A cleanroom is a controlled environment where airborne particles, temperature, and humidity are strictly regulated. Cleanrooms are classified according to ISO 14644-1, which defines the maximum allowable number of particles per cubic meter of air. The lower the ISO class number, the cleaner the room.

ISO 14644-1 Classification

ISO Class	Max Particles ≥0.5 µm /m³	Typical Application
ISO 1	10	Semiconductor fab (leading edge)
ISO 2	100	Semiconductor fab
ISO 3	1,000	Semiconductor, nanotechnology
ISO 4	10,000	Disk drives, medical devices
ISO 5	100,000	Pharmaceutical sterile filling
ISO 6	1,000,000	Electronics assembly, optics
ISO 7	10,000,000	Pharmaceutical production, medical devices
ISO 8	100,000,000	General electronics, food processing
ISO 9	1,000,000,000	Normal indoor air (reference)

Why Cleanroom Packaging Matters

Products manufactured in a cleanroom must be packaged in materials that do not introduce particles — otherwise the entire cleanroom effort is wasted at the packaging step. Cleanroom packaging means:

Aspect	Requirement
Film production	Manufactured in a controlled environment
Particle load	Low particle count on the film surface
Additives	Particle-free formulations (no migrating powders)
Packaging	Double-bagged: inner bag (clean) + outer bag (transport)
Documentation	Batch certificates with particle count data
Storage	Sealed packaging until use in the cleanroom

Standard Film vs. Cleanroom Film

Property	Standard PE Film	Cleanroom PE Film
Production environment	Standard factory	ISO Class 9 cleanroom
Particle control	None	Monitored and documented
Surface cleanliness	Not specified	Low particle count
Double packaging	No	Yes (inner + outer)
Documentation	Standard CoA	Batch certificate with particle data
Additives	Standard	Low-migration, particle-free
Price	Base	Premium (15–30 % higher)

Cleanroom Film Applications

Industry	Application	ISO Class Required
Semiconductor	Wafer transport packaging	ISO 4–5
Electronics	PCB, IC packaging	ISO 6–8
Pharmaceutical	Drug packaging, device packaging	ISO 5–7
Medical devices	Sterile packaging	ISO 5–7
Optics	Lens, display packaging	ISO 6–8

Parainesis Cleanroom Film

• ISO Class 9 production — Dedicated cleanroom production area
• All PE film formats — Flat film, tubing, bags, pallet covers
• Antistatic + cleanroom — Combined for electronics
• ESD + cleanroom — Combined for sensitive components
• Double packaging — Inner + outer bag standard
• Batch documentation — Particle count, material certificate