What We Do?

Get in touch with us to find out how we can assist you.

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services.

expertise.

Based on our practical implementation experience, we support regulated companies, suppliers, communities of practice and expert groups in the development of standards and guidelines for the compliant implementation of MTP-based Plug & Operate (Plug & Produce, Plug & Play) operating philosophies in GxP-regulated environments. supported expert groups include BIOPHORUM®, GAMP®, ISPE®, NAMUR, Pharma 4.0TM Plug & Produce, PROFIBUS and PROFINET International (PI).

consulting.

we support our clients to adapt and optimise existing quality and engineering management systems to implement MTP-based solutions in GxP-evironments efficiently and GMP compliant.
achievable benefits include:

reducing engineering effort by up to 70% by accelerating the development process and transition to industrial production;
increasing expandability and reusability of modular units/equipment by up to 80%;
reducing time to market and commissioning by up to 50%;
reducing on-site testing by up to 60 %;

Elimination of redundant tests by systematically identifying and tagging quality-related and non-quality-related requirements and related verification measures into:

GEP: Verification measures regarding non-quality-relevant requirements are carried out under Engineering-Oversight. This means that tests are carried out in accordance with demonstrably established Good Engineering Practices (GEP) and the results are documented in accordance with Good Documentation Practices;
GMP: Verification measures regarding quality-related requirements, qualification and validation measures are carried out under QA-Oversight. This means that tests are carried out in accordance with Good Manufacturing Practices (GMP) based on Good Engineering Practices (GEP) and documented in accordance with Good Documentation Practices.

training.​

our interdisciplinary training curricula provide the basis for successful implementation and operation of MTP-based solutions in GxP-regulated environments.

for regulated companies:
Engineering and Technical Compliance functions:
How to establishing or updating the Engineering Quality Management System based on Quality By Design (QbD), Good Engineering Practices (GEP) and Good Documentation Practices to be able to procure smart models as pre-qualified automated manufacturing equipment.
Quality Assurance functions:
How to establishing or updating the Pharmaceutical Quality Management System to enable efficiency gains possible by modularization based on Quality By Design (QbD), Good Engineering Practices (GEP) and Good Documentation Practices. Allowing for data driven Integrated Engineering, Commissioning & Qualification to be able to procure smart models as pre-qualified automated manufacturing equipment.
for smart module / Process Equipment Manufacturers(PEA) manufacturers:
How to implement traceable approaches and methods allowing clients from GxP-regulated industries to leverage manufacturer executed qualification, validation activities and documentation to procure smart models as pre-qualified automated manufacturing equipment.

implementation.​

together with our experienced MTP-technology focussed industry and university partners we are currently the first organization capable to provide MTP-based end-2-end solutions for the GxP-regulated pharmaceutical industry:

FLEXELERATE GmbH
FLEXCELERATE accelerates time-to-market and flexible, scalable production with flexible plant solutions—enabled by modularization and integrated digital methods.
MTP4Pharma
for over 13 years, we have been at the forefront of digital technologies in GxP-regulated environments. We work closely with universities, expert groups, communities of practice and standardisation organisations to bring the latest technology to the pharmaceutical industry in a compliant and efficient way!
Pruess GmbH
Pruess GmbH has over 40 years of experience in plant engineering and extraction technology and has already implemented numerous projects for the pharmaceutical and food industries, primarily in the field of thermal process engineering. The company operates in Germany and Europe as well as worldwide.
P2O – Process-to-Order Group
is building on solution approaches from the fields of modularization and digitization as well as artificial intelligence, to investigating the next steps to serve highly variable markets with short product life cycles.
SEMODIA GmbH
Semodia makes machines talk – adding semantics to modular automation with MTP for seamless Plug & Produce and smarter engineering.
SpiraTec AG
With its interdisciplinary services in the area of Industrial Engineering & Solutions and the forward-looking technologies and methods applied in this field, SpiraTec is ideally positioned to accompany you on your path to digital transformation.
All Services.

This Is How We Can Help You.

art direction
branding & branding strategy
service design
ui / ux design
digital media plans
mobile apps
digital marketing
digital experience
motion graphics and video
interaction design
backend & CMS development
frontend development
mobile apps development
CRM development
ERP integration
Clients.

Forward Thinking Clients.

Statistics.

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view projects.

Photoshop.

75%

25%

Illustrator.

87%

13%

After Effects.

65%

35%

Indesign.

80%

20%

Don’t Be Shy, ask us.​

Get in touch with us.
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