WELCOME TO IIRT.pptx

Welcome to Institute for Industrial Research & Toxicology

1. WELCOME TO II R T A Research & Innovation Group

2. INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY

3. ABOUT US Institute for Industrial Research & Toxicology (IIRT) started in the year 2007. An independent self sustaining, multi-disciplinary contract research organization (CRO) Providing exceptionally reliable and cost-effective Laboratory Testing Services..  IIRT provides Chemical, Microbiological, Pharmacological, Toxicological & Ecotoxicological testing of Agrochemicals, Microbial Products, Pharmaceuticals and Medical devices, respectively.

4. BOARD OF DIRECTORS NN MISHRA ABHISKEK MISHRA SHALINI MISHRA

5. 5 This multidisciplinary research institute runs with the motto of “ Advancing Life through Novelty and Reliability” and to provide services to Industry which addresses problems critical to human health and environment. IIRT is committed to develop, innovate, analyze and apply technology for products and processes.  OUR PROMISE

6. OUR SERVICES REGULATORY TOXICOLOGY STUDIES ECOTOXICOLOGY STUDIES DRUG & PHARMA TESTS METHOD VALIDATION & CHEMICAL ANALYSIS MICROBIOLOGY TESTS

7. SMALL ANIMAL HOUSE FACILITY

8. SMALL ANIMAL HOUSE FACILITY IIRT specialized animal house facility with controlled environment designed for the housing, care, and study of laboratory animals like Rat, Mice, Rabbit, Hamster & Guinea pig. These facilities play a critical role in scientific research across various disciplines, including biology, medicine, pharmacology, toxicology, and genetics. Strict hygiene and biosecurity measures are implemented to prevent the introduction and spread of diseases among animals. Animals are often housed in isolation or specific pathogen-free (SPF) conditions to ensure their health. Ethical considerations and animal welfare regulations are followed to ensure the humane treatment of animals. This includes providing proper housing, nutrition, veterinary care, and enrichment to promote their well-being.

9. SMALL ANIMAL HOUSE FACILITY

10. INTRAVENOUS TOXICITY TEST

11. INTRAVENOUS TOXICITY TEST Test Guideline: IP/BP/USP Intravenous (IV) toxicity testing is a laboratory procedure used to assess the toxic effects of a substance when it is administered directly into the bloodstream through intravenous injection. This type of testing is typically conducted in animal models, such as rats or rabbits, to evaluate the potential harm of chemicals, pharmaceuticals, or other test materials when introduced directly into the circulatory system. The primary purpose of intravenous toxicity testing is to evaluate the acute toxicity of a substance following direct injection into the bloodstream. It helps assess the substance's potential to cause systemic toxicity, organ damage, and lethality.

12. PYROGENICITY/SYSTEMIC TOXICITY TEST IN RABBIT Test Guideline: IP/BP/USP Pyrogen toxicity refers to the potential harmful effects of pyrogens when introduced into the body. Pyrogens are substances, typically endotoxins or exotoxins, that can induce fever or an immune response in organisms, including humans. The term "pyrogen" is derived from the Greek words "pyro," meaning fire, and "gen," meaning to produce, reflecting the fever-inducing properties of these substances. Pyrogen testing is crucial in industries that manufacture or use medical devices, pharmaceuticals, and parenteral drugs (those administered via injection or infusion). These products must be free of pyrogens to prevent adverse reactions in patients.

13. INTRAPERITONEAL TOXICITY TEST IN RAT/MICE Test Guideline: OECD 420 The intraperitoneal (IP) toxicity test is a laboratory procedure used to assess the toxic effects of a substance when it is administered directly into the peritoneal cavity of test animals, typically rodents like rats or mice. This test provides information about the substance's potential to cause toxicity, including systemic effects, organ damage, and lethality. The primary purpose of the intraperitoneal toxicity test is to evaluate the acute toxicity of a substance following direct injection into the peritoneal cavity. It is commonly used in toxicological studies to assess the potential harm posed by chemicals, pharmaceuticals, or other test materials.

