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Product Details:

TEK1-WFG is a cleanroom safe, portable device that uses supersonic waves to agitate purified water creating a visible mist. TEK1-WFG has SS304 body which can be wiped clean with mild disinfectants and it is ideal for use in sterile areas in Pharmaceuticals cleanrooms. The fog volume can be controlled by a potentiometer.

It has a quick drain valve which facilitates hassle free emptying of the water tank

TEK1-WFG has a higher tank capacity which allows the unit to be used for a long time without taking a stop to cool the ultrasonic generator and comes with snap fit hose adapter which eliminates the need for any tools.

Available accessories are - 9ft. expandable hose, carrying case with Internal padding, Sparge tube and tapering nozzle, Connecting Handle (Optional), 1 Mt. Extension Tubes (Optional), Tapering Nozzle, Sparge Tube and Multi Colour LED Light.

Product Details:

TEK1 pure steam sampler is designed in a way so that sample coolers prevent steam flashing-off from hot pressurized steam samples, which can be dangerous and will result in an incorrect water sample.

This device may be used for boiler water analysis and other sampling or cooling applications. 

The TEK1 PSS Pure Steam Sampler is designed to allow pure steam and high purity water samplers to be taken quickly and easily whilst maintaining product sterility during testing.

Product Details:

DBM 620 capture hood is ideal for checking air volume for Air Supply Units as per ISO14644-3. It is a perfect solution for balancing and commissioning of airflow.
The device has a measuring range from 40-3500m3/h or from 24-2060 cfm. The hood of flow meter can be changed quickly with ease. It allows both airflow and temperature to be displayed simultaneously.
DBM 620 automatically detects the direction of airflow, its supply and exhaust. It also has thermo-anemo-manometer functions. DBM620 airflow meter comes in standard with a 610 x 610 mm hood with 4 other hood options as 1020 mm x 1020 mm, 720 mm x 720 mm , 720 mm x 1320 mm and 420 mm x 1520 mm. Hoods are airtight and have a transparent part on each side allowing the user to see through the vent and ensure that the hood is in a good position. The rods, made of fiberglass, provides a good hoods sturdiness. The flow area is attached to the base and allows the measurement on 48 points, all over the surface of the flow area. Measurement is performed using a differential pressure sensor, calibrated and compensated in atmospheric pressure and in temperature

Steam that is generally produced by a Pure Steam Generator and whose condensed shall meet the requirements of WFI. Pure Steam is used in much area in pharmaceuticals industries such as sterilizing tanks, Autoclave, filters and piping systems, as well as products in sterilizers. Moreover, it is used for air-moistening in clean room systems. 

Steam Testing is required for following reasons: 

To check the quality of steam.To qualify plant/utility/clean/pure steam generators, steam distribution systems and steam supplies to autoclaves in accordance with HTM 01-01, HTM 2010 & EN 285.To satisfy your Regulator/QA immediately.

mk teknology1 carried all the tests which are mandatory to check for quality of Pure Steam. All the tests, testing methods along with standard guidelines are mention below:

A) Type of Tests – Non condensable gas Test, Dryness Test & Super Heat Test.
B) Testing Method – Physical Tests
C) Guidelines References - HTM 01-01, HTM 2010, EN 285.  

Product Details:

The High Pressure Diffuser is used when sampling compressed air or gases with Climet particle counters and microbial air samplers.

Applying compressed air or gases directly into a particle counter and microbial sampler may cause damage to the instrument (i.e., the HEPA filter). Also, with particle counters it will also cause turbulence inside the sensor that produces false high counts, and will also result in gross under-sizing of particles. Connecting high pressure gases directly to a microbial air sampler without a diffuser will result in a substantial degradation of biological efficiencies due to an extremely high impaction velocity.

The High Pressure Diffuser works by regulating the flow rate with an exhaust port to provide a path for the excess air pressure. This allows the particle counter and microbial sampler to "pull in" and regulate the flow of air or gas into the instrument.

Product Details:

The High Pressure Diffuser is used when sampling compressed air or gases with Climet particle counters and microbial air samplers.

Applying compressed air or gases directly into a particle counter and microbial sampler may cause damage to the instrument (i.e., the HEPA filter). Also, with particle counters it will also cause turbulence inside the sensor that produces false high counts, and will also result in gross under-sizing of particles. Connecting high pressure gases directly to a microbial air sampler without a diffuser will result in a substantial degradation of biological efficiencies due to an extremely high impaction velocity.

The High Pressure Diffuser works by regulating the flow rate with an exhaust port to provide a path for the excess air pressure. This allows the particle counter and microbial sampler to "pull in" and regulate the flow of air or gas into the instrument.

Product Details:

In manufacture for over a decade, the CI99 microbial air sampler is the only model manufactured to meet or exceed all ISO 14698 standards and recommendations for microbial air sampling. Eliminate or mitigate deviation reports and investigations due to interval calibration out-of-tolerance conditions of microbial air samplers.

