Sterile Manufacturing

Sterile Manufacturing Services

Quality Built In. End-to-End Delivered.

Aseptic & Sterile Fill-Finish Solutions Purpose-Built for Early-Phase Clinical Trials

Eramol delivers a purpose-built, EU GMP Annex 1–compliant 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.

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.

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 Manufacturing for Clinical Trials

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

Aseptic and sterile 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
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 (<1% line loses) 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

Phase 2 Expansion

Our facility includes ~2,000 m² expansion space to increase sterile capacity and automation:

Fully automated vial, cartridge, PFS, and pen filling
Additional cleanrooms for scalable, flexible sterile operations
>50L 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.