STABILITY (HUMIDITY) CHAMBERS
Stability Tests are an important step in the development of new drugs and pharmaceutical substances and an indispensable element in the licensing process defined by federal regulating authorities. However, these tests are just as important for safeguarding the quality of the product within the framework of quality assurance.
Together with committees from the pharmaceutical industry, experts from the licensing authorities (such as the FDA) have developed the ICH Guidelines for the harmonization of stability tests. These guidelines define standardized storage and batch evaluation as well as the time sequence of the required analytic tests.
According to the ICH Guideline Q1AR2, stability tests have to be performed under defined climatic conditions in order to provide evidence of the stability of active substances.
NEWTRONIC offers a range of test chambers to meet these regulatory requirements as well as stability testing requirements for other industry segments of Cosmetic, Food & Beverages, etc.
We offer a centralized solution across all ICH conditions of real-time, intermediate, accelerated & semi-permeable study conditions along with a state-of-the-art 21 CFR Part 11 ready software that provide tools for viewing, trending, alarm management, audit trails, MKT & many other such features.
WALK-IN STABILITY (HUMIDITY) CHAMBERS WITH ECOTRONIC TECHNOLOGY
These are medium to large-sized chambers that are custom-built to ensure that they not only fit optimally in your lab's stability area but also address your large-scale stability testing requirements.
Walk-In Chambers have now become a de-facto requirement for companies planning multiple ANDA filings & planning to launching various products simultaneously.
NEWTRONIC Walk-Ins ensure a smooth air-flow pattern to improve the temperature & humidity distribution across the chamber. This has also led to huge load reduction on the heating, cooling & humidifier systems. This & many other innovations in the construction & design aspects have ensured dramatic reduction in power consumption of our Walk-Ins.
NEWTRONIC has also been regularly exporting the Walk-In Chambers to all the major markets of the world. We ensure our products meet all kinds of country-specific requirements such as voltage specifications, regulatory needs, container shipping, etc
These are medium to large-sized chambers that are custom-built to ensure that they not only fit optimally in your lab's stability area but also address your large-scale stability testing requirements.
Walk-In Chambers have now become a de-facto requirement for companies planning multiple ANDA filings & planning to launching various products simultaneously.
NEWTRONIC Walk-Ins ensure a smooth air-flow pattern to improve the temperature & humidity distribution across the chamber. This has also led to huge load reduction on the heating, cooling & humidifier systems. This & many other innovations in the construction & design aspects have ensured dramatic reduction in power consumption of our Walk-Ins.
NEWTRONIC has also been regularly exporting the Walk-In Chambers to all the major markets of the world. We ensure our products meet all kinds of country-specific requirements such as voltage specifications, regulatory needs, container shipping, etc
PHOTOSTABILITY CHAMBERS
Photostability chambers are specifically designed to perform near UV and visual light testing with fluorescent lamps per ICH Q1B Guidelines, Option 2. This unit controls light and temperature conditions through an easy-to-use color touch-screen interface. Uniform light distribution and high intensity levels allow quick response for forced degradation testing and confirmatory studies. The confirmatory studies should identify precautionary measures needed in manufacturing or in formulation of the product, and if light resistant packaging is needed.
At the end of the exposure period, the samples should be examined for any changes in physical properties (e.g., appearance, clarity, or colour of solution) and for assay degradation.
NEWTRONIC chambers are fully controlled via the PLC with features such as alarms for aging lamps, auto-switch off of UV lights upon door opening. Specular reflective surfaces provide uniform UVA & VIS light reflection and maintain proper SPD (spectral power distribution). Additionally, the chamber also provides precise humidity control.
Photostability chambers are specifically designed to perform near UV and visual light testing with fluorescent lamps per ICH Q1B Guidelines, Option 2. This unit controls light and temperature conditions through an easy-to-use color touch-screen interface. Uniform light distribution and high intensity levels allow quick response for forced degradation testing and confirmatory studies. The confirmatory studies should identify precautionary measures needed in manufacturing or in formulation of the product, and if light resistant packaging is needed.
At the end of the exposure period, the samples should be examined for any changes in physical properties (e.g., appearance, clarity, or colour of solution) and for assay degradation.
NEWTRONIC chambers are fully controlled via the PLC with features such as alarms for aging lamps, auto-switch off of UV lights upon door opening. Specular reflective surfaces provide uniform UVA & VIS light reflection and maintain proper SPD (spectral power distribution). Additionally, the chamber also provides precise humidity control.
