Hanegbi Engineering - Process Engineering Consulting, Design, and Project Execution

Hanegbi Engineering Ltd. specializes in high-quality process engineering solutions for the biotechnology, pharma, cosmetics, food, and electronics industries. The company was founded in 2015 by Oshi Hanegbi.

The company has several professional departments specializing in the following areas:

  • Engineering consulting, design, and supervision in the characterization, planning, and establishment of aseptic production, filling, and packaging lines.
  • CMC support from the concept stage through all registration phases.
  • Process solutions for problem-solving and scaling.
  • Validation services, consulting, training, and support.
  • Project planning, execution, and management from initial design to implementation.
  • Representation of leading companies and manufacturers of machines and systems in biotechnology, pharma, and food industries.

The company’s team includes engineers and process experts with advanced degrees and decades of cumulative experience.

The company’s success is based on its ability to identify and characterize each client’s unique needs, deep familiarity with the existing market solutions, meticulous and methodical work, and unwavering commitment to meeting goals.

We focus on the problem the client wants to solve, and together with the client, we create and tailor a comprehensive solution of the highest quality and professionalism.

We bring practical knowledge from fieldwork, management, and in-depth familiarity with leading factories in the pharma, biotech, and startup industries in Israel.

We understand the complexities of engineering, process development, regulatory stages, quality requirements, and operational budgeting.

Hanegbi Engineering has planned and executed a variety of complex projects. All required the integration of knowledge from many disciplines and areas of expertise.

A correct solution is one that optimally addresses all necessary aspects and enables continuous production without interruptions over time.

 

Our specialties include:

Aseptic Production and Filling solutions of Sterile Products

  • Characterization of needs, planning and establishment, problem-solving, and validation execution.
  • Characterization and planning of the entire aseptic production process, from conceptual design to detailed planning.
  • Characterization of all necessary production systems and issuing specifications, including URS (User Requirements Specifications).
  • Engineering alignment of production lines to Annex 1 requirements
  • Establishment and adaptation of filtration process systems, including PUPSIT (Pre-use Post-sterilization Integrity Testing).
  • Risk management execution, writing CCS (Contamination Control Strategy) documents.
  • Characterization of solutions for filling sterile powders and liquids.

Isolation

  • Representation of companies providing solutions, including glove testing systems, control systems, and cameras.
  • Characterization of required isolator setups according to necessary aseptic production and filling processes.
  • Planning, implementation, and supply of isolators according to required production processes and ergonomic comfort.
  • VHP sterilization process planning for required processes.
  • Writing and development of IQOQPQ validation for sterilization and working with isolators.
  • Characterization and supply of glove integrity testing devices, including full support and IQOQPQ validation.
  • Planning and implementation of RABS device integrity tests according to the production process and ergonomic comfort.

Fermentation and Bioreactors

  • System planning for any need and work volume, including scaling solutions, including biosimilar processes.
  • Representation of companies providing solutions for both upstream and downstream stages.
  • Support systems for the cultivation of bacteria, fungi, yeast, and various cell cultures:
    • Fermenters – ranging from a few liters to 100,000 liters.
    • Bioreactors – growth of various cell cultures.
    • Magnetic stirrers – of all types with excellent finishing and scaling capability.
    • Process support in scaling up processes, problem-solving, CMC.
    • CIP and SIP systems.
    • Concentration systems – TFF, UF.

Aseptic Filling Lines

  • Customized to the client’s needs for products with varying properties and filling into diverse final containers.
    • BFS (Blow Fill Seal) machines, among the most advanced in the world.
    • Machines for filling vials and syringes with powders and liquids.
    • Machines for filling radioactive materials.
    • Machines for precise filling of very small quantities.

Production of Emulsions, Suspensions, and Solutions for Pharma, Biotech, and Food

  • Conceptual design of the entire process.
  • Characterization of all necessary production systems and issuing appropriate specifications, including URS.
  • Full basic and detailed planning.
  • Project management and execution.
  • Planning and supply of a complete production system, including automated production, cleaning, and sterilization processes.
  • Writing all necessary operational procedures.

Validation Work

  • IQ, OQ, PQ – meeting various standards and all working ranges required by the client.
    • Washing, dishwashers, ultrasonic baths – with unique and innovative methods.
    • Sterilization processes, autoclave.
    • Stability chambers, incubators, heat chambers – for laboratory or industrial use.
    • Refrigerators, freezers, safes.
    • Production systems, including isolators and RABS.
    • Cleanrooms of all cleanliness levels.
    • Systems: water, gases, compressed air, and more.
    • Unique equipment of all kinds.

