FAQ & Technical Guides

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.

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.

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.

Yes. While based in Israel, Arnan has extensive international experience including management of global sterile production networks (12 sites at Teva), international technology transfers (Omrix/J&J), and vendor FATs at manufacturing facilities across Europe. 10AR serves clients globally, with particular focus on DACH countries (Germany, Austria, Switzerland), Ireland, and the US East Coast.

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.

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.

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.