Image Credit: EKF Diagnostics
Diagnostic enzymes and contracted custom products are manufactured by EKF Life Sciences for use in medical diagnostics, pharmaceuticals and industry.
Based in Elkhart, Indiana, EKF Life Sciences isolates and delivers the highest quality enzymes and specially engineered biomolecules through the use of bacterial fermentation and downstream processes.
Micro-organisms, including recombinant organisms, are produced within the fermentation facility for the manufacture of post-fermentation products, for example, enzymes, proteins and related biomaterials.
Their 21,000 sq.ft. ISO 13485:2003 certified manufacturing facility has 12,000 square feet dedicated to fermentation production activities.
Two segregated HEPA filtered fermentation suites are routinely operated within the plant with production vessels ranging from 40 liters to 1,600 liters.
Two AS-16 Super Sharples centrifuges are situated in a clean, HEPA filtered processing suite, and further downstream processing equipment includes a microfiltration unit for cell harvesting, two cell homogenizers, freeze drying unit for product processing and liquid nitrogen storage for cell banking.
EKF Life Sciences Services
Microorganisms, including recombinant organisms, are produced within EKF Life Sciences' specifically designed fermentation facilities for clinically important enzymes and proteins used in many industrial applications. These enzymes are then either sold in bulk or used to produce in vitro diagnostic devices (IVDs).
A multitude of client applications are addressed through downstream processing applications. EKF Life Sciences can produce customer specific cell paste through various intermediary fractions to the final freeze-drying of final product.
Enzymes used in clinical diagnostic reagents are manufactured by EKF Life Sciences including:
- Beta-Hydroxybutyrate Dehydrogenase
- Salicylate Hydroxylase
Stanbio Chemistry branded reagents rely on these enzymes for their production, along with OEM reagents. The enzymes are also sold commercially for reagent production by third party clinical diagnostic companies.
Conveniently located just 90 miles from Chicago in Elkhart, Indiana, the ISO13485:2003 certified facility demonstrates extensive manufacturing capabilities and many years of experience in producing quality products
FDA regulations and ISO13485:2003 Standards (Medical Devices) are strictly adhered by EKF Life Sciences in the development, manufacture, and delivery of quality products. Currently certified for ISO13485:2003 by DEKRA Certification B.V., they have been successful in their inspection track record since their initial certification back in 1998.
Customers from a variety of industries also regularly audit EKF Life Sciences and they work alongside these customers to meet their specific quality system requirements.
Quality Assurance Responsibilities include:
- Finished product disposition
- Deviation and CAPA systems
- Customer and regulatory audits
- Internal audits
- Vendor qualification
- Training systems
- Document control
- Change control
About EKF Diagnostics
EKF Diagnostics is a global medical diagnostics business with a long history in point-of-care testing and central laboratory manufacturing. Our products have a hard earned reputation for ease of use, reliability and accuracy.
Our core focus is the Point of Care market with over 80,000 haemoglobin, A1c, glucose and lactate analyzers in regular use in more than 100 countries running more than 50m tests every year.
Our range of HbA1c analyzers and glucose analyzers are used in GP surgeries, sports clinics, and diabetes clinics. They deliver fast and reliable results that provide both practitioner and patient with the information they need to make clinical or lifestyle decisions in minutes.
EKF Diagnostics offer the largest range of hemoglobin and hematocrit analyzers on the market, giving physicians and specialists a choice of product with different methodology, measurement speed, connectivity and price options. Our aim is to make blood donation and anaemia screening easier, more affordable and more accessible than ever before.
The EKF Maternal & Women’s Health Point of Care range aims to improve healthcare outcomes for women and children by providing physicians with a suite of products covering pregnancy testing, anaemia screening, fetal scalp lactate testing and post birth creamatocrit measurement.
EKF Diagnostics is also a global manufacturer of central laboratory products including Stanbio Chemistry reagents, benchtop laboratory analyzers, rapid tests and centrifuges. Our chemistry reagents can be used on the majority of analyzers found in hospital laboratories around the world.
The ordinary shares of EKF Diagnostics Holdings plc are traded on the AIM market of the London Stock Exchange.
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