Production ramp up at AMRC Broughton after regulator approves first Ventilator Challenge device

The first life saving medical ventilator which will be built in Flintshire has received regulatory approval and is ready to be sent to the NHS frontline.

Penlon’s Prima ES02 model is now authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in hospitals to support coronavirus patients.

Extensive final testing of the devices has taken place in hospitals to ensure that they are safe and effective.

Penlon has worked with the VentilatorChallengeUK consortium which includes Airbus, High Value Manufacturing Catapult, Siemens and a number of UK based F1 teams.

Oxford based Penlon’s production line have been replicated at a number of sites across the UK including at the Advanced Manufacturing Research Facility next door to Airbus Broughton.

Following the device’s approval, the Government has confirmed an order for 15,000 Penlon devices.

Hundreds of units are expected to be built over the next week, with production being further scaled up in the coming weeks.

At AMRC Broughton, production will take place round the clock with more than 500 employees working shifts – 125 per shift – to ensure they can manufacture, test and distribute units to the front line as quickly as possible.

The first dispatch of 40 Ventilator Challenge Penlon devices will be sent to MOD Donnington today (Thursday April 16) and will be delivered to the NHS front line soon after.

Dick Elsy, CEO of the High Value Manufacturing Catapult and Chair of the VentilatorChallengeUK consortium said:

“I’m very pleased to confirm that we have now secured MHRA approval for the Penlon Prima ESO2 device which has been undergoing stringent testing and clinical trials for the last two weeks.

Ventilators of this type are complex and critical pieces of medical equipment so ensuring the absolute adherence to regulatory standards and meeting clinical needs were always our priorities.

We will now accelerate the ramp up of production at the Penlon site in Oxfordshire and the new VCUK production lines we’ve built in Broughton, Dagenham, Woking and Maidenhead.

Having already commenced deliveries of the Smiths Group’s paraPAC plus devices, we are working closely with our supply chain partners to rapidly scale up production to achieve our target of at least 1,500 units a week of the combined Penlon and Smiths models.

I want to take this opportunity to again thank every member of the consortium and the hundreds of dedicated colleagues who have been working day and night to get us to this point.”

Chancellor of the Duchy of Lancaster Michael Gove said:

“The approval of Penlon’s device underlines the significant progress being made in the Ventilator Challenge.

I pay tribute to the incredible ingenuity and commitment of our manufacturing industry, coming together as part of the national effort to protect the NHS and save lives.”

Currently, over 10,000 mechanical ventilators are available to NHS patients in the UK, there are around 1450 in Welsh hospitals.