HELP GUIDE - LINKS - EKF - Flipbook - Sida 36
Hemoglobin
Hematology
& Hematocrit
Life Sciences
Over 30 years experience in custom and bulk enzyme
production for life science products.
• Contract fermentation • Custom bioprocessing
• Diagnostic enzymes • Fully FDA and ISO13485:2003 compliant
Diabetes Care
Care
Diabetes
Fermentation
Our fermentation facility is designed to produce
micro-organisms, including recombinant
organisms, for clinically important enzymes and
proteins used in many product applications.
Our enzymes are distributed globally and sold
in either bulk or custom format for use in the
production of in-vitro diagnostic devices (IVDs).
Custom Bioprocessing
Sports
Sports Performance
Performance
Our downstream processing is entirely
customer-driven, including:
• Cell freezing
• Cell homogenization
• Column fractionation
• Preparation of concentrated cell paste
• Freeze drying of final product
Full suite of fermentation
vessels including:
40 L / 80 L / 250 L and 1,600 L
Maternal &
Women’s Health
Our core capabilities
• Pilot and small manufacturing
• Bulk orders
• Process development and
optimization
• Process transfer and scale up
• cGMP documentation
• Validation
• Quality Assurance and Quality Control
Quality assurance - Our promise to you
Central Laboratory
EKF Life Sciences is committed to the development,
manufacture, and delivery of quality products that
exceed customer expectations. We are fully compliant
with FDA regulations and ISO13485:2003 Standards
(Medical Devices).
We are also audited regularly by customers from
various industries, and we work with them to meet their
specific quality system requirements.
36 | Central Laboratory Life Sciences
Our quality assurance responsibilities include:
• Finished product disposition
• Customer and regulatory audits
• Internal audits
• Deviation and CAPA systems
• Vendor qualification
• Change control
• Training systems
• Document control
