【正文】 ,使用不同規(guī)格 PVC模板 ,必須保證被 取樣面積為 100cm2。擦拭完畢，將棉簽頭置具塞試管中。擦拭過程應(yīng)覆蓋整個 PVC模板內(nèi)所有表面。 Add appropriate amount of methanol into a beaker, presoak a swab used for sampling with methanol. Expel the excess methanol from swab by pressing it against the beaker wall. Put the top of swab on the surface of sampling location, bend the handle of swab slightly to make a face of the swab 題目： XXXX片（ 10mg規(guī)格）清潔驗證方案 編號： 頁碼： 14/50 Cleaning Validation Protocol of XXXX Tablets(10mg) No.: Page:14/50 pletely contact the surface of sampling location, then swab this sampling location as the direction shown in schematic diagram this swab over, swab the same sampling location with another face of swab as the direction shown in schematic diagram 2. Then put the top of swab into a scintillation vial with stopper. There will be two swabs used to clean each sampling location, total two swabs will be collected into one scintillation vial. The whole face within the PVC template should be covered during swabbing. After sampling, clean the surface of sampling location with singleservice cleaning cloth soaked with 75% ethanol. 圖一 圖二 Schematic diagram 1 Schematic diagram 1 /Sampling for microbial testing ? 接觸法 /Contact plate 若取樣點位置光滑平整，面積大于 25cm2，使用表面積為 25cm2的接觸碟以接觸法取樣，取樣方法為：在靠近取樣點的位置打開接觸碟上蓋，輕壓接觸碟使其與取樣表面完全接觸后，移開接觸碟，立即蓋上平皿并作好標(biāo)識。 If the surface of sampling location is smooth and area is more than 25cm2m 25cm2 of contact plate can be used for sampling. Sampling method is shown as following: open the cap of contact plate near sampling location, slightly press plate to make it pletely contact the surface of sampling location, then remove the plate, immediately cap and label it. After sampling, clean the surface of sampling location with a singleservice cleaning cloth soaked with 75% ethanol. ? 擦拭法 /Swabbing method 若取樣點位置凸凹不平或面積小于 25cm2，可選擇適宜大小的 PVC 模板確定取樣面積。角，至聽到按閥折斷。抽出棉簽，將棉簽頭按在取樣表面上，使棉簽與取樣表面成 30176。擦拭過程應(yīng)覆蓋整個 PVC 模板內(nèi)所有表面。 If the surface of sampling location is not smooth or the area is less than 25cm2, choose an appropriate PVC template to determine sampling area. Take a 3M rapid sampling swab, bend the red valve to 45176。and bend emphatically it, swab this sampling location as the direction shown in schematic diagram this swab over, swab the same sampling location with another face of swab as the direction shown in schematic diagram 2. The whole face within the PVC template should be covered during swabbing. After sampling, put swab in tube, seal and label, then clean the surface of sampling location with singleservice cleaning cloth soaked with 75% ethanol. Chemical analytical method and acceptable criteria A. 標(biāo)準(zhǔn)品溶液的配制： Standard solution: 標(biāo)準(zhǔn)品溶液濃度計算公 式： Calculation formula of concentration for standard solution B. 