一次性使用的制造、组装和安装 | ASME BPE-2022 新增内容解读

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。

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