Sterile Fill Finish in a UDAF Environment
All fill finish activities for terminally sterilised products are conducted within a qualified Unidirectional Airflow (UDAF) booth, providing controlled cleanroom conditions prior to sterilisation.
Our filling process includes:
- High-accuracy fill-to-weight technology
- Fill volumes ranging from 0.5 mL to 10 mL
- Maximum batch size of 10 litres
- Typical production volumes of up to 5,000 vials
Precision fill-to-weight controls ensure dosing accuracy and minimise variability prior to terminal sterilisation.
Validated Terminal Sterilisation by Autoclave
Following fill finish, products undergo validated autoclave terminal sterilisation, providing enhanced sterility assurance compared to aseptic-only processes.
Eramol offers multiple autoclave cycle options, enabling optimisation of sterilisation parameters to protect product integrity, including:
- Variable temperature and pressure profiles
- Customised exposure times
- Product-specific cycle validation
This flexibility allows us to tailor terminal sterilisation to sensitive formulations while maintaining regulatory compliance.
Enhanced Product Protection & Quality Assurance
To ensure container integrity and sterility assurance, Eramol performs:
- Container Closure Integrity Testing (CCIT) on finished products
- Full batch documentation and electronic data traceability
- GMP-compliant quality oversight
Terminal sterilisation provides a high sterility assurance level (SAL), making it a preferred approach for suitable injectable products where formulation stability permits.
Integrated Terminal Sterilisation CMO Services
Eramol’s terminal sterilisation services are delivered within a fully integrated CMO model, including:
- Primary and secondary packaging
- Clinical and commercial labelling
- In-house QC testing
- UK, EU, US Qualified Person (QP) release
- GMP-compliant temperature-controlled storage
- Managed global distribution via a wide network of depots.
By integrating fill finish, terminal sterilisation, quality testing and distribution under one partner, we reduce supply chain complexity and accelerate time to clinic.
Flexible Clinical & Early Commercial Supply
Our terminal sterilisation capability is particularly suited to:
- Phase I and Phase II clinical trials
- Early commercial sterile injectable supply
- Products suitable for autoclave sterilisation
- Sponsors seeking enhanced sterility assurance
With batch sizes up to 10L and up to 5,000 vials per campaign, Eramol provides scalable yet flexible sterile manufacturing support.
Why Choose Eramol for Terminal Sterilisation?
- UK-based terminal sterilisation CMO
- UDAF-based fill finish
- Autoclave sterilisation with multiple cycle options
- Fill-to-weight dosing accuracy
- CCIT testing on finished products
- Fully integrated end-to-end services
- Regulatory expertise and QP release
Eramol’s terminal sterilisation platform delivers sterility assurance, flexibility and operational efficiency to support modern injectable development programmes.
Contact Eramol
If you are searching for a trusted terminal sterilisation fill finish CMO in the UK, contact Eramol to discuss your sterile injectable manufacturing requirements.
