Regulatory Trust Hub

Cleanroom Surgical Packs (CPT) & Institutional Medical Textiles Regulatory Hub

Quality management, environmental particle monitoring, liquid barrier classification, and EO sterilization validation for SterileValley single-use hospital procedure packs.

1. ISO 14644-1 Cleanroom Environmental Classification

SterileValley procedure pack assembly, folding, and heat-sealing occur within validated ISO Class 7 (Class 10,000) cleanrooms featuring positive HEPA filtration pressure:

Particle Limits: Continuous optical monitoring ensuring ≤ 352,000 particles/m³ (≥ 0.5 μm) and ≤ 2,930 particles/m³ (≥ 5.0 μm).
Air Exchange Rates: Minimum 30 to 60 complete air changes per hour through certified 99.99% H14 HEPA filters.
Microbiological Bioburden: Settle plates and active air sampling complying with ISO 11737-1 bioburden alert and action limits.

2. ANSI/AAMI PB70 Liquid Barrier Performance Hierarchy

AAMI Level	Test Method	Challenge Fluid	Clinical Intended Use
Level 1	AATCC 42 (Impact Penetration)	Water ≤ 4.5g	Basic care, visitor isolation, standard medical unit cover
Level 2	AATCC 42 & AATCC 127	Hydrostatic ≥ 20cm	Phlebotomy, suturing, intensive care unit procedures
Level 3	AATCC 42 & AATCC 127	Hydrostatic ≥ 50cm	Arterial blood draw, IV insertion, ER trauma, general OR
Level 4	ASTM F1671 (Viral Penetration)	Phi-X174 Bacteriophage	Open orthopedic trauma, cesarean section, high-fluid cardiovascular