總數(shù) Total bacteria 50CFU 25cm 2（棉簽擦拭法 cotton sticker wiping ）4. 職責(zé) Role & Responsibilities4.1. QA manager4.1.1. 負責(zé)指派驗證小組組長，負

6、責(zé)驗證方案及報告批準，發(fā)放驗證證書，確認再驗證周期。 Assign team leader, approve validation protocol and reports, issue validation certificate and decide re-validation frequency.4.2. 驗證小組組長 Team leader4.2.1. 即具體驗證項目的主導(dǎo)人，主導(dǎo)和協(xié)調(diào)驗證工作，負責(zé)方案的起草，記錄數(shù)據(jù)的收集以 及報告整理。Team leader is the leader of specific qualification projects, lead to and

7、 coordinate qualification assignment, draft the protocol and collect the data and records and sort out reports.4.2.2. 負責(zé)首次清潔驗證方案的起草，完成報告。并指導(dǎo)驗證實施、培訓(xùn)及技術(shù)移轉(zhuǎn)。Draft first cleaning validation protocol and complete the reports, and guide the implementation, training and technical transfer of the qualificati

8、on.4.3. QA4.3.1. 負責(zé)驗證數(shù)據(jù)及結(jié)果的審核， Review of qualification data and results.4.3.2. 負責(zé)驗證過程的監(jiān)督和驗證報告的審批。Supervise the qualification and review validation report.4.3.3. 負責(zé)驗證文件管理。 Manage qualification documents.4.3.4. 負責(zé)驗證管理的日常工作，制定驗證計劃及監(jiān)督實施，驗證方案管理，驗證工作的協(xié)調(diào)， 驗證文件的管理。Develop validation plan and supervise the i

9、mplementation of validation and manage the documents.4.4. 實驗室 LAB4.4.1. 負責(zé)制定清潔后殘留物(產(chǎn)品殘留、微生物、清潔劑等)的檢測方法和殘留限度。 Develop inspection methods and limits of residue (products left, microorganism, cleaning agent).4.4.2. 負責(zé)制定取樣方法和執(zhí)行取樣，并對清潔驗證的結(jié)果進行評價。 Establish sampling methods and sample for tests, and evalua

10、te the qualification results.4.4.3. 負責(zé)對生產(chǎn)選用清潔劑種類及清潔方法進行指導(dǎo)。 Guide the production department to choose cleaning agent and cleaning methods.4.5. 生產(chǎn)部 Production4.5.1. 負責(zé)制定清潔作業(yè)指導(dǎo)書，執(zhí)行清潔操作以及對操作人員的培訓(xùn)和考核。 Make the procedure for cleaning and conduct cleaning activities and do training for the operators.4.5.2.

11、 配合協(xié)調(diào)時間及人員的安排。提供必要的資源。Arrange personnel and adjust time, andprovide necessary resources.4.6. 設(shè)備部 Maintenance4.6.1. 負責(zé)設(shè)備清潔時， 對相關(guān)設(shè)備的拆卸、 安裝提供指導(dǎo)培訓(xùn)。 Do training of de-assembly and installation.5. 驗證內(nèi)容 Qualifications5.1. 在產(chǎn)品生產(chǎn)結(jié)束后，按照作業(yè)指導(dǎo)書進行清潔。Follow the procedure to clean the equipmentsafter production.5.2

12、. 最難清潔部位： Position uneasy to clean設(shè)備名稱 Equipment編號 Number部位 Position真空乳化攪拌鍋組vacuum emulsification mix tank group均質(zhì)頭 Homo-mixer液體自動填充機Liquid Automatic Filling Machine下料管 output pipe5.3. 可接受的限度范圍標準： Acceptance Limits項目 Project標準范圍 Limits物理外觀檢測 Physical test目測潔凈，干燥，無嗅 Clean, dry, no scent殘留物濃度限度 Limits

13、 of residue目測潔凈無色（說明見 5.5 ） Clean and chromaticity （see section 5.5）微生物限度 Microbial test細菌總數(shù) Total bacteria 100CFU mL （淋洗水 washing water ） 細菌總數(shù) Total bacteria 50CFU 皿5.4. 物理外觀檢查：清洗后用含 75% 乙醇的藍色或者與產(chǎn)品不同顏色的無紡布（已消毒）擦拭表面 后應(yīng)無任何可見的殘留物痕跡，設(shè)備及無紡布表面見本色。 Physical inspection: use sterile blue or color different

14、from that of the product cloth with 75% ethanol to wipe their surfaces, no residue is visible5.5. 殘留物濃度限度：該組設(shè)備生產(chǎn)的產(chǎn)品所使用的活性成分均為二甲基硅油。均為無毒原料，安 全性高。因此以物理外觀檢測潔凈來代替。必要時送第三方檢測一次殘留物含量 Residue concentration limits: active ingredients used include dimethicone, they are highly safe raw materials without toxin.

15、 So we use physical check after cleaning is accepted. And if necessary we will send once to 3 rd party for checking residue.5.6. 微生物限度檢驗 Microorganism examination5.6.1. 真空乳化攪拌鍋組和液體自動填充機采用淋洗水沖洗方法。在清潔工序完成后，用純化 水淋洗均質(zhì)頭，然后參照 WI-006 微檢室作業(yè)指導(dǎo) ，進行取樣，送微生物實驗室進行 檢測。具體檢測方法參照 WI-006&WI-008 。Vacuum emulsificat

16、ion mix tank group & Liquid Automatic Filling Machine use washing water to clean. After clean the tank and homo-mixer, we use purified water to wash the homo-mixer. Samplings refer to WI-006, and sent to micro lab. Micro test method refers to WI-006&WI-008.5.7. 再驗證周期 Re-qualification frequencyQA 部門根據(jù)驗證結(jié)果確定設(shè)備再驗證周期 QA to decide the re-qualification frequency after verifying the results.6. 偏差處理 Deviation Handling驗證出現(xiàn)偏差的指導(dǎo)原則，參考偏差處理程序。Any deviation found will follow Deviation