Eurofins BioPharma Product Testing New Zealand provides the following services:
- Raw materials and finished product testing
- Conformance to GMP requirements
- Analysis performed using the latest Pharmacopoeial methods available
- Range of validated methods available
- One of the few GMP certified stability rooms in New Zealand. Fully compliant with VICH and ICH standards
- Expertise to develop new analytical testing methods and validation of customer methods
- AS/NZS 4020 Test for WaterMark Certification
- AMES Test
- Modified AMES Test
- Ethylene Oxide (EtO) Residual Test
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- Conformance to GMP requirements
- Analysis performed using the latest Pharmacopoeial methods (British, European and United States)
- Analysis performed using the ISO standards for medical devices (11737-1 and 11737-2)
- Analysis performed using the Cosmetic standards (CTFAA)
- Analysis performed using customer supplied methods (on request)
- Sterility Testing on medical devices and animal health products and Product validation
- Microbial Limits Testing and Product Validation
- Antimicrobial Efficacy Testing and Product Validation
- In house challenge testing
- Expertise to develop new analytical testing methods
- Endotoxin testing
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Testing at Eurofins is conducted according to international standards from the British, US, European, Japanese Pharmacopoeias and International Organization for Standardization (ISO). Alternatively, if requested, we can also perform the tests according to documented client specifications.
- Enumeration and Identification
- Stability Study - Water Activity Test
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Sterile Products Testing
These tests include but are not limited to those shown below:
- Sterility Test
- Endotoxin Test
- Sub-visible Particle Count
- Mycoplasma Detection
- Extraneous Viral Agents Test
- Seal Integrity Test
- Viral Penetration
- Test Media Fill Studies
- Cytotoxicity Studies
- Antimicrobial Efficacy Studies
- Antibiotic Potency Test
- Laundry Trial
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