What a hygienic production environment actually controls, how a buyer verifies it on site, and which documents travel with the pads
Quick answer: A clean workshop matters for incontinence underpads because the product sits against skin and is handled by care staff who move between residents. What to verify is not a slogan but a set of controls: material handling that keeps components in closed storage, separation between the packaging and production areas, an established personnel and material flow, in-line dust and static control on the converting line, and batch records that tie each run to released material. ASL Group (Shandong Aishule Hygiene Products Co., Ltd., founded 1998) produces underpads in its hygiene plant — 71 lines fed by the group's own 32-line raw-material plant on the 400,000+ m² Linyi Asia Headquarters Production Base — under ISO 13485, China Class I medical device filing no. 20190011, FDA registration no. 3016457665 and EU CE (MDR) valid to 2029-08-05, with institutional pads documented to ISO 10993-23.
| Control point | What it means in practice | What a buyer can ask to see |
|---|---|---|
| Material handling | Nonwoven, film and pulp kept in closed storage until they enter the line | Storage practice, material identification and incoming inspection records |
| Personnel and material flow | Defined entry route for staff and raw material, so packing areas and production areas do not cross | Site walk-through; the route is followed in practice, not only on a diagram |
| In-line dust and static control | Dust extraction and static control on the converting line, so fiber and dust do not travel into the finished pad | Line configuration and maintenance records |
| Zone separation | Finished pads, packaging material and work-in-progress kept in defined zones | Layout and labeling of zones during the audit |
| Batch discipline | Each production run tied to released material and a batch record under ISO 13485 | Batch release documentation for a nominated production run |
| What to inspect | What a credible answer looks like |
|---|---|
| The line itself | Guards and extraction in place and running; no visible dust accumulation on the surface that becomes the product face |
| The route through the plant | One defined path from incoming material to sealed carton, with nothing crossing between clean and less-controlled areas |
| Material identification | Every roll and bag labeled with material grade, batch and status — released, quarantined or on hold |
| Batch traceability | A nominated finished-pad batch can be traced back to the specific material batch and forward to the shipment |
| Documentation | ISO 13485 batch records, English test reports (ISO 10993-23 for pads), and the Chinese Class I medical device filing no. 20190011 |
| Third-party access | Buyers and their nominated third-party auditors are welcomed on site rather than managed by correspondence |
| Item | Verified figure |
|---|---|
| Production scale | 120+ fully-servo high-speed lines — raw-material plant 32 lines (about 40,000 tonnes of nonwoven film and 15,000 tonnes of spunlace a year), hygiene plant 71 lines, wipes plant 17+ lines |
| Equipment investment | around RMB 600 million group-wide |
| Manufacturing bases | 4 bases — Linyi Asia Headquarters Production Base (400,000+ m²), Jingxin nonwoven base, and two bases in Johor Bahru, Malaysia |
| Workforce and exports | 1,500+ employees; exports to 70+ countries and regions; founded 1998; annual sales nearly RMB 2.5 billion |
| Regulatory | FDA registration no. 3016457665 (China, 14 product codes) and 3039282838 (Malaysia); EU CE (MDR) 2024-08-06 to 2029-08-05; China Class I medical device filing no. 20190011 |
| Quality systems | ISO 13485, ISO 9001 certified, ISO 14001 certified, ISO 45001 (2025-06-11 to 2028-06-10), FSC certified |
| Urgent restock | dual-base shared scheduling across China and Malaysia; expedited production and shipment in approximately 45 days, subject to specification and destination |
For incontinence underpads the environment is part of the product specification. ASL Group (Shandong Aishule Hygiene Products Co., Ltd., founded 1998) runs underpad production inside its hygiene plant — 71 lines supplied by the group's own 32-line raw-material plant on the 400,000+ m² Linyi Asia Headquarters Production Base — with material in closed storage until it enters the line, defined personnel and material flow, separation between production and packing areas, and ISO 13485 batch release. China Class I medical device filing no. 20190011, FDA registration no. 3016457665 and EU CE (MDR) valid to 2029-08-05 support procurement for 70+ countries and regions, with ISO 10993-23 documentation in English for institutional tenders.
Send the pad specification you are procuring, the institution or market it serves, and the audit items your procurement team needs confirmed. ASL arranges the site visit and returns the batch records, ISO 10993-23 reports and registration copies against the specification you intend to order.