TR34 隔离器系统的设计和验证(中英)2001.pdf

PDA TECHNICAL REPORT NO. 34

第

34

号

PDA

技术报告

DESIGN AND VALIDATION OF ISOLATOR SYSTEMS FOR THE

MANUFACTURING AND TESTING OF HEALTH CARE PRODUCTS

卫生保健产品生产和测试的隔离器系统的设计和验证

Table of Contents 内容列表

1.0 INTRODUCTION 概述

1.1 Preface 绪言........................................................................................................................................................1

1.2 Scope 范围........................................................................................................................................................ 1

3.0 ISOLATOR DESIGN AND GENERAL CONSTRUCTION隔离器设计和总体结构

4.3 Ergonomics 人体工程学.....................................................................................................................................10

6.1 General User Requirement Specifications 一般用户需求规格............................................................................ 11

6.1.4 Environmental Control 环境控制............................................................................................................... 16

7.0 RE-QUALIFICATION TESTING 再确认测试...........................................................................................................18

1.0 INTRODUCTION 绪论

1.1 Preface 前言

for the production and testing of many different types of health care products. The operational characteristics of

isolators make them ideally suited for use in the preparation of sterile materials, as well as in the containment of potent

materials. Additional applications can be found in the preparation of clinical supplies, sterile bulk

drugs/bio-pharmaceuticals, sterile cytotoxic materials, and in sterility testing.

近几年来，隔离器快速成为应用于多种不同类型的卫生保健产品的生产和测试的非传统的

人造级别环境。隔离器本身的操作性能参数使得它很好的适用于无菌材料的制备，也同样适用于对药效较强的原料的抑

制，除此之外，它还附加有应用于临床补给的配制剂，无菌原料药，生物制药，无菌细胞毒素原料，和无菌测试的应用。

The absence of authoritative implementation and validation guidance for this technology and the considerable

以上原因，PDA在此基础上提出了这份文件。它是由美国PDA的代表，PDA日本篇，A

3

P，注射药物科学和R

3

-Nordic组成

的国际委员会的提出并产生的。

This document should be considered as guidance; it is not intended to establish any mandatory or implied

standard.

这份文件需要将其作为一种指导，并不是为了确定任何强制性的和隐含的标准。

1.2 Scope 范围

range of manufacturing, development, and testing applications in the health care product manufacturing industry. This

hazardous materials.

recommendations made within this technical report.

词汇表（附录A）是这篇技术报告中一个很重要的组成部分。在卫生保健生产行业里，缺少一套对隔离器技术的统

一的定义。委员会认为，为了提出真实可行的技术资料，我们必须要保证使读者不会混淆这篇技术报告中的应用建议标

准。

The committee also recognizes that in some regions of the world, processing environments called "isolators" are

widely used in the clinical pharmacy setting. These devices have some general features in common with isolators as

defined in this document, however, they are distinctly different from the isolator systems currently in use for sterile

product manufacturing and testing in the health care product industry. This technical report does not pertain to devices

that do not meet the minimum performance criteria defined and explained in this document.

委员会同时认为在世界上某些地区，被称为“隔离器”的加工环境在很大范围上应用于临床药学的环境。这些设备

工业中应用到的隔离器的定义：

may be reproducibly decontaminated (1). When closed, it uses only decontaminated (where necessary) interfaces or

Rapid Transfer Ports (RTPs) for materials transfer. When open, it allows for the ingress and/ or egress of materials

through defined openings that have been designed and validated to preclude the transfer of contamination. It can be

used for aseptic processing activities, for containment of potent compounds, or simultaneously for both asepsis and

containment.

仅使用净化排污接口或者专为物料传送用的快速传输接口。当其打开时，它可以允许通过被设计和经过验证的通道进行

材料的进入和/或者输出来防止污染的转移。同样它可以用于进行无菌操作的活动，用于对药效较强的化合物的抑制或者

同时用于无菌处理和抑制。

isolators can be decontaminated using reproducible and validated methods, do not allow the ingress of airborne

contamination from the surrounding environment, and prevent the introduction of personnel borne contamination into

the isolator. In contrast, a barrier system is an open system which can exchange unfiltered air with the surrounding

environment, can only be manually disinfected, and is directly accessed by gowned personnel.

当隔离器处于密闭或者开放式的操作模式下时，与障碍系统向比它具有明显的优点：隔离器可以通过可再生的和验证

的方法进行净化处理，并且不允许周围环境中的空气污染物进入，并且能防止由个人携带的污染物进入隔离器内。相比

之下，障碍系统只是一个能与周围环境进行未过经滤空的气的交换的开放式系统，它只能利用手动消毒，并且允许穿着

便装的人员直接进入。

The increased use of isolators in the health care product industry over the last decade and a half has been

clean rooms. Experience has taught scientists and engineers that functional requirements for isolators are, in fact,

distinctly different from those for human scale or "conventional" clean rooms. Although human scale clean rooms and

isolators have much in common, they have many important differences and this technical report endeavors to focus on

and discuss these differences.

在开始经常提到的“隔离器时代”中，隔离器被认为仅仅是一个小型的洁净室。实际上，经验提醒科学家和工程师，

隔离器的功能要求明显不同于人类尺度上的或者传统意义上的洁净室。尽管人类尺度意义上的洁净室与隔离器有很多相

似之处，但是它们之间依然有许多明显区别，因此这篇技术报告尝试着将重点关注和论述这些区别。

2.0 TYPES OF ISOLATORS 隔离器的类型

2.1 Closed Isolators 密闭式隔离器

Isolators operated as closed systems do not exchange unfiltered air or contaminants with adjacent environments.

Their ability to operate without personnel access to the critical zone makes isolators capable of levels of separation

between the internal and external environment unattainable with other technologies. Because of the effectiveness of

当隔离器处于密闭式系统操作时，它和周围相邻环境中没有与未过滤空气或者污染物的交换。隔离器能够在没有人

员进入其关键区域进行操作，表明了隔离器在其他技术不能达到的分离其内部环境和外部环境的能力水平。鉴于这种高

效的隔离效果，封闭式隔离器能很好的适用于无菌制备和/或者对有毒材料的处理。

隔离器内部所有对原料进行的加工或者处理都是在远程操作模式下完成的。操作期间操作人员或者其身体的任何部