Facilities

We have purpose built manufacturing facilities in both Redditch and Durham that cover almost 4,200m2, incorporating an area for storage and loading, handling and filling sterile liquids, plus the packaging and componentry for device assembly. 

facilities

ISO 7 Cleanroom

Our ISO 7 (Class 10,000) Cleanroom occupies 135 square metres, and is operated and monitored to EN ISO 14644 class 7. This facility has been designed and built for the manufacture and packaging of Class I, IIa, IIb and III medical devices.

ISO 5 Localised Air Shower

We also offer EN ISO ISO 5 (Class 100) localised air-shower for assembly and contract packing of pharmaceutical products.

Quality Assurance

We have the experience and capability to CE mark medical devices. Please contact us for further details.  

We are registered to ISO 9001:2008 and BS EN ISO 13485:2003. We manufacture and package medical devices for USA customers under FDA QSR 21 CFR 820. GMP accredited containing EN ISO Class 5 & 6 Cleanrooms for contract pharmaceutical manufacturing.

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ISO 6 Cleanroom

Our new purpose built NETPark facility at Durham occupies the 2,000m2, Discovery 2 Building, a new technology centre for the manufacture of GMP Pharmaceutical products. Our state of the art building housing a 100m2 EN ISO 6 (Class 1,000) Cleanroom, with purpose built goods in/out, environmental monitoring and microbiological monitoring to GMP.

ISO 9 Control Room

This facility is 190m2 and environmentally controlled to EN ISO 14644 ISO 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.

Contact us

Please call our team on U.K. 0845 0739529, International +44 (0) 1527 830942 or fill in the form below, and we will be in touch at the earliest opportunity:

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InSpec Burstable Pouch Wipes

InSpec Burstable Pouch Wipes

Sterile biocidal and sporicidal session wipes. Maximum convenience via wipe format, with the maxiumum power of InSpec rotationals: OX, HA, AN, QT.

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Contamination Control

Contamination Control

Explore our InSpec product range for validated cleanroom contamination control solutions.

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