The following article presents a basic overview of common questions relating to the classification of a cleanroom.

 

表的内容

 

什么是洁净室?

越来越强调产品产量的最大化, 加强质量控制,确保安全, companies throughout many industries are looking to install cleanrooms or controlled environments in their facilities. 洁净室不再局限于高科技半导体制造或大学研究实验室. 今天,洁净室被用于各种类型的环境中.

什么是洁净室?, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平
 
什么是洁净室?, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

选择洁净室分类

There are a lot of determining factors involved in choosing a 洁净室分类 and every industry has a default standard to start with. 例如在医疗器械包装中, 默认的分类是ISO 7(或10类,000)洁净室.

 

如何选择正确的洁净室来满足您的需求? 决定你所需要的洁净室水平的决定因素是什么, 或者您的操作是否更适合于受控环境?

您可能需要的洁净室将由几个不同的因素决定:

  • 行业标准
  • 政府规定
  • 客户需求
  • 易于清洁
  • 限制访问
  • 微粒
  • 温度
  • 湿度
  • 微生物

一旦考虑到所有这些因素, 然后你就可以对你应该实施的洁净室操作的范围做出准确的选择, 或者您的操作是否更适合于受控环境.

ISO 6 1000级洁净室, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

请咨询电竞游戏App下载的专家-洁净室分类

这是电竞游戏App下载洁净室系列的两个视频. 有关洁净室的更多视频和信息,请访问电竞游戏App下载PortaFab Youtube频道.

如何选择洁净室分类第一部分, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

如何选择洁净室的分类(第一部分)

洁净室需要过滤哪些颗粒, 什么级别的洁净室最能满足需要? 

如何选择洁净室分级2, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

如何选择洁净室的分类(二)

你所在行业的默认需求是什么? 你们需要控制哪些污染问题?

 
洁净室标准-如何选择洁净室, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

PortaFab案例研究-洁净室的考虑因素

When considering a certain ISO classification of cleanroom it is critically important to ensure that your operation’s needs align with the scope of the ISO level you select. 例如, choosing a cleanroom that is more robust than the needs of your operation may make it difficult to meet the ROI of the cleanroom. 另外, selecting a cleanroom that does not meet the needs of your operations can lead to the contamination of your 产品 or services, 哪些会产生更多的成本,并可能影响未来的客户关系. 对于电竞游戏App下载电竞游戏App下载解决方案的实际应用,下面列出了几个电竞游戏App下载案例研究.

ISO 8 100000级洁净室, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

ISO 8(10万级洁净室)

Vesta required complete environmental control with ISO 8 validation in order to completely contain one of their manufacturing processes.

ISO 7 10000级洁净室, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

ISO 7(10,000级洁净室)

Young Dental required multiple clean environments in which to contain each stage of the manufacturing process from initial mixing to product packaging.

ISO 6 1000级洁净室, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

ISO 6(1000级洁净室)

Pozzetta Micro Clean required the quick creation of a modular cleanroom that would aid in their new cleaning service targeted at semiconductors, 微电子学, 和医疗产品.

ISO 5洁净度100级, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

ISO 5(100级洁净室)

Ampex Recording Media Corporation required a high-quality yet flexible cleanroom to accommodate their expanding tape manufacturing operation.

 
洁净室环境控制。PortaFab洁净室, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

污染与洁净室分级有何关系

一个典型的洁净室的设计目的是防止外部环境进入. 一旦环境建立起来, 造成污染的两件事是人和过程. 问题是, 人类产生了多少污染啊, 这个过程会产生什么污染.

洁净室争取, propper洁净室争取, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

Propper争取

通常人们可以建立一个较低等级的洁净室, though still maintain a cleaner environment by enhancing operations within the cleanroom - for instance, 使工人达到更高的标准.

洁净室空气控制, 如何控制洁净室的空气, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

空气控制

Positioning return air grills and filtration systems at optimal locations within the cleanroom can result in cleaner areas within the environment, 从而使这些区域的洁净室分级降低到较低的水平.

Understanding the contamination sources and combating those with solid cleanroom design and enhanced operations can provide significant cost savings from both construction and operational standpoints. 

