Owner's Representative & Engineering SME
Because Sterile
Production Requires
EXPERTISE.
Arnan Ben-David is a principal consultant in sterile engineering — the independent authority pharma and biotech companies call when a facility must be built right the first time. From concept design and URS through qualification, tech transfer, and on-going production support.
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 involves bulk sterilization, homogenization, and particle size reduction, where strong technical knowledge improves 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
Three reasons owners keep calling back.
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.
Case · 001 / 2023 — Global Mfg. Site · Sterile Water System
— Featured Case Study
Saving a global facility
from regulatory shutdown.
A dead leg discovered in the sterile water system of a multi-site manufacturer threatened complete regulatory closure. Systematic root-cause analysis led to a rapid loop redesign — the facility maintained continuous operation and restored full compliance.
— Challenge
Dead leg in WFI system risking shutdown
— Solution
Loop redesign, zero production downtime
— Outcome
Facility saved, compliance restored
— In trust with
Since 1988
