Advanced Aseptic Fill-Finish in a Grade A Isolator
All aseptic fill finish operations are performed within a fully qualified Grade A isolator, ensuring the highest sterility assurance for injectable products. Our facility operates under a robust Contamination Control Strategy (CCS) aligned with EU GMP Annex 1 requirements.
We utilise single-use aseptic technologies to reduce contamination risk, improve turnaround times and support multi-product clinical programmes.
Key features of our aseptic fill-finish capability include:
- Grade A isolator-based sterile filling
- Validated 0.22μm sterile filtration
- Full electronic batch data traceability
- Annex 1-compliant contamination control
Precision Sterile Filling with <1% Line Losses
Eramol’s aseptic fill-finish line is engineered for a wide range of high value assets.
Our process consistently achieves:
- <1% line losses in aseptic filling
- High-accuracy fill volumes from 0.5 mL to 10 mL
- Maximum batch size of 5 litres
- Typical production volumes of <500 to 5,000 vials
Through precision fill-to-weight technology and optimised process design, we help sponsors minimise wastage and protect valuable clinical assets, a critical advantage in early-phase development and rare disease programmes.
SCHOTT adaptiQ® Vials for Clinical Trial Supply
We utilise SCHOTT adaptiQ® ready-to-use (RTU) vial formats, supporting efficient sterile fill-finish operations while ensuring:
- High container quality standards
- Reduced particulate and contamination risk
- Reliable placebo matching for blinded clinical trials
- Streamlined handling within isolator environments
These vial formats enhance both operational efficiency and clinical trial compliance.
Integrated Sterile CMO Services – End-to-End Support
Eramol operates as a fully integrated sterile CMO in the UK, providing complete end-to-end support beyond aseptic fill finish.
Our downstream services include:
- Primary and secondary packaging
- Clinical and commercial labelling
- In-house quality control (QC) testing
- UK, EU, US Qualified Person (QP) release
- GMP-compliant temperature-controlled storage
- Managed global distribution via a wide network of global depots.
By integrating sterile fill-finish with packaging, QC testing, QP certification, storage and distribution, Eramol reduces supply chain fragmentation and accelerates time to clinic.
Flexible Clinical Fill Finish for Early-Phase Development
Our aseptic fill finish services are optimised for:
- Phase I and Phase II clinical trials
- Small-batch sterile injectable manufacturing
- Small molecule, large molecule, Cell & Gene Therapies, AAV, radiopharma cold kits etc
- Rare disease and orphan drug programmes
- Time-sensitive sterile supply
- CCIT on finished products
We provide the agility and flexibility often missing from large-scale sterile CMOs, while maintaining the highest standards of GMP compliance.
Why Choose Eramol for Aseptic Fill Finish?
- UK-based sterile CMO
- Grade A isolator technology
- <1% line losses
- Single-use aseptic systems
- Robust contamination control strategy
- End-to-end integrated service model
- Full regulatory oversight and QP release
Eramol’s aseptic fill finish capability is designed to protect product, safeguard patients and support clinical progress.
Contact Eramol
If you are searching for a trusted aseptic fill finish CMO in the UK, contact Eramol to discuss your sterile injectable manufacturing requirements.
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