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)
Novell Pharmaceutical Laboratories
Indonesia
Novell Pharmaceutical Laboratories is one of the largest pharmaceutical companies in Indonesia, manufacturing both oral solid dosage forms (tablets, capsules, powders) and sterile injectable products (liquid and powder). The factory was originally built and operated by a multinational company, and later expanded to Australian TGA standards. The facility features Class A/B/C/D cleanrooms, Bausch & Stroebel filling equipment, Getinge autoclaves, and Lytzen depyrogenation ovens. Novell has 2 FDA-registered FEI numbers, 3 FDA-approved products, and 10 FDA inspections.
Small Molecule Drug ProductOral Solid DoseSterile Injectable
Novocol Pharma
Canada
Novocol Pharma is a CDMO headquartered in Cambridge, Ontario, Canada, specializing in sterile injectable fill-finish and combination drug product assembly. With over 40 years of experience, the company offers aseptic and terminally sterilized manufacturing from development through commercialization. Novocol Pharma is a Septodont company and has a fill-finish partnership with Moderna for mRNA vaccines.
Formulation DevelopmentFill/Finish (Vials)Fill/Finish (Syringes)
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.
Need help finding the right CDMO?
Our AI Matchmaker analyzes your project requirements and matches you with qualified manufacturing partners. Free for buyers.
