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LEF performs analytical testing in accordance with cGMP regulation, maintaining our focus on our compromise with the client. An experienced team of laboratorial technicians ensures that testing is performed with quality and in a flexible way.

Method Development and Validation

A long lasting experience of 15 years in the development and validation of state-of-the-art analytical methods is available, in full compliance with current ICH and GMP guidance.

Analytical Methods
  • Assay 
    • Raw Material • Finished Product;
  • Impurities quantification and Related Compounds
    • Raw Material • Finished Product;
  • Assay of Dissolution Testing Samples;
  • Stability-indicating Methods / Forced Degradation Studies;
  • Preservatives & Antioxidants Assays;
  • Colouring Agents Identification.

Cleaning Validation
  • Development of Equipment & Facilities Cleaning Validation Programs;
  • Development & Validation of Analytical Methods for Cleaning Validation.

​Physical and Chemical Testing

Physicochemical Methods
  • Absorption Spectrophotometry
    • IV • UV • Vis • IR;
  • Chromatography
    • HPLC • GC • TLC;
  • Mass Spectrometry;
  • LC-MS/MS;
  • Potentiometric titration;
  • Physical & Chemical Tests.

Pharmaceutical Technical Procedures
  • Disintegration;
  • Solid & Semi-solid and Dissolution Testing;
  • Percutaneous Absorption Testing;
  • Uniformity of Mass/Content • Friability • Resistance to Crushing • Apparent Volume.

Stability Studies
LEF is equipped with environmentally (temperature and humidity) controlled climatic chambers, in accordance with ICH guidelines, to perform stability studies for raw materials and finished products, in order to define expiration dates and storage conditions.

Microbiology Testing
A fully equipped microbiology unit is prepared to provide all testing required for raw materials, packaging materials and finished products, in accordance with GMP and GPL. This microbiology unit has capacity to respond to several requests from various sectors, namely pharmaceutical products, medical devices and cosmetic and toiletries.

Continuous central monitoring of environmental and equipment parameters (temperature, RH% and pressure differentials) is complemented by power supply backup, which will contribute to assure a timely and high quality service.

Team

Our team of microbiologists has extensive experience in the analysis of pharmaceutical products, medical devices, cosmetic and toiletries and disinfectants.


​​Services
  • Sterility Testing;
  • Preservative efficacy Testing (PET);
  • Bacterial Endotoxin Testing (Chromogenic Assays);
  • Microbial Contamination / Bioburden Testing;
  • Detection of Specific Pathogens;
  • Organism Identification;
  • Disinfectant Efficacy;
  • Purified Water and Water for Injection;
  • Method Development and Validation;
  • Environmental Monitoring.

Consultancy services also available
  • Preventing microbial cross-contamination, biological hazards and any troubleshooting in your plant;
  • Assisting in laboratory setup;
  • Plant Personnel training.