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[工程设计] 核黄素测试

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发表于 2021-4-2 17:24:30 | 显示全部楼层 |阅读模式

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各位业界大佬,想请教一下,设备的核黄素测试在FAT进行测试,那么在SAT的时候需要测试吗?有相关法规分享吗?[em:24:]
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药徒
发表于 2021-4-2 17:58:58 | 显示全部楼层
本帖最后由 光风霁月 于 2021-4-2 18:02 编辑

FAT和SAT都要做,具体原因可以从这个测试的目的及影响喷淋覆盖测试的因素而知。
核黄素测试参考ASME BPE,最新版已经生效的应该是ASME BPE-2019 (英文版论坛有,可以自行下载)。具体参见非强制性附录M,翻译如下,希望有帮助:
NONMANDATORY APPENDIX M 非强制性附录M
SPRAY DEVICE COVERAGE TESTING 喷淋装置覆盖测试
M-1 SCOPE 范围
This Appendix defines an acceptable method for performing spray device coverage testing for bioprocessing equipment.
本附录定义了对生物工艺设备执行喷淋装置覆盖测试的可接受方法。
M-2 PURPOSE 目的
The purpose of a spray device coverage test is to document fluid coverage of the process contact surfaces of bioprocessing equipment. The test provides information about fluid coverage and the conditions necessary to achieve this coverage as a prerequisite for cleaning of the process equipment. The coverage test is not intended to demonstrate cleanability, but rather the ability to deliver cleaning solutions to the target surfaces. Cleanability is verified using a full CIP protocol during cleaning validation.
喷淋装置覆盖测试是为了记录生物工艺设备的工艺接触表面的流体覆盖。作为工艺设备清洁的前提条件,本测试提供关于流体覆盖的信息及实现此覆盖的必要情况。覆盖测试并不是为了证明清洁能力,而是输送清洁溶液到目标表面的能力。在清洁验证期间,通过完整的CIP方案验证清洁能力。
M-3 MATERIALS 物料
(a)        A concentration of 0.08 g/L to 0.22 g/L riboflavin (vitamin B2) aqueous solution provides visible fluorescence under ultraviolet light. The riboflavin should be free of animal-derived ingredients (ADI). Riboflavin is water soluble, noncorrosive, and nonreactive on materials commonly used to manufacture bioprocessing equipment (e.g., stainless steel, polymers, and ceramics). Riboflavin fluoresces with exposure to long-wavelength ultraviolet (UV) light with peak intensity at 365 nm. Note that if other fluorescent materials are used, the UV wavelength for optimum visibility may be different.
0.08g/L~0.22g/L的核黄素(维生素B2)水溶液可在紫外光显现可见荧光。核黄素应该没有动物源性成分(ADI)。核黄素可溶于水,无腐蚀性,且与用于制造生物工艺设备的材料(如不锈钢,聚合物,和陶瓷)无反应。核黄素暴露在峰值强度365nm的长波长紫外(UV)光下发出荧光。注意,若使用其他荧光物质,最佳能见度的紫外波长可能会不同。
(b)        UV lamps are available with different wavelengths and intensities. A lamp with a peak wavelength of 365 nm and an intensity of 4000μW/cm2 at a distance of approximately 15 in. (38 cm) is optimal to observe riboflavin fluorescence. Ultraviolet lamp intensity is inversely proportional to the square of the distance from the source. Ultraviolet lamps of this intensity may present a safety hazard to the eyes and skin. Personal protective equipment (PPE) is recommended. UV lamps of other wavelengths can be used, but stronger concentrations of riboflavin may be required for detection.
紫外灯可选用不同波长和强度。峰值波长为365nm,强度为4000μW/cm2的紫外灯在大约15英寸(38cm)的距离观察核黄素荧光最佳。紫外灯的强度与离光源距离的平方成反比。这种强度的紫外灯对眼睛及皮肤可能造成安全危害。推荐使用个人防护用品(PPE)。可使用其他波长的紫外灯,但需要更高浓度的核黄素用于检测。
(c)        An extension mirror or borescope camera may be useful for visual inspection of hard-to-reach areas.
延伸镜或内窥镜摄像头可以用于难以触及区域的目视检查。
(d)        The quality of water used for the formulation of the riboflavin solution and for coverage testing shall be agreed to by the owner/user and manufacturer. The minimum acceptable water quality is non-compendial purified water (e.g., reverse osmosis or deionized).
用于配制核黄素溶液和覆盖测试的水质应当经过业主/用户和生产商的同意。最低可接受的水质是非药典规定的纯化水(如反渗透或去离子的)。
M-4 PROCEDURE 步骤
M-4.1 Equipment Preparation 设备准备
