Sterility testing
Sterility testing is used to demonstrate that a medicinal product or medical device is sterile. Our consulting laboratory will assist you in determining how to test your product according to the governing standards.
Pharmaceutical and veterinary products
Our testing capability
There are two principal test formats, the British and European Pharmacopeias, which have been harmonised with the United States and Japanese Pharmacopeias, and ISO 11737:1 test method. The “pharmacopoeia” methods are usually used for testing medicinal products but may also be used for checking medical devices to be used for clinical trial purposes before the method of sterilisation has been fully validated. The “ISO” method is used when validating a sterilisation process for a medical device.
Raw material and finished product testing
We offer both compendial and non-compendial raw material and finished product analysis to protect your manufacturing processes and ensure the highest quality outcomes.
Delivering safe, effective bio/pharmaceuticals demands that every component of your manufacturing process meets the highest standards. This begins with raw materials. Contaminated or non-compliant inputs can cause costly production delays, regulatory setbacks, or worse, compromise patient safety. Early, reliable testing of raw materials is critical to mitigate these risks.
The Eurofins BioPharma Product Testing network of laboratories in Australia offers comprehensive raw materials and excipient testing services designed to protect your manufacturing processes and ensure the highest quality outcomes. Our facilities combine extensive chemistry expertise with state-of-the-art instrumentation, delivering dependable results at every phase of bio/pharmaceutical production.
- Current BP, EP, USP, FCC
- Identification by FTIR-ATR, wet chemistry based methods, NMR
- Water content (titrator, coulometric and coulometric oven analysis)
- Residual solvents (BP/EP/USP)
- Finished product testing (APVMA, TGA, FDA)
- Particle size analysis
- Dissolution
- Disintegration
- Physical testing, thickness
- Product registration testing
- Manufacturing process validation testing
- Comparative batch analysis
- Cleaning validation testing
- Method transfer, verification and validation
- Sterility testing by current BP/EP/USP/ISO
- Microbiology – non-sterile testing
- Microbiology – bacterial endotoxin (LAL) testing
Probiotics testing
Our probiotics testing laboratory assists customers with the enumeration and identification of probiotics organisms in nutritional supplement, food and therapeutic products.
Testing is conducted according to international standards from the British, US, European, Japanese Pharmacopoeias and International Organisation for Standardisation (ISO). Alternatively, if requested, we can also perform the tests according to documented client specifications.
Method development & validation
From discovery through post-approval, analytical development is a critical part of the drug development process occurring throughout all stages with strict guidelines.
With analytical capabilities, scientific expertise and state-of-the-art instrumentation to support all stages of drug development, the Eurofins BioPharma Product Testing network of companies in Australia can support the development and validation of virtually any test for your starting material, API, bulk product, finished product, intermediate or packaging under cGMP guidelines.
We support all aspects of analytical development, including:
- Method establishment
- Method transfer
- Characterisation
- Impurities testing
- Residuals testing for bioprocess validation
- Comparator product testing
- Bioassay and cGMP potency testing
- Biosimilar potency testing
Stability studies
With many years of experience and thousands of samples on current storage in custom built, walk-in storage rooms, Eurofins BioPharma Product Testing Australia has the skills and capacity to support your stability programmes.
Stability services
- Complete stability storage and testing services
- Storage only service with temperature loggers during transportation if required
- Support in designing studies for real time, stress tests and photostability studies
- Development and validation of stability indicating methods
- Storage, coordination and management of stability samples
- Backup storage facility for customer’s in-house stability samples due to emergencies
- Stability protocol writing as required or incorporating client-written protocols