REG - EKF Diagnostics Hldg - Successful quality management audits

EKF Diagnostics HoldingsAnnouncement

03/05/2023 07:00

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RNS Number : 1824Y  EKF Diagnostics Holdings PLC  03 May 2023

EKF Diagnostics Holdings plc

("EKF" or the "Company")

 

Successful quality management audits for enzyme fermentation sites

 

Largest fermenter on track for complete validation by end of Q3 2023

Other new Life Sciences capacity on track for operational activity from this
summer

 

EKF Diagnostics Holdings plc (AIM: EKF), the AIM-listed global diagnostics
business, announces that its Life Sciences division's enzyme fermentation
sites in Indiana have successfully completed their ISO 9001: 2015 and ISO
13485: 2016 quality management audits. This is the first such audit of the
South Bend facility and is a testament to the investment and effort to date
that has gone into preparing this new site to be operational. The Company
remains on track to have all new fermentation capacity in South Bend installed
and validated towards the end of Q3 2023.

 

Once installation is completed the Life Sciences division we will have
installed 65L, 300L, 1,500L, 3,000L and 14,500L fermentation units at its
South Bend facility, complementing the existing capacity provided by the
division's existing 10L (x2), 125L and 1,600L fermentation units at the
Elkhart facility. Whilst the largest fermenter (14,500L) will be installed and
validated in Q3 2023, the new other fermenters are on track to be operational
and revenue generating over the summer.

 

ISO 9001:2015 Quality Management Certification is an International Standard
for Quality Management Systems, and demonstrates that an organisation is
customer-focused and committed to delivering high quality services. ISO
13485:2016 is a standard for Quality Management Systems that specifically
relate to products and services with a health purpose, and shows that an
organisation provides medical devices and related services that consistently
meet customer and applicable regulatory requirements.

 

The three-day audit was based on a series of successful fermentation
validation runs at the South Bend facility using  new fermenters and a full
review of the division's Quality Management Systems.

 

Julian Baines, Executive Chair, commented: "We're very pleased that the audit
planned for April has completed successfully and that our facilities continue
to operate to the highest industry standards. This business has manufactured
enzymes and biomolecules from bacterial fermentations for the last 40 years
and our customers have always welcomed our unwavering commitment to providing
the highest quality service. Developing our quality assurance as we increase
our capacity is key to the successful scale up of these operations and I'm
delighted that we remain on track."

 

 

 EKF Diagnostics Holdings plc                                 www.ekfdiagnostics.com (http://www.ekfdiagnostics.com)
 Julian Baines, Executive Chair / Marc Davies, CFO             Tel: +44 (0)29 2071 0570

 Singer Capital Markets (Nominated Adviser & Broker)                                        Tel: +44 (0)20 7496 3000
 Aubrey Powell / George Tzimas / Oliver Platts

 Walbrook PR Limited               Tel: +44 (0)20 7933 8780 or ekf@walbrookpr.com (mailto:ekf@walbrookpr.com)
 Paul McManus / Lianne Applegarth  Mob: +44 (0)7980 541 893 / +44 (0)7584 391 303

 

About EKF Diagnostics Holdings plc (www.ekfdiagnostics.com
(http://www.ekfdiagnostics.com) )

 

EKF is an AIM-listed global diagnostics business focussed on:

 

·    Point-of-Care analysers in the key areas of Hematology and Diabetes,
as well as Central Laboratory products including clinical chemistry reagents,
analysers and centrifuges

 

·    Life Sciences services provide specialist manufacture of enzymes and
custom products for use in diagnostic food and industrial applications, as
well as other higher value Contract Manufacturing services

 

EKF has headquarters in Penarth (near Cardiff) and operates five manufacturing
sites across the US and Germany, selling into over 120 countries world-wide.

 

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