Expert Details
Cleanrooms, Contamination Control, Ultrapure Media, Qualification and Validation, GMP, AMC
ID: 725173
Germany
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).
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.
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.
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.
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.
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.
Expert is currently consulting three companies in the area of antimicrobial medical devices (coating implants or antimicrobial bandages /plasters).
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.
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.
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).
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.
Turn-key concept design medical device cleanrooms Switzerland including GMP consultingTurn-key concept design, supervision, certification and GMP consulting of bio-medical and GMP research facility in Brandenburg, GermanyConsultancy for BSL 3 and BSL 4 Laboratories in the VAETurn-key project sterile and aseptic filling for Schering Germany (total 17000 m²), project manager and supervisorContamination Control and Cleanroom Certification of Bundeswehr Research Institute in Germany
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 2007 | Degree: PHD | Subject: Contamination Control Monitoring | Institution: Univ. POLITEHNICA Bucharest |
| Year: 1987 | Degree: Dipl.-Phys. | Subject: Physics | Institution: Technical University Berlin |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2005 to Present | Employer: Undisclosed | Title: Managing Director | Department: |
Responsibilities:He is the managing director. Major worldwide business areas are consultancy, supervision, qualification + validation, certification and training. |
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| Years | Employer | Title | Department |
| Years: 2003 to 2004 | Employer: WEISS KLIMATECHNIK | Title: Sales Manager Contamination Control | Department: Contamination Control |
Responsibilities: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. |
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| Years | Employer | Title | Department |
| Years: 1998 to 2002 | Employer: Krantz TKT Cleanroom Technology | Title: Director | Department: Consultancy and Design |
Responsibilities:He is responsible for worldwide sales support, consultancy and design for all applications of contamination control and cleanrooms. Focus on Pharmacy, µElectronics. |
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| Years | Employer | Title | Department |
| Years: 1995 to 1997 | Employer: Mannesmann Demag AG | Title: Director | Department: Contamination Control |
Responsibilities:He is responsible for worldwide sales support, consultancy and design, installation and certification for all applications of contamination control and cleanrooms. |
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| Years | Employer | Title | Department |
| Years: 1993 to 1995 | Employer: Rudolf Otto Meyer | Title: Director | Department: Contamination Control |
Responsibilities: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 |
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| Years | Employer | Title | Department |
| Years: 1991 to 1993 | Employer: Zander Klimatechnik gmbH | Title: Director | Department: Cleanrooms |
Responsibilities:He is responsible for certification, qualification/validation, contamination control and special applications. |
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| Years | Employer | Title | Department |
| Years: 1990 to 1991 | Employer: Digital Equipment International Corp. | Title: Contamination Control Manager | Department: Contamination Control |
Responsibilities:He is responsible for contamination control in a disc drive manufacturing facility and member of the worldwide DIGITAL contamination control group. |
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| Years | Employer | Title | Department |
| Years: 1987 to 1988 | Employer: TSI | Title: European Sales Manager | Department: Cleanroom Measurements and Monitoring |
Responsibilities:He is the European Sales Manager for contamination control measurements and monitoring for cleanrooms. |
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Government Experience
| Years | Agency | Role | Description |
|---|---|---|---|
| Years: 2007 to 2008 | Agency: Ministry of Construction of Thuringia | Role: Expert | Description: He has been responsible for the investigation of irregularities in research cleanroom laboratory |
International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 2007 to Present | Country / Region: UAE | Summary: BSL 3 and BSL 4, as well as S3 and S4 laboratories |
| Years: 2007 to Present | Country / Region: Russia | Summary: Sterile BFS Filling, Pharmacy, Moscow Turn-key concept design, supervision, GMP |
| Years: 2007 to Present | Country / Region: Thailand | Summary: He has organized Conference with Thai FDA about GMP aspects. |
| Years: 2004 to 2004 | Country / Region: Romania | Summary: He has been responsible for the design and installation and validation of antibiotics manufacturing. |
| Years: 1999 to 1999 | Country / Region: Singapore | Summary: concept design for semiconductor facility of ST Microelectronics in Singapore |
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 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 |
Additional Experience
| Expert Witness Experience |
|---|
| 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.). |
| 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. |
| Vendor 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.) |
| Marketing Experience |
|---|
| Energy Efficiency in Cleanrooms for all applications. Member of the advisory board for the German engineering association VDI TGA. |
| Other Relevant Experience |
|---|
| Member of a worldwide network of contamination control and cleanroom experts. |
Language Skills
| Language | Proficiency |
|---|---|
| German | He is a native German speaker. |
| English | Fluent |
Fields of Expertise
aerosol filtration, aerosol physics, aseptic packaging process, bio-clean room, class 10 clean-room management, class 10000 clean room, clean room coating material, clean room contamination assessment, clean room design, clean room equipment, clean room fluid filtration, clean room operations, clean room particulate material, cleanroom compressed gas handling, clean-room management, medical device manufacture clean room, nanofabrication, active pharmaceutical ingredient, Current Good Manufacturing Practice, Food and Drug Administration compliance, Food and Drug Administration validation, Good Laboratory Practice, Good Manufacturing Practice, low-acid food aseptic processing, Good Clinical Practice, Good Manufacturing Practice training, medical device auditing, medical device manufacturing quality control, pharmaceutical aseptic filling room, pharmaceutical manufacturing facility auditing, 21 CFR Part 11, air pollutant measurement, air pollution, air pollution control, air-cleaning system, air-filtration equipment, air-pollution personal protection equipment, environmental air sampling, high-efficiency particulate air filtration, indoor air pollution control, particulate pollution process, air microbial contamination, air-pollutant human health effect, air-pollution management equipment, air-quality assessment, adhesive material, GoreTex, antimicrobial medical device, thin-film processing, thin-film technology, precision cleaning, film forming technology, product cleanliness requirement specification, deionized water quality, clean room garment, bio-clean room garment, airborne molecular contamination, nanotechnology regulation, industrial air quality, pre-approval inspection, semiconductor wafer inspection, compliance testing, thin-film electromigration, ampule, particle filtration, thin-film sensor, pollution measurement, drug validation, clean-in-place, toxic air pollution control, environmental air sample, bioburden, air sample, medical injection process, facility planning, deionized water, latex glove, air pollution control system, contamination prevention, environmental monitor, pharmaceutical industry, pharmaceutical engineering, clean room contamination detection, bio-clean room equipment, facility design, thin-film optics, nanotechnology, air purification, pollutant material, air-treatment organic chemical, air-treatment inorganic chemical, mobile source air pollution control, stationary source air pollution control, medical device manufacturing, asbestos-particle control equipment, international food statute, hazard analysis critical control point, pharmacy facility, drug regulation, air pump, air filter, thin film, pharmaceutical manufacturing, microcontamination control, microbiology, medical device, injectable drug, environmental engineering, contamination control, clean room, building science, biotechnology, air pollutant