Company profile: MedIntegrity . At present, we have thousands of pharmaceutical enterprise customers, the latest model V8.0 with the system upgrade of the audit trail function to meet the latest requirements for data integrity. We believe our quality products and service, will be your correct choice.
MedIntegrity of U.S.A. our quality products and service, will be your correct choice.
Model：IntegtestV4.0
Introduction
V4.0 Integrity Tester are designed for testing integrity of filters and filter systems . The State Pharmacopoeia and GMP specification requirements. The V4.0 Integrity Tester is compact, handy to use, and fully automated integrity test instrument, which performs bubble point, diffusion flow, enhanced bubble point, and water-based test for hydrophobic filters.
Name：Full-Automatic Filter Integrity Tester
Model：IntegtestV1.1
Company：NeuronAI.LLC
TA-1.0 Total Organic Carbon (TOC) Analyzer is the high-precision offline total organic carbon analysis instrument research and development by MedIntegrity independently. The product uses the electrical conductivity difference detection technology,adopting the principle of ultraviolet catalytic oxidation, with high accuracy and short response time. The instrument completely conforms to the requirements of the national pharmacopoeia, and it can meet the offline testing requirements for the deionized water such as pharmaceutical water (injection water and purified water) and ultrapure water.
TA-2.0 Total organic carbon (TOC) is developed on the basis of the original offline total organic carbon analysis instrument, which can meet both online and offline test modes for the users. And 3 points can be online measured switching one by one, so the application is more extensive, which can completely meet various on-site use requirements for the customers, thus greatly reducing the on-line monitoring implementation cost for the customers.
TA - 3.0 independent research and development by our company which is to make a tiny adjustment on the basis of TA - 2.0, where the instrument shell adopts 304 stainless steel design,greatly improving the equipment
adaptability in different environments. It can meet the choice of two different schemes for the single point of real-time monitoring or multiple point time-division monitoring, not only meeting the requirements of national laws and regulations, but also saving investment, where we have several successful cases.
It is suitable for sealing integrity testing of pharmaceutical packaging to prevent moisture, oxygen, and microorganisms from contaminating products. Medicines: bottled, bagged, boxed, ampoules, vials, cartridges, prefilled needles (PFS), (BFS), (FFS), etc.
Spray cans: plunger spray cans; bag-lined spray cans; "energy jacket" spray cans; flexible tube spray cans.
It is suitable for sealing integrity testing of pharmaceutical packaging to prevent moisture, oxygen, and microorganisms from contaminating products. Medicines: bottled, bagged, boxed, ampoules, vials, cartridges, prefilled needles (PFS), (BFS), (FFS), etc.Spray cans: plunger spray cans; bag-lined spray cans; "energy jacket" spray cans; flexible tube spray cans.
The bag integrity tester produced by NeuronAI.LLC,:BGT-120 is based on the pressure drop test principle. The method is based on the program of ASTM F2095-01, which compliance with GAMPs and FDA 21 CFR Part 11. with authority management and electronic signature, value support, including IQ, OQ, PQ and SOP.
The on-line glove integrity tester WGT-1200 produced by MedIntegrity is designed according to the principle of the positive pressure leak detector recommended by GB/T 25915.7-2010/ISO 14644-7:2004. It is a special instrument for detecting leakage of gloves.
The on-line glove integrity tester WGT-1000 produced by MedIntegrity is designed according to the principle of the positive pressure leak detector recommended by GB/T 25915.7-2010/ISO 14644-7:2004. It is a special instrument for detecting leakage of gloves. Our company has been engaged in the production and sales of filter integrity testers for many years, and the pressure control technology is very mature.
The device uses a wireless communication mode, built-in air pump and lithium battery, through systematic management, so that multiple detection units can be linked in real time. In addition to complying with the requirements of FDA and GMP and other laws and regulations, four-level authority management and electronic signature design are also set up to comply with 21CFR part 11 electronic records and electronic signature certification requirements; The history record can store more than 12000 groups, and at the same time, it has its own storage FLASH, which can transmit and save the test records in time; the structure design is simple and exquisite, no additional equipment is required, no need to remove gloves, and the glove tray can be replaced, supporting different specifications and sizes of gloves Detection. The high-precision pressure sensor is adopted, and the glove test is fast and accurate.
The on-line gloves Integrity Tester GT-3.0 are leak detector principle proposed by GB/T 25915.7-2010/ISO 14644-7:2004, and it is a dedicated instrument to detect the gloves leakage. The simple and easy design won't need any additional equipment, no need to remove the gloves, with fast detection speed and high precision.
The on-line gloves Integrity Tester GT-2.0 produced by MedIntegrity is designed according to the positive pressure leak detector principle proposed by GB/T 25915.7-2010/ISO 14644-7:2004, and it is a dedicated instrument to detect the gloves leakage. The simple and easy design won't need any additional equipment, no need to remove the gloves, with fast detection speed and high precision.
