← Back to Home
EPDM Cleaning Validation Coupons simulate ethylene–propylene–diene rubber surfaces used in seals and gaskets. They represent flexible elastomer contact parts. EPDM offers excellent chemical and heat resistance. Useful for swab/rinse recovery on elastomer zones. Ideal for GMP cleaning validation involving rubber components.
EPDM – Full Cleaning Validation Description
EPDM Cleaning Validation Coupons are designed to represent EPDM Cleaning Validation Coupons simulate ethylene–propylene–diene rubber surfaces used in seals and gaskets. They represent flexible elastomer contact parts. EPDM offers excellent chemical and heat resistance. Useful for swab/rinse recovery on elastomer zones. Ideal for GMP cleaning validation involving rubber components..
They are used in pharmaceutical, bioprocess, and GMP-regulated systems to assess residue recovery,
detergent compatibility, and cleanability of equipment surfaces made from EPDM.
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 EPDM 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 EPDM
✔ MATERIAL CHARACTERISTICS
• Material behaves as described in its summary: EPDM Cleaning Validation Coupons simulate ethylene–propylene–diene rubber surfaces used in seals and gaskets. They represent flexible elastomer contact parts. EPDM offers excellent chemical and heat resistance. Useful for swab/rinse recovery on elastomer zones. Ideal for GMP cleaning validation involving rubber 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
