MIDPOSI has made cleanroom garments and mop systems since 2004. We work under an ISO 13485 certified quality management system and hold a CE certificate. Our autoclavable garments are suitable for EU GMP Annex 1 Grade A/B, C and D areas and withstand up to 100 autoclave cycles. ISO 13485 and CE certificates and test reports (particle, filtration, ESD) are available on request.
認定
| Certificate | What it covers | 書類 |
|---|---|---|
| ISO13485 | Certified quality management system | Certificate copy available on request |
| CE certificate | CE certificate held | Certificate copy available on request |
Request certificates and test reports
For supplier qualification, ask for the ISO 13485 and CE certificates and test reports (particle, filtration, ESD). We send them with your quotation.
EU GMP Annex 1 grade suitability
| EU GMP grade | Typical ISO 14644-1 equivalent (at rest) | MIDPOSI garments |
|---|---|---|
| Grade A / B | ISO5 | Suitable (autoclavable garments) |
| グレードC | ISO7 | Suitable |
| グレードD | ISO8 | Suitable |
ISO 14644-1 classifies cleanroom air cleanliness by particle concentration. EU GMP Annex 1 defines Grades A–D for sterile manufacturing. The equivalents above are the usual at-rest references. Confirm the final garment choice against your own contamination control strategy, or use the cleanroom garment selector.
Test reports available on request
- Particle shedding / particle release
- Filtration efficiency
- ESD / antistatic performance
Autoclavable garments withstand up to 100 autoclave cycles. See how many times cleanroom garments can be autoclaved.
Products covered
- オートクレーブ可能なクリーンルーム用衣類： coveralls、 hoods、 shoes and socks、 goggles
- Reusable mop systems そして disposable mop systems
- Your own brand: see OEM/プライベートブランド (MOQ 50 pieces per style, samples from 10 pieces, about 25 days lead time)
よくある質問
Is MIDPOSI ISO 13485 certified?
Yes. MIDPOSI works under an ISO 13485 certified quality management system. A certificate copy is available on request.
Which GMP grades are your cleanroom garments suitable for?
Our autoclavable garments are suitable for EU GMP Grade A/B, C and D.
Can I get test reports before ordering?
Yes. Test reports for particle release, filtration efficiency and ESD performance are available on request. Samples start from 10 pieces.
関連ガイド
Talk to our quality team
Send your GMP grade, products and quantities. We reply with a quotation and the documents you need.
