CNAS Standard Quality Assurance & Lab Testing

Rigorous multi-stage physical, chemical, and microbiological testing from raw polymers to finished shipping containers.

CNAS Accredited Laboratory Assays & Batch Release Protocols
ISO 13485:2016 · CE MDR · FDA FEI: 3012984570

Quanzhou Shenghongda Hygiene Products Co., Ltd. enforces an uncompromising multi-stage quality assurance architecture spanning incoming raw materials, high-speed converting lines, and finished shipping containers. Operating within an ISO Class 8 cleanroom in Quanzhou, China, our quality infrastructure combines 100% inline machine-vision CCD optical defect detection scanning at 0.1mm resolution with automated pneumatic kicker rejection systems operating at 600 pieces per minute. In our in-house testing laboratory, every production lot undergoes 8 mandatory physical and microbiological assays according to ISO 11948-1 Rothwell absorbency, INDA/EDANA WSP 70.3 surface rewet (<0.12g), ASTM E96 moisture vapor transmission rate (MVTR >3,800 g/m²/24h), and ISO 11737-1 bioburden screening (<20 CFU/g). Certified under ISO 13485:2016 and US FDA FEI 3012984570, all production lots are assigned traceable batch codes and accompanied by third-party SGS or TÜV verification reports prior to container departure from Xiamen Port.

Quality Control Parameter Testing Standard Reference Testing Instrumentation Performance Benchmark Batch Sampling Frequency
Total Fluid Absorption Capacity ISO 11948-1 (Rothwell Method) Automated Saline Immersion Rig >550 ml (Infant) / >2,200 ml (Adult) Every 2 Hours / Each Mother Roll
Liquid Strike-Through & Rewet INDA/EDANA WSP 70.3 / 70.7 Lister & Wetback Pressure Tester Acquisition <15s / Rewet <0.12 g 5 Samples per 10,000 Units
Backsheet Moisture Vapor (MVTR) ASTM E96 (Inverted Cup Method) Constant Temp/Humidity Chamber MVTR > 3,800 to 4,200 g/m²/24h Every Extrusion Film Lot
Inline 360° Optical Defect Scanning In-House Zero-Defect Protocol Cognex & Keyence AI Vision Sensors 0.1mm defect detection + pneumatic eject 100% Continuous Real-Time
Microbiological Bioburden ISO 11737-1 / USP 61 / USP 62 Cleanroom Incubator & Plate Counter Total Aerobic Count <20 CFU/g (Zero Pathogens) Every Export Container Lot
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Rothwell ISO 11948 Absorption

Precision fluid soak and centrifuge drainage testing to determine exact maximum retention capacity in saline solution.

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Rewet Metrology (<0.15g)

Standardized simulated baby/adult pressure checks measuring moisture strike-back onto filter papers to ensure surface dryness.

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Microbiological Bioburden

In-house incubated pathogen screening ensuring zero yeast, mold, or staphylococcus aureus contamination in certified cleanrooms.

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