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Sterile dosage forms extend far beyond injectables, covering ophthalmic, nasal, otic, and other topical preparations that require precise filling, microbiological control, and strict GMP compliance. These formats are especially sensitive to contamination and often preservative-free, making the role of a specialized sterile forms fill and finish CDMO critical.
Through tailored steriles fill and finish services, these CDMOs support non-injectable sterile products from formulation through aseptic filling, packaging, and regulatory support, ensuring patient safety, product performance, and global compliance.
When selecting a sterile forms fill and finish CDMO for non-injectables, key considerations include:
Expertise in ophthalmic, nasal, and otic drug products
Aseptic filling lines with isolators or RABS for liquid sterile formats
Support for multi-dose and preservative-free systems
Experience with BFS (Blow-Fill-Seal), unit-dose, and dropper bottle formats
Validated cleaning and sterilization procedures
Cold chain handling, if required for biological or sensitive actives
Proven regulatory track record with FDA, EMA, PMDA, and others
The ideal partner understands the nuances of sterile topical delivery and combines aseptic precision with device integration expertise.
Top-tier steriles fill and finish services for non-injectables typically include:
Formulation and compatibility development for ophthalmic, nasal, and otic drugs
Sterile filtration and filling into bottles, tubes, or unit-dose containers
Device integration: dropper tips, pumps, valves, twist-off units
Aseptic or BFS filling of low-viscosity solutions or suspensions
Container closure integrity testing (CCIT)
Microbial, particulate, and endotoxin testing
Labeling, serialization, and packaging
Support for regulatory submissions and batch documentation
These services ensure your sterile product meets patient expectations and market standards without compromise.
Working with a specialized sterile forms fill and finish CDMO for non-injectables offers several benefits:
Enhanced product safety through preservative-free aseptic processing
Optimized patient usability with format-specific filling (e.g., eye drops, nasal sprays)
Sterility assurance for sensitive mucosal applications
Flexible container options for single- or multi-dose strategies
Scalability from clinical trials to commercial launch
These CDMOs reduce development risk while ensuring your sterile nasal, otic, or ophthalmic product is market-ready.
Some of the most trusted sterile forms fill and finish CDMO companies for non-injectables include:
Cenexi: CDMO specialized in the manufacture and filling of injectable and non-injectable sterile liquid products. [See CDMO profile]
Pharmaloop (a Salvat company): Fully integrated CDMO solutions for Blow-Fill-Seal (BFS) sterile multidose. [See CDMO profile]
Liof Pharma: Aseptic manufacturing and lyophilization of biologics and sterile drugs. [See CDMO profile]
ASCIL Biopharm: Laboratories and a pilot plant for technical and clinical batches of sterile products. [See CDMO profile]
Ophtapharm (a Sentiss company): Ophtalmic and Otic - Solutions, suspensions, emulsions, ointments and gels - FDA Approved facility. [See CDMO profile]
Steriles CDMO Companies | Steriles Contract Manufacturing Services
FDF CDMO Services | Finished Dosage Forms Contract Manufacturing
At MAI CDMO, we connect pharma and healthcare innovators with the most qualified sterile forms fill and finish CDMO companies, specializing in steriles fill and finish services for non-injectable formats. Whether you’re launching an ophthalmic drop, nasal spray, or otic solution, we’ll help you find the partner that meets your product’s technical, regulatory, and delivery requirements.
Need a CDMO for sterile ENT or ophthalmic product filling? Contact us today and let’s get started.
If you have any questions or suggestions, click here. We will be happy to assist you.