Testing Services

 There are so many medical devices manufactured and used around the world and they are required medical devices to be sterile, that is they have to be free of viable microorganisms. To make sure that the medical devices are free from microorganisms nation and international quality assurance systems have laid down the requirements of correct validation and control of sterilization processes and bio burden testing of medical devices.
 
 
To adopting the standards for minimizing the microbiological contamination of the medical devices prior to the sterilization, we can achieved by controlling the process, raw materials, and environment during the manufacturing. Even though taking care of the controlling the process it might be small numbers of microorganisms can be found on the medical devices before sterilization making them non-sterile.
 
Bioburden is the population of viable microorganisms on a product. D10 is the radiation dose required to kill 90% (1 Log) of a homogeneous microbial population. Dose is the calculated level of radiation absorbed by the product which are present on or in a product or a sterile barrier system. It is important isssue to understand the bio burden as it.

 IIRT is in India but is a renowned and trusted name for Biocompatibility testing in world wide. Our Biocompatibility testing results are widely acknowledged and trusted. The sensitivity of testing is aware therefore, all the test is performed in the safe and secure environment considering all the necessary measures. We have a respectable and renowned clients in oversease countries as well as in India. The process of biocompatibility testing in long and costly but we here, assures to give the accurate report in the promised time at the best possible price in the market.

Various safety evaluation studies are conducted on biomaterials, medical devices, and related products to identify the presence of toxins or any other harmful components. Biocompatibility testing needs to meet FDA and international standards and for that variety of test are done which ranges from the initial screening of new materials to product release testing, periodic audit testing, and non-clinical or pre-market safety evaluations.

Biomaterials, medical devices, and related products need a biocompatibility testing. The biocompatibility testing is done to challenge the different biological models with the suitable extract. The primary test categories to determine the biological effect includes: Acute systemic toxicity testing to identify if there is the presence of toxins or any other harmful effects. Biocompatibility testing starts with initial screening of new materials before a product release testing, periodic audit testing, and non-clinical or pre-market safety are the other evaluations which are done to meet the current FDA and international standards.

IIRT performs best biocompatibility testing to evaluate appropriate use of the component material or finished product. These biocompatibility tests challenge various biological models with the test material or a suitable extract. While biocompatible testing we assure to follow all the FDA guidance and ISO standards.

IIRT offers a comprehensive set of tests for surgical face masks and general-use medical masks. These tests are essential to ensuring performance properties  to support marketing label claims and to classify these mask types, additional tests may be required depending on label claims.

Genetic toxicology studies are conducted for assessing the potential for induction of genetic mutations or chromosomal damage. For all classes of chemicals and drugs the Genetic toxicology testing is required but variations in conducts are possible. This may vary from compound to compound on account of regulatory requirements or depending on the choice and design of assays.

Since many years, IIRT Institute for Industrial Research & Toxicology has been helping clients with the customized testing strategies to provide appropriate assays to meet the requirements which are unique and varies as per chemicals and drugs. Our huge, dedicated, experienced and well-versed staff is dedicated for the genetic toxicology testing. We have the regulatory consultants and program managers which support the clients’ studies with strategic advice. We believe in upgrading ourselves with knowledge and technology with regulatory working groups and international societies ensuring that our clients are exposed to latest science and its and applications.

To determine the compound’s potential genotoxicity is an important component to assure complete safety assessment of all new launch of products in various categories  like pharmaceutical ingredients, pharmaceutical impurities, unique human metabolites, industrial chemicals, agrochemicals, cosmetics etc. Earlier the testing the better it is for the companies. As it helps in the determination of the product well-being if it’s without any adulteration and if not then the scope of further development is discussed. We do the additional testing to investigate and characterize the relevance of any observed adverse effects. Since most studies are performed in vitro, we at IIRT Institute for Industrial Research & Toxicology also incorporate vivo genetic toxicology studies if necessary.

 Sanitary Napkin Pad Testing as Per IS 5405 and ISO 10993

IIRT undertake the testing of Sanitary napkins which are used by women when they menstruate. Though using Sanitary napkins pain that comes with menstruation they can certainly reduce the inconveniences associated with vaginal discharge. Quintessential for women, sanitary napkins need to be of superlative quality, so that they don’t have to deal with leakages and discomfort.

These senitary napkins pad  make absorbtion of  the blood discharge without leaking for a specific number of hours. The senitary pad are use based on use and through systemitacally. 

Quality Standards for Sanitary Napkins

To insure good quality of sanitary napkins,  quality insured specifications have been formulated by the Bureau of Indian Standards. IS 5405 has detailed descriptions of the norms and regulations that the sanitary napkin manufacturers have to adhere to.

