So you are looking for complying ISO 14644 standard for clean room!
如果您进入医疗行业，或者您的工作性质进入商业，医疗或工业行业，那么您应该知道清洁室,如果每个医疗行业都必须在“干净”条件下工作的地方，因为极小的灰尘颗粒或脱水可以使整批药物无法使用。干净的房间是每个医疗制造过程中非常重要的一部分。一家公司还需要一个无尘的清洁室来进行测试，并在制造开始之前加速创新过程。洁净室的主要目的是用于产品产量和通过洁净室内的亚微米颗粒的有限存在在环境中改善质量控制，还提供了员工的安全性。
医疗设备的清洁房间设计顾问
作为一名干净的房间设计顾问，我们为医疗设备制造商提供专业知识清洁室设计解决方案。
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什么是干净的房间？
‘A room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room and in which other relevant parameters, eg temperature, humidity, and pressure are controlled as necessary.’
— ISO 14644-1
Contamination in a clean room can represent the risk to specialized procedures and production activities, and also the people associated with this procedure. Numerous organizations have discovered that the unguarded growth of contamination can bring about product damage, yield decrease, and even product recalls. So, nowadays医疗公司are protecting themselves from the unsafe impacts of contamination.
In a clean room, the unwanted microorganisms are always carried by humans. As indicated by ongoing investigations, there are more than 200 types of various microscopic organisms that are related with people and can be found in the digestion tracts, eyes, hair, nose, mouth, and skin. This implies that humans are not just the major source of contamination; they are likewise the agent for transferring contaminants to different areas that could represent damage to the product. These bacteria can be spread by sneezing, coughing and by just touching something. To avoid this contamination there is clean room clothing which will be discussed further.
Clean room Manufacturing as per ISO 14644 standard
测量房间的干净程度如何，如何确定？我们将在本博客文章中向您解释。干净的房间是根据每卷空气的颗粒的数量和大小来对空气的干净进行分类的受控区域。
干净的房间设计和开发需要严格控制污染，空气流量，压力，温度和湿度。制造干净的房间ISO类系统提供了一个整个行业的标准ISO 14644it’s the clean room standard for cleanliness and particles counts.
ISO 14644-1：2015指定了空气中颗粒的浓度在干净的房间和干净区域中的分类；以及ISO 14644‑7中定义的分离设备。
ISO14644由：
第1部分：按颗粒浓度分类空气清洁度
第2部分：Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
Part 3:测试方法
Part 4:设计，构建和启动
Part 5:Operations
第7部分：Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
第8部分：Classification of air cleanliness by chemical concentration (ACC)
第9部分：按颗粒浓度分类表面清洁度
第10部分：通过化学浓度分类表面清洁度
从不同的角度来看，以下是ISO 14644-1中引入的一些重大变化：
- ISO分类表
- 最小要求的样品位置数量
- UCL 95％
- Equipment Calibration
- 超级描述符
- 顺序采样
- 修订了从空气粒子计数收集的数据评估方法的修订
- 基本的ISO清洁类1至9不会从根本上改变，但是分类过程需要为每个清洁室或清洁空气设备采用修订的协议
- 修订后的标准还包括对规范和支持标准的更新引用
ISO 14644-1：2015与ISO 14644-1：1999不同
What really makes it different? Is been mentioned in the following table for the ones who are still unaware. Well, let’s consider this too, and see some points in the below image:
| ISO14644-1：2015 | ISO14644-1:1999 | |
| UCL 95％ | 如果采样位置的数量在1到10之间，则计算出标准偏差和UCL 95％，并且该数字必须在特定类别的清洁室规范之内。 | 完全消除了标准偏差，UCL 95％。如果每个样本位置的平均粒子浓度在规格范围内，则清洁室已满足其分类要求。 |
| Equipment Calibration | The instrument shall have a valid calibration certificate, the frequency and method of calibration should be based on current accepted practice. | 粒子计数器应具有有效的校准证书：校准的频率和方法应基于ISO 21501-4中指定的当前接受的实践 |
| Ultra and Micro(u, M)Descriptors | Smaller than 0.1 microns defined as u, larger than 0.5 microns defined as M. | Smaller than 0.1-micron particles will no longer exist in ISO 14644-1. This issue will address in ISO 14644-12 |
一些一般性问题ISO 14644 - 1: 2015
Here are some questionnaires that are generally asked. Well, surely many questions and doubts held by businesses interacting with ISO 14644-1:2015 standards. I have answered some questions which are put up.
- What is this ISO 14644-1:2015 standard about?
该标准是通过在清洁室内有限地存在亚微米颗粒来改善环境中的质量控制。它提供了与空气清洁相关的指南，专门研究颗粒浓度。
- ISO14644-1：2015标准适用吗？
- Clean room facility users, testers, consultants
- Vendors of cleanroom technology components such as air filters, safety cabinets
- 卫生保健operators/hospitals/clinics
- 卫生保健设计和构建/研究与开发
- 卫生保健manufacturing, including pharmaceutical and medical devices
- Life sciences research and microelectronics and biomedical technology
- Micro-mechanical industries
- 纳米技术行业
- Optics
- 航天
- 为什么是这样ISO 14644-1：2015标准需要吗？
It focuses on the definition of air cleanliness by particle number concentration and gives the updated classification procedures specified to achieve this.
This latest revision reflects recent advances in airborne particle counting science and the improved statistical rigour of cleanliness classifications for clean rooms and clean devices.
- 变化ISO 14644-1：2015年?
The 2015 revision takes into account improved industry knowledge and a reconsideration of the levels of statistical confidence that can be practically achieved during clean room and clear air device classification. Changes include:
- 修订了从空气粒子计数收集的数据评估方法的修订
- 基本的ISO清洁类1至9不会从根本上改变，但是分类过程需要为每个清洁室或清洁空气设备采用修订的协议
- 修订后的标准还包括对规范和支持标准的更新引用
