Balazs Toth

I'm

About

I am a senior development engineer specialised in the sterilisation and packaging of medical devices and combination products, with more than 10 years of experience in this field. I have worked on the new product introduction (NPI) of a combination product to the Swiss and EU market with a budget of 30+ m€, including the installation of a state-of-the-art automated production line for autoinjectors. I led a packaging validation and verification project worth 3 m€ for the whole product portfolio of a site, including 800+ products in more than 100 packaging families. I have developed abdominal and ophthalmic implants, ensured their sterility and defined their ageing and transport simulation. I have also developed drain products for the US market and an intravenous system for the Asian and Chinese markets.

I am a member of the ISO and ASTM organisations, therefore I am not just using the international standards, I am creating them. I have 3 years of experience in international project management, 1 year as R&D team deputy and 1 year as engineering manager of 7 engineers and 3 technicians.

My detailed CV is available here
Balazs Toth

Medical Field Expert

  • Website: https://balazstoth.hu/
  • Phone: +41 76 541 8153, +36 30 335 0927
  • City: Budapest (HU), Zug (CH)
  • Email: balazs.toth@iechungary.com
  • Degree:
    • Master of Science in Management and Leadership (2021 - 2023)
    • Master of Science in Mechanical Engineering (2014 - 2016)
    • Bachelor of Science in Mechatronical Engineering (2010 - 2014)

Projects

Consultant: Sterile Barrier Validation and Verification, BBraun Switzerland

April 2025 - May 2026

Responsibilities

  • Validate new material supplier for 80% of the whole product portfolio
  • Perform 16 Process Validations (OQ and PQ) during 5 months
  • Perform 12 Design Verifications (incl. accelerated and real time aging) on sterile barrier systems

Consultant: Process Engineer in Automation, Ypsomed AG

Sept. 2024 - April 2025

Responsibilities

  • Perform FAT on the state-of-the-art ATS automated production line for autoinjectors
  • Install production lines for autoinjectors (DQ, IQ)
  • Perform process validation of the new production line for autoinjectors (OQ, PQ)

Consultant: Packaging and Transport Testing, Implantica

Aug. 2023 - Feb. 2024

Responsibilities

  • Prepare the sterile barrier system bench testing plan: including extreme environmental conditioning, shipment simulation, packaging and functional tests
  • Define the necessary unique distribution cycle (DC 2 according to ASTM D4169) proper for the planned logistics
  • Coordinate the bench testing process with external labs
  • Define the packaging test methods and create test descriptions

Consultant: MDR Remediation Specialist – Sterilisation and sterile packaging, Ypsomed AG

Feb. 2022 - Sept. 2023

Responsibilities

  • Gap analysis for sterilisation and sterile packaging and define sterilisation strategy of new products
  • Risk analysis of the sterilisation and sterile barrier system
  • Prepare the sterilisation and sterile packaging Process Validation and Design Verification plan
  • Define the packaging test methods and create test descriptions
  • Calculate the EO residual limits after sterilisation for new products
  • Define endotoxin test frequency and limits and microbiological limits (CFU limits) for new products
  • Define physical contamination test frequency and limits

Engineering Manager, Medicontur Ltd.

Oct. 2020 - Feb. 2022

Responsibilities

  • Coordinate the daily work of the engineering and maintenance team (10 employees)
  • Responsible for EO and Steam sterilisation of the product portfolio
  • EO and Steam sterilisation process validation and maintenance
  • Improve manufacturing process, implement LEAN concepts
  • NPI – transfer newly developed products/machines into production

Consultant and Business Analyst, Asseco Central Europe H.

Oct. 2019 - Oct. 2020

Responsibilities

  • Optimisation of production process with plant simulation software
  • Real Time monitoring of material flow and production

Deputy – Head of Development Center, BBraun Medical Kft.

Sept. 2018 - Sept. 2019

Responsibilities

  • R&D responsible for medical device packages, whole portfolio produced on site
  • Coordinate projects, capacities and delegate tasks within the R&D group

Development Project Manager, BBraun Medical Kft.

