Thomas Halfmann

San Giovanni Battista (Mogno)

Simple forms, strict geometry, reduced colors, solid materials - these are the characteristics of Mario Botta's architectural style. To capture the geometry of this sacred building, I focused on the details of the architecture and photographed in black and white. The square format of the Hasselblad emphasizes the focus on the precise architecture.

The very special city

Brasília is not comparable to any other city in the world. Already the history of Brasília's founding is unique. Nowhere else have city planners and architects been able to realize their dream of the ideal city as consistently as in Brasília.

In my research on Brasília, I noticed that most of the articles are very critical of Brasília as a concept of a modern city. The prevailing opinion is that Brasília, or rather the master plan of the city planners, has… Mehr anzeigen

The very special city

Brasília is not comparable to any other city in the world. Already the history of Brasília's founding is unique. Nowhere else have city planners and architects been able to realize their dream of the ideal city as consistently as in Brasília.

In my research on Brasília, I noticed that most of the articles are very critical of Brasília as a concept of a modern city. The prevailing opinion is that Brasília, or rather the master plan of the city planners, has failed. Even architect and project manager Oskar Niemeyer confessed in an interview in 2001:"Brasília did not fulfil what we expected from it, what we hoped for" and called the city "an unsuccessful experiment". But even if the social experiment Brasília did not live up to the high expectations of Brazilian President Juscelino Kubitschek, Lúcio Costas and Oscar Niemeyer, what remains is, apart from the unique architecture and urban planning, a city worth living in and loving.

This is also shown by the fact that today's Brasília does not look like an architecture museum that has nothing to offer other than photogenic buildings. Brasília is a city full of life that pulsates in its own unique way.

All images have been taken with Leica M cameras (M6 (with Kodak T-MAX 400), M240, M246) and Leica lenses.

The journey to Brasília in 2016 resulted in a photo book that is offered in a limited edition of 50 numbered and signed copies. Weniger anzeigen

IT Project Manager for the implementation of an integrated solution for serialization of pharmaceutical products:
-- managing IT related activities
-- serialization IT architecture
-- IT operations model for serialization
-- developing a validation concept for the global serialisation architecture and its components

Evaluation of a vendor for a MOM / MES solution to be implemented in a packaging facility:
-- defining the scope and process modelling
-- developing the user requirements specification (URS)
-- developing the future MOM architecture
-- project planning for the MES solution evaluation project
-- preparation of RFP (Request for Proposal) documents
-- identification of suitable MES vendors and solutions
-- managing the RFP process
--- selecting potential MES vendors
… Mehr anzeigen

Evaluation of a vendor for a MOM / MES solution to be implemented in a packaging facility:
-- defining the scope and process modelling
-- developing the user requirements specification (URS)
-- developing the future MOM architecture
-- project planning for the MES solution evaluation project
-- preparation of RFP (Request for Proposal) documents
-- identification of suitable MES vendors and solutions
-- managing the RFP process
--- selecting potential MES vendors
--- assessing RFP responses
--- managing MES vendor presentations and workshops Weniger anzeigen

Modeling of manufacturing, logistics and quality assurance processes of several manufacturing plants. The process models were based upon workshops and interviews with manufacturing, logistics, QA and IT experts, material flow analysis and process analysis.

The process models were integrated into the User Requirements Specification of the future MOM / MES solution and served as basis for MES vendor and solution selection.

The HGP library of pharmaceutical manufacturing process… Mehr anzeigen

Modeling of manufacturing, logistics and quality assurance processes of several manufacturing plants. The process models were based upon workshops and interviews with manufacturing, logistics, QA and IT experts, material flow analysis and process analysis.

The process models were integrated into the User Requirements Specification of the future MOM / MES solution and served as basis for MES vendor and solution selection.

The HGP library of pharmaceutical manufacturing process flows was basis for modeling the MOM to-be processes and reduced time and effort to a third as estimated originally by the client. Process flows included manufacturing operations for API production, solid dosage forms (tablets, capsules), liquid dosage forms, and packaging. Weniger anzeigen

The history of the German settlement Kolmanskop (Kolmannskuppe in German) in the Namib desert can be told in a few words. The city was founded in 1908 as a mining camp and experienced a rapid rise to one of the richest cities in Africa due to the discovery of diamonds. However, this flourishing period lasted only a few years and with the relocation of diamond mining further south, the end of Kolmannskuppe began as a inhabited settlement.
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The time as a inhabited city that was in spite… Mehr anzeigen

The history of the German settlement Kolmanskop (Kolmannskuppe in German) in the Namib desert can be told in a few words. The city was founded in 1908 as a mining camp and experienced a rapid rise to one of the richest cities in Africa due to the discovery of diamonds. However, this flourishing period lasted only a few years and with the relocation of diamond mining further south, the end of Kolmannskuppe began as a inhabited settlement.
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The time as a inhabited city that was in spite of the hostile environment equipped with all imaginable luxury, lasted only about 30 years. The second exciting story of Kolmannskuppe was written by the Namib Desert. The houses have disintegrated over the years and the sand of the desert has reclaimed the place. The dunes did not stop on the streets and paths of the town, but conquered the interior of the houses, driven by the constant wind from the nearby coast.

