Balazs Toth

I'm

About

My name is Balazs Toth, and I am working on the medical field for more than 10 years. Since 2022 February I am working as a consultant in Switzerland. My specialties are sterilization, sterile packaging, V&V (Validation and Verification) and project management. I was responsible for MDR remediation projects for TÜV submission focusing on sterilization and sterile packaging, I was responsible for shipment simulation and sterile packaging in FDA - PMA submission NPI project. I have solid knowledge and experience on EO and gamma sterilization, sterile packaging (blister, pouch, shipment simulation) and drug-device combinational product development. I lead several development projects with cross-functional team members focusing on to introduce new products on the EU and US market.

My detailed CV is available here

Medical Field Expert

  • Birthday: 27 Aug 1991
  • Website: https://balazstoth.hu/
  • Phone: +41 76 541 8153, +36 30 335 0927
  • City: Budapest (HU), Zug (CH)
  • Age: 32
  • Email: tothbalazs91@gmail.com
  • Freelance: Available
  • Degree:
    • Master of Science in Mechanical Engineering
    • Master of Science in Management and Leadership
    • Bachelor of science in Mechatronical Engineering

Projects

Bench Testing at Implantica AG

2023.08 – 2024.02

Project

  • Testing of abdominal implant and its packaging system
  • Testing of injection tool and its packaging system for the abdominal implant

Responsibilities

  • Gap analysis of sterile barrier system
  • 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
  • Define climate conditioning parameters depending on target market
  • Create sterile packaging standard implementations and summary document
  • Coordinate the bench testing process.
  • Define the packaging test methods and create test description

MDR Remediation Specialist – Sterilisation and sterile packaging at Ypsomed AG.

2022.02 – 2023.09

Project

  • Development of infusion sets for diabetes care
  • Development of ready-to-use patch injector
  • Development of insulin pump system

Responsibilities

  • Gap analysis for sterilisation and sterile packaging
  • Coordinate the sterile barrier system developments
  • Risk analysis of the sterilisation and sterile barrier system
  • Define the sterilisation strategy of new products ▪ Prepare the sterilisation and sterile packaging process validation
  • Prepare the sterilisation and sterile packaging Design Verification plan
  • Create sterile packaging standard implementations and summary document ▪ Coordinate sterilisation and sterile packaging validation and verifica
  • Define the packaging test methods and create test descriptions
  • Define the proper machines and tools for packaging tests
  • Calculate the EO residual limits after sterilisation for new products
  • Define microbiological limits (CFU limits) for new products
  • Define endotoxin test frequency and limits
  • Define physical contamination test frequency and limits

Engineering Manager, Medicontur Ltd.

2020.10 – 2022.02

Responsibilities

  • Coordinate the daily work of the engineering and maintenance team (10 employees)
  • Ensure continuous production
  • Improve manufacturing process, implement LEAN concepts
  • Validation of new processes and equipment
  • NPI – transfer newly developed products/machines into the production

Consultant and Business Analyst, Asseco Central Europe H.

2019.10 – 2020.10

Responsibilities

  • Optimisation of production process with plant simulation software
  • Real Time monitoring of material flow and production
  • Simulation, implementation and monitoring of material handling with AGVs
  • Clarify relevant customer requirements about the product
  • Market research for possible customers

Deputy – Head of Development Center, BBraun Medical Kft.

2018.09 – 2019.10

Project

  • Update or prepare documents to be compliant according to the new MDR regulation
  • Development of new, crystal clear drain bottles with tube set to the US market
  • Packaging optimisation – define new materials, harmonise current portfolio
  • Coordination of packaging Process Validations and Design Verification based on ISO 11607-1/2 ▪ Re-validation of the EO sterilisation cycle
  • Prepare a new R&D lab – define layout, equipment, suppliers

Responsibilities

  • R&D responsible for wound drainage and suction devices
  • Substitute of the Head of Development Center in his absence
  • 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.

