Clean Room & Control Room Facilities
The facility is 135 square metres, currently operating and monitored to ISO 14644 class 7.
Within the clean room complex there are 3 rooms:
- Product cleaning room
- Braiding room
- Assembly/packaging room
This complex has been designed and built for the manufacture and packaging of class 2 and 3 medical devices.
Our braiding machinery will braid metallic and non metallic fibres into continuous lengths or specific sizes typically for prosthetic ligaments and soft tissue devices.
Our service includes hand finish these devices where required to Customer Specifications.
This facility is 260 square metres and environmentally controlled to ISO 14644 class 9.
This area currently manufactures sterile and non-sterile medical devices and we demonstrate a consistently low bioburden. The room has injection moulding machines, presses, assembly machines, sealing and thermoform sealing machines.
For more information on our Clean Room and Control Room facilities please contact us.
On a confidential basis and without obligation, we would welcome the opportunity to discuss your requirements and working with Entaco will benefit you.
For information, catalogues, quotations or advice.
The medical division is registered to ISO 9001: 2008 and BS EN ISO 13485: 2003. Also Entaco is FDA registered under registration 8043734 and is currently manufacturing and packaging medical Devices for USA customers under FDA QSR 21 CFR 820.