Cleanroom manufacturing facility — ultrasonic seam welding

Engineered
to disappear.

Particle-controlled garments for semiconductor fabs, pharmaceutical compounders, and aerospace cleanrooms. Every fiber tested. Every seam sealed. Full traceability from polymer to packout.

Tour the Facility
ISO 5Minimum Class Rating
100%In-Process Particle Testing
< 0.1μmSeam Particle Threshold
24-moValidated Shelf Life
Scroll
ISO 14644-1 CertifiedIEST-RP-CC003 CompliantEU GMP Annex 1 ReadyUSP <797> CompatibleESD-Safe Variants AvailableSterile & Non-Sterile ConfigurationsFull Lot TraceabilityParticle Shed Testing Per GarmentUltrasonic Seam WeldingASTM F1671 Barrier TestedISO 14644-1 CertifiedIEST-RP-CC003 CompliantEU GMP Annex 1 ReadyUSP <797> CompatibleESD-Safe Variants AvailableSterile & Non-Sterile ConfigurationsFull Lot TraceabilityParticle Shed Testing Per GarmentUltrasonic Seam WeldingASTM F1671 Barrier Tested

From polymer to packout —
every step controlled.

Each card below represents one production bay. Hover to inspect the particle data.

Close-up of white polymer fabric material under laboratory lighting
01Material Control

Raw Material Sourcing

Verified Polymer Inputs

Tyvek® 1422A · Cleanroom-grade PTFE · Flash-spun polyethylene

Every polymer lot is certified to ASTM D1238 melt-flow index. Supplier CoA retained per batch. Zero recycled content — virgin resin only for particle-controlled applications.

Lot-level CoA on file100%
Precision cutting equipment in a cleanroom environment with white surfaces
02Process Control

Cleanroom-Grade Cutting

ISO Class 6 Cutting Bay

Ultrasonic die-cutting · No-shed edge finish · HEPA-filtered workcell

Cutting operations run inside a dedicated ISO Class 6 bay. Ultrasonic blades fuse the fiber edge as they cut — eliminating frayed filaments before they become a contamination event.

Edge particle generation< 0.05μm
Industrial ultrasonic welding heads fusing white protective fabric panels
03Seam Integrity

Sealed-Seam Construction

Ultrasonic Welding + Tape

Dual-pass ultrasonic welding · ISO 13935 seam strength · Particle-barrier tape

No thread. No needle holes. No fiber ingress paths. Ultrasonic welding fuses Tyvek panels at the molecular level — seam strength exceeds 180 N/5cm per ISO 13935-1.

Seam integrity pass rate99.97%

Ready to qualify our garments for your cleanroom?

Receive lot samples, particle-shed data, and our full CoA package — no commitment required.

Third-party verified.
Not self-declared.

Every certification below is maintained by an accredited third-party laboratory. Certificate copies available in our Qualification Kit.

ISO 14644-1

Cleanroom Classification

Airborne particulate cleanliness classes for cleanrooms and clean zones. Our garments are validated for ISO Class 4 through Class 8 environments.

Semiconductor · Pharma · Aerospace
IEST-RP-CC003

Garment Qualification

Recommended Practice for Garment Considerations in Cleanrooms and Other Controlled Environments — the governing standard for cleanroom apparel selection and qualification.

All controlled environments
EU GMP Annex 1

Sterile Manufacturing

Revised 2022 guidance for manufacture of sterile medicinal products. Our sterile coverall line meets Grade A/B gowning requirements including particle shed and bioburden limits.

Pharmaceutical · Biotech
USP <797>

Pharmaceutical Compounding

United States Pharmacopeia chapter for hazardous and non-hazardous compounding. Garments qualified for ISO 5 primary engineering controls and ISO 7 buffer rooms.

Pharmacy · Compounding Centers
ASTM F1671

Barrier Performance

Standard test method for resistance of materials used in protective clothing to penetration by blood-borne pathogens — relevant for pharmaceutical and medical device environments.

Medical Device · Pharma
ESD S20.20

Electrostatic Control

ANSI/ESD standard for the development of an electrostatic discharge control program. Our ESD-safe garment variants meet surface resistivity requirements for Class 0 wafer handling.

Semiconductor · Electronics

Architectural elevations —
hover for particle data.

Each garment family is available in sterile (individual packaging) and non-sterile (bulk) configurations. Custom sizing on request.

White full-body cleanroom coverall garment under inspection lighting
CR-COV
ISO 4–6

Full Coverall

Head-to-toe barrier

Particle Shed< 1,200 particles/m³
Shelf Life24 months sealed
SemiconductorPharma Grade A/BAerospace

Height: 155–195 cm

Sizes: XS–3XL

Weight: 85 g/m²

White cleanroom hood garment showing sealed seams and face opening
CR-HOOD
ISO 4–7

Integrated Hood

Sealed head coverage

Particle Shed< 400 particles/m³
Shelf Life18 months sealed
PharmaMedical Device

One size fits most

Face opening: 18cm dia.

Weight: 42 g/m²

White cleanroom boot covers with sealed soles on laboratory floor
CR-BOOT
ISO 5–7

Boot Covers

Sole-sealed foot barrier

Particle Shed< 600 particles/m³
Shelf Life18 months sealed
SemiconductorPharmaAerospace

Sizes: S/M, L/XL, XXL

Sole: anti-slip PTFE

Weight: 60 g/m²

White cleanroom frock with snap front closure and elastic wrists
CR-FROCK
ISO 6–8

Cleanroom Frock

Torso + arm coverage

Particle Shed< 2,800 particles/m³
Shelf Life12 months sealed
Medical DeviceElectronics Assembly

Sizes: XS–2XL

Length: 90–100 cm

Weight: 75 g/m²

Pricing by configuration.
Click to see full spec.

Pallet pricing shown. Custom volumes and private-label programs available. Contact us for tier pricing on annual contracts above 50,000 units.

01

Tyvek® 1422A Coverall

Flash-spun HDPE with heat-sealed seams. Passes ISO 14644-1 Class 5 particulate testing. Available in sterile individual packaging (gamma-irradiated, 25 kGy) or non-sterile bulk poly bag. Minimum order: 500 units.

From $4.20 / unit (pallet)
02

Microporous Film Coverall

SMS + microporous polyethylene film laminate. Liquid-barrier rated to ASTM F1671. Suitable for ISO Class 6–8 environments where splash resistance is required alongside particulate control. Available in 6 colors.

From $6.80 / unit (pallet)
03

ESD-Safe Coverall

Conductive carbon-fiber grid woven into Tyvek substrate. Surface resistivity 10⁵–10⁹ Ω per ANSI/ESD S20.20. Certified for ISO Class 3 wafer-handling environments. Grounding snap at wrist and ankle.

From $9.50 / unit (pallet)
04

Sterile Frocks (EU GMP Grade B)

Individually gamma-sterilized. Bioburden < 1 CFU/unit pre-sterilization. Validated for EU GMP Annex 1 Grade B gowning. Certificate of Analysis and sterility test report included per lot.

From $3.10 / unit (pallet)
Download Spec Sheet

Still writing requirements?
Start with our spec sheet.

Our Contamination Control Specification Document covers particle generation methodology, seam integrity test protocols, and ISO class mapping for every garment family. 14 pages. No sales call required.

Particle shed methodology (IEST-RP-CC003.4)
Seam strength test data (ISO 13935-1)
Shelf life validation summary
ISO class compatibility matrix

Download Contamination Control Spec Sheet

Company name and role only — no phone number, no sales qualification.

No spam. No sales calls. Just the document.