A cleanroom consumable is released twice. First by the plant, against its own quality system. Then by you, against the specification you wrote. The document pack is what connects those two releases.
Cleanspec is a supply programme, not a manufacturer. The references are produced by WIPESTAR in a 100,000 m² facility in Huizhou, on lines that run wipes, swabs, masks and sterile packs under one quality system. Our job is to specify the reference, hold the documentation and make sure the next shipment matches the last one.
The quality system behind the catalogue
The plant operates an ISO 9001 quality management system and an ISO 14001 environmental management system. Incoming materials, converting, packing and sterile processing are controlled under the same system, so a change on the line is visible to the people who release the lot.
Wiper performance is measured with the methods in IEST-RP-CC004 where they apply: particle counts, fibre release, extractables and sorption. Not every reference needs every test. The test report states which methods were run, on which lot, and what the result was — rather than a single marketing number without a method behind it.
What ships with each lot
One folder per shipment, in English. The exact contents depend on the reference, but the core pack is consistent:
| Document | Issued | What it proves |
|---|---|---|
| Certificate of analysis | Every lot | Model, lot number, measured results and release signature. |
| Test report | Every lot or family | The IEST-RP-CC004 methods run, the sample and the result. |
| Packing list | Every shipment | Carton count, pack format and lot mapping. |
| Sterility release | Sterile references | Sterilisation method, SAL 10-6 and barrier stack record. |
| Safety data sheet | Where applicable | Handling and transport information for pre-wetted or chemical products. |
Incoming inspection, without the investigation
The document pack is designed so that incoming inspection is a check, not a reconstruction. The carton label, the packing list and the certificate of analysis carry the same lot number. If they do not match, stop and call the desk before the pallet enters the store.
A practical incoming check covers four things: packaging integrity, the lot label against the packing list, the physical pack count, and the certificate for the reference. For sterile references, add the sterility indicator and the barrier stack condition. Everything else is a periodic verification, not a per-carton task.
Change control
References change when a material, converting line or sterilisation cycle changes. Those changes are not silent. If a substitution is proposed, it is proposed in writing before shipment, with the reason, the affected lots and the test data that supports the alternative. You decide whether to accept it, re-qualify it or hold the line.
The same rule applies to packaging. A new carton, a different bag or a changed pack count is a change to the specification, even when the wipe inside is identical.
Audit support
Quality teams are welcome to audit the documentation before or after an order. Send the reference and the cleanroom class; we will return the current test report, the certificate template and the traceability path for a recent lot. If an auditor needs a specific record that is not in the standard pack, ask — the production record is retained at the plant.
What we do not claim
We do not claim that a reference is suitable for every room. A wipe that passes IEST-RP-CC004 in one process can still fail in another because the surface, solvent or wiping motion is different. The document pack tells you what was tested; the qualification on your surface remains yours. That is why the desk asks for the application before it quotes a reference.
Documentation