Tyvek® IsoClean® Sterile Hood with Integrated Face Mask - GMP A/B

The DuPont™ Tyvek® IsoClean® IC 689 B WH WS is a sterile, clean-processed hood with a fully integrated face mask, designed for use in critical cleanroom environments requiring aseptic handling and advanced particle control. This accessory is suitable for GMP Grade A/B cleanrooms and ISO Class 5 environments.

Manufactured and packed under cleanroom conditions, this hood-mask combination supports contamination control in pharmaceutical, biotech, and medical device applications.

Key Features:

• Design: Bound internal seams, bound face opening, chest ties for adjustable fit
• Integrated Face Mask: Blue pleated polyethylene outer layer, 17.5 cm width
• Sterility: Gamma sterilized to a Sterility Assurance Level (SAL) of 10⁻⁶
• Packaging: Individually double-bagged, aseptically folded, 100 units per case
• Material: Tyvek® IsoClean® TS-WS
• Color: White hood with blue mask
• Size: Universal

Certifications & Standards:

• CE Category III PPE – Partial Body Protection (Type PB [6-B])
• EN 14126 – Barrier to infective agents
• ISO 11137 – Sterilization by gamma irradiation
• Bacterial Filtration Efficiency (BFE): 98.4% ± 0.9%
• Particle Shedding: Helmke Drum Category III
• Cleanroom classification: ISO Class 5 / GMP Grade A/B

Note:

• The mask is not classified as respiratory protection (not FFP rated)
• For use in aseptic environments where sterile and low-lint accessories are required
• Risk assessment should be conducted to ensure suitability for specific chemical or biological hazards

Recommended For:

• Aseptic manufacturing
  
• Pharmaceutical and biotech cleanrooms
• Medical device production (Grade A/B)

More information:
Tyvek® IsoClean® IC 689 B WH WS – DuPont