Parameters for testing quality of sanitary napkins

Sanitary napkin has an absorbent filler like cellulose pulp, cellulose wadding, tissues and cotton. These filters are tested to ensure that they do not contain lumps, oil spots, dirt and foreign contaminants.

The covering of the absorbent fillers is the material that allows the discharge to flow into it. It has to be porous. Mostly materials like cotton, gauze and non-woven fabrics are used for making the coverings. They should also be clean and hygienic.

Test of finishing

The surface of the pad should feel soft and comfortable and should not cause any irritation to the skin. The adhesive used to assemble the pad should be used carefully to stick only at the correct points. The absorbent fillers should be placed at even distances to make the surface of the pad smooth.

Testing of absorbents

IIRT is conducting tests on absorbents by subjecting them to liquids. If they can soak adequately without leaking, they are accepted to be good.

Testing sanitary napkins on these parameters according to IS 5405 the biocompatibility test should be according to ISO 10993 to quality Cytotoxicity, Skin irritation and skin senstization. 

 We at IIRT do all the medical device testing, following all the measures and assuring the most appropriate result. The sensitivity of all medical device test is well known to us and therefore, we here assure to follow the instructions and take care of minute details. IIRT is the renowned and trusted institute for medical device testing not only in India but also abroad. We give the extreme service of medical device testing in South Africa, Kenya and India. A wide range of MEDICAL DEVICE test methods is built. We at IIRT make your testing quicker to access and do the product analysis of your product with detailed properties which are prepared and shared with you. The medical device testing and stamping from IIRT is widely recognised and apricated. We are renowned for our medical device testing in South Africa, Kenya and India. If you are one of the medical device manufacturers and is looking for the trusted laboratory for getting your medical equipment attested, then trust IIRT.

We are respected medical device testing institute with handful of experience with medical device testing, medicine and combination product testing. Medical device manufacturers need testing to medical device's each functionality. Medical device testing help to identify unforeseen challenges ot prevent unacceptable risks to patients. We have dedicated team of medical device test experts. our highest level technology ensure accuracy in medical device testing. We follow all the standards set by the device industry and our certification for medical device testing is renowned and recognized. We are popular among our clients as medical device testing laboratory because of our integrated regulatory policies, toxicology, microbiology, chemistry, clinical and quality services which all are conducted with the prime objective that the device available in market is safe and effective.

IIRT is a renowned service provider to various industries for microbiological testing. The microbiological test done here assures that the tested product should be a quality product and safe to consume. Our microbiological testing also checks the meeting of the product quality measures as per the product-specific standards. All microbiological testing done at IIRT is to ensure that the product is free from disease-causing contaminants and can be consumed.

Microbiological testing is necessary for contamination detection and to ensure that the quality standards are met. Microbial testing is the most important testing against disease-causing bacteria and toxins. 

IIRT has state of the art pathology facility. Our services include:

Histopathology

• Routine and specialized necropsy procedures of different species of animals.
• Tissue processing and slide preparation.
• Routine (H&E) and special staining techniques.
• Microscopic evaluation of slides by Veterinary Pathologists.

Clinical Pathology Services:
Hematology (multispecies).

• Serum biochemistry.
• Urinalysis.

Residue like pesticides are regulated by law. Therefore, it is vital to check their presence in food commodities. For this one needs to get the pesticide level checked in different food products. To do the pesticide testing one needs to do the product sampling. It is the sampling and testing that enable us to find the amount and type of pesticide present, which further helps in rating the quality and quantity (which is safe to be consumed) of the pesticide in the sample product.

Toxicological research centre has an experienced team of expertise scientist who go into the detail pesticide studies of the sample for testing the commodity. It is our scientist and the high standards well equipped laboratories that ensures the high accuracy in the results. It is because of the accurate results that our reports are widely accepted.

Pesticides are chemicals are used in agricultural production. These are used to control pest and save crops. The term ‘pesticide’ includes insecticides, herbicides, fungicides, algaecides and fumigants. Toxicity plays an important role in analysing and certifying the pesticides both technically and for safe usage formulation. Toxicity is well established and has the facilities to carry all the tests related to pesticide testing to ascertain the conformity as per national and international specifications.

 Pharmacological testing square measure used once one needs to judge if a substance or plant extract is biologically active. Pharmacological Testing ways for medicine performing on the Peripheral system. Our Pharmacological testing services enable us to predict biological effects of latest molecular entities. Safety Pharmacological testing studies square measure studies that investigate potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure at intervals the therapeutic vary or higher than. These Pharmacological testing studies studies ought to be designed to spot undesirable pharmacodynamic properties of a substance which will have connexion to its human safety, to judge adverse pharmacodynamic  and pathophysiological effects discovered in materia medica  and clinical studies.