Managing Complex Projects

  • Unique projects for the food and cosmetics industry.
    • Automation and control.
    • Unique conveyor lines.

Functionaries:

Hanegbi Oshi - Founder & CEO

Oshi has a bachelor degree in mechanical engineering from Ben Gurion University and a master degree in business and management . Oshi has great experience and in-depth familiarity with the pharma, biotechnology and food industry. Oshi started his career as a validation and project engineer at a pharmaceutical plant, and later also managed engineering, maintenance and validation divisons at pharmaceutical factories. Over the years, Oshi successfully performed complex projects, including the range of services being offered. Oshi has great familiarity with the GMP&GDP regulatory requirements and extensive experience in designing, managing and building aseptic manufacturing and filling systems for biotechnology plants, and great experience in consultation for, preparation and leading of factories to pass audits of Israel’s Ministry of Health and the FDA.

Hanegbi Boaz, Project Management Divison Manager

Boaz has a bachelor degree in industrial engineering and management from Ben Gurion University, great managerial experience as an engineer and project manager in global companies having many manufacturing sites. Boaz has previous experience managing automation engineering departments in multinational electronics contract manufacturer In recent years, Boaz has managed and led complex multidisciplinary projects for new production and packaging lines, the projects included characterization processes, analysis of price quotations and building budgets, leading procurement processes and contracts with machine manufacturers, and deploying the lines in factories to achieve efficient work, and building of suitable manufacturing halls and work areas.

Eylan Mason, Process and Validation Engineer

Eylan holds dual Bachelor's degrees in Materials Science and Chemistry, with experience in the pharma industry working in clean rooms, scaling and developing production processes. He has knowledge of engineering and characterizing polymeric, ceramic, engineering, and composite materials. Ilan has experience working in GMP and GLP environments.

Ksenia Fadeev, Senior Validation and Project Engineer

Ksenia holds a Bachelor's degree in Pharmaceutical Engineering and an MBA from the Hebrew University. She has experience as a quality, validation, and production engineer in leading pharmaceutical plants and extensive experience executing numerous and varied validations for all existing systems, including the qualification of sterile isolators in pharmaceutical plants. She brings extensive knowledge of aseptic work, process, and engineering understanding and a deep familiarity with GMP and GDP requirements, as well as extensive experience preparing plants for inspections by the Israeli Ministry of Health and the FDA.

Sarit Heifetz – Professional Development, Quality, and Regulation Manager

Sarit holds a Master's degree in Life Sciences, with over 20 years of senior management experience in the pharma industry, including quality control, production management, and plant management. She has extensive familiarity with process scaling and operational efficiency, aseptic work in all biological production methods, building, implementing, and applying quality and regulatory requirements, and managing product lifecycle. Sarit is skilled in economic feasibility assessment, risk management, and process monitoring and control. She also has experience in building training programs and implementing learning and certification processes.

Dr. Or Degani, CMC Expert and Technology Manager

Or holds Bachelor's degrees in Pharmacy and Biology, and a PhD in Biochemistry. He has over 17 years of experience managing and consulting in the biopharmaceutical field in startup companies and both local and international pharmaceutical companies. Or has extensive experience in process development, planning and executing process validations, and problem-solving in scaling. He is also experienced in project management and executing complex risk management, with a deep familiarity with all ISO, GMP, and GLP requirements.

Hanegbi Hagar, Chief Financial Officer and human resources manager

Hagar has a bachelor degree in management from Ben Gurion University. Hagar has past experience in the banking field and managing bank branches, and is responsible for finances and human resources management. In addition to her function, Hagar is also a regional manager in the Paamonim Organization and contributes extensively to improving the economic situation of many families.

Hanegbi Tzviel, Validation Divison Manager

Tzviel holds a bachelor degree in mechanical engineering, Tzviel has experience as a validation and project engineer, and in recent years is responsible for writing and performing many qualification and validation projects for all types of systems used in pharma and biotechnology industries. Tzivel has extensive understanding of GMP & GDP requirements.

Establishing maintenance and engineering apparatuses, professional consultation and execution of the formation of engineering, maintenance, validation and calibration divisions
Designing and building of clean rooms, compatible with Good Manufacturing Practice (GMP).
Designing and managing the construction of warehouses and refrigerated and freezing rooms for pharmaceutical factories according to the GMP requirements. GDP & GMP
Improving the efficiency of manufacturing processes by upgrading existing layouts, process equipment and supporting systems.