14. ACUTE ORAL TOXICITY TEST IN RAT/MICE Test Guideline: OECD 420, 423 & 425 Acute oral toxicity testing in rats is a standard toxicological assessment conducted to evaluate the potential adverse effects of a substance when it is ingested orally by rats. This type of testing provides important data for assessing the safety of chemicals, pharmaceuticals, and other substances. The primary objective of acute oral toxicity testing in rats is to determine the median lethal dose (LD50) or estimate the dose at which a substance is toxic enough to cause mortality in 50% of the test animals within a defined observation period.

15. BACTERIAL ENDOTOXIN TEST (BET) The bacterial endotoxin test, also known as the Limulus amebocyte lysate (LAL) test, is a laboratory assay used to detect and quantify the presence of bacterial endotoxins in various substances, particularly pharmaceuticals, medical devices, and biological products. Bacterial endotoxins are lipopolysaccharides (LPS) found in the cell walls of Gram-negative bacteria. Detecting and quantifying these endotoxins is essential for ensuring the safety and quality of medical and pharmaceutical products.

16. MICROBIAL LIMIT TEST (MLT) The microbial limit test, also known as microbial enumeration or microbial bioburden testing, is a quality control test performed in various industries, including pharmaceuticals, cosmetics, food, and beverages. Its purpose is to determine the total number of viable microorganisms present in a given sample or product. The primary goal of the microbial limit test is to assess the microbial contamination of a product and determine if it meets specified microbiological quality standards. This is crucial for product safety, stability, and shelf life.

17. STERILITY TEST (ST) The sterility test is a crucial quality control procedure used primarily in pharmaceutical, biotechnology, and medical device manufacturing industries to ensure that products are free from viable microorganisms that could potentially harm patients or users. The test aims to confirm that a product, such as a drug, medical device, or sterile packaging, is sterile and does not contain any living microorganisms. The primary goal of the sterility test is to determine whether a product is free from viable microorganisms that could cause infections, illnesses, or other adverse effects when administered to patients or used in clinical settings.

18. ANALYTICAL TEST LABORATORY Analytical testing refers to a set of laboratory techniques and procedures used to determine the chemical composition, physical properties, quality, and purity of substances and materials. It plays a critical role in various industries, including pharmaceuticals, food and beverages, environmental monitoring, materials science, and more. Analytical testing is essential for ensuring product safety, compliance with regulatory standards, and quality control. Many industries, such as pharmaceuticals and food production, are subject to regulatory requirements that mandate specific analytical testing to ensure product safety and quality. Compliance with these regulations is crucial for market approval.

19. DRUG & PHARMA LABORATORY Pharmaceutical laboratories perform a wide range of quality control tests to verify the identity, purity, potency, and safety of pharmaceutical products. These tests include chemical, physical, and microbiological analyses. These laboratories utilize various analytical techniques and instruments, including high-performance liquid chromatography (HPLC), gas chromatography (GC), mass spectrometry (MS), nuclear magnetic resonance (NMR) spectroscopy, ultraviolet-visible (UV-Vis) spectroscopy, and more, to perform tests on drug substances and pharmaceutical formulations.

20. DRUG & PHARMA LABORATORY Raw materials used in pharmaceutical production, such as active pharmaceutical ingredients (APIs), excipients, and packaging materials, undergo extensive testing to ensure their quality and suitability for use. Pharmaceutical laboratories perform a wide range of quality control tests to verify the identity, purity, potency, and safety of pharmaceutical products. These tests include chemical, physical, and microbiological analyses. Laboratories develop and validate analytical methods specific to each drug or pharmaceutical product. Method validation ensures that the testing procedures are accurate, precise, and reliable.

21. METHOD VALIDATION & 5-BATCH ANALYSIS Method validation is a critical process in analytical chemistry and laboratory testing. It involves a series of experiments and procedures to demonstrate that an analytical method is suitable for its intended purpose, providing reliable and accurate results. Method validation is essential to ensure the quality, accuracy, and consistency of analytical data generated by a specific method. Batch analysis in chemistry refers to the process of analyzing multiple samples or batches of substances or products for quality control, research, or testing purposes.

