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 Expert  725173

Expert in Cleanrooms, Contamination Control, Ultrapure Media, Qualification and Validation, GMP, AMC


Available for your Consulting and Expert Witness Needs

Germany
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

Expert has been active in aersol physics for more than 25 years. His PhD covers also the areas of environmental, indoor and cleanroom aerosols.

He worked in a variety of scientific and technical projects covering the health effects of particles to the effects of particles to µelectronic products.

Since he has been working in the field of turn-key design and construction of cleanroom facilities for all applications and cleanliness, the aerosol filtration have been alway s one of the focus points of each and every project.

He has been responsible or working in more than 200 projects in the past decades including all applications like biotech, bio-cleanrooms, pharmacy, semiconductor and nanotechnology industry, medical device, cosmetics and food industries (mostly dairy or steril and aseptic filling).

He published a scientific article about the dynamic effects of aerosol filtration over long term periods on the ICCCS conference in Bonn/Germany in 2004.

He worked as an application manager and sales manager for the American company TSI and installed more than 5 filter scanners for the major aerosol filter companies in the world.

He built (and operated) 4 filter scanners in the past 25 years (starting in 1984) for the inline filter test for the installed filters onsite. He personally scanned some 10.000 m² of cleanroom ceiling filters.

He is an expert on all kinds of aersol measuring devices like: - laser particle counters - impactors - differential mobility sizers - aersol spectrometers - Aerodynamic Particle sizers - ATOMFS - Electrometers - Photometers - Off line analysis with TEM, AFM

In the past 2 years Expert consulted two BSL 3 and BSL 4 laboratories in the risk management and compliance with international biosafety standard (UAE and Germany).

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aerosol filtration

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aerosol physics

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aseptic packaging process

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bio-clean room

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class 10 clean-room management

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class 10000 clean room

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clean room coating material

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clean room contamination assessment

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clean room design

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clean room equipment

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clean room fluid filtration

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clean room operations

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clean room particulate material

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cleanroom compressed gas handling

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clean-room management

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medical device manufacture clean room

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nanofabrication

Expert has performed GMP compliance audits for two biotechnological active pharmaceutical ingredients facilities with each more than 500 m³ fermenter capacities in Russia.

He consulted with 2 facilities in Romania for the production of APIs in 2004 and 2005. Currently he is lecturer for the GMP aspects of API production and handling. In the moment he is finishing as a chairman a German guideline dealing with separative devices for personnel and product protection including the production and handling of APIs.

Expert has intense knowledge in the qualification and validation of pharmaceutical and medical device manufacturing facilities (more than 100 GMP projects in the past 20 years).

Expert more and more was contacted and is consulting the food industries in the areas of contamination control and certification in the past 5 years. Due to contamination control the due date for sensitive food can be extended up to the factor of 3.

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active pharmaceutical ingredient

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Current Good Manufacturing Practice

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Food and Drug Administration compliance

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Food and Drug Administration validation

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Good Laboratory Practice

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Good Manufacturing Practice

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low-acid food aseptic processing

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Good Clinical Practice

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Good Manufacturing Practice training

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medical device auditing

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medical device manufacturing quality control

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pharmaceutical aseptic filling room

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pharmaceutical manufacturing facility auditing

Expert wrote in cooperation with an American colleague the automation system worldwide policy for ROCHE, Switzerland, including the aspects of 21 CFR Part 11 compliance. He was for the short period of 1 year (2002) a member of the DACH GAMP organization. In addition he has been the external validation supervisor for a big vaccine production MES system in Austria supplied by Emerson Process Management in 2002.

Beside these he has been the European sales manager for cleanroom monitoring systems and has been responsible for the installation and qualification/validation of building control systems, monitoring systems in at least 30 projects over the past 25 years.

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21 CFR Part 11

Expert intensively worked on the effects of air pollutants onto the cleanroom facilities.

He published his first research results about Clean Air Purifications for the > 64 MB Chip Generations on 12th ICCCS Conference, Yokohama, 1994. The results have been generated by an one year research project together with IBM chip manufacturing facitlity in Germany and former company HOECHST. Mainly airborne molecular contamination have been addressed and the influences from outdoor pollution as well as the filtration aspects investigated.

Today he is the co-chairman for the German AMC cleanroom guideline currently published. As a member of the ISO 14644 German mirror group he supported the internation guideline ISO 14644, part 7, dealing with AMCs. He worked with all standard measurement devices to measure gaseous pollutants (GC, GC-MS, etc.).

