Sterile Fill-Finish

Sterile Fill-Finish Services

Your early-phase sterile fill-finish partner. From drug substance to UK or EU QP finished product release, Eramol delivers everything required to move your injectable product into clinical trials, with quality, regulatory expertise and collaboration at every step.

Aseptic & Terminal Sterilisation Fill Finish Solutions Purpose Built for Early Phase Clinical Trials

Eramol delivers a purpose-built, EU GMP Annex 1–aligned sterile manufacturing service dedicated to Phase I and Phase II clinical trial supply. Our facility is designed for agility, reliability, and regulatory strength, integrating advanced isolator technology, closed-system processing, moist heat terminal sterilisation, and a full end-to-end clinical supply chain, ensuring your sterile injectable reaches patients safely, on time, and in full regulatory compliance.

Designed to minimise waste, our isolator achieves <0.1% line losses to maximise yields and protect our clients valuable drug substances.

We support a wide range of modalities including small molecules, large molecules/biologics, ATMPs/Cell & Gene Therapies, ADCs, RNA therapeutics, oligonucleotides, peptides, monoclonal antibodies (mAbs), viral vectors, radiopharmaceutical cold kits and some cytotoxics.

Early-Phase Sterile Fill-Finish Capabilities:

Requirement	Eramol capability
Clinical stage	Phase I–II
Maximum batch size	Up to 10 L
Processes	Aseptic and terminal sterilisation
Environment	Grade A IWT & 3P isolator, UDAF & Fedegari Autoclave
Formats	Vials, cartridges & pre filled syringes
Fill volume	Up to 10 mL
Supporting services	Packaging, labelling, QC testing, QP release, storage and distribution
UK/EU release	UK and EU QP release

Why Partner With Eramol?

Quality-Led Organisation Run by Qualified Persons (QPs)

Founded and operated by QPs, Eramol embeds a culture of quality, compliance, and patient safety throughout the organisation. Every process is designed to meet the highest global regulatory standards, giving clients confidence in GMP-compliant sterile manufacturing for early-phase trials.

One-Stop Sterile Fill Finish for Clinical Trials

Our end-to-end service reduces handovers and accelerates timelines, covering:

Aseptic and Terminal Sterilisation fill-finish
Primary and secondary packaging & labelling, including blinding-ready configurations and placebo matching
QC testing
QP certification for UK and EU clinical trial release
Controlled temperature storage, including frozen capabilities
Global distribution via qualified logistics partners

A single, accountable partner from sterile manufacturing through to clinical site delivery.

State-of-the-Art Facility

Aligned with 2023 EU GMP Annex 1, our sterile suite features:

Grade A aseptic isolators and UDAF booth filling environments
LAF & PCC hoods
Controlled Grade C backgrounds
Closed-system technologies ensuring exceptional sterility assurance and contamination control

Scalable Fill-Finish for Phase I & II Trials

Batch sizes from <500 up to 5,000 vials (cartridges and pre-filled syringes also supported)
Fill volumes 0.5–10 mL per vial
24/7 shift operations for high-throughput early-phase supply
Line design and single-use technologies minimise drug product loss
Robust CCS
Reduced wastage (<0.1% line losses) and increased drug product yield

Aseptic Processing & Terminal Sterilisation Options

Eramol provides multiple sterile pathways:

Isolator-based aseptic fill-finish
UDAF booth filling
Moist heat autoclave terminal sterilisation with validated, traceable cycles

This ensures regulatory-compliant sterility, maximises yields, and preserves valuable APIs during early-phase development.

Key Sterile Manufacturing Capabilities

Compounding & Sterile Filtration

Closed single-use mixing systems
Sterile compounding with 0.22 μm inline filtration
Filter integrity testing pre- and post-use

Aseptic Fill-Finish Services

Grade A isolator or UDAF booth filling
Weighing, crimping, and in-process control
Real-time environmental monitoring for reproducibility and accuracy

Terminal Sterilisation

Autoclave-based moist heat sterilisation
Full cycle validation and traceability

Container Closure Integrity Testing (CCIT)

Non-destructive vacuum/pressure decay testing
Manual and automated visual inspection

Placebo & Blinded Study Support

SCHOTT adaptiQ® vials for consistent supply
Placebo matching and blinding-ready configurations

Enhanced Services (On Request)

Custom container formats, fill volumes, and batch sizes
Cartridge, pre-filled syringe (PFS), and pen device fills
Drug–device combination assembly
Coordination of off-site lyophilisation or irradiation

Stage 2 Expansion

Our facility includes ~2,000 m² expansion space to increase sterile capacity and automation. This will allow Eramol to support Phase III to Commercial from ~2028

Fully automated vial, cartridge, PFS, and pen filling
Additional cleanrooms for scalable, flexible sterile operations
>50L future max batch size

Why Eramol?

EU GMP Annex 1-compliant, QP-led sterile manufacturing
Supports small molecules, biologics, ATMPs, RNA, peptides, oligonucleotides, mAbs, ADCs
Maximum batch size 5,000 vials for Phase I/II supply
End-to-end clinical supply chain from formulation to global distribution
24/7 operations for rapid early-phase trial delivery
Expansion-ready for fully automated sterile fill-finish

Eramol combines quality, regulatory expertise, and operational excellence to provide a reliable partner for early-phase sterile injectables, ensuring sterility, compliance and precision at every stage.