What You Can Expect

Cross-industry expertise from the pharmaceutical, biotech, and medical technology sectors, combined with:

  • Fresh perspectives
  • Personality
  • Specialization
  • Quick availability
  • Dynamic action
  • 5 years of project success

What You Can Expect

Cross-industry expertise from the pharmaceutical, biotech, and medical technology sectors, combined with:

  • Fresh perspectives
  • Personality
  • Specialization
  • Quick availability
  • Dynamic action
  • 5 years of project success

Our Services for You

Our Services for You

Measurement

Measurement

  • Air quality (particles and germs)

  • Air flow measurement – volume and velocity

  • Measurement of air pressure difference

  • Air flow direction and visualization

  • Temperature measurement/ relative humidity

  • Air sampling/air germ collection

  • Filter integrity tests for HEPA filters (high-efficiency submicron particulate air filter)

  • Tight fit/tightness tests for filters

  • Temperature distribution/uniformity measurement on freezers/cold-storage rooms and refrigerators

Planning service

Planning service

  • Concept development for contamination control

  • Line and layout planning

  • Creation of personnel, material and product flows

  • Developing pressure zone concepts

  • Define hygiene zones

  • Creating room plans

  • Summary of all requirements and creation of user requirement specifications (URS)

  • Helping to select suppliers

  • Site supervision for reconstruction measures

Pharmaceutical water systems

Pharmaceutical water systems

  • System design for production and distribution facilities

  • Development of requirement specifications and risk analyses

  • Implementation and oversight of qualification processes

Qualification and validation service

Qualification and validation service

  • Development of qualification concepts

  • Implementation of plant qualification (solid and liquid forms)

  • Implementation of clean room qualifications

  • Qualification of pharmaceutical water installations

  • Qualification of clean benches, LAF (laminar air flow), TAV (low-turbulence displacement flow)

  • Thermal validation of refrigerators/cold-storage rooms

Visual inspection (MVI, AVI)

Visual inspection (MVI, AVI)

  • Design of qualification strategies

  • Risk-based development and design of test sample sets

  • Development of product-specific defect patterns

  • Creation of qualification plans

  • Execution of human-machine interaction tests

Years of experience at the cutting edge of knowledge

QP-Engineering TEAM
We develop your business roadmap

QP-Engineering is backed by a team with extensive specialist and practical knowledge. Three GMP specialists, a technical assistant, and a sales manager are ready to provide fresh ideas for solutions. In addition to high-level technical expertise, training in communication skills and team processes is particularly important here. M. Eng. Mechatronics Mr. Simon Menges is an „out-of-the-box thinker“ and founder of QP-Engineering. He has turned his spirit into a corporate vision:

Personality + Specialization = Successful Projects. 

Simon Menges

Owner, M. Eng. Mechatronics

QP Engineering Team Simon Breitenbach Dr. biol. hum., GMP-Consultant
Simon Breitenbach

Dr. biol. hum., GMP-Consultant

QP Engineering Team Melissa Rensland Consulting
Melissa Rensland

Sales Manager

QP Engineering Team Elena Haugg Dr. rer. nat., GMP-Consultant
Elena Haugg

Dr. rer. nat., GMP-Consultant

Tatjana Seidl

M. Sc. Biotechnology, GMP-Consultant

Years of experience at the cutting edge of knowledge

QP-Engineering TEAM
We develop your business roadmap

QP-Engineering is backed by a team with extensive specialist and practical knowledge. Three GMP specialists, a technical assistant, and a sales manager are ready to provide fresh ideas for solutions. In addition to high-level technical expertise, training in communication skills and team processes is particularly important here. M. Eng. Mechatronics Mr. Simon Menges is an „out-of-the-box thinker“ and founder of QP-Engineering. He has turned his spirit into a corporate vision:

Personality + Specialization = Successful Projects. 

Simon Menges

Owner, M. Eng. Mechatronics

QP Engineering Team Simon Breitenbach Dr. biol. hum., GMP-Consultant
Simon Breitenbach

Dr. biol. hum., GMP-Consultant

QP Engineering Team Melissa Rensland Consulting
Melissa Rensland

Sales Manager

QP Engineering Team Elena Haugg Dr. rer. nat., GMP-Consultant
Elena Haugg

Dr. rer. nat., GMP-Consultant

Tatjana Seidl

M. Sc. Biotechnology, GMP-Consultant

Satisfied Customers

Restructuring Project of a Qualification Department

„QP-Engineering works independently yet closely with the customer. An excellent combination that drove the project forward very well and quickly. I highly recommend working with QP-Engineering and would work with them again anytime.“

Successful
FDA Audit Project

„The service provided by QP-Engineering was a great investment, as we were unable to implement the topics internally at this speed.“

Medical Technology Assembly Machines FAT Project

„Beside his support on various projects, Simon was leading the FAT activities of a fully automated assembly line. He has a great understanding of the overall processes and their implications. With his experience and ability to easily connect with people, he quickly became a valuable member of the team.“

LET’S GET STARTED TOGETHER

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