Sept. 2016 - Sept. 2018

Responsibilities

  • Led the packaging optimisation project: a new packaging system was developed for ~800 products, including 100+ packaging families
  • 2 m€ cost savings during the project
  • Responsible for the Hungarian site, the most complex of the 13 sites, in the global project
  • Best performing project compared to all the other packaging optimisation projects at BBraun worldwide

Development Engineer, BBraun Medical Kft.

Sept. 2015 - Sept. 2016

Responsibilities

  • R&D responsible for wound drainage and suction devices
  • Development of new, crystal clear drain bottles for the US market. The new product was delivered in time; the development took 12 months
  • Implement new back check valve to drain bottles and verify new components from an alternative supplier

Professional Experience

Sterile Packaging Systems

During my professional career I have worked for several years on sterile packaging and packaging system developments. I have deep knowledge of blister and pouch packaging materials, their manufacturing processes and packaging design development. I led a packaging optimization project including 100+ packaging families with ~800 different medical devices. I have prepared plenty of packaging process validations and design verifications, and I performed shipment simulations (truck, rail, and airfreight) for several packaging configurations. I supported the development and testing of a combination product, pre-filled patch injectors with state-of-the-art sterile barrier systems.

Sterilization

I was responsible for the EO and gamma sterilization of medical devices. I have solid experience in the validation of new EO sterilization cycles, including PPQ, MPQ and EO residual measurements. In gamma sterilization I have experience in cycle re-validation, dose-mapping, and dose audits. I also supported steam sterilization of medical devices during my career. For the proper sterilization of medical devices, it is also essential to have a good understanding of the manufacturing area. I have the necessary experience in clean room validation and the monitoring of bioburden in the manufacturing area.

Validation and Verification

Over the years I have worked on different development and optimization projects: sterilization projects, sterile packaging projects, and product development and optimization projects. In almost every area I had to deal with validation and verification tasks. I have experience in new product development including design verification, and process development including process validations (IQ, OQ, PQ). I have solid knowledge in preparing documentation for new product introduction to the EU and US markets, fulfilling the requirements of the FDA or any European Notified Body.

Project management

I have led several product development and process optimization projects with cross-functional teams (R&D, QA, RA, QC etc.) in an international environment. The teams usually included internal members, external service providers and suppliers.

Certificates & Standards

Certificates

Material Science MSC
Mechanical Engineering MSC
Mechatronical Engineering BSC
Internal auditor (EN ISO 13485:2016)
Member of the organisation: ASTM (American Society for Testing and Materials)
Project management
4DX and 7 Habits (Franklin Covey)
Agile project management

Standards

Biological evaluation & microbiology

  • ISO 10993-1
    Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
  • ISO 10993-2
    Biological evaluation of medical devices — Part 2: Animal welfare requirements
  • ISO 10993-4
    Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
  • ISO 10993-5
    Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
  • ISO 10993-17
    Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
  • USP<151>
    Pyrogen test
  • USP<161>
    Medical devices — Bacterial endotoxin and pyrogen tests

Quality management

  • ISO 13485
    Medical devices — Quality management systems — Requirements for regulatory purposes
  • ISO 14971
    Medical devices — Application of risk management to medical devices

Product related standards

  • DIN EN 1618
    Catheters other than intravascular catheters — Test methods for common properties
  • ISO 9626
    Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
  • ISO 80369-20
    Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods
  • ISO 8536-4
    Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
  • ISO 11979-2
    Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods
  • ISO/IEC 17025
    General requirements for the competence of testing and calibration laboratories
  • ISO 11608-1
    Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems
  • ISO 11608-2
    Needle-based injection systems for medical use — Requirements and test methods — Part 2: Double-ended pen needles
  • ISO 11608-3
    Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths
  • ISO 8836
    Suction catheters for use in the respiratory tract
  • ISO 20697
    Sterile drainage catheters and accessory devices for single use

