Ultem – Full Cleaning Validation Description Ultem Cleaning Validation Coupons are designed to represent Ultem (Polyetherimide, PEI) Cleaning Validation Coupons represent high-temperature, high-strength engineering plastic surfaces. They simulate non-metallic components such as manifolds, housings, sensor blocks and structural parts. PEI offers excellent chemical resistance and dimensional stability under CIP/SIP conditions. These coupons enable RF% studies for high-performance polymer MoCs. Ultem’s low extractables profile suits regulated pharma and biotech systems. Ideal for validating cleaning on PEI-based contact and utility components.. They are used in pharmaceutical, bioprocess, and GMP-regulated systems to assess residue recovery, detergent compatibility, and cleanability of equipment surfaces made from Ultem. These coupons support RF% studies, swab and rinse recovery validation, and regulatory documentation for cleaning procedures involving this material of construction. ✔ KEY PURPOSES • Establish residue recovery factors (RF%) for Ultem surfaces • Validate swab and rinse recovery in GMP cleaning procedures • Assess chemical compatibility with detergents and disinfectants • Provide FDA/EMA/PIC/S-compliant cleaning validation documentation • Ensure robust justification for equipment made from Ultem ✔ MATERIAL CHARACTERISTICS • Material behaves as described in its summary: Ultem (Polyetherimide, PEI) Cleaning Validation Coupons represent high-temperature, high-strength engineering plastic surfaces. They simulate non-metallic components such as manifolds, housings, sensor blocks and structural parts. PEI offers excellent chemical resistance and dimensional stability under CIP/SIP conditions. These coupons enable RF% studies for high-performance polymer MoCs. Ultem’s low extractables profile suits regulated pharma and biotech systems. Ideal for validating cleaning on PEI-based contact and utility components. • Suitable for RF% reproducibility • Stable under standard cleaning conditions ✔ FORMATS • 50×50 mm or 75×75 mm validation plates • 2–5 mm construction depending on material