Owner's Representative & Engineering SME
Because Sterile
Production Requires
EXPERTISE.
Arnan Ben‑David provides principal‑level engineering consulting, offering deep technical expertise across sterile manufacturing, aseptic processing, and full lifecycle qualification for the pharmaceutical and biopharmaceutical industries. His specialization includes sterile production facility design, equipment procurement, regulatory compliance, and operational troubleshooting — representing only part of the comprehensive services he delivers.
What We Do
Comprehensive Sterile Engineering Services
Facility Design
Clean room design, production flows, pressure cascades, and layout optimization for regulatory compliance.
Equipment & URS
Specification writing, vendor evaluation, FAT/SAT management, and procurement optimization.
Production & Scale-Up
Process development, tech transfer from R&D to production, and complex product manufacturing.
New Technologies & Equipment Implementation
Sterile production includes complex technologies such as bulk sterilization, homogenization, and particle size reduction. Deep knowledge of these technologies and equipment provides significant advantage in assimilation time and implementation accuracy.
Training
Targeted training programs for engineering, operations, and quality teams supporting sterile manufacturing environments.
Support on-going Production Activities
Ongoing production support for sterile manufacturing sites, including troubleshooting, process optimization, and assistance with operational challenges.
Sterilization Processes - Design and Validation
Design and validation support for moist and dry heat sterilization processes, including cycle development, technical review, and process assurance.
CQV
IQ/OQ/PQ management, protocol writing, clean room qualification, and 21 CFR Part 11 compliance.
Troubleshooting
Rapid root cause analysis, emergency support for filling lines, and complex process diagnostics.
Annex 1 Compliance
CCS development, gap analysis, barrier technology guidance, and PUPSIT implementation.
Filling Lines
Vials, syringes, ampoules — washing, depyrogenation, filling, stoppering, and crimping.
Automatic Visual Inspection Systems
Support from purchasing to testing for automatic visual inspection systems in sterile production lines.
The 10AR Difference
Why Choose 10AR
Owner's Representative
Unlike engineering firms that serve their own interests, Arnan stands on the owner's side — protecting your investment, ensuring every decision serves your facility's long-term operational efficiency and regulatory standing.
Equipment DNA Knowledge
Intimate familiarity with leading vendors — Bosch, Optima, Skan, Fedegari and more — enables precise specification writing, effective technical negotiations, and optimal equipment selection at the best cost.
Holistic One-Stop-Shop
From the big picture of an entire plant's needs down to the root cause of a specific filling line defect — comprehensive, continuous support until the collaboration objective is fully achieved.
Featured Case Study
Saving a Global Facility from Regulatory Shutdown
A dead leg identified in the sterile water system of a global manufacturing facility threatened complete regulatory closure. Through systematic root cause analysis and rapid loop redesign, the facility maintained continuous operation and full compliance.
Read the Full StoryChallenge
Dead leg in WFI system risking regulatory shutdown
Solution
Complete loop redesign with zero production downtime
Outcome
Facility saved from closure, full regulatory compliance restored
Trusted by Leading Organizations
Ready to Ensure Your Sterile Facility Is Built Right?
Whether you are planning a new facility, upgrading an existing line, or facing a critical production challenge — get expert guidance from day one.
Schedule a Free Consultation