Commissioning and qualification of production equipment

Commissioning is the process where we thoroughly check, test, and confirm that production equipment meets specific standards and performance criteria. Our engineers are experts in this process, carefully examining equipment functionality, validating control systems, and verifying operational parameters. This detailed approach helps to reduce potential risks and ensures that key assets are ready for operation.

Alongside this, Qualification is the essential practice of proving that production equipment and systems perform as expected. Our engineers are skilled in managing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. These protocols involve a complete evaluation of equipment integrity and process performance, including the validation of crucial utility systems, to ensure they meet the strict criteria set by regulatory bodies.

Moreover, our specialists are fully aware of the current regulatory frameworks and standards that govern Commissioning and Qualification processes, including the current Good Manufacturing Practice (cGMP) guidelines. They stay updated with changes in regulatory standards, ensuring that our clients always comply with the latest requirements.
In addition to these skills, our engineers have practical experience in carrying out Commissioning and Qualification tasks across a wide range of pharmaceutical facilities. This includes both traditional pharmaceutical manufacturing processes and new technologies in medical device production, ensuring a comprehensive and adaptable approach to compliance.

In conclusion, our consultancy offers unmatched expertise in Commissioning and Qualification processes, backed by the exceptional skills of our engineers. We enable pharmaceutical manufacturers and medical device developers to navigate regulatory compliance accurately and effectively, leading to the production of top-quality therapeutics and medical devices.

We strive to implement simple and operational solutions, and can support the implementation of procedures and training activities that ensure compliance with existing authority requirements and inspection readiness.

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Commissioning and qualification of production equipment cases

Technical writer (Author) of rationale documents (Parameter, Access etc.) on Sec. Pack. Equipment. Preparing, supporting and executing of qualification (IQ, OQ) for Blister, Cartoning and USP (Uhlmann Serialization Platform)

Packaging project

Project engineer. Develop of URS, design review, FAT/SAT/XQ test protocols and execution. Bavarian Nordic A/S, Kvistgaard, Denmark – 2014

Basic & detail Design – Semi automatic packaging line

Project engineer. Develop of URS, design review, FAT/SAT/XQ test protocols and execution.

Basic & detail Design – Semi automatic assembly and test machine

Project manager/project engineer. Develop of URS, design review, FAT/SAT/XQ test protocols and execution.

Basic & detail Design – Semi automatic labelling machine for injection pen

Test plan writer Wrote test plans for new high-speed / high volume packaging line

Test plans for new high-speed packaging line

Facilitating risk analysis workshops and writing the risk analysis report for two new blister packaging lines

Risk analysis of two new blister packaging lines

Packaging project

Project engineer. Develop of URS, design review, FAT/SAT/XQ test protocols and execution. Bavarian Nordic A/S, Kvistgaard, Denmark – 2014

Basic & detail Design – Semi automatic packaging line

Project engineer. Develop of URS, design review, FAT/SAT/XQ test protocols and execution.

Basic & detail Design – Semi automatic assembly and test machine

Project manager/project engineer. Develop of URS, design review, FAT/SAT/XQ test protocols and execution.

Basic & detail Design – Semi automatic labelling machine for injection pen

Test plan writer Wrote test plans for new high-speed / high volume packaging line

Test plans for new high-speed packaging line

Facilitating risk analysis workshops and writing the risk analysis report for two new blister packaging lines

Risk analysis of two new blister packaging lines

Commissioning and qualification of production equipment profiles

Sille is a passionate design engineer with experience in project management and innovation processes from her entrepreneurial venture. She founded a start-up in London focused on using machine learning and AI for sustainable shopping solutions and advised start-ups on life cycle and circular design practises. Throughout her education, Sille honed her skills in project management, business development, innovation processes as well as stakeholder engagement. Sille has worked across the fashion, food and construction industry and is eager to apply her skills and expertise in the pharmaceutical industry as well. Having worked in Denmark, Norway and the United Kingdom Sille has developed strong communication and collaboration skills.

Documentation

Innovation methods

Personal

Project Management and Organizational skills

Technology

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Silla Eva Bertelsen

Finished Products Engineering Consultant

Through 5 years at university, internship and professional work, Mikhail has acquired a wide range of competences from different projects at the university and industry.

Analyzing and optimizing processes for production lines

Data analysis

Development of concepts

Problem solving for production lines

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Mikhail Vladimirovich Prokopiev

Finished Products Engineering Consultant

Nermin has a wide range of competencies related to Project Management, GMP, Process Optimization, Automation and Quality Management through his time at DTU and professional work. Based on previous experience, he is a service-minded individual that prioritize the needs and satisfaction of customers in his work and strive to provide high-quality solutions.

Data Driven

Personal

Technology

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Nermin Fejzic

Finished Products Engineering Consultant

With customer service and an understanding of manufacturing, Linus systematically finds the solution between man and technology. His open mindset and stakeholder management are used to create maintain and evolve relations. Relations he used technological knowledge to create SOP, which lifts quality and is intuitive.

GMP

Personal

Project management

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Linus Knoop

Finished Products Engineering Consultant

Torben has +20 years of experience in the pharmaceutical industry with focus on project management and validation of several inspection and assembly lines as well as packaging lines for the Packaging of Finished Goods.

Performing commissioning/validation tests.

Project management

Writing commissioning/validation documentation

Writing URS

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Helene is a passionate engineer with competencies within project management, documentation, and Good Manufacturing Practice (GMP). She has worked on projects spanning from sterile production and assay design to protocol optimization and chemical analysis.

Good Manufacturing Practice

Personal

Project management

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Helene Cecilie Kiilerich Frederiksen

Finished Products Engineering Consultant

Bo has more than 25 years of experience in the pharmaceutical and medical device industry. Bo has spent the years working as designer, consultant and project manager in projects concerning medical devices and drug delivery systems.

Management Consulting

Mechanical Engineering/Design

Project management

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Bo Hejgaard Pedersen

Co-founder, specialist and senior project manager

Jonas has a wide range of competences acquired through 10 years of experience from the Pharma and life science industry through his work for a variety of national and international life science/pharmaceutical/medical device companies both big scale API chemical synthesis and finished product aseptic production.

Extensive Technology knowledge

GMP documents

Process and equipment lead responsible

Project overview and management

Test and verification

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