欧盟GMP附录一对灌装线的最新要求

秘制红烧肉

[color=rgba(0, 0, 0, 0.9)]5.8 A conveyor belt should not pass through a partition between a grade A or B area and a processing area of lower air cleanliness, unless the belt itself is continually sterilised (e.g. in a sterilising tunnel).

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传送带不应穿越A级或B级区与较低空气洁净度生产区域之间的隔墙，传送带本身能连续灭菌者除外（例如，灭菌隧道内）

[color=rgba(0, 0, 0, 0.9)]8.12 The unwrapping, assembly and preparation of sterilised equipment, components and ancillary items with direct or indirect product contact should be treated as an aseptic process and performed in grade A with a grade B background. The filling line set-up and filling of the sterile product should be treated as an aseptic process and performed in grade A with a grade B background. Where an isolator is used, the background should be in accordance with paragraph 4.20.

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[color=rgba(0, 0, 0, 0.9)]与产品直接或间接接触的已灭菌设备、组件和辅助用品的开启、装配和准备应作为无菌工艺过程，并在B级背景下的A级内执行。无菌产品的灌装线组装和灌装应作为无菌工艺过程，并在B级背景下的A级内执行。当使用隔离器时，背景应符合4.20的规定。

[color=rgba(0, 0, 0, 0.9)]8.26 Where the equipment used to crimp vial caps can generate large quantities of non-viable particle, measures to prevent particle contamination such as locating the equipment at a physically separate station equipped with adequate air extraction should be taken.

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[color=rgba(0, 0, 0, 0.9)]如果轧盖设备会产生大量非活性微粒，则应采取措施防止微粒污染，例如将设备放置在独立的物理空间，并配备足够的抽气装置。

[color=rgba(0, 0, 0, 0.9)]8.26 Where the equipment used to crimp vial caps can generate large quantities of non-viable particle, measures to prevent particle contamination such as locating the equipment at a physically separate station equipped with adequate air extraction should be taken.

[color=rgba(0, 0, 0, 0.9)]如果轧盖设备会产生大量非活性微粒，则应采取措施防止微粒污染，例如将设备放置在独立的物理空间，并配备足够的抽气装置。

[color=rgba(0, 0, 0, 0.9)]8.27 Vial capping of aseptically filled products can be undertaken as an aseptic process using sterilised caps or as a clean process outside the aseptic processing area. Where the latter approach is adopted, vials should be protected by grade A conditions up to the point of leaving the aseptic processing area, and thereafter stoppered vials should be protected with a grade A air supply until the cap has been crimped. The supporting background environment of grade A air supply should meet at least grade D requirements. Where capping is a manual process, it should be performed under grade A conditions either in an appropriately designed isolator or in grade A with a grade B background.

[color=rgba(0, 0, 0, 0.9)]无菌灌装产品的西林瓶轧盖可使用经灭菌的瓶盖而作为无菌工艺，或作为无菌工艺区外的洁净工艺进行。采用后一种方法的情况下，西林瓶应受到A级条件的保护直至离开无菌工艺区，之后加塞的西林瓶应用A级送风保护直至瓶盖压合。 A级送风的辅助背景环境应至少满足D级要求。如果轧盖是一个手动操作，则应在A级条件下进行，可在经适当设计的隔离器中或在B级背景下的A级内。

[color=rgba(0, 0, 0, 0.9)]8.28 Where capping of aseptically filled sterile product is conducted as a clean process with grade A air supply protection, vials with missing or displaced stoppers should be rejected prior to capping. Appropriately qualified, automated methods for stopper height detection should be in place.

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[color=rgba(0, 0, 0, 0.9)]当无菌灌装的无菌产品的轧盖作为洁净工艺在A级送风保护下进行时，应在轧盖前剔除胶塞缺失或移位的西林瓶。应有经适当确认的自动化方法检测胶塞高度。

[color=rgba(0, 0, 0, 0.9)]8.51 The position of the temperature probes used for controlling and/or recording should be determined during the validation and selected based on system design and in order to correctly record and represent routine cycle conditions. Validation studies should be designed to demonstrate the suitability of system control and recording probe locations, and should include the verification of the function and location of these probes by the use of an independent monitoring probe located at the same position during validation.

[color=rgba(0, 0, 0, 0.9)]用于控制和/或记录的温度探头的位置应在验证过程中确定，并根据系统设计进行选择，以正确记录和反映常规循环条件。验证研究的设计应证明系统控制和记录探头位置的适用性，并应包括在验证过程中使用位于同一位置的独立监测探头来确认这些探头的功能和位置。

[color=rgba(0, 0, 0, 0.9)]8.53 After completion of the high temperature phase of a heat sterilisation cycle, precautions should be taken against contamination of a sterilised load during cooling. Any cooling liquid or gas that comes into contact with the product or sterilised material should be sterilised.

[color=rgba(0, 0, 0, 0.9)]在加热灭菌循环的高温阶段结束后，应采取预防措施防止已灭菌负载在冷却过程中被污染。与产品或已灭菌物料接触的任何冷却液体或气体均应进行灭菌。

[color=rgba(0, 0, 0, 0.9)]8.68 When a thermal process is used as part of the depyrogenation process for any component or product contact equipment/material, validation studies should be performed to demonstrate that the process provides a suitable Fh value and results in a minimum 3 log10 reduction in endotoxin concentration. When this is attained, there is no additional requirement to demonstrate sterilisation in these cases.

[color=rgba(0, 0, 0, 0.9)]当使用热处理作为任何组件或产品接触设备/物料的除热原工艺的一部分时，应进行验证研究以证明该工艺能提供合适的Fh值，并使内毒素浓度至少降低3 log10。当达到这一要求时，在这些情况下不需要证明灭菌。