Eramol | Early Phase Sterile Fill Finish

https://eramol.com/clinical-services-category/sterile-fill-finish/ 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 Enquire Today 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. 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. 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 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