Microbiological quality control for the pharmaceutical industry, healthcare facilities and pharmacies
The Department of General Microbiology and Hygiene (MIHY) at AGES in Graz supports pharmaceutical companies, healthcare facilities and pharmacies by carrying out microbiological testing of sterile and non-sterile medicinal products, raw materials and process water.
As a GMP-certified and FDA-registered quality control laboratory, as well as an accredited testing laboratory in accordance with EN ISO 17025, we offer our clients the highest quality, regulatory assurance and sound microbiological expertise (see Downloads).
With up to 27,000 microbiological tests per year, three Qualified Persons (QPs) at our Graz site and more than 60 long-standing contract clients, we are one of the most experienced microbiological testing laboratories in the pharmaceutical sector.
Your benefits
- GMP-compliant testing in accordance with international standards
- FDA-registered site
- Accredited testing procedures in accordance with EN ISO 17025
- Short turnaround and analysis times
- Prompt and reliable reporting
- Personalised expert advice
- Extensive experience gained from thousands of tests per year
- Many years’ expertise in audits and regulatory inspections
Sterility testing of medicines and medical devices
Every year, more than 10,000 sterile medicinal products and medical devices are tested in our laboratories.
The tests are carried out in accordance with the requirements of the current pharmacopoeias, in particular the European Pharmacopoeia (Ph. Eur.), and in compliance with national and international regulatory requirements.
Our range of services
- Sterility testing in accordance with Ph. Eur. 2.6.1
- Method development and method validation
- Tests to support product and batch release
- Preparation of test reports in accordance with standards
- Scientific consultancy and expert opinions
State-of-the-art cleanroom laboratory in Graz
Sterility testing is carried out in a purpose-built cleanroom laboratory comprising cleanroom classes A to D and covering a total area of 92 m². The infrastructure complies with the current requirements of the EU GMP guidelines and state-of-the-art cleanroom technology.
Three Class A laminar-flow workbenches enable sterile testing to be carried out under strictly controlled conditions. Temperature, relative humidity, particle levels and differential pressure are continuously monitored and controlled.
Comprehensive environmental monitoring, validated processes and periodic requalifications ensure the highest levels of safety and reliability of the test results.
Sterility testing at AGES
As a general rule, the membrane filtration method is used in accordance with Ph. Eur. 2.6.1, as this is the method preferred in the Ph. Eur. and also allows for the removal of antimicrobial substances through post-rinsing. If a product cannot be filtered, the direct inoculation method is used to test for sterility. The required number and volume of samples must be determined for each product, taking careful account of the applicable pharmacopoeia requirements.
For each product, prior to the actual testing, a test strategy must be established and a method suitability test carried out, depending on the product characteristics, to demonstrate that the method is capable of detecting microorganisms in the product. The effort, costs and duration of the testing depend on the product characteristics and the chosen testing strategy.
Drawing on our many years of experience and extensive expertise, we would be happy to advise you on selecting the appropriate sample volume and number of samples to be tested.
Product testing – Microbiological testing of non-sterile products
In addition to sterility tests, we carry out up to 17,000 tests annually on non-sterile medicinal products, raw materials and pharmaceutical waters.
The analyses are based on the requirements of internationally recognised pharmacopoeias such as Ph. Eur., USP and JP, and are carried out in accordance with GMP-compliant procedures.
Our range of services
- Microbiological testing of non-sterile products: Enumeration of total viable microorganisms in accordance with Ph. Eur. 2.6.12
- Microbiological testing of non-sterile products: detection of specific microorganisms in accordance with Ph. Eur. 2.6.13
- Microbial identification using MALDI-TOF
- Testing for adequate microbial preservation in accordance with Ph. Eur. 5.1.3
- Endotoxin determination in accordance with Ph. Eur. 2.6.14
- Analysis of pharmaceutical waters and process waters in accordance with Ph. Eur. 0008 and Ph. Eur. 0169
- Microbial identification of environmental monitoring samples
- Microbiological testing of sterilisation processes and bioindicators in accordance with Ph. Eur. 5.1.2
- Method development and method validation
- Preparation of laboratory test reports on out-of-specification (OOS) results
- Technical consultancy on quality and compliance issues
The establishment and performance of further customer- or product-specific microbiological tests can be arranged at any time upon request. We would be happy to support you in this with our technical expertise and many years of experience.
If you have any questions on this matter, please contact our technical experts
Contact
Leitung
Dr.in Klarissa Eibl (Qualified Person)
- klarissa.eibl@ages.at
- +43 50555 61126
-
Beethovenstraße 6
8010 Graz
Leitung Stv.
Christian Holzmann, MMSc. (Qualified Person)
- christian.holzmann@ages.at
- +43 50555 61126
-
Beethovenstraße 6
8010 Graz
Last updated: 19.08.2026
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