— Expertise Support on-going Production Activities Reliable technical support for routine sterile manufacturing Sterile manufacturing requires continuous control, technical discipline, and fast response to operational challenges. Even well-designed and validated…
— Expertise Automatic Visual Inspection Systems Expert owner-side support for automatic visual inspection systems in sterile pharmaceutical production — from URS and vendor selection to FAT, SAT, qualification, recipe development,…
— Expertise Filling Lines Deep specialization in sterile filling lines —From containers washing and depyrogenation filling, stoppering, crimping, and inspection. Decades of hands-on experience with every major filling technology and…
— Regulatory Annex 1 Compliance The updated EU GMP Annex 1 is the most significant regulatory change in sterile manufacturing in decades. 10AR provides expert guidance in understanding, implementing, and…
— Emergency Support Troubleshooting When a sterile production line goes down, when product quality is at risk, when regulatory deadlines are approaching — rapid, expert diagnostic response from someone who…
— Services CQV — Commissioning, Qualification & Validation Full lifecycle qualification services — from protocol development through execution, review, and regulatory-ready documentation. Ensuring every system performs as intended, every time.…
— Expertise Sterilization Arnan is recognized as a worldwide expert in moist‑ and dry‑heat sterilization, combining his engineering background in heat transfer and thermodynamics with a scientific, data‑driven approach to…
— Expertise Training Targeted training programs for engineering, operations, and quality teams supporting sterile manufacturing environments — focused on GMP readiness, contamination control, aseptic operations, and practical production performance. Training…
— Expertise New Technologies & Equipment Implementation Successful implementation of complex sterile production technologies Introducing new technologies and production equipment into a sterile manufacturing environment requires much more than installation…
— Expertise Production Processes & Scale-Up From development concept to reliable full-scale manufacturingSuccessful production scale-up requires more than increasing batch size or transferring parameters from laboratory to production equipment. It…
