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Clean room moulding for diagnostic consumables
For parts that touch a sample, particulate and mould release residue are analytical problems, not housekeeping ones.
A diagnostic consumable is part of the measurement. Anything on its surface can interact with the sample or the reagent, which means particulate from the moulding environment and residue from mould release agents both show up in the assay rather than staying in the factory.
ISO 8, also called class 100000, is the working standard for this category. What matters as much as the class is where the boundary sits: moulding and assembly both inside it means the part is never exposed between operations, which is different from moulding in a clean room and assembling outside one.
The practical consequence for a tool designer is that release agents are avoided rather than managed, which changes draft angles and surface finish decisions at the design stage. That is why the clean room requirement should be stated before the tool is designed, not after.
Specifications
| Class | ISO 8 (class 100000) |
|---|---|
| Boundary | Moulding and assembly both inside the clean room |
| Design consequence | Release agents avoided, affecting draft and finish |
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