Screen inhalatoria

Regulatory studies. Total traceability versus deficiency

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Among the main concerns related to the chemical industry, with great impact on health and the environment, the generation of poor regulatory studies is located or, in some cases, false. This was the circumstance that gave rise to the BPL in the Decade of the ’ 70 in the United States of America. Despite the controls implemented since, the strength of the programs of monitoring, the development of the MAD by the OECD and the progress in the management of quality systems, is still a red alarm on the emergence both of those made in conditions unfit to ensure the traceability of the same fake studies and, sometimes, the adequacy of these objectives intended in the respective guidelines.

The various scientific fields under which studies develop regulatory toxicology is, and it has been, the most sensitive in the aforementioned appearance and traditionally subject to regulatory control products (pesticides, drugs, additives in food, etc., etc.) now appear in other recent development or use for which it is being considered the adequacy and creation of new guidelines updated to the same regulatory (Nanomaterials, OMG´s, natural products, etc., etc.).

In the world of computer telecommunications are tools that provide one of the solutions most appropriate to the issue that we are facing.

The possibility of recording by video cameras and both transmit real-time implementation of a regulatory testing and archiving in the form complete the development of the same, He gives an invaluable strength to guarantee the real and proper execution of studies, It offers an indisputable traceability and is a unique utility for the further review of the proceedings during the trial for the purpose of improving the understanding of the scientific and technical aspects involved, not to mention the educational usefulness of the event.

Test entities that implement transmission, to order/authorization of the sponsor, they will be providing the best tool available to complement the BPL in the sense to avoid deficiency and falsehood in the field of regulatory studies.

 

 

Technical Director Prof.. Mg. Alejandro Lucini

 

 

 

UILI

The 2015 UILI Labmeeting & 26th General Assembly

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On Thursday 17 September is it will be carried out in Buenos Aires, Argentina, the event “The 2015 UILI Labmeeting & 26th General Assembly”

Taking advantage of the visit to our country, We will be pleased to receive in our laboratory the Directive UILI procession. It will be integrated by:

  1. DRS. Luc h.. Scholtis LABWING B.V., NETHERLAND
  2. Dr. Toru Matsumura IDEA, JAPAN
  3. Dr. Alvaro Silva Ribeiro NATIONAL LABORATORY FOR CIVIL ENGINEERING
  4. Mrs. Mary-Anne Adeeko FRALS TESTING, NIGERIA
  5. Lic. Gabriel Verlanga group INDUSER SRL, Argentina
  6. Mr. Alfredo Montes child MICROBIOTICOS, PARAGUAY-URUGUAY - BRAZIL
  7. Mr. José Luis Sánchez CEIS, SPAIN
  8. Mr. Masahiro Tanaka TOKAI-TECHNO, JAPAN
  9. Dr. Horacio LADIAC Denari, Argentina

The visit will take place on Friday 18 and you will have as main purpose to know our facilities and the management of the BPL (LPG) in our country.

Chemistry

QUALITY ASSURANCE

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  • Assays by HPLC;
  • Gas chromatography;
  • Infrared Spectrum;
  • Atomic absorption;
  • UV - visible Spectrum;
  • Potentiometric titrations;
  • Humidity by Karl Fischer;
  • Specific rotation;
  • Dissolution test;
  • Pharmacotechnical controls;
  • Tightness test;;
  • Several counter assays.
Microbiology

MICROBIOLOGY

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  • Trial of sterility in medicinal products, veterinary and medical technology;
  • Microbiological controls of not necessarily sterile products (medicinal products, veterinary and cosmetics);
  • Identification of microorganisms;
  • Microbial count;
  • Bacterial endotoxins - LAL Test;
  • Microbiological evaluations of antibiotics and vitamins;
  • Validation of microbiological evaluations;
  • Test of effectiveness of preservatives ( Challenge Test );
  • Assessment of heparins;
  • Determination of aflatoxin B1-B2; G1-G2;
  • Verification of microbiological technique.
Circle of vials - blue

ANALYTICAL DEVELOPMENT

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The analytical area offers the necessary support to the Galenic area in the different stages of the new product release..

Also performs:

  • Preparation of Monographic development to be presented below the different Sanitary Authorities;
  • Development and validation of analytical methods;
  • Studies of stability of formulations under controlled condition of temperature and humidity;
  • Comparative profiles of dissolution;
  • Analytical transferences.
Chemistry

CHEMISTRY

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The Chemistry Department has the most qualified professionals to perform the studies under the most stringent quality standards.. Among them are:

  • Chemical , with the use analysis of technical grades and formulated products for it registration using US-EPA, CIPAC and OECD. Some of them are:

Assay of active ingredient ((HPC - GLC - AA - – Titration method - Gravimetric method);
IR, H-NMR, and Mass Spectrometry;
Partition coefficient n-octanol/water;
Vapor pressure;
Explodability;
Hydrolysis;
Photolysis;
Surface Tension.

