![](\"https:\/\/qp-eng.de\/wp-content\/uploads\/2023\/09\/Konzepterfassung-1024x701.jpg\" "\\"Konzepterfassung\\"")
<\/span><\/div><\/div><\/div>What You Can Expect<\/h2><\/div>Cross-industry expertise from the pharmaceutical, biotech, and medical technology sectors, combined with:<\/p>\n
\n- Fresh perspectives<\/strong><\/li>\n
- Personality<\/strong><\/li>\n
- Specialization<\/strong><\/li>\n
- Quick availability<\/strong><\/li>\n
- Dynamic action<\/strong><\/li>\n
- 5 years of project success<\/strong><\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/span><\/div><\/div><\/div>
What You Can Expect<\/h2><\/div>Cross-industry expertise from the pharmaceutical, biotech, and medical technology sectors, combined with:<\/p>\n
\n- Fresh perspectives<\/strong><\/li>\n
- Personality<\/strong><\/li>\n
- Specialization<\/strong><\/li>\n
- Quick availability<\/strong><\/li>\n
- Dynamic action<\/strong><\/li>\n
- 5 years of project success<\/strong><\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div>
Our Services <\/span>for You<\/h2><\/div>Our Services <\/span>for You<\/h2><\/div><\/div><\/div>Measurement<\/h3><\/div>Measurement<\/h3><\/div>- <\/i><\/span>\n
Air quality (particles and germs)<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Air flow measurement – volume and velocity<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Measurement of air pressure difference<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Air flow direction and visualization<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Temperature measurement\/ relative humidity<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Air sampling\/air germ collection<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Filter integrity tests for HEPA filters (high-efficiency submicron particulate air filter)<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Tight fit\/tightness tests for filters<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Temperature distribution\/uniformity measurement on freezers\/cold-storage rooms and refrigerators<\/p>\n<\/div><\/li><\/ul><\/div><\/div>
Planning service<\/h3><\/div>Planning service<\/h3><\/div>- <\/i><\/span>\n
Concept development for contamination control<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Line and layout planning<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Creation of personnel, material and product flows<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Developing pressure zone concepts<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Define hygiene zones<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Creating room plans<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Summary of all requirements and creation of user requirement specifications (URS)<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Helping to select suppliers<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Site supervision for reconstruction measures<\/p>\n<\/div><\/li><\/ul><\/div><\/div>
Pharmaceutical water systems<\/h3><\/div>Pharmaceutical water systems<\/h3><\/div>- <\/i><\/span>\n
System design for production and distribution facilities<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Development of requirement specifications and risk analyses<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Implementation and oversight of qualification processes<\/p>\n<\/div><\/li><\/ul><\/div><\/div>
Qualification and validation service<\/h3><\/div>Qualification and validation service<\/h3><\/div>- <\/i><\/span>\n
Development of qualification concepts<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Implementation of plant qualification (solid and liquid forms)<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Implementation of clean room qualifications<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Qualification of pharmaceutical water installations<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Qualification of clean benches, LAF (laminar air flow), TAV (low-turbulence displacement flow)<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Thermal validation of refrigerators\/cold-storage rooms<\/p>\n<\/div><\/li><\/ul><\/div><\/div>
Visual inspection (MVI, AVI)<\/h3><\/div>Visual inspection (MVI, AVI)<\/h3><\/div>- <\/i><\/span>\n
Design of qualification strategies<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Risk-based development and design of test sample sets<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Development of product-specific defect patterns<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Creation of qualification plans<\/p>\n<\/div><\/li>
- <\/i><\/span>
Cross-industry expertise from the pharmaceutical, biotech, and medical technology sectors, combined with:<\/p>\n
- \n
- Fresh perspectives<\/strong><\/li>\n
- Personality<\/strong><\/li>\n
- Specialization<\/strong><\/li>\n
- Quick availability<\/strong><\/li>\n
- Dynamic action<\/strong><\/li>\n
- 5 years of project success<\/strong><\/li>\n<\/ul>\n<\/div>
<\/div><\/div><\/div><\/div><\/div><\/span><\/div><\/div><\/div>What You Can Expect<\/h2><\/div>
Cross-industry expertise from the pharmaceutical, biotech, and medical technology sectors, combined with:<\/p>\n
- \n
- Fresh perspectives<\/strong><\/li>\n
- Personality<\/strong><\/li>\n
- Specialization<\/strong><\/li>\n
- Quick availability<\/strong><\/li>\n
- Dynamic action<\/strong><\/li>\n
- 5 years of project success<\/strong><\/li>\n<\/ul>\n<\/div>
<\/div><\/div><\/div><\/div><\/div><\/div>Our Services <\/span>for You<\/h2><\/div>
Our Services <\/span>for You<\/h2><\/div><\/div><\/div>
Measurement<\/h3><\/div>
Measurement<\/h3><\/div>
- <\/i><\/span>\n
Air quality (particles and germs)<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nAir flow measurement – volume and velocity<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nMeasurement of air pressure difference<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nAir flow direction and visualization<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nTemperature measurement\/ relative humidity<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nAir sampling\/air germ collection<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nFilter integrity tests for HEPA filters (high-efficiency submicron particulate air filter)<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nTight fit\/tightness tests for filters<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nTemperature distribution\/uniformity measurement on freezers\/cold-storage rooms and refrigerators<\/p>\n<\/div><\/li><\/ul><\/div><\/div>
Planning service<\/h3><\/div>
Planning service<\/h3><\/div>
- <\/i><\/span>\n
Concept development for contamination control<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nLine and layout planning<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nCreation of personnel, material and product flows<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nDeveloping pressure zone concepts<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nDefine hygiene zones<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nCreating room plans<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nSummary of all requirements and creation of user requirement specifications (URS)<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nHelping to select suppliers<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nSite supervision for reconstruction measures<\/p>\n<\/div><\/li><\/ul><\/div><\/div>
Pharmaceutical water systems<\/h3><\/div>
Pharmaceutical water systems<\/h3><\/div>
- <\/i><\/span>\n
System design for production and distribution facilities<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nDevelopment of requirement specifications and risk analyses<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nImplementation and oversight of qualification processes<\/p>\n<\/div><\/li><\/ul><\/div><\/div>
Qualification and validation service<\/h3><\/div>
Qualification and validation service<\/h3><\/div>
- <\/i><\/span>\n
Development of qualification concepts<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nImplementation of plant qualification (solid and liquid forms)<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nImplementation of clean room qualifications<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nQualification of pharmaceutical water installations<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nQualification of clean benches, LAF (laminar air flow), TAV (low-turbulence displacement flow)<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nThermal validation of refrigerators\/cold-storage rooms<\/p>\n<\/div><\/li><\/ul><\/div><\/div>
Visual inspection (MVI, AVI)<\/h3><\/div>
Visual inspection (MVI, AVI)<\/h3><\/div>
- <\/i><\/span>\n
Design of qualification strategies<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nRisk-based development and design of test sample sets<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nDevelopment of product-specific defect patterns<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nCreation of qualification plans<\/p>\n<\/div><\/li>
- <\/i><\/span>
- <\/i><\/span>
- <\/i><\/span>
- <\/i><\/span>
- <\/i><\/span>
- <\/i><\/span>
- Personality<\/strong><\/li>\n
- Personality<\/strong><\/li>\n
![](\"https:\/\/qp-eng.de\/wp-content\/uploads\/2023\/05\/qpengineering_team_simon_menges-07.jpg\" "\\"qpengineering_team_simon_menges-07\\"")
<\/span><\/div>