(a)        All internal appurtenances should be installed (e.g., agitators, level probes, and dip tubes) during the spray device coverage testing. If conducting the test with all interior appurtenances in place is not practical, alternative means to simulate shadowing should be agreed on with the owner/user (e.g., dummy shafts and dip tubes may be used). If the agitator is installed, it should be rotated at the same rate as planned for CIP.
在喷淋装置覆盖测试期间,所有内部附件(如搅拌器,液位传感器,和汲取管)应已安装。如果在内部附件均就位情况下执行测试不可行,则应与业主/用户协商模拟遮蔽的替代物(如模拟轴和汲取管)。如果搅拌器已安装,其应以CIP计划的相同速率转动。
(b)        All internal surfaces and appurtenances shall be clean prior to the coverage test. Contaminated surfaces (e.g., with grease or oil) may produce inconclusive results.
在覆盖测试前,所有内表面和附件应已清洁。受污染的表面(例如润滑脂或油)可能会造成无定论结果。
(c)        Verify that the spray device(s) are installed in the designed location and orientation (where applicable).
确认喷淋装置是否安装于设计位置和方向(如适用)。
M-4.2 Application of Fluorescent Solution 荧光溶液涂抹
(a)        The test shall be performed by spraying the fluorescent solution as a mist on all targeted surfaces of the bioprocess equipment including walls, nozzles, baffles, and other appurtenances. The solution application should minimize droplet formation and runoff. Care should be taken to avoid applying the fluorescent agent to areas that are outside of the process boundary (e.g., the side of the manway gasket that is not exposed to the process). Note that the inside of dip tubes or similar hollow members not targeted by the spray device may require a separate rinse path during the test.
本测试应通过将荧光溶液雾状喷淋在生物工艺设备的所有目标表面上来进行,包括壁、管口、挡板和其他附件。溶液涂抹应尽量减少液滴的形成和径流。应注意避免将荧光剂涂抹于工艺边界外的区域(如人孔垫片未暴露于工艺的一侧)。注意,在测试过程中,喷淋装置未作用到的汲取管或类似空心构件的内部可能需要单独的清洗路径。
(b)        Using an ultraviolet light permits visual verification that the targeted surfaces have been wetted with the fluorescent solution. Fluorescent agents such as riboflavin typically fluoresce only when they are wet.
使用紫外光可以目视验证目标表面是否已经被荧光溶液湿润。核黄素等荧光剂通常只在潮湿状态下产生荧光。
(c)        The riboflavin application inspection methods shall be consistent with the postrinse inspection methods.
核黄素涂抹检查方法应该与清洗后检查方法一致。
M-4.3 Execute Rinse 执行清洗
(a)        The rinse should be performed with ambient (or colder) temperature water to allow for immediate inspection of wet surfaces. The use of other temperatures shall be agreed on with the owner/user.
应该使用室温(或更冷)的水来进行清洗,以便于湿润表面的即时检查。其他水温应与也业主/用户商定。
(b)        The rinse should be performed before the riboflavin solution has dried, as the test is designed to confirm coverage and not cleaning.
因本测试是为了确认覆盖而不是清洁,清洗应该在核黄素溶液干掉之前执行。
(c)        The rinse shall be performed in a once-through mode.
清洗应以直流模式执行。
(d)        Conditions such as flow rate, pressure, and time shall be recorded during the coverage test as described in M-6.
如M-6所述,在覆盖测试中记录流量、压力和时间等条件。
M-4.4 Inspection 检查
(a)        Inspection should be performed before the surfaces dry. Surfaces must be wet to detect riboflavin fluorescence.
在表面干燥前进行检查。表面必须是湿润的,以检查核黄素荧光。
(b)        If surfaces are dry at the time of inspection, the surfaces shall be gently rewetted from bottom and up with ambient or cold water to observe any residual riboflavin fluorescence. Rewetting and inspecting lower surfaces first and higher surfaces next will reduce the likelihood of misidentification of the location of residual riboflavin.
如果检查时表面变干,应该用室温或更冷的水从底部向上小心重新湿润表面,以观察是否有核黄素荧光。重新湿润,先检查下表面再到上表面,这将减少误判残留核黄素位置的可能性。
(c)        Ambient light should be minimized to improve the visibility of riboflavin fluorescence.
应尽量减少环境光,以提高核黄素荧光的可见度。
(d)        The postrinse inspection methods shall be consistent with the riboflavin application inspection methods.
清洗后检查方法应该与核黄素涂抹检查方法一致。