供試品的配制： Test solution: : Chromatographic conditions /System suitability test /Calculation ? 按外標(biāo)法計算設(shè)備表面殘留量。對于計算修約后的為 0μg/100cm2的檢測結(jié)果，報告為 1μg/100cm2；對于未檢測出的檢測結(jié)果，報告為 ND。 if testing results are “not detectable” , report it as ND. Microbial analytical method and acceptable criteria A. 培養(yǎng) /Incubation ? 以 cfu/25cm2形式報告 Report the result in cfu/25cm2 ? 直接以培養(yǎng)結(jié)束后的菌落數(shù)報告。 Report the number of cfu after incubation is finished, if there is no growth of microanism, report is as ＜ 1 cfu/25cm2. ? 可接受標(biāo)準(zhǔn)： 所有取樣點微生物殘留不得超過 20cfu/25cm2。 Production staff will clean equipments and utensils according to corresponding SOPs for equipments after the manufacturing of 10mg strength of XXXX Tablets is finished. 清潔結(jié)束后， QC 人員按清潔 驗證 方案規(guī)定取樣、對樣品進(jìn)行檢測，并報告檢測結(jié)果。清潔 驗證 完成后，由制造部人員寫出清 潔 驗證 報告。以下的簽字表明受訓(xùn)者承認(rèn)已接受了培訓(xùn)并理解。 QC instruments 制造部設(shè)備確認(rèn)表 list of verification for production equipments 名稱 Name 設(shè)備編號 Equipment No. 確認(rèn)文件編號 Verification Documentation No. 設(shè)備標(biāo)準(zhǔn)操作規(guī)程編號 SOP No. 檢查人 /日期 Checked by /date 復(fù)核人 /日期 Reviewed by/date 部門經(jīng)理審核 /日期 Dept. Manager/Date QA檢查員 /日期 QA Inspector /Data 題目： XXXX片（ 10mg規(guī)格）清潔驗證方案 編號： 頁碼： 22/50 Cleaning Validation Protocol of XXXX Tablets(10mg) No.: Page:22/50 QC儀器 確認(rèn)表 list of verification for QC instruments 名稱 Name 儀器編號 No. 確認(rèn)文 件 編號 Verification Documentation No. 確認(rèn) 有效期至 Date of expiry 儀器 /設(shè)備操作規(guī)程編號 SOP No. 檢查人 /日期 Check by 復(fù)核人 /日期 Verified by QC主管審核 /日期 QC Supervisor/date QA檢查員 /日期 QA Inspector/date 題目： XXXX片（ 10mg規(guī)格）清潔驗證方案 編號： 頁碼： 23/50 Cleaning Validation Protocol of XXXX Tablets(10mg) No.: Page:23/50 附件二：取樣位置示意圖 Attachment 2 Schematic diagram for sampling locations 注： ※ 標(biāo)注的取樣位置為專用零部件上的取樣，只進(jìn)行微生物檢測樣品取樣，不進(jìn)行化學(xué)檢測樣品取樣。 Notes: fill “√” if visual inspection meet the criteria, otherwise provide the reason. 題目： XXXX片（ 10mg規(guī)格）清潔驗證方案 編號： 頁碼： 26/50 Cleaning Validation Protocol of XXXX Tablets(10mg) No.: Page:26/50 附件三： QC化學(xué)檢測取樣記錄表（ 2） Attachment 3 Sampling record form for QC chemical testing (2) 生產(chǎn)批號 /Batch No.： 設(shè)備名稱 Equipment Name 取樣點 Sample Locations 樣品編號 Sample No. 目測結(jié)果 Results of Visual inspection 取樣人 /日期 Sampled by /date 內(nèi)表面 T007 配液桶內(nèi)表面 T008 配液桶攪拌槳表面 T009 物料槽內(nèi)壁表面 T010 物料槽篩網(wǎng) T011 物料槽及擴展室視窗 T012 擴展室進(jìn)料口閥門表面 T013 擴展室盲蓋表面 T014 過濾袋支架內(nèi)表面 T015 連接口內(nèi)表面 T016 出料閥門表面 T017 進(jìn)料口內(nèi)表面 T018 轉(zhuǎn)子表面 T020 篩網(wǎng)表面 T021 進(jìn)料口蓋內(nèi)表面 T022 進(jìn)料口內(nèi)表面 T023 內(nèi)部任意一角表面 T024 呼吸口內(nèi)表面 T025 出料口閥門表面 T026 與壓片機料斗連接桶內(nèi)表面 T027 料斗內(nèi)表面 T029 料斗閥門表面 T030 填料器內(nèi)部攪拌齒輪表面 T031 題目： XXXX片（ 10mg規(guī)格）清潔驗證方案 編號： 頁碼： 27/50 Cleaning Validation Protocol of XXXX Tablets(10mg) No.: Page:27/50 設(shè)備名稱