一次性使用的制造、组装和安装 | ASME BPE-2022 新增内容解读
时间：2023-08-19 阅读：3204
一次性使用技术应用于制药领域已有30余年历史。凭借其聚合物材料可塑性强、便于运输和使用的优势，在质量可控的前提下，一次性使用系统已经广泛应用于液体储存、液体转移、无菌过滤、超滤和透析换液，以及病人使用的输液系统等。近年来，随着单抗药物和细胞治疗药物的成功发展，相关技术迅速升级，一次性使用技术在制药领域的应用不断拓展。目前一次性使用技术几乎可以涵盖整个生物制药工艺过程的各个单元操作。
ASME BPE 2022已发布，本次版本升级，增加了一次性使用部件和组件的要求，分为三个章节，分别是第七章一次性使用设计、第八章一次性使用工艺组件和第九章一次性使用的制造、组装和安装。本文继续介绍第九章一次性使用的制造、组装和安装。
第9章一次性使用的制造、组装和安装
SJ部分 一次性使用的连接方法
对于一次性使用，部件的接合可以以多种方式进行。这些连接技术的实例包括但不限于焊接、热封、包覆成型、溶剂粘合、机械连接和粘合剂。使用这些方法中的任何一种，应控制聚合物、部件或组件的连接程序，以确保结果可重复。接头应无泄漏，应满足预期用途的压力要求，并应保持部件或组件的完整性。
本节适用于使用软管倒钩、软管和固定装置（通常称为软管倒钩连接）的一次性组件的机械连接。PM-4.3.2和SD-3.2中阐述了预期重复使用的柔性软管组件。
有关其他设计注意事项，请参阅非强制性附录GG，一次性机械软管倒钩设计建议。
SJ-2.1 操作条件
所有者/用户应规定软管倒钩连接预期用途的工作温度范围、工作压力范围和灭菌方法（如适用）。
SJ-2.2 组装
一次性软管倒钩接头的手动组装应遵循文件化的标准操作规程。装配设备（例如，管道拉伸器、接头插入器、保持装置和应用工具）应保持校准状态。用于辅助软管倒钩插入软管的液体应通过化学类型进行识别，并符合PM-2.1的要求。
SJ-2.3 确认
一次性软管倒钩接头应由供应商鉴定，以确保其符合规范中规定的性能标准。供应商应制定测试计划，以证实机械连接的性能。测试应参考以下至少一项：
(a)压力测试。参考ASTM D1599、ISO 1402
(b)泄漏试验
(1)气压。参考A STM E515
(2)真空。参考ASTM D4991
(3)液压。参考ASTM 1003
(c)示踪气体测试。参考ASTM E499
SJ-3 热塑性弹性体管的热焊接
当需要在不使用机械配件的情况下将组件与一次性系统或其他工艺设备连接或分离时，热塑性弹性体（TPE）管路用作一次性组件的一部分。MJ-9中介绍了刚性热塑性塑料管材和管道的焊接。
SJ-3.1 规范
应使用焊接设备制造商提供的程序进行热焊接。管路材料、尺寸（例如：内径和外径），且管路焊前灭菌应与焊接设备的性能兼容。
SJ-3.2 设计参数
封闭加工的TPE管焊接设备应设计成
(a)熔合两个整体的管组件并在焊接过程中保持无菌流动路径以形成一个封闭系统
(b)在熔合后保持组件的流量和压力特性
SJ-3.3 验收标准
应对焊缝进行评估，以确认其无泄漏并符合所有者/用户的验收标准。验收标准可能包括
(a)管对管对齐的公差要求
(b)存在气泡、间隙、污染物或异物，以及管路内腔的内部溢边或堵塞
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CHAPTER 9 FABRICATION, ASSEMBLY, AND ERECTION FOR SINGLE-USE
PART SJ JOINING METHODS FOR SINGLE-USE
SJ-1 GENERAL
The joining of components may be performed in many ways for single-use applications. Examples of these joining techniques include, but are not limited to, welding, heat sealing, over-molding, solvent bonding, mechanical connections, and adhesives. With any of these methods, the procedure for the joining of polymers, components, or assemblies shall be controlled to ensure repeatable results. The joint shall not leak, shall meet the pressure requirements for the intended use, and shall maintain the integrity of the component or assembly.
SJ-2 MECHANICAL HOSE BARB CONNECTIONS
This section applies to the mechanical joining of single-use assemblies using a hose barb, flexible tubing, and a retention device, commonly referred to as a hose barb connection. Flexible hose assemblies intended for repeated use are addressed in PM-4.3.2 and SD-3.2.
Refer to Nonmandatory Appendix GG, Single-Use Mechanical Hose Barb Design Recommendations, for additional design considerations.
SJ-2.1 Operating Conditions
The owner/user should define the operating temperature range, operating pressure range, and sterilization method (if applicable) for the intended use of the hose barb connection.
SJ-2.2 Assembly
Manual assembly of single-use hose barb connections shall follow documented standard operating procedures. Assembly equipment (e.g., tubing stretchers, fitting inserters, retention devices, and application tools) shall be maintained in a state of calibration. Fluids used to aid in the insertion of a hose barb into flexible tubing shall be identified by chemical type and meet the requirements of PM-2.1.
SJ-2.3 Qualification
Single-use hose barb connections shall be qualified by the supplier to ensure they meet performance criteria as stated in their specification. The supplier shall have an established testing program to substantiate performance of the mechanical connection. The testing should reference at least one of the following:
(a) Pressure Testing. Reference ASTM D1599, ISO 1402
(b) Leak Testing
(1) Pneumatic. Reference ASTM E515
(2) Vacuum. Reference ASTM D4991
(3) Hydraulic. Reference ASTM 1003
(c) Tracer Gas Testing. Reference ASTM E499
SJ-3 THERMAL WELDING OF THERMOPLASTIC ELASTOMER TUBING
Thermoplastic elastomer (TPE) tubing is used as part of single-use assemblies when there is a need to join or separate the assembly from the single-use system or other process equipment without the use of mechanical fittings. Welding of rigid thermoplastic tubing and piping is addressed in MJ-9.
SJ-3.1 Specifications
Thermal welding shall be performed using the procedure provided by the welding equipment manufacturer. Tubing material, dimensions (e.g., inner and outer diameters), and tubing prewelding sterilization shall be compatible with the capabilities of the welding equipment.
SJ-3.2 Design Parameters
TPE tube welding equipment for closed processing shall be designed to
(a) fuse two integral tubing assemblies and maintain an aseptic flow path during the welding process to form one closed system
(b) maintain the flow and pressure characteristics of the assembly after fusing
SJ-3.3 Acceptance Criteria
The weld shall be evaluated to confirm it is leak free and meets the owner/user’s acceptance criteria. Acceptance criteria may include
(a) tolerance requirements for tube-to-tube alignment
(b) presence of bubbles, gaps, contaminants or foreign material, and internal flash or occlusion of tubing lumen