Labelling

  • DIN EN 1041
    Information supplied by the manufacturer of medical devices
  • DIN EN 15986
    Symbol for use in the labelling of medical devices — Requirements for labelling of medical devices containing phthalates
  • ISO 20417
    Medical devices — Information to be supplied by the manufacturer
  • ISO 15223-1
    Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements

Sampling

  • ISO 2859-1
    Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
  • ISO 16269-6
    Statistical interpretation of data — Part 6: Determination of statistical tolerance intervals

Shipment simulation

  • ISO 2233
    Packaging — Complete, filled transport packages and unit loads — Conditioning for testing
  • DIN EN 60721-3-7
    Classification of environmental conditions — Part 3-7: Classification of groups of environmental parameters and their severities — Portable and non-stationary use
  • ASTM D6179
    Standard Test Methods for Rough Handling of Unitized Loads and Large Shipping Cases and Crates
  • ASTM F2825
    Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery
  • ISTA 3A
    Packaged-products for parcel delivery system shipments 70 kg (150 lb) or less
  • ISTA 3B
    Packaged-products for less-than-truckload (LTL) shipment

Sterile packaging

  • ISO 15378
    Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
  • ISO/TS 16775
    Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
  • ISO 5636-3
    Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method
  • ISO 5636-5
    Paper and board — Determination of air permeance (medium range) — Part 5: Gurley method
  • ISO 11607-1
    Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
  • ISO 11607-2
    Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
  • EN 868-10
    Packaging for terminally sterilized medical devices — Part 10: Adhesive coated nonwoven materials of polyolefines — Requirements and test methods
  • EN 868-5
    Packaging for terminally sterilized medical devices — Part 5: Sealable pouches and reels of porous materials and plastic film construction — Requirements and test methods
  • ASTM D4169
    Standard Practice for Performance Testing of Shipping Containers and Systems
  • ASTM D4332
    Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
  • ASTM D5276
    Standard Test Method for Drop Test of Loaded Containers by Free Fall
  • ASTM D5487
    Standard Test Method for Simulated Drop of Loaded Containers by Shock Machines
  • ASTM D7386
    Standard Practice for Performance Testing of Packages for Single Parcel Delivery Systems
  • ASTM F1608
    Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
  • ASTM F1886/F1886M
    Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
  • ASTM F1929
    Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
  • ASTM F1980
    Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
  • ASTM F2095
    Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates
  • ASTM F2096
    Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
  • ASTM F2252
    Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape
  • ASTM F2338
    Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
  • ASTM F2638
    Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
  • ASTM F88/F88M
    Standard Test Method for Seal Strength of Flexible Barrier Materials

Sterilization

  • AAMI TIR28
    Product adoption and process equivalence for ethylene oxide sterilization
  • ISO 11135
    Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
  • ISO 14937
    Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
  • ISO 10993-7
    Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
  • ISO 11137-1
    Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  • ISO 11137-2
    Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
  • ISO 11138-1
    Sterilization of health care products — Biological indicators — Part 1: General requirements
  • ISO 11138-2
    Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
  • ISO 11138-3
    Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
  • ISO 11737-1
    Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
  • ISO 17665-1
    Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

Clients

Recommendations

I would like to recommend Balazs Toth to any employer that would like to use his expertise.

Balazs is very friendly, easy to work with, highly dedicated to his tasks and is capable of working independently with minimum orientation. He is a team player and you can trust that his deliverables are both ready on time and of high quality.

Balazs receives from me my highest recommendation.

Susana Mogensen Ph.D.

It was very easy to work with Balázs, because he quickly understand the most complex processes as well. Even in difficult situations, he communicates in a balanced manner and is able to make quick decisions. He has extremely diverse knowledge, which he is able to use in his work.

Balázs' further strengths:

  • helpfulness
  • result orientation
  • professionalism
Jozsef Szarvas

Mr. Toth consistently demonstrated strong technical expertise, analytical skills, and a high degree of reliability. He required minimal onboarding time and quickly contributed effectively to project outcomes. He delivered high-quality results, met deadlines, and maintained strong documentation standards

Ivo Schüpfer

Contact

Location:

Budapest (HU), Zug (CH)

Call:

+41 76 541 8153, +36 30 335 0927