servicios en I+D laboratorios Dr Goya

RESEARCH AND DEVELOPMENT SERVICES

Support services for R&D Departments,

servicios para puesta en el mercado Laboratorios Dr Goya

PLACING ON THE MARKET SERVICES

Services to confirm compliance with placing on the market requirements.

servicios en el control de calidad laboratorios Dr Goya

QUALITY CONTROL SERVICES

Services to guarantee batch quality according to specifications
servicios en control de instalaciones en laboratorio Dr Goya

FACILITIES CONTROL SERVICES

Services to guarantee safety and hygiene of facilities and equipment
servicios en I+D laboratorios Dr Goya

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.
servicios para puesta en el mercado Laboratorios Dr Goya

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.

servicios en control de instalaciones en laboratorio Dr Goya

THE LABORATORY WHO MAKES THE DIFERENCE

91 889 36 00

info@laboratoriogoya.com

Vía Complutense, 75
28805 Alcalá de Henares
MADRID

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