— Resources
FAQ
Common questions about 10AR sterile engineering consulting services.
What types of companies does 10AR work with?
10AR supports pharmaceutical, biopharmaceutical, medical device, cosmetics, and superfood manufacturers, along with any facility producing sterile or low‑bioburden products. Its client base spans multinational corporations such as Teva and J&J, mid‑size pharmaceutical companies, and early‑stage biotech startups in scale‑up phases. 10AR also supports equipment manufacturers, CMOs (Contract Manufacturing Organizations), and organizations in adjacent industries that require sterile or clean manufacturing environments.
What is the typical engagement model?
Engagements range from focused troubleshooting calls (days) to ongoing project support (months or years). Common models include: project-based consulting for specific initiatives, retainer-based continuous support, and one-time expert assessments or gap analyses. The model is always tailored to the client’s actual need — there is no one-size-fits-all approach.
What does "Owner's Representative" mean in practice?
Unlike engineering firms that may have commercial relationships with equipment vendors, 10AR operates solely in the client’s interest. As Owner’s Representative, Arnan evaluates vendor proposals objectively, challenges specifications that don’t serve the facility’s needs, identifies hidden costs and risks, and ensures that every technical decision is optimized for the client’s operational and regulatory requirements — not for any vendor’s commercial benefit.
Can 10AR support international projects?
10AR serves clients globally
How quickly can 10AR respond to an emergency?
For critical production issues, Arnan typically provides an initial remote consultation within 24 hours. On-site response time depends on location and current commitments, but urgent cases are always prioritized. The troubleshooting process begins immediately with remote assessment — often the root cause can be identified before an on-site visit.
What regulatory frameworks does 10AR cover?
10AR’s expertise covers FDA (US), EMA (EU), and related international regulatory requirements. Specific areas include EU GMP Annex 1 (the updated 2023 version), 21 CFR Part 211, 21 CFR Part 11, ICH guidelines, WHO GMP, and PIC/S requirements. Arnan has direct experience with FDA and EMA inspections, BLA submissions, and regulatory authority meetings.
What is a Contamination Control Strategy (CCS)?
A CCS is a comprehensive document required by the updated EU GMP Annex 1 that describes all the measures a facility takes to prevent, detect, and control contamination throughout the manufacturing process. It covers facility design, personnel practices, equipment, cleaning, sterilization, environmental monitoring, and more. It should be a living engineering document that is regularly reviewed and updated — not just a compliance checkbox.
Engineering Glossary
URS
User Requirements Specifications
VPHP
Vaporized Phase Hydrogen Peroxide
CCS
Contamination Control Strategy
Grade A
Highest cleanliness classification (ISO 5)
RABS
Restricted Access Barrier System
SIP
Steam-In-Place
CIP
Clean-In-Place
WFI
Water for Injection
FAT
Factory Acceptance Test
SAT
Site Acceptance Test
CQV
Commissioning, Qualification & Validation
PUPSIT
Post-Use Post-Sterilization Integrity Test
CCI
Container Closure Integrity
BMS
Building Management System
HEPA
High-Efficiency Particulate Air (filter)
RTF
Ready-to-Fill (containers)
Technical Guides
Documents posted on LinkedIn.
Arnan Ben-David
PDA journal article
Mention the article in the PDA journal (Cannot share it as the PDA has the rights).
