Pharmaceutical and Healthcare
Industry (Medical Devices)
In the most demanding sector in terms of quality, we help you find the solution to achieve your objectives, in design and control.
We know the pressure that the industry imposes on the rapid launch of new products in the market. Our goal is to offer a fast, personalized and quality service.
You will find our support for all those tests, studies, technical advice or know-how transfer that you need for your business to grow and develop.
Algunas de nuestras actividades y servicios en estos sectores serían:
Physicochemical Analysis
- Physicochemical parameters: humidity, density, viscosity, pH, conductivity, ...
- Determination of actives by volumetric, spectrophotometric and chromatographic techniques.
- Development and validation of analytical methods (ICH Q2 (R1))
- Determination of impurities and degradation products
- Limit tests: heavy metals, sulfur ashes, residual solvents, ethylene oxide and dioxane residues, fatty acid composition, ...
- Essential parameters: complexometric titrations, Karl Fischer, Kjeldahl, oxidizing substances, indexes, ...
- Reactions and identification analysis
- Quality control of APIs according to Ph. Eur. and USP monographs.
- Quality control of plastic materials and containers (Ph. Eur. 3.2 Containers, USP ˂661,1˃ and <661,2> Containers - plastic)
- Ethylene oxide sterilization residues (ISO 10993-7).
- Chemical characterization:
- Leachables & Extractables (ISO 10993-13/14/15/17/18)
- Generation of Medical Device Extracts (ISO 10993-12)
- Pharmaceutical technology methods: dissolution, uniformity, friability, sieve analysis, bulk density, visible and invisible particles, ...
Microbiological Analysis
- Microbiological quality control (Ph. Eur. 2.6.12 and Ph. Eur. 2.6.13): Suitability of method and product control.
- Determination of the microbial load Bioburden (ISO 11737-1): Method suitability and product control.
- Sterility test (ISO 11737-2 and Ph. Eur. 2.6.1): Method suitability and product control.
- Media Fill Test
- Growth promotion of Ph. Eur. 2.6.12 culture media.
- Antimicrobial preservative efficacy (Ph. Eur. 5.1.3 and USP ˂51˃).
- Identification of microorganisms by:
- Advanced phenotypic methods: identification by MALDI-TOF MS (matrix-assisted laser desorption/ionization time-of-flight (maldi-tof) mass spectrometry (ms)).
- Large staining, microscopy/classical phenotypic methods (biochemical galleries)
Biocompatibility/Biosafety
- Determination of cytotoxicity in vitro
- According to ISO 10993-5 / USP <87>.
- Readout: XTT / Neutral Red Uptake (NRU) / MTT / MTS
- Determination of phototoxicity (OECD TG 432)
- Determination of Genotoxicity (AMES Test, OECD TG 471)
- Skin irritation and in vitro sensitization
- In vitro skin irritation on reconstructed human epidermis: ISO 10993-10/23 as draft/OECD TG 439)
- ARE-Nrf2 luciferase test method (Kerationsens assay): OECD TG 442d
- Human Cell Line Activation Test (h-CLAT): OECD TG 442e
- In vitro skin corrosion (OECD TG 431)
- Eye corrosion and irritation
- Test similar to human corneal epithelium: OECD TG 492
- Ocular corrosives and severe irritants: OECD TG 460
- Genotoxicity
- Bacterial reverse mutation test (AMES test): DIN ISO 10993-3 / OECD TG 471
- In vitro mammalian micronucleus test: DIN ISO 10993-3 / OECD TG 487
Other Analysis
- Facility qualification: Environmental and surface control and cleaning validation
- ICH Q1a (R2) stability testing: Design, storage and/or analysis
- Sealing test - Self-sealing test (Ph. Eur. 3.2.9 Enclosure systems)