He worked in the development of condesation nuclei counters and the effects of gase to particle conversion process in the outdoor and cleanroom environment.

Pollution and environmental measurements are essential parts of his PHD thesis. More and more the influences of the outdoor to the indoor cleanroom environments become part of the consulting activites (from semiconductor industries to fertilization) from gases, vapors to living or dead particles.

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air pollutant measurement

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air pollution

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air pollution control

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air-cleaning system

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air-filtration equipment

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air-pollution personal protection equipment

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environmental air sampling

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high-efficiency particulate air filtration

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indoor air pollution control

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particulate pollution process

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air microbial contamination

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air-pollutant human health effect

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air-pollution management equipment

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air-quality assessment

Expert is currently working in 3 projects for adhesive material as medical devices or as combined products (medical devices + drug -coated plasters with fentanyl) in Germany, Switzerland and Russia.

In addition he is active in the area of Tissue Engineering with Chitosan based structures.

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adhesive material

Expert delt with all kinds of filter materials (including PTFE or GoreTex material) in his filter test studies. Some experiments have been performed for the use of this type of filters in the sterile and aseptic filling of food industries.
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GoreTex

Expert is currently consulting three companies in the area of antimicrobial medical devices (coating implants or antimicrobial bandages /plasters).
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antimicrobial medical device

Expert made his degree in physics in thin film coatings of substrates. Due to his activities in semiconductor manufacturing, disc drives, optical data storages and coatings of optical surfaces in the past decades he gained some additional experiences. He worked for 2 years as the contamination control engineer for Digital Equipment Corporation HDA manufacturing. Here he has been responsible for the cleanliness of the manufacturing environment as well as the cleaning of surfaces, the inspection of surfaces and monitoring of the cleanliness.
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thin-film processing

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thin-film technology

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precision cleaning

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film forming technology

Expert has established in the VDI contamination control regulations together with his colleagues the guidelines for contamination control and cleanroom compatibility specification and testing. He currently is consulting and testing around 10 products / manufacturers (partitions, ceilings, equipments, components) per year for product cleanliness requirements.
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product cleanliness requirement specification

Expert has been a member of the purified water regulatory guideline group in the 90'. Today he is the moderator for the necessary rework in the guidelines dealing with the today requirements in the pharmacy, semiconductor and other cleanroom industries (VDI 2083, Part 13). He has been the project manager for various purified water systems of several sizes (his last project for a sterile aseptic pharmaceutical manufacturer): 40 m³/d highly purified water, 280 m³/d WFI, some kilometers of piping, including qualification and validation).
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deionized water quality

Expert has been dealing with cleanroom garments very often in his expert life: - as the contamination control manager he tested garments, gloves and other consumables 3 month every year for the evaluation of the compatibility of this material in the production process - as the member of the VDI 2083, part 4, guideline activities he worked on the specification of the requirements for garments, gloves and other consumables - he consulted and built 2 cleanroom laundries for garments for bio- and other applications - today he is training cleanroom personnel and cleanroom operators also in the area of garments and gowning (VDI 2083, Part 15), where he has been the co-chairman in the German guideline activities.
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clean room garment

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bio-clean room garment


Show Secondary and Basic Areas of Expertise

Education:
Year   Degree   Subject   Institution   Honors
2007   PHD   Contamination Control Monitoring   Univ. POLITEHNICA Bucharest   Summa Cum Laude
1987   Dipl.-Phys.   Physics   Technical University Berlin  

Work History:
Years   Employer   Department   Title   Responsibilities

2005 to

 

(Undisclosed)

 


 

Managing Director

 

He is the managing director. Major worldwide business areas are consultancy, supervision, qualification + validation, certification and training.

2003 to 2004

 

WEISS KLIMATECHNIK

 

Contamination Control

 

Sales Manager Contamination Control

 

He is responsible for the world wide sales and acquisition for cleanrooms and contamination control as well as the consultancy and concept design for all applications. Focus on pharmacy and food.

1998 to 2002

 

Krantz TKT Cleanroom Technology

 

Consultancy and Design

 

Director

 

He is responsible for worldwide sales support, consultancy and design for all applications of contamination control and cleanrooms. Focus on Pharmacy, µElectronics.

1995 to 1997

 

Mannesmann Demag AG

 

Contamination Control

 

Director

 

He is responsible for worldwide sales support, consultancy and design, installation and certification for all applications of contamination control and cleanrooms.