COOLING (LABORATORY REFRIGERATOR) CHAMBERS
Protecting the integrity of your work is imperative which is why laboratories rely only on NEWTRONIC for their expertise in high quality refrigeration solutions. Our full line of refrigerators provide superior temperature uniformity, reliability and an eco-friendly construction for the safe storage of working and reference standards, vaccines, reagents, raw materials and other critical samples.
NEWTRONIC chambers have become the defacto standard for stability studies of Refrigerated Products.
They also come with specially designed trays for segregating Working Standards & Reference Standards samples for effective storage & quick retrieval.
The chambers are connected through Ethernet to state-of-the-art 21 CFR Part 11 ready software that provide tools for viewing, trending, alarm management, audit trails, MKT & many other such features.
Remember, your lab is not a kitchen! And therefore, domestic fridges can never be a substitute to industrial refrigerators.
Protecting the integrity of your work is imperative which is why laboratories rely only on NEWTRONIC for their expertise in high quality refrigeration solutions. Our full line of refrigerators provide superior temperature uniformity, reliability and an eco-friendly construction for the safe storage of working and reference standards, vaccines, reagents, raw materials and other critical samples.
NEWTRONIC chambers have become the defacto standard for stability studies of Refrigerated Products.
They also come with specially designed trays for segregating Working Standards & Reference Standards samples for effective storage & quick retrieval.
The chambers are connected through Ethernet to state-of-the-art 21 CFR Part 11 ready software that provide tools for viewing, trending, alarm management, audit trails, MKT & many other such features.
Remember, your lab is not a kitchen! And therefore, domestic fridges can never be a substitute to industrial refrigerators.
BOD INCUBATORS(COOL INCUBATORS)
B.O.D. stands for Bacteriological Oxygen Demand. NEWTRONIC's BOD Incubators are ideal for the growth & storage of bacterial cultures, gentle incubation & conditioning and Media Preparation.
Media Prepartion & Culture growth at temperatures of 22.5°C (±2.5°C) & 32.5°C (±2.5°C) have become a standard practice in any Microbiology or ARD labs.
The chambers ensure consistent performance at any temperature within a range of 5°C to 60°C at an accuracy of ±0.5°C & at an uniformity of ±1°C.
The chambers are provided with a glass door for sample viewing & quick retrieval. They are connected through Ethernet to state-of-the-art 21 CFR Part 11 ready software that provide tools for viewing, trending, alarm management, audit trails, MKT & many other such features so as to comply with regulatory guidelines.
B.O.D. stands for Bacteriological Oxygen Demand. NEWTRONIC's BOD Incubators are ideal for the growth & storage of bacterial cultures, gentle incubation & conditioning and Media Preparation.
Media Prepartion & Culture growth at temperatures of 22.5°C (±2.5°C) & 32.5°C (±2.5°C) have become a standard practice in any Microbiology or ARD labs.
The chambers ensure consistent performance at any temperature within a range of 5°C to 60°C at an accuracy of ±0.5°C & at an uniformity of ±1°C.
The chambers are provided with a glass door for sample viewing & quick retrieval. They are connected through Ethernet to state-of-the-art 21 CFR Part 11 ready software that provide tools for viewing, trending, alarm management, audit trails, MKT & many other such features so as to comply with regulatory guidelines.
LABORATORY (BACTERIOLOGICAL) INCUBATORS
The basic requirement of a microbiological lab is to have an environment that is free from contamination. Laboratory incubators provide this environment that give microbiological cultures, cell cultures and tissue cultures with special conditions regulating viable growth factors such as temperature, ventilation etc. This is the ultimate equipment for the growing and storing of bacterial cultures.
The basic requirement of a microbiological lab is to have an environment that is free from contamination. Laboratory incubators provide this environment that give microbiological cultures, cell cultures and tissue cultures with special conditions regulating viable growth factors such as temperature, ventilation etc. This is the ultimate equipment for the growing and storing of bacterial cultures.
LABORATORY OVEN
These units are primarily used in applications which require rapid drying and sterilization. Totally homogenous temperature distribution, rapid dynamic response and a special air turbine developed by us which has higher output have made it a genuine time-saving device.
They are also used to measure the loss on drying & are also referred to as LOD Ovens or Hot Air Ovens.
Units are equipped with Stainless steel trays, high quality PT-100 sensor & a microprocessor based controlling system with 2 line alphanumerical LED display. Alarms are generated for any deviations. The PID controller comes with an integrated timer functionality from 0 to 99 hours for ramp & soak functionality.
These units are primarily used in applications which require rapid drying and sterilization. Totally homogenous temperature distribution, rapid dynamic response and a special air turbine developed by us which has higher output have made it a genuine time-saving device.
They are also used to measure the loss on drying & are also referred to as LOD Ovens or Hot Air Ovens.
