（风险管理）欧盟清洁验证⽅案（带风险分析）
1. Responsibility
职责
●QA is responsible for plan the cleaning validation.
QA负责整个清洁验证的安排
●QC is responsible for sampling and analysis.
QC 负责抽样及测试
●Production Department is responsible for performing cleaning production equipment.
⽣产部负责设备的清洁.
2. Purpose⽬的
The purpose of this cleaning validation protocol is to demonstrate that the cleaning procedure used
to clean JHZ-250B high shear mixer / granulator, three－dimensional mixer，CT-C-2Hot Air Circulating Drier，JZF-400 granulators & mill Korsch PH300-36 Tablet Press，BGD-150D
high-efficiency coating machine and DPP-250B blister packaging machine can effectively remove residues of the products manufactured in ZS-650 Vortex Oscillator/Compact Sieve，JHZ-250B high shear mixer / granulator, three－dimensional mixer，CT-C-2Hot Air Circulating Drier，JZF-400 granulators & mill Korsch PH300-36 Tablet Press，BGD-150D high-efficiency coating machine and
DPP-250B blister packaging machine to a predetermined level that does not raise any safety concerns.
清洗验证⽅案的⽬的是证明JHZ-250B⾼效湿法制粒机、 HLD-1000B型料⽃式混合机清洁操作
规程、CT-T-II型热风循环烘箱、JZF-400型整粒、粉碎机、Korsch PH-300-36旋转式压⽚机、BGD-150D型⾼效包⾐机和DPP-250B型多功能⾃动铝塑包装所使⽤的清洗程序能够有效地除去产
品残留，达到预先确定的限度，从⽽达到对下批产品⽆影响。
swabbing3. Frequency周期
The cleaning validation study is performed after three consecutive major cleanings of ZS-650 Vortex Oscillator/Compact Sieve，JHZ-250B high shear mixer / granulator, three－dimensional mixer，CT-C-2 Hot Air Circulating Drier，JZF-400 granulators & mill Korsch PH300-36 Tablet Press，BGD-150D high-efficiency coating machine and DPP-250B blister packaging machine after the manufacture of Lovastatin Tablets.
连续三批⽣产后，进⾏清洗验证研究。
4
5.Equipments设备
The list of Equipment used in the manufacture of Lovastatin Tablets:
1．HLSG-300 high s peed mixer / granulator HLSG-300⾼效湿法混合制粒机
2. LF120E-B airpillow-dry Granulator LF120E-B沸腾⼲燥制粒机器
3. ZP43Tablet Press ZP43 Tablet Press ZP43旋转式压⽚机
4. METAL DETECTOR ⾦属探测仪
5. HLD-1000BHLD-1000B Hopper type of blender HLD-1000B 型料⽃式混合机
6. YK-160granulators YK-160 型整粒机
7. DPH-130\DPP-250blister packaging machine DPH-130、DPP-250型多功能⾃动铝塑
包装机
8. BG-300Ehigh-efficiency coating machine BG-300E型⾼效包⾐机
Table 1表1:
5.2 Validation Scope验证范围
●HLSG-300 high shear mixer / granulator HLSG-300⾼效湿法制粒机
●LF120E-B airpillow-dry Granulator LF120E-B沸腾⼲燥制粒
机器
●ZP43Tablet Press ZP43旋转式压⽚机
●METAL DETECTOR ⾦属探测仪
●HLD-1000B g ranule mixer HLD-1000B型料⽃式混合机
●YK-160 granulators YK-160型整粒机
●DPH-130、DPP-250 blister packaging machine DPH-130、DPP-250型多功能
⾃动铝塑包装机
●BG-300E high-efficiency coating machine BG-300E型⾼效包⾐机
6.Test Method测试⽅法
The cleaning validation studies are based on the swabbing technique and rinsing sampling. The selected swabs should be characterized for their suitability and a recovery test should be performed prior to the validation studies. The validation studies include swabbing of the main surface area as well as the hard-to-clean locations. Swabbing and ringing is carried out for the active ingredient.
