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 TrialsEnquire TodayEramol 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 TrialsOur end-to-end service reduces handovers and accelerates timelines, covering:Aseptic and Terminal Sterilisation fill-finishPrimary and secondary packaging & labelling, including blinding-ready configurations and placebo matchingQC testingQP certification for UK and EU clinical trial releaseControlled temperature storage, including frozen capabilitiesGlobal distribution via qualified logistics partnersA single, accountable partner from sterile manufacturing through to clinical site delivery.State-of-the-Art FacilityAligned with 2023 EU GMP Annex 1, our sterile suite features:Grade A aseptic isolators and UDAF booth filling environmentsLAF & PCC hoodsControlled Grade C backgroundsClosed-system technologies ensuring exceptional sterility assurance and contamination controlScalable Fill-Finish for Phase I & II TrialsBatch sizes from <500 up to 5,000 vials (cartridges and pre-filled syringes also supported)Fill volumes 0.5–10 mL per vial24/7 shift operations for high-throughput early-phase supplyLine design and single-use technologies minimise drug product lossRobust CCSReduced wastage (<0.1% line losses) and increased drug product yieldAseptic Processing & Terminal Sterilisation OptionsEramol provides multiple sterile pathways:Isolator-based aseptic fill-finishUDAF booth fillingMoist heat autoclave terminal sterilisation with validated, traceable cyclesThis ensures regulatory-compliant sterility, maximises yields, and preserves valuable APIs during early-phase development.Key Sterile Manufacturing CapabilitiesCompounding & Sterile FiltrationClosed single-use mixing systemsSterile compounding with 0.22 μm inline filtrationFilter integrity testing pre- and post-useAseptic Fill-Finish ServicesGrade A isolator or UDAF booth fillingWeighing, crimping, and in-process controlReal-time environmental monitoring for reproducibility and accuracyTerminal SterilisationAutoclave-based moist heat sterilisationFull cycle validation and traceabilityContainer Closure Integrity Testing (CCIT)Non-destructive vacuum/pressure decay testingManual and automated visual inspectionPlacebo & Blinded Study SupportSCHOTT adaptiQ® vials for consistent supplyPlacebo matching and blinding-ready configurations