Units are equipped with Stainless steel trays, high quality PT-100 sensor & a microprocessor based controlling system with 2 line alphanumerical LED display. Alarms are generated for any deviations. The PID controller comes with an integrated timer functionality from 0 to 99 hours for ramp & soak functionality.
VACCUM OVENS
These units are fitted with highly accurate controller that allows gentle drying of heat sensitive materials & highly hygroscopic materials.
The vacuum ovens can dry faster than the conventional ovens & avoid damage due to rapid temperature overshooting.
They come with a separate vacuum release valve to release the vacuum by gentle turn of the knob. An air release inlet is located below the tray to avoid sample disturbance due to air blowing.
These units are fitted with highly accurate controller that allows gentle drying of heat sensitive materials & highly hygroscopic materials.
The vacuum ovens can dry faster than the conventional ovens & avoid damage due to rapid temperature overshooting.
They come with a separate vacuum release valve to release the vacuum by gentle turn of the knob. An air release inlet is located below the tray to avoid sample disturbance due to air blowing.
PLASMA FREEZERS
“Plasma” is the most critical component of the blood system. It contains the vital mineral and salts that needs to be supplied to various parts of the body. Thus it becomes important to store plasma at a temperature below -30OC for the safe storage of frozen plasma, red cells, cryoprecipitate and platelet concentrates.
We have designed a plasma freezer that offers you a sturdy body, with a host of safety features that guarantees the safe storage of plasma components. Our product is capable to meet the regulations of hospitals, Laboratories, biomedical research centre and Universities.
“Plasma” is the most critical component of the blood system. It contains the vital mineral and salts that needs to be supplied to various parts of the body. Thus it becomes important to store plasma at a temperature below -30OC for the safe storage of frozen plasma, red cells, cryoprecipitate and platelet concentrates.
We have designed a plasma freezer that offers you a sturdy body, with a host of safety features that guarantees the safe storage of plasma components. Our product is capable to meet the regulations of hospitals, Laboratories, biomedical research centre and Universities.
ULTRA LOW TEMPERATURE FREEZERS
We have developed a revolutionary ultra-low temperature freezer that seamlessly joins the ranks of proven NEWTRONIC products in terms of reliability as well as setting new standards for safety. In addition, our commitment to after sales-support & service ensures satisfaction throughout the life of your product. Whether storing blood products, reagents, vaccines, or medication, a NEWTRONIC product offer true protection.
We are introducing an intelligent freezer with unique features of extended warm-uptime, remote monitoring, SMS alerts. Constructed from high-quality proven components with energy-efficient refrigeration design, ULT freezers provide top notch performance that can withstand the test of time to guarantee the integrity of your samples.
We have developed a revolutionary ultra-low temperature freezer that seamlessly joins the ranks of proven NEWTRONIC products in terms of reliability as well as setting new standards for safety. In addition, our commitment to after sales-support & service ensures satisfaction throughout the life of your product. Whether storing blood products, reagents, vaccines, or medication, a NEWTRONIC product offer true protection.
We are introducing an intelligent freezer with unique features of extended warm-uptime, remote monitoring, SMS alerts. Constructed from high-quality proven components with energy-efficient refrigeration design, ULT freezers provide top notch performance that can withstand the test of time to guarantee the integrity of your samples.
Deep Freezers
When you need clinical-grade storage, it's important to choose a refrigerator or freezer that is designed specifically for the demands that come with these kinds of environments. Whether it's a concern with temperature variation impacting sensitive materials, size, sound, energy use, or all of the above and more, we have the storage solution for you and for the needs of your environment. For the perfect fit of your application, choose from the various options of upright models, large size floor models to jumbo double door models. We also offer smartly designed two zone temperature refrigerator combined with freezer. Manufactured at state of the art manufacturing facility with automated machinery and quality testing equipments.
When you need clinical-grade storage, it's important to choose a refrigerator or freezer that is designed specifically for the demands that come with these kinds of environments. Whether it's a concern with temperature variation impacting sensitive materials, size, sound, energy use, or all of the above and more, we have the storage solution for you and for the needs of your environment. For the perfect fit of your application, choose from the various options of upright models, large size floor models to jumbo double door models. We also offer smartly designed two zone temperature refrigerator combined with freezer. Manufactured at state of the art manufacturing facility with automated machinery and quality testing equipments.