清洁验证研究⽤擦拭取样法和最终淋洗⽔取样。验证研究之前，选择的棉签的特性应适合并进⾏回收率研究。验证研究包括主要表⾯积和难清洁部位的擦拭。对活性成分擦拭取样和淋洗⽔取样。
●Sampling Method抽样⽅法
Swab Sampling擦拭法
Ringing sampling最终淋洗⽔取样法
7.Acceptance Criteria
接受限度
●Visual Inspection
⽬测检查
Acceptance Criteria
There is no visible residue in equipment surface after cleaning.
设备在清洁后，⽆可见的物质残留在设备表⾯
●Acceptance Criteria of microbe
微⽣物测试接受限度
Microbes微⽣物含量: ≤ 2 CFU/cm2，即≤ 50 CFU / 25 cm2
-For rinsing samples / 对冲淋样品：
Microbes微⽣物含量: ≤100 CFU/ml
●Acceptance Criteria of assay
化学测试接受限度
Active Ingredient (see Attachment 26)
活性成分(见附件26)
MC (mg/swab) = ____0.0843_______
(Active)
For rinsing samples
对冲淋样品：
MC (mg/L) = ____0.084_______
(Active)
●Test frequency
检测次数
The cleaning validation studies are conducted after three consecutive major cleanings of Nourkrin Tablets.
三批鲨鱼软⾻⽚⽣产结束后进⾏清洗验证。
8.Risk Analysis风险分析
The residues of the products are not distributed uniformity, so the risk analysis should be done before cleaning validation sampling. The Critical location will be determined at risk
analysis. Risk analyses are summarized in Attachment 1and Attachment 18.
由于上⼀产品⽣产对下⼀产品的污染并不是均匀分布在整个设备的接触⾯上，因此清洁验证的活性成分抽样计划的确定必须先进⾏风险分析，且在风险分析中确定清洁验证的关键部位。风险分析见附件1到附件18：风险分析表
9.Sampling Plan
抽样计划
For a ctive ingredient活性成分
9.1 Swab sampling
擦拭法
The following location will be sampled as risk analysis:
根据风险分析，在下列抽样部位取样：
9.1.1HLSG-300high shear mixer/granulator
Total are 7 samples:
总共7个取样点:
9.1.3 ZP43Tablet Press
ZP43旋转式压⽚机 Total are 8 samples: 总共8个取样点:
9.1.4
HLD-1000B HLD-1000B Hopper type of blender HLD-1000料⽃式混合机
Total are 3 samples: 总共3个取样点:
9.1.6 JZF-400 granulators & mill
JZF-400型整粒、粉碎机
9.1.7 DPP-250B blister packaging machine
DPP-250B型多功能⾃动铝塑包装机
Total are 4 samples:
总共4个取样点:
9.1.8 METAL DETECTOR
⾦属探测仪
Total are 4 samples:
总共4个取样点:
9.1.9 BGD-150D high-efficiency coating machine
包⾐机
Total are 8 samples:
总共8个取样点:
9.2 Ringing sampling淋洗⽔取样
BGD-150D high-efficiency coating machine包⾐机
Sampling location取样部位：硅胶管、喷
Three－dimensional mixer HLD-1000B型料⽃式混合机清洁操作规程Sampling location取样部位：腔体
微⽣物取样点
9.3.1 JHZ-250B high shear mixer/granulator JHZ-250B⾼效湿法制粒机
Total are 7 samples:
总共7个取样点:
9.3.2 ZS-650 Vortex Oscillator/Compact Sieve ZS-650漩涡振荡筛
Total are 5 samples:
总共5个取样点:
9.3.3 Korsch PH300-36 Tablet Press KORSCH PH-300-36旋转式压⽚机
Total are 8 samples:
HLD-1000B型料⽃式混合机清洁操作规程Total are 3 samples:
总共3个取样点:
9.3.5 CT-C-2 Hot Air Circulating Drier
CT-C-2型热风循环烘箱
Total are 10 samples:
总共10个取样点:
9.3.6 JZF-400granulators & mill
9.3.7 DPP-250B blister packaging machine DPP-250B型多功能⾃动铝塑包装机
Total are 4 samples:
总共4个取样点:
9.3.8 METAL DETECTOR
⾦属探测仪
Total are 4 samples:
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