  • Design and development of analytical techniques.
  • Validation of analytical methods.
Green chemistry

PESTICIDE RESIDUES IN CROPS

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The Department of Organic Traces and Impurities is specialized in carrying out the following studies:

  • Determination of pesticide waste in vegetable matrices, water and soil;
  • Elaboration of degradation curves after use of agrochemical products;
  • Development and validation of analytical methods;
  • Impurity analysis in agrochemical products;
  • Impurity analysis in pharmaceutical products;
  • 5 5 Batch analysis of impurities in agrochemicals with registration purpose..

In order to perform these studies, the department counts with highly qualified and constantly trained staff, , and the following analytical equipment::

  • Gas chromatographs with NPD detectors, ECD and MS;
  • Liquid chromatographs with detectors DAD, FLD and MS-MS.
Hand holding test tube with water

ENVIRONMENT

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The Environment Department is specialized in carrying out the following studies::

  • Physicochemical, microbiological, biological analyses of waters, soils, mud and gaseous effluents;
  • Physicochemical Analysis of water for human consumption and recreation use according to C.A.A.;;
  • Microbiological Analysis of the environmental air and solid surfaces,
  • Ecotoxicological Analysis of waters and liquid effluents;
  • Studies on toxicological and ecotoxicological classification of chemical products and dangerous wastes;
  • Analysis of PCB´s in transformer oil, waters and contaminated soils;
  • Studies on environmental impact and evaluation;
  • Analysis of environmental risk.

Besides, it is enabled by the Environmental Protection Agency of C.A.B.A. (Buenos Aires Autonomous City),, Provincial agency for sustainable development.

Provincial Organism for the Sustainable Development. Performs the studies of Fertilizers and Organic Amendments following the A.O.A.C. guidelines,:

  • Nitrogen (ammoniacal, urea, devarda, total);
  • Phosphorus (Total, Assimilable, removable);
  • Soluble potassium;
  • Microelements (Calcium, Magnesium, Sulphur);
  • Oil elements (Cobalt, Copper, Iron, Manganese, Zinc, Molybdenum);
  • Heavy metals;
  • Biuret;
  • Soil reaction;
  • Dry sieving test;
  • Humidity;
  • Organic material and ashes;
  • Relation C/N;
  • pH;
  • Electrical conductivity;
  • Density (for liquid fertilizers) ;
  • Solubility;
  • Surface tension (for foliar fertilizers).

Finally, It is enabled by the national health service and agricultural quality (SENASA)

And performs the studies of Agrochemicals and chemical products with environmental purpose following the OECD-EPA guidelines:

  • Biodegradability;
  • Toxicity of elongation of root;
  • Toxicity to terrestrial plants;
  • Adsorption/desertion trial in soil.
  • To perform these studies the area counts with the following analytical instruments::
  • Gas chromatographs with FID detector, NPD, ECD and MS;
  • Liquid chromatographs with detectors DAD, FLD and MS-MS;
  • Spectrophotometer of Atomic Adsorption (FAAS and GFAAS) ;
  • Infrared spectrophotometer (FT-IR) ;
  • UV-VIS spectrophotometer;
  • Inductively Coupled Plasma Atomic emission spectrometer (ICP AES);
  • Total organic carbon Analyzer (TOC).
thirst

BIOLOGY

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The Biology Department is specialized in the following studies:

Toxicological studies, following the principles OECD-EPA :

  • Acute oral toxicity, subchronic and chronic oral toxicity;
  • Acute , subchronic and chronic oral toxicity;
  • Inhalation toxicity, subchronic and chronic oral toxicity;
  • Corrosive/ Irritant ocular effects;
  • Corrosive/ Irritant dermal effects;
  • Skin sensitisation;
  • Mammalian erythrocyte micronucleus test;
  • Mutagenicity test.

Ecotoxicological studies, following the principles OECD-EPA :

  • Phytotoxicity assay;
  • Toxic effects on algae;
  • Toxic effects on microcrustaceans;
  • Toxic effects on earthworms;
  • Acute oral and contact toxicity to honey bee;
  • Acute oral and dietary toxicity to birds;
  • Acute and prolonged toxicity to fish;
  • Nitrogen/Carbon transformation test: Soil microorganisms;
  • Avian reproduction toxicity test.

Biological trials on medicinal and cosmetic products, following the guidelines of USP-FDA-EP:

  • Dermic primary irritation index;
  • Eye irritation index;
  • Index of superficial dermal aggressiveness by repeated application;
  • Index of dermal sensitization;
  • Photosensitizing agents and Phototoxicity test;
  • Vivo pyrogenic substances test;
  • Safety test;
  • Intracutaneo toxicity test;
  • Histolesividad muscle test;
  • Biological assessment of hormones.

Biological studies for registration of medicinal products for human and veterinary use.

Biological studies to obtain authorizations of use commercialization of medical technology products.

Design and carrying out of non-clinical studies (Pre-clinical).