— 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.