The CI99 microbial air sampler is able to accommodate either industry standard 90 mm petri dishes, or RODAC plates. The lower microbial air sampling flow rates of 25 LPM or 1 CFM are recommended for continuous microbial monitoring applications. Testing has confirmed that up to 3 hours (possibly longer) of continuous microbial sampling with a custom agar fill of 40mL in a 90 mm petri dish is possible. Independent validation is recommended.

CI99 microbial air sampler can be integrated for Viable and Non-viable applications, with control and monitoring through common DataPro3 software, which is used for CLiMET Online air particle counters.

Product Details:

AG-1800 is designed to generate multiple diameters aerosol for testing HEPA filtration system with safest oil insurance supply system and heat interchange function. AG 1800 is ideal for certifying or testing HEPA filters or installations with air flows from 1,500 to 65,000 cfm. 

Product Details:

AG-60 is a small, light and rugged portable, self-contained Laskin-Nozzle aerosol generator. It can generate aerosol of 10ug/l to 100ug/l with airflow 50cfm/min to 4725cfm/min. Laskin-Nozzle aerosol generators is with rugged stainless steel structure, big filling port, independent spray-head and pressure control, and normative and clean joint output. 

AG-60 is lightweight and durable Laskin-Nozzle aerosol generator and the only one with switchable two modes. It can produce dispersed suspension of submicron particles just needing a suitable voltage source, which also can use an external air source, can make fog volume triple big. We believe whatever you want to have about our instrument, you will find the one you want.

Product Details:

AG230 is a kind of portable Laskin nozzle aerosol generator, which produce a sub-micron polydispersed oil mist aerosol in concentrations from 10 to 100 micrograms per liter (ug/l) at air flows from 50 to 8,100 cfm @ 20 psi.

Product Details:

Durasyn 164 PAO oil with certificate 

Product Discription:-
PAO Oil (Poly Alpha Olefin) - This PAO oil is used to produce poly dispersed aerosol, using Laskin Nozzle Type / Thermal Aerosol Generator to carry out HEPA Filter integrity test accorrding to ISO14644.

Product Details:

 

TEK1-PSQT Pure Steam Quality Test Kit is equipped with all the components that are necessary to perform the required test and report the results in accordance with EN 2855, HTM 20102 and ISO 111343 for the following parameters:

•    Non-Condensable Gas
•    Value Steam Superheat
•    Value Steam Dryness Value

 

STANDARD SUPPLY INCLUDES

Non-Condensable Gas apparatus with radiant flow valve.

Dual digital thermometer & welded tip type K ???Thermocouple probe & Digital thermometer

Stainless steel flexible steam hose

Adjustable Spanner and Pair of industrial protective gloves

 

Pitot tube with a tri clover connection all in stainless steel, 0.4mm, 0.6mm and 0.8mm orifice and superheat expansion tube 1 Litre flask with rubber stopper, dip tubes, rubber connecting tube, SS flask holder.

Product Details:

CI-9xA Series of microbial samplers is the only model manufactured to meet or exceed all ISO 14698 standards and recommendations. Eliminate or mitigate deviation reports and investigations due to interval calibration out-of-tolerance conditions.

The CI-90A is fully compliant with ISO 14698, PIC/S; FDA CGMP; EU GMP, Annex 1; 21 CFR Part 11, and others.The CI-90A is an active air microbial sampler used in either sequential or continuous monitoring applications in aseptic areas.

CLiMET CI-90A has a built in label printer, Each CLiMET Air Sampler has HEPA Filtered Exhaust with factory certified emissions better than ISO Class3. CLiMET Air Samplers are available with high quality anodised aluminium and SS316 Sample Head to accommodate 90mm dish & RODAC. 

Each CLiMET microbial air sampler has built in mass flow controller for consistency of sample volume far superior as compared to any microbial air sampler in the market.

Repair and maintenance contracts are undertaken for the entire range of instruments supplied by us including for CLiMET, PAMAS, PALAS, Particle Metrix, CS-Instruments, Sentronic, In-Process, GMN and Systec & Solutions products. Our engineers have excellent electronics, opto-electronics & mechanical troubleshooting and instrument operating software knowledge. Support is extended via telephone and skype video calls, online teamviewer & anydesk support and personal visits.

 

Product Details:

DP-30 Aerosol Photometer is designed on the base of light scattering principle, displays real-time leakage rate by detecting aerosol concentrations of upstream and downstream. DP-30 has solid die-cast aluminum housing, easy for maintenance and calibration having a measuring scope of 0.0001% to 100.0% and has alarm for user selection and visualisation. It also has vibratory alarms to notify the user when the defined set point is exceeded. Light source of DP 30 is for Long time. It can work under low power and generate low heat and deviation value.  Service life of DP-30 is 50,000 h to 100,000 h with Continuous mode/Auto-save mode/print mode reporting options. Scanning probe of DP 30 is very comfortable in handling and it comes with the 2.5 meter connection, 2.8inch LCD display and soft probe with a adjustment of 360 angles.

CLiMET Air particle counters are calibrated in accordance with ISO 21501-4, PAMAS Liquid Particle counters as per USP or other pharmacoepia standards and oil particle counters according to ISO 11171/4406. Our team is equipped with necessary instruments and traceable standards. All master instruments are calibrated with NIST or NABL traceable standards. Team of trained engineers conduct onsite and offsite calibrations as per customer requirement. CLiMET and third party microbial air sampler are calibrated in accordance with ISO14698 requirements.

