Quality Control

Fortune Cat™：Zero Compromise. Full Traceability.

We operate a multi-stage quality management system aligned with ISO 13485 (medical devices), ISO 9001, and GMP guidelines. Every batch of sanitary pads, diapers, or sheet masks – especially chitosan-based and fully biodegradable products – undergoes rigorous testing before shipment.

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1. Incoming Raw Material Control (IQC)

Material Category	Tests Performed	Acceptance Criteria
Nonwoven fabrics (top sheet, back sheet)	Gram weight, tensile strength, liquid strike-through	±5% of spec; no tears
Chitosan fiber/fabric	Degree of deacetylation (DD), molecular weight, antibacterial activity (ASTM E2149)	DD ≥90%; >99% reduction vs E. coli & S. aureus
Biodegradable film (PLA/PBAT)	Thickness, biodegradability certificate	EN 13432 or ASTM D6400
SAP (superabsorbent polymer)	Absorbency under load (AUL), retention capacity	AUL ≥20 g/g; retention ≥25 g/g
Fluff pulp	Whiteness, moisture content, foreign matter	≤8% moisture; chlorine-free
Mask fabric & serum	pH, microbial count, chitosan content (for chitosan masks)	pH 4.5–6.5; total plate count <100 CFU/g

All chitosan raw materials are accompanied by third-party test reports for heavy metals (Pb, Hg, As, Cd) and residual protein (for hypoallergenic claims).

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2. In-Process Quality Control (IPQC)

We perform real-time checks at critical control points:

Sanitary Pads & Diapers Line

Stage	Check
Web lamination	Adhesion strength, layer alignment
Core forming	SAP/fluff distribution uniformity (±2g)
Embossing	Pattern clarity, no over-pressure
Folding & packing	Count accuracy, seal integrity (peel test)

Sheet Mask Line

Stage	Check
Fabric cutting	Dimension tolerance (±1.5mm)
Serum filling	Fill weight (±2%), no leakage
Pouch sealing	Seal strength (hot tack test)

Every 30 minutes – operators record dimensional, weight, and visual data.
Every 2 hours – line supervisor performs functional testing (strike-through, rewet, mask serum release).

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3. Finished Product Testing (OQC)

Before release, finished products are sampled per AQL Level II (ANSI/ASQ Z1.4) :

For Sanitary Pads & Diapers

Test	Method	Standard
Absorbency (synthetic menstrual fluid)	ISO 11948-1 / GB/T 8939	≥30mL for regular; ≥60mL for overnight
Rewet (surface dryness)	ISO 11948-1 (modified)	≤1.0g for chitosan pads
Leakage	Dynamic fluid penetration	Zero leakage under 2kPa pressure
pH of surface	EN 13726-1	4.5–7.5
Biodegradability (for eco line)	EN 13432 / ASTM D6400	≥90% disintegration in 12 weeks
Chitosan antibacterial activity (if claimed)	ASTM E2149 or JIS L1902	≥90% reduction

For Sheet Masks

Test	Method	Standard
Microbial limit	USP <61>/<62>	No pathogens; TPC <100 CFU/g
Chitosan content (for chitosan mask)	Colloidal titration or HPLC	≥0.5% (w/w) of fabric weight
Serum pH and viscosity	USP <791> + Brookfield	As per formula spec
Skin irritation	HET-CAM or patch test (human repeat)	Non-irritant

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4. Biodegradability & Compostability Verification

For fully biodegradable pads and diapers:

• Disintegration test – ISO 16929 / EN 13432 (pilot-scale composting)
• Ecotoxicity test – Plant growth ≥90% of control
• Certificate – Issued by DIN CERTCO, TÜV OK Biodegradable, or BPI (upon project)

We provide batch-specific biodegradation certificates for EU/export markets.

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5. Microbiological & Sterility Control

Although our products are non-sterile, we maintain strict limits:

Product	Total Aerobic Count	Yeast & Mold	S. aureus	Pseudomonas	Candida
Sanitary pads / diapers	≤100 CFU/g	≤20 CFU/g	Absent	Absent	Absent
Sheet masks	≤100 CFU/g	≤10 CFU/g	Absent	Absent	Absent

Products can be gamma or EO sterilized upon request (medical-grade diapers or wound-care masks).

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6. Traceability & Batch Records

Every finished good carries a unique batch number printed on the master carton. Our traceability system links:

• Raw material lot number
• Production line and date
• IPQC operator ID
• OQC test report
• Shipping destination

Batch records are retained for 5 years minimum.

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7. Stability & Shelf-Life Testing

We conduct real-time and accelerated stability studies per ISO 11607 / ISTA:

Condition	Duration	Tests Performed
40°C ± 2°C / 75% RH	3 months (accelerated)	Absorbency, pH, microbial, seal strength
25°C ± 2°C / 60% RH	12–24 months (real-time)	Full functional + biodegradability (for eco line)

Result: Minimum shelf life of 2 years for pads and diapers, 3 years for unopened sheet masks.

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8. Third-Party Audits & Certifications

We welcome customer or third party audits. Current certifications include:

Certification	Scope
ISO 13485:2016	Design & manufacture of absorbent hygiene products (Class I medical device in some markets)
ISO 9001:2015	Quality management system
OEKO-TEX® STANDARD 100	Product class I or II (upon project)
FDA (US)	Device listing for sanitary pads / adult diapers
CE (EU)	MDR compliance for absorbent products (if applicable)
BPI / DIN CERTCO	Biodegradability for eco line (project-based)

Additional certifications (BCI cotton, FSC, vegan, cruelty-free, halal) can be arranged per order.

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9. Customer Rejection & Non-Conformance Handling

Any non-conforming batch triggers our CAPA system:

1. Quarantine – blocked from shipment
2. Root cause analysis – within 48 hours
3. Corrective action – process or material adjustment
4. Preventive action – updated FMEA and operator training

Rejection rate (customer claims) maintained at <0.2% over last 24 months.

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10. Quality Reports We Provide Upon Shipment

With every commercial order, you receive:

• Certificate of Analysis (CoA) – batch-specific test results
• Raw material certificate (from our suppliers, including chitosan DD and biodegradability)
• AQL sampling report
• Seal integrity & leakage test summary
• Biodegradability certificate (if applicable)

Third-party lab reports (SGS, TÜV, Intertek) available at additional cost.