 
洁净室如何控制颗粒大小, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

粒度如何影响分类

决定何时建造洁净室的最重要因素之一是 需要过滤掉多大的颗粒. 它是任意大小的粒子吗? 它是一个特定的大小或范围的粒子? 通常, people look at the 洁净室分类 (see chart below) and they go to the lowest level particle count to determine what classification they need.

ISO 5洁净度100级, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

如何选择正确的ISO级别

An example of this would be someone that determines they need less than 100 particles per square foot within their cleanroom. 基于这些信息, 他们决定将需要分类为ISO 5(或100级)洁净室. 然而, an issue can arise if they do not take into account the size of the particle they are trying to filter out.

ISO 8 100级,000年洁净室分类, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

微米尺寸可以确定ISO等级

There’s a significant difference in the classification that is needed if that particle is 1/2 micron in size versus 5 微米 in size (see Micron description below). 如果他们认为他们看到的是一个½微米大小的粒子, but really the particle that is a problem for them is a 5 micron particle – From a 洁净室分类, 这不能转化为ISO 5洁净室(或100级). 这实际上意味着ISO 8洁净室(或10万级).

在洁净室环境中,测量空气颗粒 微米. 1微米等于 百万分之一米. Micron-sized particles are smaller than a living cell and can be seen only with the most powerful microscopes.

 

从这个角度来看,一根头发的宽度可以从大约变化 20到180微米,而平均大小是典型的 50 - 70微米.

  • 在一缕阳光中看到的一个小尘埃颗粒大约相当于60微米.
  • 人眼不能始终看到小于50微米的物体.
  • 花粉约为30-50微米.
  • 细菌大约有2到10微米大小.
  • 一个典型的室内空气样本的含量可能在500左右,每立方英尺空气中有000到100万个微粒.
一微米有多大, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

相比之下,ISO 5级洁净室的设计允许不超过 大于等于0的颗粒数为3520个.每立方米空气5微米. 这相当于一个100级洁净室下面 联邦标准209 e,它允许100个粒子(0.5微米或更大)每立方英尺空气.

 
空气循环如何影响洁净室分级, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

空气循环如何影响分级

分类在类下面的任何时候, 或高于一个类——例如ISO 8 (class100,000)到ISO 7 (class10,000) -这将需要 两倍的空气量. 过滤和移动空气的费用是操作洁净室的重要费用. 这个过程一直向下转换到需要的过滤器的数量, 所需要的回风空间量, 需要多少空调来冷却回风等等. 在这个过程中,它会自我增殖.

 

一个常见的错误是客户要求的洁净室太高, 或者超出了他们真正需要的. 如果您需要一个8英尺高的电竞游戏App下载, but decide to make it taller in order to align better with the surrounding environment and make it 10-feet high, 这改变了25%的面积. 因此他们增加了洁净室所需的空气量 25% 因为他们决定建一个10英尺高的,而他们只需要8英尺高.

What would seem to be a simple difference (moving from one class to the other) significantly changes the cost of a cleanroom - almost 25% for the same sized cleanroom at the same classification.

洁净室采用单道空气循环设计, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

控制温度、湿度、 & 气流

控制ling the environment within a clreanroom is critical to the success of a cleanroom and operations that take place within it. Provided below are two videos that go into further depth regarding controlling a cleanroom environment. 有关洁净室的更多视频和信息,请访问电竞游戏App下载PortaFab Youtube频道.

空气流量是否影响洁净室建设或设计成本?, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

空气流动是否影响洁净室建设或设计成本?

单次设计vs. 空气再循环设计. 哪种类型的洁净室适合您?

洁净室的温度和湿度如何影响成本, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

洁净室的温度和湿度如何影响成本

公差将决定您的洁净室将需要的温度和湿度. 

 
洁净室标准, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

洁净室分级标准

对于那些需要坚持特定洁净室设计标准的公司, they must understand that cleanrooms can be built and operated to meet different cleanliness classifications, 取决于使用它们所需的环境条件. 洁净室分类的主要权威是 国际标准化组织 或ISO.

