GfPS
GFPS mbH is a certified and GMP-certified institute based in Aachen, specializing in biological, microbiological, and physical testing and analysis of medical products, pharmaceutical products, cosmetics, and healthcare environments. They support continuous improvement of hygiene processes, packaging testing, cleanroom qualification, and microbiological monitoring, ensuring safety and reliability for medical devices. The company also offers microbiological analytics, cleanroom qualification, and packaging testing, adhering to international standards and guidelines.
Industries
Nr. of Employees
medium (51-250)
Services
Accredited analyses for medical devices, pharmaceuticals and cosmetics including microbial culture methods, sterility testing, bioburden quantification (including MPN) and physical packaging evaluations.
Qualification and requalification (IQ/OQ/PQ) services including particle counting, airflow and flow visualization, differential pressure and pressure cascade verification, HEPA filter integrity testing, microbiological monitoring and requalification planning.
Physical and microbiological packaging assessments including bubble/immersion tests, dye penetration, seal strength, accelerated and real‑time aging, and ISTA transport simulation to demonstrate sterile barrier performance and shelf life.
Bioburden determination, method validation (including recovery-rate and MPN approaches), verification dose determination and sterility testing workflows for radiation, steam and gas sterilization according to applicable ISO and pharmacopeial guidance.
Visual and sub-visual particulate analysis of filled containers and product extracts using light-blockage particle counters and microscopy to quantify particulate loads and support risk assessment.
Online portal for order submission, sample documentation, automated shipping documentation and secure electronic delivery of test reports.
Accredited analyses for medical devices, pharmaceuticals and cosmetics including microbial culture methods, sterility testing, bioburden quantification (including MPN) and physical packaging evaluations.
Qualification and requalification (IQ/OQ/PQ) services including particle counting, airflow and flow visualization, differential pressure and pressure cascade verification, HEPA filter integrity testing, microbiological monitoring and requalification planning.
Physical and microbiological packaging assessments including bubble/immersion tests, dye penetration, seal strength, accelerated and real‑time aging, and ISTA transport simulation to demonstrate sterile barrier performance and shelf life.
Bioburden determination, method validation (including recovery-rate and MPN approaches), verification dose determination and sterility testing workflows for radiation, steam and gas sterilization according to applicable ISO and pharmacopeial guidance.
Visual and sub-visual particulate analysis of filled containers and product extracts using light-blockage particle counters and microscopy to quantify particulate loads and support risk assessment.
Online portal for order submission, sample documentation, automated shipping documentation and secure electronic delivery of test reports.
Expertise Areas
- Microbiological testing and sterility assurance
- Bioburden quantification and method validation (ISO 11737-1)
- Packaging integrity testing and shelf‑life studies
- Cleanroom qualification and environmental monitoring (IQ/OQ/PQ)
Key Technologies
- Microbiological culture methods and environmental air/surface sampling
- Most Probable Number (MPN) enumeration
- Method-suitability testing and neutralization assays (MST)
- Sterility testing workflows (ISO 11737 / pharmacopeial methods)
News & Updates
Free live webinar scheduled for June 25, 2025, covering development, validation, and sterilization processes.
Conference discussing updates in MDR and developments in the regulated environment of life sciences.
GFPS participated in the Medica trade fair from November 11-14, 2024, the world's leading medical trade fair.
GFPS was recognized for its participation in various research projects with the 'Innovation through Research' seal from the Stifterverband.
Free live webinar scheduled for June 25, 2025, covering development, validation, and sterilization processes.
Conference discussing updates in MDR and developments in the regulated environment of life sciences.
GFPS participated in the Medica trade fair from November 11-14, 2024, the world's leading medical trade fair.
GFPS was recognized for its participation in various research projects with the 'Innovation through Research' seal from the Stifterverband.