QUIÉNES SOMOS SERVICIOS AUTORIZACIONES EQUIPO E INSTALACIONES NOTICIAS INFORMES CONTÁCTANOS MEDICAL DEVICE RESEARCH AND DEVELOPMENT SERVICES Support services for R&D Departments, Learn more PLACING ON THE MARKET SERVICES Services to confirm compliance with placing on the market requirements. Learn more QUALITY CONTROL SERVICES Services to guarantee batch quality according to specifications Learn more FACILITIES CONTROL SERVICES Services to guarantee safety and hygiene of facilities and equipment Learn more RESEARCH AND DEVELOPMENT SERVICES MICROBIOLOGICAL TESTS Sterility test according to ISO 11737-2 or Pharmacopoeia. Determination of the population of microorganisms in the 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 the products (Bioburden) in surgical drapes and gowns according to UNE-EN 13795-1. Bacterial identification PHYSICAL-CHEMICAL TESTS Organoleptic characteristics, Ph, density, viscosity, peroxide index, acid number, moisture, dry residue. Water activity. Preservative studies. Heavy metal studies. PLACING ON THE MARKET SERVICES CHALLENGE TEST OR STUDY OF THE EFFECTIVENESS OF THE PRESERVATIVE Performed according to Pharmacopoeia. Possibility of pathogens “in house”, and re-circulation. STABILITY Carried out in Climatic Chambers under temperature and humidity control. Accelerated stability. Long term stability. COMPATIBILITY Performed out in Climatic Chambers under control of temperature, humidity and light. Accelerated compatibility. Long term compatibility. BIOCOMPATIBILITY / TOXICOLOGY STUDIES Sensitization. Cytotoxicity. Skin, mucosa and eye irritation. Acute dermal toxicity. EFFICACY STUDIES Request for a clinical study of a health product to the Ethics Committee (CEim) and study request to the Spanish Medicines Agency (AEMPs). Preparation and preparation and documentation in front of the CEim and in front of the AEMPS. Clinical evaluations in Class IIa, IIb and III products. QUALITY CONTROL SERVICES MICROBIOLOGICAL TESTS Sterility test according to ISO 11737-2 or Pharmacopoeia. Determination of the population of microorganisms in the 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 the products (Bioburden) in surgical drapes and sheets according to UNE-EN 13795-1. Bacterial identification by VITEK. PHYSICOCHEMICAL TESTS Organoleptic characteristics, Ph, Density, Viscosity, Peroxide index, Acidity index, Humidity, Dry residue. Water activity. Preservatives studies. Metals studies. Others: consult the laboratory. FACILITIES CONTROL SERVICES PURIFIED WATER TESTS Microbiological control: Aerobic count and determination of pathogens Physicochemical Control: Odor, color, turbidity, pH, conductivity, nitrites, ammonia, oxidability, total chlorine, free residual chlorine, heavy metals. AIR AND SURFACE TESTS Microbiological control: Determination of aerobes, molds and yeasts. THE LABORATORY THAT MAKES A DIFERENCE 91 889 36 00 Follow us on Twitter info@laboratoriogoya.com Find us on Linkedin Vía Complutense, 75 28805 Alcalá de Henares MADRID Empresa perteneciente Our Company About Us authorizations Equipment and Facilities Contact Us News Reports Services Clinical Analysis Cosmetic Products Medical Device Food Suplements Services Clinical Trials Hygienic Control of Facilities Water Analysis Food Legal Advice Privacy Policy Cookies Policy Contact Laboratorios Dr Goya | Vía Complutense, 75 | 28805 | Alcalá de Henares | Madrid | info@laboratoriogoya.com | 91 889 36 00 Aceptación de Cookies Utilizamos cookies propias y de terceros para fines analíticos. Puede aceptar todas las cookies pulsando en el botón de ACEPTAR o configurarlas o rechazar su uso, pulsando en el botón "Administración de cookies". Haga click aquí para Leer más Administración de Cookies ACEPTO ▲