T&E - Analítica






PHARMACEUTICAL QUALITY CONTROL

 

    The T&E Center has a structure to meet the companies in their Quality Controls, both in the inputs, intermediate products and finished products. For all analyzes we follow the International Quality Standards such as ISO17025; GLP and ANVISA, the latter being in its specific trials.

 

In order to serve the companies, we consider two types of Quality Control service:

 

·         CONTROL OF OFFICIAL QUALITY TO BE PRESENTED TO ANVISA- REBLAS

·         QUALITY CONTROL FOR INTERNAL COMPANY NEEDS

 

Both analyzes are official and use the same quality systems, that is, they have both purposes, which are available for audits of contracting companies and / or partners.

 


ON ANALYTICAL CONTROL-REBLAS

 

 

    On February 16, 2012 ANVISA published the RDC Nº12 regulating the laboratories known as REBLAS. The acronym REBLAS, which means: Brazilian Network of Analytical Laboratories in Health refers to a Network of Laboratories coordinated by ANVISA. The accreditation or accreditation of the laboratories is carried out by INMETRO (National Institute of Metrology, Quality and Technology)..

    The certification process takes place on request directly to this body, with the needs for the scope desired by the laboratory for pharmaceutical, cosmetic and other analyzes. The documentation consists of previous tests and methodologies with indicative of stability, validated according to the current standards, as well as calibrations and qualifications of all the equipment necessary for such analyzes. The service must include ISO17025 for both equipment and substances.

    At the time of the visit for certification, INMETRO's auditors in their different specialties, follow the analyzes, conduct interviews with analysts and management, verify company data such as: permit, VISA, ANVISA, permits from the Police, Army, Federal Police, warehouse , reference standards, qualifications, calibrations, operational procedures, training of employees, quality manual, that is, all documentation proving the credibility of the institution.

After the audit, documentation is sent with the audited scope informing the approval or disapproval. This document is sent to ANVISA to insert in the REBLAS scope. This process occurs between the request and the insertion of the scope in the ANVISA time between 12 and 18 months.

   

Only after publication / insertion of the scope on ANVISA's website, the laboratory can start providing services.

 

 

LABORATORY REBLAS is solely for QUALITY CONTROL analyzes, and may be requested by ANVISA for special studies

 

 

ANALYTICAL CONTROL - other fronts

    T&E Analytical Center since its creation has as its affinity analytical challenges, both in instrumental techniques and in classical chemistry.

Over the years, we have developed sampling systems for air-compressed air collection (chimneys, flares, etc.), lakes, rivers, soils, wells, swimming pools, among other challenges.

 

Studies and Products:

  

Mass balance of processing units, in different matrices, pyrophoric products, process chains, fuels, adulterations, analyzes in animal matrices, animal excrement, dairy-vegetable-animal foods.

·         Wine and Spirits: Resveratrol;

·         TCA(2,4,6 Trichloroanisole);

·         TBA (2,4,6 Tribromoanisole);
TeCA (2,3,4,6 Tetrachloroanisole); 

·         PCA (Pentachloroanisol); - Guaicol.

·         Carbamates, aldehydes, ethanol methanol, carboxylic acids, among others.

·         Beverages in General, Rations and Pre Mix, Petrochemical, Chemical, Dyes, among others.

 

MICROBIOLOGY: Microbiological analyzes for sterile, non-sterile and antineoplastic products

Determination of Content - Development and Validation, among other tests:

 

·         Coliformes Thermo tolerant;

·         Search of Salmonella;

·         Countable viable cells;

·         Challenge test (challenge test)

·         Endotoxins LAL

·         Fungi

·         Sterility

·         Determination of content (power)

·         Vitamin analysis

·         Testing in lids and containers,

·         Supports restaurant kitchens in contamination,

·         Sampling and analysis of process air and packaging,

·         Process validation analysis,

·         Verification of industrial contamination.

 

 ANALYTICAL TECHNIQUES

   To meet a variety of analytical methods, the REBLAS laboratory must have a range of analytical techniques, as well as professionals with expertise in this area. The equipment must be calibrated or qualified in its different needs. They must be enabled by INMETRO and ANVISA. The equipment can be divided for analysis of Organic and Inorganic. T&E Analytics has a high number of techniques and in quantity of equipment would require a large space on this page, however it can be inserted by category:

 

CHROMATOGRAPHY:

 

·         Liquid Chromatography (HPLC);

·         Gas Chromatography (CFG)

·         Preparative Chromatography;

·         Chromatography in Column;

·         Chromatography in Plate (CCD) in different detectors and couplings.

 

METALS / Ametais and Semi Metals:

·         ICP-OES - optical induced plasma;

·         AA- Atomic Absorption Spectrum;

·         FC- Flame Photometry;

·         Complexiometry, Calorimetry; Selective Electrodes; Potentiometry

 

INHALATION:

   They are specific equipment, for Sprays; DPI; MDI, such as:

 

·         DUSA for DPI / MDI / Spray;

·         NGI; ACI; MSLI;

·         Laser particle size;

·         Feather test;

·         Internal pressure test;

·         Balloon particle test;

 

  Other tests can be requested from our professionals, as well as the molecules we have

  dedicated since the year 2006.

 

 

·         IDENTIFICATION / quantification and General

·         IVFT - Transformed Fourier Infrared

·         TOC - total organic carbon

·         DSC- Differential Calorimetry

·         LCMSMS - liquid phase chromatography coupled to mass spectrometry

·         GCMS - gas chromatography coupled to mass spectrometry

·         HSS - Head Space Static coupled to gas chromatography and its detectors

·         Determination of peak purity using DAD.

·         Insulation of impurities by: SPE; SPMS; SBE; Liquid-liquid; Liquid-Vapor; chromatography Preparative;

·         Camera stability photo

·         Dissolver

·         Post-column reactions in chromatography

 

MICROBIOLOGY:

Microbiological analyzes for sterile, non-sterile and antineoplastic products

Determination of Content - Development and Validation, among other tests:

 

·         Coliformes Thermo tolerant;

·         Search of Salmonella;

·         Countable viable cells;

·         Challenge test (challenge test);

·         Endotoxins LAL;

·         Fungos;

·         Sterility;

·         Determination of content (power);

·         Vitamin analysis;

·         Testing in lids and containers;

·         Supports restaurant kitchens in contamination;

·         Sampling and analysis of process air and packaging;

·         Process validation analysis;

·         Verification of industrial contamination;

 

 

 

ARE VARIOUS TECHNIQUES, SO WE ARE ORIENTED TO CONTACT OUR PROFESSIONALS

FOR MORE DETAILS