Expertise
Sterile Production
Deep expertise in aseptic manufacturing processes — from formulation through filling, sealing, and final product inspection — ensuring product sterility, patient safety, and regulatory compliance at every stage.
Aseptic Filling Technologies
Comprehensive knowledge of filling technologies for all primary container types, with hands-on experience across dozens of production lines worldwide.
- Vials — liquid and lyophilized fills, multiple volume ranges
- Pre-Filled Syringes — glass and polymer barrels, staked needle and Luer lock
- Ampoules — open and closed filling systems
- Cartridges — for pen-delivery systems
- Ready-to-Fill (RTF) — pre-sterilized containers and nest/tub configurations
Sterilization & Processing
Mastery of bulk product sterilization methods and processing equipment critical for maintaining sterility assurance levels throughout the manufacturing chain.
- Steam Sterilization — saturated steam autoclaving
- SIP — Steam-in-Place for process vessels and piping
- Sterile Filtration — 0.2 µm and nanofiltration processes
- Depyrogenation — hot-air dry heat processes
Homogenization
Particle size reduction technologies including aseptic configurations:
- HPH (High Pressure Homogenizer) — GEA Niro Soavi
- Microfluidizer — Microfluidics
- Agitated Beads Mill — Netzsch
- Rotor Stator — Ytron
Visual Inspection
Automatic visual inspection for particulate and cosmetic defect detection:
- Eisai
- Körber \ Seidenader
- Brevetti
Process Development
End-to-end support for bringing products from development to full-scale production:
- Tech transfer from R&D to production
- Scale-up methodology and execution
- Process robustness assessment
- Control system design (21 CFR Part 11)
Critical Insight
Not all equipment is adapted to sterile production. In many cases, well-known manufacturers have made design mistakes or failed to consider all requirements for aseptic equipment. There is a need to examine the design in-depth, and if necessary, to propose changes and adjustments before procurement. This is where independent SME expertise prevents costly downstream failures.