We also carry out study and research on drugs & pharmacological testing, which is called the Pharmacological Study Services. Everything about the drugs is carefully studied by us and we also conduct various experiments to substantiate our study. We also carry out research activities to find out how the living tissues and the organisms function. Their scope for modification by the chemical substances is also studied. The pharmacological study is divided into two streams pharmacodynamics and the pharmacokinetics.

 Personal Protective Equipment (PPE) Testing wich is provide by IIRT also popularly known as PPE kit testing This test ensures different types of PPE equipment’s which are safe and secure and can protect the wearer. There is a testing requirement of PPE kit with a specific PPE test.

Currently when pandemic disease COVID-19 is a fear for all humankind, the workers working at potentially dangerous workplace environment use PPE kit to protect them against health and safety risks. The assurance of the PPE manufacturers that their equipment will perform as promised the PPE Kit testing is done here.

The PPE kit test passes through government recognised 6/6 synthetic blood penetration resistance test pressure where the minimum requirement is of 3/6 synthetic blood penetration resistance

We take global measures during the process of testing and our reports are widely recognised and accepted for their authenticity. We are a renowned testing laboratory globally and you can get the benefit from our PPE kit testing report. Our PPE kit testing report is supported completely regardless of where PPE is manufactured or distributed.

To know more about the PPE Kit testing send us an enquiry below and our team of expertise will contact you at the earliest with answer to all your queries.

New genetic technologies are increasingly being used in the clinical testing; the need for this is to ensure the discourse on the ethical use of the products on the offspring. The greatest urgency in reproductive toxicity study is the genetic testing. The main reason for the increasing demand of this test is the increasing commercialization and expanding scope of noninvasive prenatal testing.   The study done on the commodity/ product is to ensure that there are no possible threats neither on disability nor on genetic diversity on consumption of the same. Reproductive toxicity testing reports ensures thorough acknowledgment from clinicians, researchers who are expertise in genetics. Reproductive toxicity testing is a highly sensitive test and we here surely understand the “dangers of oversimplification” therefore in hypothetical scenarios, giving full consideration to our social responsibility our reports also address the common misconceptions about the human genome and about the capabilities of some reproductive genetic technologies. It is our detailed report and our latest technology usage that has made us the renowned and trusted name for reproductive toxicity testing in South Africa. We at IIRT have exxtended ourselves and has gained the popularity as the trusted reproductive toxicity testing service provider in India, South Africa and Kenys.

 Stability testing is to certify that the how long a medical devices, pharmaceutical product, chemicals product and pesticide products can be stored without any change in its original chemical composition within prescrived limits.
 
The material and products when stored for long durations there should not be any changes and release byproducts. Stability testing provides evidence on how certain pharmaceutical drugs can be stored at room temperature and in controlled conditions.
 
The physical, chemical and microbial properties of a chemicals, medical devices and pharmaceutical product may change under extreme storage conditions. The shelf-life of a product has been studied during the stability testing under the prsecrived temparature and humidity.

Swab test is provided to determine compliance with the requirements given in the individual monograph / specifications.Swab test is the counting of total number of aerobic bacteria, yeasts and molds on any surface.

 IIRT (Institute For Industrial Research & Toxicology) is a prominent name in toxicity testing laboratories. We committed towards developing, analysing, innovating toxicity testing for our all global and Local clients.  Our  toxicity testing lab has using and  all modern equipment, techniques & technologies through Scientific way to do correct toxicity reports.  Our work performance  have been able to become a trusted choice of clients for their toxicity testing . We do our toxicity testing for majorly in India, Turkey, Ezypt, Malaysia, USA, Kenia, Africa, Canada, Saudi arabia apart from these country we also available all over the world. At our  highly advanced toxicity testing laboratory in India wherein we carry out all kinds of toxicity testing and topological research work. We are  operating  from India, Bangladesh  as well as from other parts of the world such as  , Ezypt, Malaysia, Kenia, Africa, Saudi Arabia.
 
 
We provide custom toxicity testing services. At our Toxicity testing lab we can test the degree to which a substance can damage a living organism. Our toxicity testing  Laboratory offers a full vary of industrial toxicity testing . Our workplace has much experience in toxicity testing report provider. We tend to additionally give a range of  toxicity testing services.

With extensive experience, IIRT offers a comprehensive range of accredited water testing services from our modern, well-equipped laboratories. We carry out tests on all types of water from across a broad range of industries including raw, potable, recreational, process and waste, ensuring that our customers’ needs are met in full, whatever their requirements.