End To End Sterile Manufacturing

Why Choose Eramol?

• State-of-the-Art Facility – Fully aligned with 2023 EU GMP Annex 1, with aseptic isolator, LAF and PCC hoods for sterility assurance and contamination control
• Aseptic Processing & Terminal Sterilisation – Flexible solutions including aseptic fill finish within Grade A isolator or fill finish within a Unidirectional Airflow (UDAF) booth and terminal sterilisation by autoclave.
• Maximise Yields – Equipment and process design minimises line losses associated to traditional processing methods to ensure maximum yields.
• Scalable Manufacturing – Batch sizes from <500 to 5,000+ vials; high accuracy fill volumes 0.5–10 ml; seamless scale-up from early development to small-scale commercialisation.
• Robust Contamination Control – Fully closed processing with single-use technologies combined with environmental monitoring in alignment to our Contamination Control Strategy (CCS).
• Comprehensive In Process Monitoring – In-house and contract testing services cover sterility, BET, CCIT, identity, potency, impurities, particulate matter, and more – aligned with UKP, EP, USP, and ICH.
• Fit-for-Purpose Process Design – From placebo matching and cleaning validation to custom fill-finish workflows, our expert teams design efficient, compliant processes tailored to your product.

Key Capabilities

• Compounding & Filtration: Compounding with inline sterile filtration to sterile single use closed system supported by filter integrity testing.
• Fill-Finish Services: Grade A isolator or UDAF filling and crimping, integrated weighing, and real-time environmental monitoring.
• Sterilisation: 0.22μm Filtration or Autoclave cycles for terminal sterilisation with full data traceability.
• Container Closure Integrity: Non-destructive CCIT (vacuum/pressure decay) and visual inspection to ensure sterility barrier maintenance.
• Placebo & Blinded Trial Ready: SCHOTT adaptiQ® vial formats ensure high quality and placebo matching for trial blinding.
• End to End service: Post manufacture downstream packaging, labelling, QC testing, QP release, storage & global distribution capabilities.

Enhanced Services on Request

• Custom container formats, fill volumes, or batch sizes
• Cartridge fills and medical gas headspace fills
• Drug-device combination assembly
• Coordination of off-site services (e.g., lyophilisation, radiation)

📜Sterile Manufacturing Flyer