22. GCMS ANALYSIS OF CHEMICAL PRODUCTS GC-MS, which stands for Gas Chromatography-Mass Spectrometry, is a powerful analytical technique used for the qualitative and quantitative analysis of a wide range of compounds in various samples. It combines two separate analytical methods, gas chromatography (GC) and mass spectrometry (MS), to provide detailed information about the chemical composition of a sample.

23. ACUTE & CHRONIC TOXICITY TEST IN EARTHWORM Test Guideline: OECD 207 & 222 Earthworm acute toxicity tests are scientific studies designed to assess the toxic effects of substances or environmental conditions on earthworms (often Eisenia fetida ) over a short exposure period. Earthworms play a vital role in soil ecosystems and are sensitive indicators of soil quality. These tests are conducted to evaluate the potential risks of various contaminants, pesticides, and chemicals to soil ecosystems. Earthworm reproduction toxicity tests are laboratory experiments designed to assess the impact of substances or environmental conditions on the reproductive capabilities of earthworms . Data from earthworm acute and reproduction toxicity tests may be used in regulatory evaluations, especially for assessing the safety of pesticides, chemicals, or soil amendments that could affect soil ecosystems. Regulatory decisions may be based on these test results. Eisenia fetida

24. ACUTE CONTACT/ORAL TOXICITY TEST IN HONEYBEE Test Guideline: OECD 213 & 214 Honey bee oral and contact tests are laboratory-based experiments designed to evaluate the toxicity of substances (e.g., pesticides, chemicals) to honey bees ( Apis mellifera). These tests help assess the potential risks of these substances to honey bee populations and can be crucial for regulatory approval and environmental protection. In the contact toxicity test, honey bees are exposed to the test substance through direct contact with treated surfaces or materials. In the oral toxicity test, honey bees are exposed to the test substance through their food source, often a sugar syrup or pollen supplement.

25. ACUTE TOXICITY TEST IN FRESHWATER ALGAE Test Guideline: OECD 201 Algae tests are scientific studies designed to assess the effects of various factors, including pollutants, environmental conditions, and treatments, on algal populations. Algae are essential components of aquatic ecosystems, and studying their responses can provide insights into water quality, ecological health, and potential environmental stressors. Data from algae tests are often used in regulatory contexts, such as assessing water quality standards or the environmental impact of industrial discharges. Regulatory agencies may rely on these tests to establish guidelines and regulations for pollutant levels in water bodies Algae Culture

26. ACUTE TOXICITY TEST IN FISH Test Guideline: OECD 203 Acute toxicity tests on fish are conducted to assess the short-term toxic effects of chemicals, pollutants, or environmental stressors on fish species. These tests are crucial for evaluating the potential risks that substances pose to aquatic ecosystems and fisheries. The data is used to establish the concentration-response relationship and to calculate key parameters, such as the median lethal concentration (LC50) or median effective concentration (EC50) for the test substance. Zebra fish

27. ACUTE TOXICITY TEST IN Daphnia magna Test Guideline: OECD 202 This test is a commonly used bioassay in ecotoxicology to assess the toxicity of substances to aquatic organisms, particularly Daphnia magna, a small freshwater crustacean commonly known as the water flea. This test is used to determine the potential harmful effects of chemicals and pollutants on aquatic ecosystems. Daphnia magna

28. Daphnia magna REPRODUCTIVE TOXICITY TEST Test Guideline: OECD 211 Daphnia magna is commonly used in toxicity testing to evaluate the effects of chemicals and pollutants on aquatic life. Their short reproductive cycle allows for rapid assessment of potential hazards. Research involving Daphnia can help identify harmful substances and assess the ecological risks associated with various pollutants.

29. AVIAN TOXICITY TEST Test Guideline: OECD 223 Avian toxicity tests are a type of scientific study designed to assess the toxic effects of substances or chemicals on birds. These tests are essential for understanding the potential risks of environmental contaminants, pesticides, industrial chemicals, and other substances to avian species and their ecosystems. Birds can be exposed to the substance through various methods, such as ingestion (oral exposure), inhalation (airborne exposure), or dermal contact (skin exposure). The exposure duration may vary from acute (short-term) to chronic (long-term) exposure.

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