1993 to 1995

 

Rudolf Otto Meyer

 

Contamination Control

 

Director

 

He is responsible for worldwide sales support, consultancy and design, installation and certification for all applications of contamination control and cleanrooms. Focus on Pharmacy and µElectronics

1991 to 1993

 

Zander Klimatechnik gmbH

 

Cleanrooms

 

Director

 

He is responsible for certification, qualification/validation, contamination control and special applications.

1990 to 1991

 

Digital Equipment International Corp.

 

Contamination Control

 

Contamination Control Manager

 

He is responsible for contamination control in a disc drive manufacturing facility and member of the worldwide DIGITAL contamination control group.

1987 to 1988

 

TSI

 

Cleanroom Measurements and Monitoring

 

European Sales Manager

 

He is the European Sales Manager for contamination control measurements and monitoring for cleanrooms.


Career Accomplishments:
Associations/Societies

Member of VDI, member of the advisory board of VDI TGA Deputy chairman of VDI 2083 guideline activities Member of mirrorgroup for ISO 14644 German COD of ICCCS Member of DPG (German Society of Physics)

Licenses/Certifications

Legalized expert cleanrooms and contamination control of German IHK

Professional Appointments

Cleanroom and Contamination Control Auditor of TÜV SÜD


Publications:
Publications and Patents Summary

He has more than 40 publications, he is co-author in 2 books about contamination control and co-editor about contamination control in a coming book

Selected Publications and Publishers  
 - Doctoral Thesis, University Politehnica Bucharest  
 - Fresenius Environmental Bulletin  
 - ICCCS Conference  
 - Pharmaceutical Industries  

Government Experience:
Years   Agency   Role   Description
2007 to 2008   Ministry of Construction of Thuringia   Expert   He has been responsible for the investigation of irregularities in research cleanroom laboratory

Consulting Services:
Selected Consulting Examples:
  • Turn-key concept design medical device cleanrooms Switzerland including GMP consulting
  • Turn-key concept design, supervision, certification and GMP consulting of bio-medical and GMP research facility in Brandenburg, Germany
  • Consultancy for BSL 3 and BSL 4 Laboratories in the VAE
  • Turn-key project sterile and aseptic filling for Schering Germany (total 17000 m²), project manager and supervisor
  • Contamination Control and Cleanroom Certification of Bundeswehr Research Institute in Germany
Recent Client Requests:
  • Particle reduction expert for consulting on a Particle Reduction Project.
  • Expert in Air Filtration.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Expert Witness Experience Summary:
He is the only legalized expert (2008) in Germany for contamination control and cleanrooms. He is the deputy chairman of all German contamination control guidelines (VDI 2083) and he is the chairman of several parts of the VDI 2083. He is in the CEN and ISO mirror group for contamination control (ISO 146449: He worked in all phase of the life cycle of turn-key cleanroom projects (feasibility, concept, basic, detail design, installation, commissioning, certification) as well as in nearly all applications of contamination control (Pharmacy, Food, Cosmetics, µElectronic, Flat Panel, VLT Astrophysics, etc.).
Recent Litigation Client Requests:
  • Clean room testing expert for consulting on contamination issue.
  • Expert for consulting in litigation involving building a materials recovery facility next to a pharmaceutical plant in Northern Ireland.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Years   Country / Region   Summary
2007 to   UAE   BSL 3 and BSL 4, as well as S3 and S4 laboratories
2007 to   Russia   Sterile BFS Filling, Pharmacy, Moscow Turn-key concept design, supervision, GMP
2007 to   Thailand   He has organized Conference with Thai FDA about GMP aspects.
2004 to 2004   Romania   He has been responsible for the design and installation and validation of antibiotics manufacturing.
1999 to 1999   Singapore   concept design for semiconductor facility of ST Microelectronics in Singapore

Language Skills:
Foreign Language   Description
German   He is a native German speaker.
English   Fluent

Market Research:
Energy Efficiency in Cleanrooms for all applications. Member of the advisory board for the German engineering association VDI TGA.



Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.


Additional Skills and Services:
Training/Seminars

He is giving lectures at the Bauhaus Academy, Weimar. He is giving cleanroom and contamination control training courses following the VDI guideline VDI 2083, part 15. He is giving seminars on GMP and qualification/validation.

Supplier and Vendor Location and Selection

The sourcing and/or locating of vendors and suppliers for all kind of contamination control and cleanroom services is part of his daily life since 25 years (HVAC, ultrapure media (gases, liquids, water, etc.), cleanroom panels and ceilings, M&E for cleanroom environments, engineering, consultancy, certification, etc.)

Other Skills and Services

Member of a worldwide network of contamination control and cleanroom experts.


 

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