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Wisdom For Polyethylene vol.27

27. What Does a “Class 1000 Poly Bag” Mean?

2025-12-04
In cleanrooms and manufacturing environments for semiconductors and pharmaceuticals, clean poly bags are commonly used to package products and components.
However, expressions like “I want a Class 1000 poly bag” or “I need a bag equivalent to Class 10000” are often heard—but are these technically correct?

Is “Class 1000 Poly Bag” a Correct Expression?

Inquiries about the cleanliness of clean poly bags have been increasing. Many customers request bags labeled as “Class 1000” or “Class 10000 equivalent.”
 However, these expressions can be misleading.


Understanding Cleanroom Classification and ISO 14644

Cleanroom cleanliness is classified under ISO 14644-1, based on the number of particles ≥0.1 µm per cubic meter of air.
For example, ISO Class 5 allows a maximum of 10,200 particles (≥0.1 µm) per cubic meter.
It is not appropriate to apply cleanroom class numbers directly to poly bags themselves.


How to Measure Clean Poly Bag Cleanliness

To evaluate the cleanliness of a bag, we use the following method:
(1) Fill the bag with particle-free water.
(2) Agitate to wash off insoluble particles from the film surface.
(3) Measure the particles in the water.

This method minimizes the effect of static electricity and allows standardized, comparable results.
In general, ordinary poly bags may contain millions of insoluble particles ≥2 µm per bag, making the difference with clean poly bags clearly measurable.


Selecting Clean Poly Bags

It is important to select a clean poly bag appropriate for your application and control standards.
By specifying the target particle size and required cleanliness level, you can design packaging that meets your exact requirements.


ISO Global Standards

As a side note, the ISO is developing the first global unified standards for cleanrooms and controlled environments:
  • ISO 14644-1 Part 1: Classification of air cleanliness by particle concentration
  • ISO 14644-2 Part 2: Testing and monitoring methods

ISO class specifications are based on a 0.1 µm particle size and a reference volume of 1 m³, following the JIS method.
Our own cleanroom is maintained at ISO Class 6.

In conclusion, rather than relying on the term “Class 1000 poly bag,” it is essential to clearly define the required particle size and particle count for your application. This ensures optimal clean bag selection.


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28. Gamma & Electron Beam Sterilization
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