DECIDE FOR SAFETY - TRUST GFPS mbH.
We are your reliable partner for supporting your process line and research and development projects. In addition to various standard-compliant tests, we create individual solution concepts for your specific issues. We offer you our expertise in the field of laboratory analysis, measurement technology in cleanrooms, physical and microbiological packaging tests and comprehensive hygiene support.
Do you have any questions about our services? Please feel free to contact us at info@gfps.de
Non-sterile products
At GfPS mbH, we are an accredited and GMP-certified institute for the analysis of medical devices. As a testing laboratory, we have DIN EN ISO 17025 certification in the field of medical devices and are GMP-certified. In accordance with § 14 (4) of the German Medicines Act (AMG), we are qualified to carry out microbiological analyses and to fulfill the requirements of the EC guidelines on good manufacturing practice for medicinal products.
The term bioburden refers to the microbial contamination of a medical device before it is sterilized. The bioburden load is the sum of all microorganisms from different sources.
The identification and differentiation of bacteria, yeasts and molds are essential components of microbiological analysis.
Sterile products
Medical devices are subject to similarly stringent requirements as pharmaceuticals. We support you in product analysis as well as in the planning, testing and optimization of your production conditions.
The sterility test is a microbiological GMP test requirement for sterile products before they are released and administered to patients.
A pyrogen is a molecule that causes fever. Some bacteria produce pyrogens known as endotoxins. Endotoxins are an integral part of the bacterial cell itself.
Testing for sterility is a very important aspect of quality control for medical devices. Testing using the BACTEC™ system is a method that can only be used to test liquid samples.
Sterilization processes
Our institute GfPS mbH offers radiation sterilization validation as a service pact. This includes microbiological validation using representative test samples.
As GfPS mbH, we offer our customers a complete service package for radiation sterility validation.
Identifications
The identification and differentiation of bacteria, yeasts and molds is an essential part of micro-biological analysis. Precise identification can provide valuable information about the underlying origin or cause of contamination; the measures to be taken as a result vary and may need to be adapted individually. Years of experience and annual training of our specialists ensure our expertise and your analysis results.
We use state-of-the-art methods, such as mass spectrometry, for the precise identification of microorganisms.
Sequencing enables us to identify microorganisms on the basis of genetic information.
Clean room
Overall, cleanroom qualification is a comprehensive concept that combines various aspects such as safety, hygiene and quality control. By carefully planning, implementing and monitoring all relevant measures, laboratories and production facilities can continuously improve their cleanroom conditions and ensure the safety and quality of their products.
Cleanroom qualification is a comprehensive concept that combines various aspects such as safety, hygiene and quality control.
Air handling units (AHUs) are special HVAC systems that are used in clean rooms to control and maintain the air quality in these sensitive environments.
Microbiological testing of air or surfaces in cleanrooms, for example, is an important part of production facility inspections and is used to determine the composition and activity of microorganisms in an environment.
We offer you the creation of individual cleanroom and hygiene management concepts, cleanroom training courses and cleanroom acceptance tests in accordance with the German Cleanroom Act. DIN EN ISO14644, DIN EN 17141 and GMP, source of supply for the equipment, and training for your production staff.
Product testing
Scientific demands and questions are constantly being posed anew in companies. It does not matter whether these are formulated by authorities, for example, or from their own established processes. Our team for special tests works closely with you to develop a test plan that is individually tailored to your requirements.
Our team will work closely with you to develop a customized test plan based on your current issues.
The inhibition zone test, also known as the agar diffusion test, is a method for testing the sensitivity of microorganisms to certain antibiotics or other diffusible inhibitors.
The JIS Z 2801 standard (also known as the “film contact method”) is used to test the antimicrobial effectiveness of hard, non-porous surfaces such as plastics, metals and ceramics.
Packaging tests
The demands on the production of cosmetics have increased enormously. On the one hand, the consumer expects first-class products of consistently high quality, on the other hand, the legislator requires GMP conditions in production. As a competent partner for your products, we accompany you in the microbiological field from the raw material to the finished product.
Physical packaging testing makes it possible to verify the stability and reliability of packaging for medical products through integrity testing.
The microbiological testing of packaging for medical devices is an important aspect of the basic safety requirements.
Our packaging tests are primarily geared towards medical products in sterile packaging and take mechanical and climatic stresses into account. Products are exposed to high loads during transportation, handling and storage. In our institute, we simulate the complete transport cycle of your product for you.
Further analysis
The identification and differentiation of bacteria, yeasts and molds is an essential part of micro-biological analysis. Precise identification can provide valuable information about the underlying origin or cause of contamination; the measures to be taken as a result vary and may need to be adapted individually. Years of experience and annual training of our specialists ensure our expertise and your analysis results.
The detection of depyrogenation is subject to various guidelines and standards for medical devices and medicinal products.
By integrating the test for growth-promoting properties of your sewing media into your product testing process, you lay the foundation for assured quality and the reliability of your products.
Media fill testing is an important quality control procedure in the pharmaceutical industry, especially in the manufacture of sterile drugs.
With a focus on precise analyses, we give you an insight into microbiological relationships.