Cosmetics cleanrooms
Clean production rooms for cosmetics.
Compounding, filling and packaging rooms with washable finishes, filtered air and a clear flow from raw material to finished goods.
What matters
Designed around your process
- Washable wall and ceiling panels
- Raw material, product and people flows kept separate
- Air system sized for your batch rooms
- Room data shared with your team for your ISO 22716 records
Rooms
Common room types
| Room | Common class |
|---|---|
| Compounding | ISO 8 |
| Filling | ISO 7–8 |
| Packaging | ISO 8 or controlled |
| Gowning | ISO 8 |
Typical classes, confirmed with your process, product and regulator. Sector photos are illustrative.
How product type sets your zones
China's cosmetics GMP (NMPA Announcement 2022 No. 1, in force 1 July 2022) splits a workshop into clean, semi-clean and general areas. The product type decides which steps go where. Eye-area and children's skin-care products and toothpaste need a clean area for semi-finished storage, filling and clean container storage. Powders are excepted from the eye-area and children's rule. Other cosmetics use a semi-clean area for these steps. Packaging and storage sit in a general area.
Typical room list and limits
Limits are from annex 2 of the GMP, as printed.
| Area | Steps | Limits |
|---|---|---|
| Clean area | Semi-finished storage, filling, clean container storage, for eye-area and children's skin care and toothpaste | 0.5 µm and larger: up to 10,500,000 per m³. 5 µm and larger: up to 60,000. Airborne bacteria up to 500 cfu/m³. Settle plate up to 15 cfu per 30 min |
| Semi-clean area | Weighing, compounding, buffer, gowning, for the same products | Airborne bacteria up to 1,000 cfu/m³ |
| Semi-clean area | Those steps plus storage and filling, for other cosmetics | Airborne bacteria up to 1,000 cfu/m³ |
| General production area | Packaging, storage | Kept tidy |
Rules and standards that apply
The clean area must hold at least 10 Pa against the general area and 5 Pa against the semi-clean area. Article 21 asks for physical separation of zones and yearly testing of the workshop. Test methods follow GB/T 16292, 16293 and 16294. Where compounding, storage and filling use fully closed piping, a semi-finished storage room can be left out. For the EU, Regulation 1223/2009 Article 8 requires GMP. The Commission lists EN ISO 22716:2007 as the harmonised standard. Your regulator approves your facility.
Common design mistakes
A clean area built for the whole plant. The rules put packaging and storage in the general area.
A cascade with no step between zones. Clean to general needs 10 Pa. Clean to semi-clean needs 5 Pa.
No gowning or buffer step ahead of semi-clean work. Both are listed in that area.
No test access for the yearly workshop test in Article 21.
What to send for a scope
Send the product list by category: eye-area, children's, toothpaste, powder or other. Add batch sizes, tank layout, whether piping is closed, the water system, your target markets and the site drawing.
Questions
Common questions
Do all cosmetics need a clean area?
No. Under the NMPA annex, the clean area applies to eye-area and children's skin-care products and toothpaste. Other cosmetics use a semi-clean area for storage, filling, weighing and compounding.
What pressure difference does the NMPA annex set?
At least 10 Pa from the clean area to the general area, and at least 5 Pa to the semi-clean area.
Is ISO 22716 required for the EU?
EU Regulation 1223/2009 Article 8 requires GMP. EN ISO 22716:2007 is the harmonised standard the Commission lists for it. Your regulator confirms what proof they need.
Sources
Standards
Designed to ISO 14644 requirements
We design and build to the standard your project specifies. Finished rooms are tested against the agreed ISO 14644 class. CE-marked and FM-approved panels can be supplied for projects that require them, and other product certification can be arranged for your project. Independent third-party room testing can also be arranged.
On site
Our crews at work
Panel walls, ceilings and air showers going in on cleanroom projects.
Proof
What you can verify today
ISO certificates
ISO 9001, 14001 and 45001 certificates for production of metal building components, available on request.
Live video factory tour
Walk our panel lines by video before you order. Ask for a time.
Project record
380+ projects for 210+ customers since 2023. References include hospitals and export projects in Indonesia, Iraq, Mongolia, Mexico and Costa Rica.
Payment and inspection
Payment by T/T or L/C. You can appoint an inspection company of your choice to check the goods before loading.
Project enquiry
Send what you have
A room list, a floor plan or only the floor area is enough to start. After you submit, send drawings by email or WhatsApp.
We reply by email within one working day. We can sign an NDA before you send drawings.
WhatsApp +44 7962 561184 is our UK number for export enquiries. The factory is in Tianjin, China.
Email: [email protected]
WhatsApp: +44 7962 561184