The freezing point osmometer FPOSM-V3.0 produced by MedIntegrity with independent research and development is in accordance with Raoul freezing point theory, based on the solution freezing point declined value proportional to the solution molar concentration, using high sensitivity of temperature-sensing element, to measure the freezing point of different solutions, so as to derive the osmotic pressure molar concentration. This theory has been widely used for the test and research of osmotic pressure molar concentration in the fields such as pharmaceuticals,pharmaceutical analysis, biological and food therapy
The freezing point osmometer FPOSM-V2.0 produced by MedIntegrity with independent research and development is in accordance with Raoul freezing point theory, based on the solution freezing point declined value proportional to the solution molar concentration, using high sensitivity of temperature-sensing element, to measure the freezing point of different solutions, so as to derive the osmotic pressure molar concentration. This theory has been widely used for the test and research of osmotic pressure molar concentration in the fields such as pharmaceuticals,pharmaceutical analysis, biological and food therapy
Sterility test pump based on the principle of membrane filtration. The pump give positive pressure transmit liquid sample to the canister and filtered under positive pressure. After filtration, the filter membrane is washed to remove the antimicrobial agent of the product, and then the culture medium is filled in the filter to check whether the sample contains bacteria
Cartridge filter media is a hydrophobic PTFE membrane, applicable to pre-filtering of gas and solvent and sterilization. Its hydrophobicity is 3.75 times stronger than the erosion resistance capability of ordinary PVDF; thus, filters are applicable to pre-filtering and precise filtration of gas and solvent sterilization. At present, they are widely applied in pharmacy, food, chemical industry, and electronics, which show excellent heat resistance, they can be repeatedly used in online steam sterilization or high-pressure disinfection. NWF cartridges also have high interception efficiency, high guarantee, and long service life.
Filters are made of Micro series hydrophilic asymmetric sulfonated PES. They have universal chemical compatibility, pH range 3~11. They feature large throughput and long service life, applicable to bio-pharmacy and other fields. Before delivery, each cartridge has experienced 100% integrity test, to ensure product filter efficiency. NSS cartridges are endurable to repeated online steam or high-pressure disinfection, meeting asepsis requirements of new version GMP.
HPP series cartridge filter is an advanced fixed deep cartridge filter. Its filter media is an imported PP thermal-sprayed fiber nonwoven membrane, avoiding fiber shedding problem and offering high interception efficiency. Its hierarchical filter process makes the cartridge less blocked, prolonging their service life.
Filter precision: 0.1, 0.2, 0.45, 0.65, 0.8, 1.0, 3.0, 5.0, 10, 20, 30, 60 (unit: μm)
Effective filter area: 0.4~2.0 m2 /10"
Cartridge diameter: 69 mm, 83 mm, 130 mm
Titanium filters are made of ultrapure titanium using special process through sintering. Their porous structure is uniform and stable, having high porosity and high interception efficiency. Titanium filters are also temperature insensitive, anticorrosive, highly mechanical, regenerative, and durable, applicable to filter various gases and liquids. In particular, they are widely used in pharmacy industry for removing carbon.
MedIntegrity is an innovative technology company that provides high-precision measurement and verification instruments for the pharmaceutical industry. We cover the entire product development cycle, starting with the R&D team, then the production process, and finally the sales and support teams.
Know us
MedIntegrity provide products and services covering the pharmaceutical analytical instrument industry, including packaging leak testing, glove integrity leak detection testing, filters integrity testing and other fields. The specialty includes geometry, heat, mechanics, electromagnetism, radio, time frequency, chemistry, optics, acoustics, flow, vaccine and other fields. It also has the world's advanced calibration equipment and professional R &D and testing personnel.
MedIntegrity provides customers with one-stop service. We will escort you with exquisite technology and scientific management.
During the period of rapid development of MedIntegrity, we deeply realize that unity is strength.
Under the guidance of various regulations of regulatory bodies and through cooperation with customers, we have promoted the manufacturing industry to accelerate the process of providing global markets, hospitals, pharmaceutical equipment and facilities and related medical and safety solutions.
We have developed computerized system solutions such as audit trail and remote technical support, so as to reduce risks while carrying out business. In this new and changing world, we have always been a loyal worthy partner for our customers
MedIntegrity provides customers with safety testing and verification services for pharmaceutical analyzers, medical devices, equipment and basic medical supplies in the pharmaceutical industry. Carry out customized one-stop service support for customer products, and help our partners with risk management to ensure pharmaceutical quality and safety
We do not forget our mission: face the difficulties and challenges, share our experiences through professional forums and inclusive dialogues in a series of global pharmaceutical industry dynamic consultation and sharing, and put forward new professional commitments: help China's pharmaceutical industry to create a safer future