2016.09 - 2018.09

Project

  • Packaging optimisation – define new materials, harmonise current portfolio
  • Coordination of packaging Process Validations and Design Verification based on ISO 11607-1/2
  • Development of new, crystal clear drain bottles with tube set to the US market
  • Supplier Audit – external lab
  • Ensure the clean water supply for production
  • Define frequency of testing and the sampling points of the clean water system
  • Prepare URS for new production equipment
  • Revise specifications and drawings of supplier.

Responsibilities

  • R&D responsible for wound drainage and suction devices
  • R&D responsible for medical devices packages produced on site

Development Engineer, BBraun Medical Kft.

2015.09 - 2016.09

Project

  • Development of new, crystal clear drain bottles to the US market
  • Implement new back check valve to drain bottles
  • Revise specifications and drawings of supplier
  • Verification of new components from alternative supplier

Responsibilities

  • R&D responsible for wound drainage and suction devices

Project Manager, Varmegye Media Kft.

2011.09 - 2013.10

Project

  • Support the tasks of web developers
  • Ensure the right and fluent communication between the customers and web develop

Trainee at Orvostechnika Kft.

2013.07 - 2013.08

Project

  • Develop a new, blood homogeniser machine for blood analysis

Professional Experience

Sterile Packaging Systems

During my professional carrier I have worked several years on sterile packaging and packaging system developments. I have deep knowledge in blister and pouch packaging materials, in their manufacturing processes and in the packaging design development. I lead packaging optimization project including 100+ packaging families with ~800 different medical devices. I have prepared plenty of packaging process validations, design verifications, and I performed the 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 cycle, including PPQ, MPQ and EO residual measurements. In the gamma sterilization process I have experience in the cycle re-validation, dose-mapping, and dose audits. I also supported steam sterilization of medical devices during my career. For the proper sterilization of the 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 process of the bioburden in the manufacturing area.

Validation and Verification

During the years I have worked on different development and optimization projects. I have worked on sterilization projects, on sterile packaging projects, product development and optimization projects. On the different areas I had to deal almost every time on 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 to prepare documentation for new product introduction to EU and US markets, fulfilling the requirements of FDA or any European Notified Bodies.

Project management

I have led several product development and process optimization projects with cross-functional team (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

Microbiology

  • ISO 10993-1
    Biological evaluation of medical devices — Part 1: Guidance for Industry and Food and Drug Administration Staff
  • ISO 10993-17
    Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
  • 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 10993-7
    Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
  • 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 EN1618
    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 17025
    Clause-by-clause explanation of ISO 17025:2017
  • 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 1617
    Sterile drainage catheters and accessory devices for single use
  • ISO 8836
    Suction catheters for use in the respiratory tract
  • ISO 20697
    Sterile drainage catheters and accessory devices for single use

Labelling

  • DIN EN1041
    Information supplied by the manufacturer of medical devices
  • DIN EN15986
    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

  • 2859-1
    Sampling procedures for inspection by attributes – Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lotbylot inspection (ISO 28591:1999 + Cor. 1:2001 + Amd.1:2011)
  • 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 EN60721-3-7
    Klassifizierung von Umweltbedingungen
  • 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

Sterile packaging

  • ISO 2233
    Packaging — Complete, filled transport packages and unit loads — Conditioning for testing
  • 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/TS16775
    Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
  • 5636-3
    Paper and board -- Determination of air permeance (medium range) — Part 3: Bendtsen method
  • 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
  • ISTA 3A
    Particulate contamination: sub-visible particles — overview
  • ISTA 3B
    Particulate contamination: sub-visible particles — overview
  • 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 (BSI)
  • 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 — AMENDMENT 1: Revision of Annex E, Single batch release
  • 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 14937:2000)
  • ISO 10993-7
    Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — TECHNICAL CORRIGENDUM 1
  • 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 AMENDMENT 2
  • ISO 11137-2
    Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 111372:2013)
  • 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

Contact

Location:

Budapest (HU), Zug (CH)

Call:

+41 76 541 8153, +36 30 335 0927