Thus an impressive urban ensemble emerged, which still seems to defy the outer structures of the desert today, and whose interior reflects the past time and the decay impressively. Weniger anzeigen

Evaluation of the business case for an MES implementation at three pharmaceutical manufacturing sites across Europe (solids, liquids, packaging)
-- definition of future production processes and architecture model
-- project and operations cost estimation
-- investigation, assessment and evaluation of business benefits due to implementation of MES for each production site

Implementation of an MES solution for two facilities for manufacturing clinical and technical batches (solids)

- Project Management
- Business Case Evaluation
- User Requirements Specification
- Training Concept and Training Delivery
- MBR Concept and MBR Authoring
- Validation

A standard MES solution was selected that required significant customization based upon the URS to accommodate the requirements for producing technical batches (non-GMP) and clinical… Mehr anzeigen

Implementation of an MES solution for two facilities for manufacturing clinical and technical batches (solids)

- Project Management
- Business Case Evaluation
- User Requirements Specification
- Training Concept and Training Delivery
- MBR Concept and MBR Authoring
- Validation

A standard MES solution was selected that required significant customization based upon the URS to accommodate the requirements for producing technical batches (non-GMP) and clinical batches (GMP) in the same facility. Weniger anzeigen

Global deployment of paperless manufacturing (MOM / MES) for top 10 bulk manufacturing and packaging sites
-- Definition of the global MES roll-out strategy
-- MES deployment roadmap (10 sites)
-- Managing the global deployment team and the local Project Managers
-- Business case evaluation and tracking (global and local)
-- Managing global stakeholders
-- Definition of standard project approach
-- Supporting the individual MES projects with
---- project management… Mehr anzeigen

Global deployment of paperless manufacturing (MOM / MES) for top 10 bulk manufacturing and packaging sites
-- Definition of the global MES roll-out strategy
-- MES deployment roadmap (10 sites)
-- Managing the global deployment team and the local Project Managers
-- Business case evaluation and tracking (global and local)
-- Managing global stakeholders
-- Definition of standard project approach
-- Supporting the individual MES projects with
---- project management (project planning, cost estimation, staffing)
---- business process analysis
---- stakeholder management Weniger anzeigen

Remedition of CSV documentation after a FDA 483
-- Managing remediation activities for US supplying sites in Germany, Switzerland and Italy
-- Update of all life cycle documentation for an ERP system
-- Implementing improved change management, configuration management, and documentation management processes

Global consolidation (25 sites) of all implementation activities for electronic records and electronic signature according to 21 CFR Part 11.
-- Inventory of all systems in scope (IT, automation, laboratory)
-- Analysis of 21 CFR Part 11 requirements for all systems
-- Development of a 21 CFR Part11 assessment
-- Identification and assessment of compliance risks
-- Planning of all 21 CFR Part 11 remediation actions
-- Managing the global project activities and team

Software validation of a fully automated tablet press (Kilian T300 / A100) according to principles that were defined by ICI Pharmaceuticals and FJ Systems in a document called VMAN. It was one of the first projects where pharmaceutical validation principles were applied for a new automation software. Together with the software development team and consultants from FJ Systems (Scott Thompson, Asif Khan), we developed the entire SDLC documentation:
-- Validation Plan
-- User Requirements… Mehr anzeigen

Software validation of a fully automated tablet press (Kilian T300 / A100) according to principles that were defined by ICI Pharmaceuticals and FJ Systems in a document called VMAN. It was one of the first projects where pharmaceutical validation principles were applied for a new automation software. Together with the software development team and consultants from FJ Systems (Scott Thompson, Asif Khan), we developed the entire SDLC documentation:
-- Validation Plan
-- User Requirements Specification
-- Functional Specification
-- Software Design Specification
-- Test Specifications (IQ, OQ, PQ)
-- Validation Report

Eventually during this software project VMAN developed into GAMP and we decided to use GAMP for all future software and validation projects. The quality management system that was developed and certified in 1994 too GAMP into consideration for software development. Weniger anzeigen