一次性使用技術(shù)應用于制藥領域已有30余年歷史。憑借其聚合物材料可塑性強、便于運輸和使用的優(yōu)勢，在質(zhì)量可控的前提下，一次性使用系統(tǒng)已經(jīng)廣泛應用于液體儲存、液體轉(zhuǎn)移、無菌過濾、超濾和透析換液，以及病人使用的輸液系統(tǒng)等。近年來，隨著單抗藥物和細胞治療藥物的成功發(fā)展，相關(guān)技術(shù)迅速升級，一次性使用技術(shù)在制藥領域的應用不斷拓展。目前一次性使用技術(shù)幾乎可以涵蓋整個生物制藥工藝過程的各個單元操作。
ASME BPE 2022已發(fā)布，本次版本升級，增加了一次性使用部件和組件的要求，分為三個章節(jié)，分別是第七章一次性使用設計、第八章一次性使用工藝組件和第九章一次性使用的制造、組裝和安裝。本文繼續(xù)介紹第九章一次性使用的制造、組裝和安裝。
第9章一次性使用的制造、組裝和安裝
SJ部分 一次性使用的連接方法
對于一次性使用，部件的接合可以以多種方式進行。這些連接技術(shù)的實例包括但不限于焊接、熱封、包覆成型、溶劑粘合、機械連接和粘合劑。使用這些方法中的任何一種，應控制聚合物、部件或組件的連接程序，以確保結(jié)果可重復。接頭應無泄漏，應滿足預期用途的壓力要求，并應保持部件或組件的完整性。
本節(jié)適用于使用軟管倒鉤、軟管和固定裝置（通常稱為軟管倒鉤連接）的一次性組件的機械連接。PM-4.3.2和SD-3.2中闡述了預期重復使用的柔性軟管組件。
有關(guān)其他設計注意事項，請參閱非強制性附錄GG，一次性機械軟管倒鉤設計建議。
SJ-2.1 操作條件
所有者/用戶應規(guī)定軟管倒鉤連接預期用途的工作溫度范圍、工作壓力范圍和滅菌方法（如適用）。
SJ-2.2 組裝
一次性軟管倒鉤接頭的手動組裝應遵循文件化的標準操作規(guī)程。裝配設備（例如，管道拉伸器、接頭插入器、保持裝置和應用工具）應保持校準狀態(tài)。用于輔助軟管倒鉤插入軟管的液體應通過化學類型進行識別，并符合PM-2.1的要求。
SJ-2.3 確認
一次性軟管倒鉤接頭應由供應商鑒定，以確保其符合規(guī)范中規(guī)定的性能標準。供應商應制定測試計劃，以證實機械連接的性能。測試應參考以下至少一項：
(a)壓力測試。參考ASTM D1599、ISO 1402
(b)泄漏試驗
(1)氣壓。參考A STM E515
(2)真空。參考ASTM D4991
(3)液壓。參考ASTM 1003
(c)示蹤氣體測試。參考ASTM E499
SJ-3 熱塑性彈性體管的熱焊接
當需要在不使用機械配件的情況下將組件與一次性系統(tǒng)或其他工藝設備連接或分離時，熱塑性彈性體（TPE）管路用作一次性組件的一部分。MJ-9中介紹了剛性熱塑性塑料管材和管道的焊接。
SJ-3.1 規(guī)范
應使用焊接設備制造商提供的程序進行熱焊接。管路材料、尺寸（例如：內(nèi)徑和外徑），且管路焊前滅菌應與焊接設備的性能兼容。
SJ-3.2 設計參數(shù)
封閉加工的TPE管焊接設備應設計成
(a)熔合兩個整體的管組件并在焊接過程中保持無菌流動路徑以形成一個封閉系統(tǒng)
(b)在熔合后保持組件的流量和壓力特性
SJ-3.3 驗收標準
應對焊縫進行評估，以確認其無泄漏并符合所有者/用戶的驗收標準。驗收標準可能包括
(a)管對管對齊的公差要求
(b)存在氣泡、間隙、污染物或異物，以及管路內(nèi)腔的內(nèi)部溢邊或堵塞
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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
