Medical device cleanrooms
Cleanrooms for medical device assembly and packaging.
Controlled rooms for assembly, moulding and sterile barrier packaging, planned with your quality team.
What matters
Designed around your process
- Product and people flow planned to limit contamination
- Machine heat loads included in the air system concept
- Smooth, cleanable wall and ceiling finishes
- Room data shared with your quality team for your ISO 13485 records
Rooms
Common room types
| Room | Common class |
|---|---|
| Device assembly | ISO 7–8 |
| Injection moulding | ISO 7–8 |
| Sterile barrier packaging | ISO 7–8 |
| Gowning | ISO 8 |
Typical classes, confirmed with your process, product and regulator. Sector photos are illustrative.
How device contact sets the class
How the device touches the body sets the class, not the product name. China's NMPA annex for sterile medical devices (Announcement 2015 No. 101, in force 1 Oct 2015) sets a minimum class by contact type. It applies to final cleaning, assembly, primary packing and sealing.
The base GMP was revised by NMPA Announcement 2025 No. 107, in force 1 Nov 2026. Ask your regulator which annex text applies to your product.
Typical room list and classes
Class 10,000 is ISO 7, class 100,000 is ISO 8 and class 100 is ISO 5 (FDA table, Sept 2004).
| Device or step | Minimum class | Clause |
|---|---|---|
| Implanted or placed in blood vessels | Class 10,000 | 2.2.3 |
| Contact with blood, bone marrow or non-natural openings | Class 100,000 | 2.2.4 |
| Contact with damaged skin or mucosa | Class 300,000 | 2.2.5 |
| Aseptic processing | Local class 100 in a class 10,000 background | 2.2.7 |
| Primary packaging material not touching the use surface | Class 300,000 | 2.2.6 |
Rules and standards that apply
The annex asks for more than 5 Pa between rooms of different class and more than 10 Pa to outdoors, with a pressure indicator (2.2.2). With no special process need, it says 18 to 28 °C and 45 to 65% relative humidity (2.2.11). FDA's QMSR, effective 2 Feb 2026, incorporates ISO 13485:2016. ISO 11607-2:2019 covers validation of forming and sealing for packaging of terminally sterilised devices. Your regulator approves your facility.
Common design mistakes
One class for the whole hall. The annex sets class by process step and contact.
Primary packaging made in a lower class than the device. Where the pack touches the use surface, clause 2.2.6 asks for the same class.
Doors that open toward the less clean side, or floor drains in class 100 areas (2.2.14).
No plan for routine testing. Clause 2.7.3 lists particles, microbes, air changes or velocity, pressure, temperature and humidity.
What to send for a scope
Send the device list with contact type and sterile status. Add the process steps (moulding, cleaning, assembly, packing, sealing), the sterilisation route, machine heat loads and target markets. Share your quality manual extracts so room data can feed your ISO 13485 records.
Questions
Common questions
Which class does a sterile device need?
It depends on how the device touches the body. The NMPA 2015 annex sets class 10,000, 100,000 or 300,000 as the minimum by contact type. Your regulator confirms what applies.
What temperature and humidity should the room hold?
With no special process need, the NMPA annex says 18 to 28 °C and 45 to 65% relative humidity (clause 2.2.11).
Does FDA accept ISO 13485?
FDA's QMSR, effective 2 Feb 2026, incorporates ISO 13485:2016 into its quality regulation. Your quality team owns the records. We supply room data sheets.
Sources
- NMPA, Medical device GMP appendix: Sterile medical devices, Announcement 2015 No. 101
- NMPA Announcement 2025 No. 107, revised medical device GMP, in force 1 Nov 2026 (Hong Kong Trade and Industry Department circular)
- FDA, Quality Management System Regulation (QMSR)
- FDA, Sterile Drug Products Produced by Aseptic Processing, Sept 2004 (class to ISO table)
- ISO 11607-2:2019 listing (EVS)
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