Deep Freezer (-25 C)
Double Door Deep Freezer (-25 C)
Combo Freezer (Upper Chamber 4 C) | (Lower Chamber -25 C )
SMART COOL (Portable Deep Freezers)
Temp. Range:+5 ℃ to -20 ℃
The NEWTRONIC SMART COOL is a simple and versatile Digital Portable Laboratory transporter designed for the transportation of critical samples that needs to be moved under low temperature conditions. Complete with an easy to read digital controller, this is an ideal “Last Mile Solution” for transporting vaccines by road as well as collecting samples in the field.
Temp. Range:+5 ℃ to -20 ℃
The NEWTRONIC SMART COOL is a simple and versatile Digital Portable Laboratory transporter designed for the transportation of critical samples that needs to be moved under low temperature conditions. Complete with an easy to read digital controller, this is an ideal “Last Mile Solution” for transporting vaccines by road as well as collecting samples in the field.
ULTRA LOW DEEP FREEZERS (-80 ℃)
Temp. Range: -60 ℃ to -80 ℃
Newtronic sub-zero Temperature Freezers are developed for reliable storage conditions of research samples for laboratories, hospitals, repositories and more. Through research and development, a new focus has been placed on our refrigeration system, controls, alarms/monitoring, ergonomics, construction and energy efficient operation to make our Freezers the reliable solution for long-term storage of cancer cells, stem cells, cord blood, T-cells, organ/tissue and other critical samples
Temp. Range: -60 ℃ to -80 ℃
Newtronic sub-zero Temperature Freezers are developed for reliable storage conditions of research samples for laboratories, hospitals, repositories and more. Through research and development, a new focus has been placed on our refrigeration system, controls, alarms/monitoring, ergonomics, construction and energy efficient operation to make our Freezers the reliable solution for long-term storage of cancer cells, stem cells, cord blood, T-cells, organ/tissue and other critical samples
MEDICAL REFRIGERATOR
Temp Range: 2℃ to 8℃
Medical refrigerators are used to cool medical / pharma products for preservation. They include refrigeration units for storing vaccines and other medical or pharmaceutical supplies. Temperature variation can have an impact on the viability and efficacy of vaccines, reagents and other temperature-sensitive medical products. These variations can shorten product shelf life, degrade enzymes and reduce vaccine effectiveness. Therefore, it is important to choose a high-performance refrigerator that has been designed for the demanding standards of laboratory and clinical environment.
Newtronic Medical refrigerators maintain a consistent temperature in order to minimize the risk of degradation. It achieves a high degree of accuracy.
Temp Range: 2℃ to 8℃
Medical refrigerators are used to cool medical / pharma products for preservation. They include refrigeration units for storing vaccines and other medical or pharmaceutical supplies. Temperature variation can have an impact on the viability and efficacy of vaccines, reagents and other temperature-sensitive medical products. These variations can shorten product shelf life, degrade enzymes and reduce vaccine effectiveness. Therefore, it is important to choose a high-performance refrigerator that has been designed for the demanding standards of laboratory and clinical environment.
Newtronic Medical refrigerators maintain a consistent temperature in order to minimize the risk of degradation. It achieves a high degree of accuracy.
BLOOD BANK REFRIGERATOR
Temp. Range: 2 ℃ to 6 ℃
The blood bank refrigerator is an essential piece of equipment in the immuno- hematology department and provides safe and convenient storage of whole blood, blood components (e.g, blood cells, plasma) and reagents. Blood bank refrigerators ensure freshness and integrity of blood and blood components. Our Blood Bank Refrigerators meet the highest regulatory requirements.
Temp. Range: 2 ℃ to 6 ℃
The blood bank refrigerator is an essential piece of equipment in the immuno- hematology department and provides safe and convenient storage of whole blood, blood components (e.g, blood cells, plasma) and reagents. Blood bank refrigerators ensure freshness and integrity of blood and blood components. Our Blood Bank Refrigerators meet the highest regulatory requirements.
PLASMA FREEZER
Temp. Range: -30℃ to -40℃
Newtronic sub-zero Temperature Freezers are developed for reliable storage conditions of research samples for laboratories, hospitals, repositories and more. Through research and development, a new focus has been placed on our refrigeration system, controls, alarms/monitoring, ergonomics, construction and energy efficient operation to make our Freezers the reliable solution for long-term storage of cancer cells, stem cells, cord blood, T-cells, organ/tissue and other critical samples.
Temp. Range: -30℃ to -40℃
Newtronic sub-zero Temperature Freezers are developed for reliable storage conditions of research samples for laboratories, hospitals, repositories and more. Through research and development, a new focus has been placed on our refrigeration system, controls, alarms/monitoring, ergonomics, construction and energy efficient operation to make our Freezers the reliable solution for long-term storage of cancer cells, stem cells, cord blood, T-cells, organ/tissue and other critical samples.
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