(e)        For large enclosures (e.g., vessels with manways) confined space entry may be necessary to conduct a thorough inspection.
对于大型外壳(如带人孔的容器),可能需要进入密闭空间进行彻底检查。
(f)        The inspection sequence should be designed to avoid false results due to transfer of residual riboflavin from internal or external sources.
检查顺序的设计应避免由于内源或外源的残留核黄素转移而产生错误结果。
M-5 ACCEPTANCE CRITERIA 可接受标准
(a)        Acceptance criteria and coverage test protocol shall be agreed on with the owner/user before the coverage test.
可接受标准和覆盖测试方案应该在覆盖测试前与业主/用户商定。
(b)        A typical acceptance criterion is removal, to the limit of visual detection, of the riboflavin solution from all targeted areas or as otherwise agreed on with the owner/user.
典型的可接受标准是将核黄素溶液从所有目标区域或与业主/用户商定区域的目检程度上的清除。
(c)        If areas of residual riboflavin are present, they should be documented, and a corrective action plan should be established with the owner/user.
如果存在核黄素残留区域,应对其进行记录,并与业主/用户一起制定纠正措施计划。
M-6 RECOMMENDED DOCUMENTATION 推荐记录
(a)        Test configuration sketch (reference the OEM (Original Equipment Manufacturer) drawing) and description (with, e.g., line size, instrument locations, elevation)
测试配置草图(参考OEM原始设备制造商图纸)和描述(例如,管线尺寸、仪表位置、标高)。
(b)        Spray Device Data 喷淋装置数据
(1) Model, make, serial number, and tag number.
型号,品牌,序列号和标签号。
(2) Verify correct installation, orientation, down pipe, and down pipe length.
确认安装、方向、回管、回管长度是否正确。
(3) Recommended pressure and flow conditions (data sheet).
推荐的压力和流量条件(数据表)。
(c)        Instrument Data 仪表数据
(1) Data sheets (instrument ranges)
数据表(仪表范围)
(2) Calibration certificates for instruments
仪表校准证书
(d)        Riboflavin Solution Data 核黄素溶液数据
(1) Riboflavin catalog number and lot number
核黄素目录号和批号
(2) Expiration date
有效期
(3) Amount of riboflavin
核黄素含量
(4) Amount of water and quality
水量和水质
(5) Time and date of preparation
制备时间和日期
(6) Time and date of application and preinspection
涂抹和预检的时间和日期
(7) Time and date of rinse and postinspection
清洗和检查后的时间和日期
(e)        UV Lamp Data. Model number and data sheet
紫外灯数据,型号和数据表
(f)        Temperature of Rinse Water
清洗水温
(g)        For initial flow path and each subsequent transition to a different flow path, document
对于初始流动路径和每个后续到不同流动路径的切换,记录:
(1) Flow rate
流量
(2) Time (burst/delay sequence, if applicable)
时间(如适用,记录迸发/延迟顺序)
(3) Pressure (measured as close to the spray device as practical)
压力(尽量靠近喷淋装置测定)
(4) For dual-axis dynamic spray devices, time, flow, and pressure to complete a pattern
对于双轴动态喷淋装置,完成一个模式的时间、流量、压力
(h)        Test Results 测试结果
(1) Pass/fail
通过/失败
(2) If applicable, residual riboflavin location(s) and descriptions
如适用,残留核黄素位置和说明
(3) If applicable, corrective actions taken
如适用,采取的纠正措施
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药生
发表于 2021-4-3 14:11:26 | 显示全部楼层
核黄素测试只是覆盖测试,也就是看洗球的喷射范围,要符合洗球的进水压力和流量要求,才能满足洗球的工作要求,FAT和SAT现场安装条件还是有一些区别的,建议还是SAT时复测
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 楼主| 发表于 5 天前 | 显示全部楼层
光风霁月 发表于 2021-4-2 17:58
FAT和SAT都要做,具体原因可以从这个测试的目的及影响喷淋覆盖测试的因素而知。
核黄素测试参考ASME BPE, ...

谢谢大佬的分享!
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 楼主| 发表于 5 天前 | 显示全部楼层
东北以东 发表于 2021-4-3 14:11
核黄素测试只是覆盖测试,也就是看洗球的喷射范围,要符合洗球的进水压力和流量要求,才能满足洗球的工作要 ...

谢谢大佬建议!
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药徒
发表于 5 天前 | 显示全部楼层
SAT更倾向于各使用点在各使用点峰值时,确认流速和润湿情况。
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药徒
发表于 5 天前 | 显示全部楼层
个人建议SAT做一次就OK,话说这玩意你门有放入再验证里年年确认吗
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 楼主| 发表于 3 天前 | 显示全部楼层
死库水 发表于 2021-4-6 16:46
个人建议SAT做一次就OK,话说这玩意你门有放入再验证里年年确认吗

我们是放入了再验证里面,每年进行确认的
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