Quick answer

ISO Class 7 describes airborne particle cleanliness in a controlled space. It does not, by itself, define the full manufacturing method or approve a component.

Scope of this guide: AJSM describes its operational Gandhinagar cleanroom as ISO Class 7. This guide explains the boundary of that statement. Programme controls and evidence still need customer agreement.

Illustrative controlled cleanroom workspace with stainless steel benches and inspection equipment

What does ISO Class 7 describe?

ISO 14644-1 classifies air cleanliness by particle concentration. The class describes the environment under stated test conditions. It does not describe every activity inside the room.

A clear facility statement should separate room classification from product, process and quality-system claims. Each claim needs its own evidence.

Sources: ISO — ISO 14644-1:2015, classification of air cleanliness by particle concentration

Which workflow controls still matter?

The programme should define entry, gowning, material movement, workstation preparation, cleaning, assembly, inspection and exit. It should also define how items are identified and protected.

People and materials should follow a planned route. Unclear movement can weaken control even when the room classification is suitable.

The work instruction should name the environmental conditions and handling rules needed for the component. Training and records should use the same requirements.

The device manufacturer should decide which monitoring, cleaning and review evidence it needs. Those decisions depend on the product and process.

What should a cleanroom review cover?

Review the room, workflow and component method as one route.

  • Current room classification evidence and stated test condition.
  • Entry, gowning and personnel-flow instructions.
  • Material entry, identification and protected storage.
  • Workstation cleaning and preparation records.
  • Programme-specific assembly, inspection and handling rules.
  • Agreed monitoring, review and response responsibilities.

Source notes

Sources and further reading