Catálogo de servicios
Service catalog
Catalogue de services
PRECLINICAL STUDIES
CLINICAL TRIALS
R&D – QUALITY CONTROL
MICROBIOLOGICAL TESTS
- Sterility test according to ISO 11737-2 or Pharmacopoeia.
- Determination of the population of microorganisms in products (Bioburden) according to ISO 11737-1.
- Determination of the population of microorganisms in the products (Bioburden) in masks according to UNE-EN 14683.
- Determination of the population of microorganisms in products (Bioburden) in surgical drapes and gowns according to UNE-EN 13795-1.
- Bacterial identification by means of VITEK.
PHYSICAL-CHEMICAL TESTS
- Organoleptic characteristics, PH, density, viscosity, peroxide value, acid value, moisture, dry residue.
- Water activity.
- Preservative studies
- Metal studies
SERVICES FOR PLACING ON THE MARKET
CHALLENGE TEST OR STUDY OF PRESERVATIVE EFFICACY
- Performed according to Pharmacopoeia.
- Possibility of “in house” pathogens and re-inoculation.
STABILITY AND COMPATIBILITY
Our climatic chambers, with controlled humidity and temperature, allow us to design stability studies of medical device according to ICH guidelines.
- ACCELERATED STABILITY: predicts the estimated shelf life of the sample. It is essential to perform in parallel a real stability.
- LONG-TERM STABILITY: performed for 2 years, although this period can be extended.
- PHOTOSTABILITY: performed on new formulations or new active ingredients in order to demonstrate that the product is not altered when exposed to light.
- STABILITY IN USE: to be consulted.
Dr. Goya analysis offers its clients:
- Advice on the design of stability studies.
- Conservation of samples under controlled conditions.
- Control of the critical parameters of the stored products according to the established sampling plan.
- Elaboration of the final report of the stability study with an evaluation of the results obtained, proposing a specific shelf life for each product according to the results obtained during the test.
BIOCOMPATIBILITY / TOXICOLOGY STUDIES
- Sensitization.
- Cytotoxicity.
- Dermal, mucosal and ocular irritation.
- Acute dermal toxicity.
IN VITRO TEST
In vitro safety studies carried out with our partner: GAIKER centro tecnológico
Safety tests are required by the regulatory agencies and are usually performed following international standard testing protocols.
BIOCOMPATIBILITY ISO 10993
- Skin absorption OECD 428
- ADME studies
TOXICOLOGY STUDIES
- Skin Irritation OECD 439.
- Skin corrosion OECD 431, OECD 435.
- Skin sensitisation OECD 442C, 442D, 442E
- Eye irritation OECD 492, Het-Cam
- Nasal irritation
- Oral, gingival, vaginal irritation
- Mutagenicity and genotoxicity
- Ames test OECD 471.
- Micronucleus test OECD 487
- In Vitro Mammalian Cell Gene Mutation Test OECD 476
- Phototoxicity OECD 432
- Cytotoxicity ISO 10993-5
- Endocrine disruption OECD 455
- Nanotoxicology
