Capability
Aseptic Processing CDMOs
Compare CDMOs with validated aseptic processing capabilities. Filter by isolation technology, cleanroom classification, and sterility assurance approach.
329 companies listed
About Aseptic Processing
Aseptic processing is the manufacturing of sterile drug products without terminal sterilization. The product is sterilized by filtration (0.22 micron) and filled into pre-sterilized containers in classified clean environments. This technique is essential for biologics, proteins, and other heat-sensitive products that cannot withstand autoclaving.
The sterility assurance strategy defines CDMO capability. Modern approaches use isolator technology (closed systems with HEPA-filtered air, vaporized hydrogen peroxide decontamination) for the highest contamination control. Older approaches use RABS (Restricted Access Barrier Systems) or conventional cleanrooms. FDA and EMA increasingly favor isolator-based systems for new facilities.
Companies (329)
European Medical Contract Manufacturing (EMCM)
Netherlands
European Medical Contract Manufacturing (EMCM) is a Dutch full-service contract manufacturer and centre of excellence in developing and manufacturing sterile medicinal products for the pharmaceutical and medical device markets. The company has 2000m2 of GMP-accredited facilities with cleanrooms from class D to class A, handling liquids, suspensions, gels, and powders in ampoules, vials, pre-filled syringes, and pouches.
Small Molecule Drug ProductFormulation DevelopmentFill/Finish (Vials)
Euticals (now part of Curia)
France
Euticals, now part of Curia Global, is a global CDMO with over 30 years of experience in drug discovery, development, and manufacturing across small molecules, generic APIs, sterile drug products, and biologics. Curia (which acquired Euticals through AMRI) operates an extensive global network with hundreds of FDA-registered facilities and provides end-to-end services from API manufacturing through sterile fill/finish.
Frequently Asked Questions
What is the difference between isolators and RABS?+
Isolators are completely sealed enclosures with HEPA-filtered air supply and H2O2 decontamination between batches. Personnel never enter the isolator environment. RABS (Restricted Access Barrier Systems) use physical barriers but share air with the surrounding cleanroom and allow limited interventions through glove ports or open doors (active vs passive RABS). Isolators provide superior sterility assurance but require longer setup times and higher capital investment.
How do CDMOs validate their aseptic process?+
Aseptic process validation requires: media fill (process simulation) studies where sterile growth medium is filled in place of product, with the goal of zero contaminated units. FDA requires a minimum of three consecutive successful media fills. Environmental monitoring data, personnel qualification (gowning, aseptic technique), and equipment qualification are also required components of the validation package.
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