Biolab biological assays are performed mainly within two areas: toxicology and microbiology. The tests are performed in accordance with official methods, EU. Ph., USP Ph., OECD Guideline, UNE EN-ISO, and specific methodologies for R&D. The laboratory offers orientation to manufacturers and importers in accordance with current regulations advice. As well as technical advice regarding the minimum tests to be performed to ensure the quality and safety of its products, in accordance with the regulations in force.
Microbiology
Microbiological determinations could be aimed to highlight the contaminants present in the sample or to assess the different substances used to eliminate or reduce the microbial loads, such as preservatives, antibiotics.
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Toxicology
The tests are performed in accordance with official methods, European Pharmacopoeia, USP Pharmacopoeia, OECD, UNE EN-ISO, etc. and specific methodologies developed for experimental products.
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Physicochemical
Additional toxicological tests and microbiological tests are performed. Those who assist in the characterization of the product and to assess the conditions and quality in the manufacture of such products.
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Validations & Biocompatibility
Our analytical procedures are all validated. While others are studied and validated test methods to be replaced by those specific protocols that the client has established for your product.
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Other tests by request. If you haven’t seen what your looking for among our catalogue. Please do not hesitate to contact us.
- Microbiological determinations
- Sterility test on pharmaceutical products
- Sterility test on cellular products
- Sterility test on sanitary products
- Preservative Efficacy Testing
- Determination of the spore load
- Bioburden test
- Growth Promotion Testing
- Microbiology analysis on water
- Environmental control
- Identification of contaminants
- Bactericidal, fungicidal, virucidal and bactericidal activity
- Preservative in ophthalmic products (UNE 14729/14730)
- Hygienic hand washing (UNE 1499)
- Hygienic hand treatment (UNE 1500)
- Disinfection of hands (UNE 12791)
- Potency of antibiotics
- Abnormal toxicity (Eu Ph.)
- Immunosera and vaccines toxicity (EU Ph. or USP)
- Acute systemic toxicity (ISO-10993-11)
- Subacute systemic toxicity (ISO-10993-11)
- Sub chronic systemic toxicity (ISO-10993-11 or Guide 407)
- Chronic systemic toxicity (ISO-10993-11 or Guide 408)
- Chronic systemic toxicity (Guide 453)
- Photoprotection
- Skin irritation (Guide 404 or ISO 10993-10)
- Ocular irritation (Guide 405 or ISO 10993-10)
- Analysis “in vitro” – Skin test
- Analysis “in vitro” – Ocular test
- Sensitisation (Guide 406 or ISO 10993-10)
- Cytotoxicity, solubilisation (ISO 10993-5)
- Cytotoxicity, agar diffusion (ISO 7405)
- Hemocompatibility (ISO 10993-4 or Ph Eu)
- Intracutaneous reactivity (ISO 10993-10)
- Histopathology
- Pyrogens
- Protocol for environmental control facilities
- Protocol for microbiological suitability following the harmonized method
- Protocol for the determination…
- Protocol with special development
- Protocol for the Sterility test
- Protocol for LAL analysis
- Protocol for the Sterilisation process
- Protocol for the Bioburden test
- Biocompatibility