Testing
 
We test in accordance with international standards and guidelines (EN ISO, EP, USP,ASTM, etc.). We work with you to determine the optimal testing for you on the basis of your needs and resources. As an experienced diagnostics manufacturer and service provider, we know about the importance of cost-effectiveness, reliability, customer focus and high quality.
 
Our laboratory participates in various ring trials.

1. Virology testing

Manufacturing processes for pharmaceuticals or medical devices must be able to inactivate or deplete known and unknown viral contaminants. Early, targeted tests are also desirable in disinfectant manufacturing, starting in the development phase.
Process validation studies are performed in a validated downscale of the manufacturing process to determine the virus depletion rate or virus inactivation capacity. Our extensive experience in virology permits us to flexibly respond to customer requests and to apply our experience in downscaling of production processes and project implementation.
 
Furthermore we provide support in issues of safety to viral and infectious agents for purposes of legal regulations and normative requirements.
 
Our wide range of available test and reference viruses includes more than 50 different enveloped and non-enveloped viral strains, including animal and human pathogens with different physicochemical properties and resistances.
 
(Download: Flyer "List of established viruses, bacteria and fungi", 21 kB)
 
Additional virus strains can be established at any time upon customer request. Various virus-sensitive cell lines are available for optimal virus culture.
 

1.1 Testing

Testing Application examples
Testing for viricidal effect Disinfectants, virostatics (also accompanying development)
Validation of virus depletion in manufacturing processes Starting materials of animal or human origin, e.g. collagens, antibodies, heart valves, homografts, implantable medical devices
Examination for viral contamination Raw material and end product testing in medical devices and pharmaceuticals, diagnostic antigens, hospital waste and sewage sludge samples
 

1.2 Techniques

Standardized functional assays and bioassays are performed in accordance with international and European standards and guidelines. The following techniques are available for virus detection:
 
Quantitative virus detection in cell culture (TCID50)
Plaque and plaque reduction tests
Molecular biology detection methods (PCR)
Immunological test systems (immunofluorescence, ELISA)
Haemagglutination tests
Haemadsorption tests

2. Microbiological tests

All microbiological tests are performed in accordance with international standards, norms and regulations (EP, USP, EN, and ISO). Our laboratory has a general handling licence for bacteria, viruses and fungi of biosafety level BSL-2. More than 60 bacteria and fungi have been established as reference and test strains.

(Download: Flyer "List of established viruses, bacteria and fungi", 21 kB)
 
Additional strains of bacteria or fungi can be established at any time upon customer request.
 
 
Excerpt from our range of microbiological services:
 
Testing for sterility in the pharmaceutical and medical device industries, etc.:
GMP-isolator, direct inoculation, membrane filtration method, validation of sterility tests
Bioburden determination in the pharmaceutical and medical device industries, etc.:
Bioburden (validation) / product load, hygiene tests
Safety tests (raw materials, intermediate products and end products) and test procedures: According to customer requirements
Test for mycoplasmas aaccording to EP 2.6.7
Microbial differentiation
Tests for adequate antimicrobial effectiveness
Validation of chemical and/or thermal disinfection methods and inactivation processes
Validation of sterilization processes:
Validation of the sterilization of products with components of animal origin. Validation of gamma sterilization, steam sterilization, etc.
Examination of water samples (TrinkwV – drinking water ordinance)

3. Toxicological tests

Toxicity and compatibility tests in tissue cultures are a suitable alternative model for animal testing and are used for basic testing of medical devices and for pharmacological screening tests. Cytotoxicity tests offer initial information about the biological compatibility of materials that were previously extracted with culture media or other suitable solvents. Cytotoxicity or growth inhibition is established either through measurement of the total protein content, which depends on the cell number, or through identification of the cells' metabolic activity.
 
Depending on the specific requirements, we perform standardized and quantifiable functional and bioassays in accordance with international and European standards.
 

4. Immunological tests

Immunological in vitro test systems with human leukocytes and methods for determining parameters of the innate and antigen-specific immune systems offer important information on immunosuppressive, anti-inflammatory and immunostimulating agents.
 
Phagocytic activity of leukocytes
Analysis through flow cytometry and FITC-labelled E. coli bacteria
Cytolytic activity of natural killer cells
For studies on spontaneous cytolytic activity, flow cytometry is used with PHK 26/PI-labelled K562 cells.
Cell proliferation - toxicity
The stimulating or suppressive effect of materials on peripheral blood mononuclear cells (PBMC) is tested using MTT assays and CFSE assays (based on flow cytometry)
Cytokines
Cytokines (with anti-inflammatory, immunostimulating or antiviral effect) are detected using enzyme immunoassays (ELISA)
In vitro inflammation model
Examination of surface modulation through expression of adhesion molecules (ICAMs, VCAMs, selectins) on human endothelial cells after the addition active substances. Analysis using flow cytometry and detection of inflammatory cytokines in ELISA.