ISO 14644 - 1洁净室标准

Class

最大颗粒/ m3

美联储STD 209 e
等效

≥0.1 µm

≥0.2 µm

≥0.3 µm

≥0.5 µm

≥1 µm

≥5 µm

ISO 1

10

2.37

1.02

0.35

0.083

0.0029

 

ISO 2

100

23.7

10.2

3.5

0.83

0.029

 

ISO 3

1,000

237

102

35

8.3

0.29

1级洁净室

ISO 4

10,000

2,370

1,020

352

83

2.9

类10洁净室

ISO 5

100,000

23,700

10,200

3,520

832

29

100级洁净室

ISO 6

1.0×106

237,000

102,000

35,200

8,320

293

1000级洁净室

ISO 7

1.0×107

2.37×106

1,020,000

352,000

83,200

2,930

10000级洁净室

ISO 8

1.0×108

2.37×107

1.02×107

3,520,000

832,000

29,300

100000级洁净室

ISO 9

1.0×109

2.37×108

1.02×108

35,200,000

8,320,000

293,000

室内空气

(µm为微米粒径)

ISO 14644 - 1 classifies a cleanroom based on the size and number of airborne particles per cubic meter of air (see chart above).

在实施之前 ISO 14644 - 1, 美国联邦标准209E制定了洁净室分类的行业指南, 表示粒子数为0.每立方英尺空气5 μ m或更大. 例如,根据美联储- std - 209e,“1000级洁净室”意味着1000个颗粒为0.每立方英尺空气中5 μ m或更小. 美联储- std - 209e计划于11月29日正式取消, 2001, 尽管这两种标准仍然被广泛使用.

 
受控环境vs洁净室, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

通过受控环境节约成本

One of the reasons for the development of the ISO standards was to accommodate an environment called “ISO Class 9” which was never a 洁净室分类 before. This classification translates roughly into what the pharmaceutical industry calls a “controlled and classified area.”

 

受控分类, 这意味着它被控制在颗粒水平(通过高效空气过滤器), 它控制在指定的温度和湿度, 但它不是按照粒子数来分类的. 一个“受控和机密区域”是加压的, 它具有温度控制和空气过滤. 它不是根据给定空气体积内粒子的数量和大小来确定的.

在许多情况下,这种类型的环境就是客户所需要的“洁净室”。. 如果公司不小心, they can end up building a cleanroom far beyond their actual requirements and there are dramatic costs involved with doing that.

洁净室环境, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平
 
洁净室的考虑, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

洁净室注意事项-附加读数

你想知道其他类型的洁净室吗, 或者可以添加的各种组件,以确保您的流程, 产品, 和技术人员符合ISO标准? Listed below are several different links you can follow to learn more about the additional 产品 and systems that PortaFab can offer for your cleanroom build.

负压空气传播感染隔离室, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

负压空气传播感染隔离室

控制洁净室的气压重要吗? 您的操作是否要求外部空气不能进入洁净室, 任何挥发性化学物质或微生物都不能离开洁净室? 在这里阅读更多关于控制你的洁净室的气压- 负压空气传播感染隔离室.

 

模块化的电竞游戏App下载, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

PortaFab的模块化洁净室

模块化洁净室为传统的施工方法提供了一个极好的选择. 它们安装起来很简单, 不需要切割, 创建没有碎片, and can be relocated with ease giving your operations a degree of versatility that a permanent-non moveable construction would not be able to offer. 点击此链接了解PortaFab的更多信息 模块化的洁净室.

 

洁净室组件, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

洁净室组件

Cleanroom Operations often consist of several different components working simultaneously to ensure that processes or 产品 are protected. 如果您的洁净室需要额外的组件, PortaFab有几个不同的解决方案,您可以使用来增强您的构建- 洁净室组件.

 

如何建造洁净室, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

洁净室施工专业知识

30多年来, PortaFab一直在帮助组织的所有洁净室和环境控制需求. Our staff of design consultants work with architects and general contractors to deliver functional and cost-effective solutions, 从而使洁净室施工过程顺利、快速. 点击这里阅读更多- 洁净室施工专业知识.

 

洁净室的信息, 洁净室分类, 洁净室分类, 洁净室类型, 洁净室分类水平

PortaFab的洁净室学习中心

关于洁净室或受控环境,您有更多的问题吗? PortaFab的 洁净室学习中心 有几个资源可以帮助回答您的问题.

 

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