Direct compression after blending and lubrication has been the mainstay of Solid Oral Dosage Form pharmaceutical manufacturing for over 100 years. Until now the only way to verify content uniformity and assay in the tablet has to been to take a very small sample and perform laboratory testing for quality control purposes. This is an expensive, slow and laborious process that results in a large amount of very high value material being held in inventory awaiting QC release for final processing steps. Well known issues such as blend segregation that cause sub or super potent material to be produced during the tabletting run can be very difficult to detect and assess using these traditional QC tools. At-line PAT solutions have proven to be expensive and difficult to implement. Recent advances in inline PAT measurement systems such as the miniaturisation of measurement technology in the Sentronic DRLS measurement head has meant that is now possible to continuously monitoring tablet die filling blend potency and uniformity through out the entire tabletting production run. This is a cost effective way to ensure production consistency and quality and significant enabler of Real Time Release Testing.

The high shear wet granulation process

This typical pharmaceutical production process is a fast process, which is known for producing very dense granules resulting in a slow release of the API in the body. The process consists of three phases a) dry mixing, b) liquid addition and c) massing or granulation.

Why use NIR technology to monitor HSWG?

NIR spectroscopy is the only analyzer technology which provides deep insight about the physical and chemical properties during the process at very high measurement speed. It can detect changes in the particle size of excipients or API during the mixing phase and detect the end point based on the homogeneity in this phase, variation in particle growth throughout the process. Free and bound moisture can be monitored, since they have different effects on the NIR spectra. The monitoring of the dissolution of sugars during the granulation could be followed as well.

Why Diode array technology

Diode array spectrometers are much faster than other available technologies. In our optimized SentroPAT diode array systems a typical integration time is only approx. 10 ms giving an overall measurement interval of 1 sec or less. But even further, a diode array NIR detects all wavelengths of the spectrum simultaneously. This is totally different to all other NIR technologies including FT-NIR. When sample presentation is not constant during the process, (typical in the case of smaller granulators,) every single spectrum looks smooth. Only the baseline might be at different heights. Fast variations in a scanning spectrometer would make the spectrum unusable or show only noise. Similar effects reduce the data quality in FT-NIR systems.

Continuous Manufacturing (CM) offers many attractive properties for the pharmaceutical manufacturing industry such as enhanced consistency of production as well as the ability to dial up a design space point for experimental formulation or process design or to scale output of manufacture seemlessly. As solid oral dosage form CM becomes more common place in the pharmaceutical industry, PAT deployment in these processes has become an essential part of the control strategy and the basis of Real Time Release Testing (RTRT). As such, the speed and robustness of the PAT measurements are of paramount importance. Other considerations in ensuring the quality & robustness of in-line PAT measurements in a CM environment such as robustness of the measurement, stability of the instrument and consistency between instruments to facilitate calibration transfer. Sentronic offers unparalleled high performance in these areas. In addition, Sentronics fully validated SentroSuite software platform offers excellent compliance in data integrity and 21CFR11. Sentronic Analysers can be directly integrated into the PAT stack with Siemens SiPAT, Optimal SynTQ and Perceptive Engineering PharmMV for process control integration.

The glass and membrane keyboards were developed specially for cleanroom applications - both are provided with particularly smooth and easy to clean surfaces. They are designed to withstand regular cleaning with the standard cleaning agents and disinfectants used in cleanrooms. 

The keyboards are flush-mounted in a high-grade stainless steel housing and conform to protection class IP65. Glass keyboards operate on the capacitive principle with audio feedback. The short-stroke keys of membrane keyboards feature tactile feedback.

 

Desktop, rack and built-in versions of the cleanroom keyboards are available and can be combined with HMIs, Bioprocess equipments and pharma machineries.

 

A freely adjustable torque hinge connects the keyboard to the HMI system. Wall mounting or cabinet installation is also possible using a double torque hinge. This permits internal cable routing and ergonomic setting of the angle of inclination to suit the user.

 

The MEDICAL GLASS KEYBOARD is particularly suitable for medical environments with the highest hygiene standards. Almost all cleaning agents and disinfectants can be used for cleaning purpose. It can be used without any problems even when wearing gloves. The MEDICAL GLASS KEYBOARD is ideal for use in hospitals, hospital pharmacies, laboratories, clean rooms, pharmacies, and medical practices.

Product Details:

Systec offers ergonomic workstations to GMP standards for laboratories and clean rooms. These are based on the WAVE and PILOT HMI systems, with the option of monitor, PC or thin client configuration. All versions conform to IP65 and are particularly easy to clean. They can be operated via the touch screen and using clean room glass keyboards.

The workstations are available with space-saving stainless steel stand for fixed installation, as well as, mobile solutions can be combined with trolley system and integrated SS printer box, scanner box, scanner holder, SS cabinet. Both the options can be supplied with optional battery which can run up to 20hours

Models::

Mobile workstation

·         Trolley light with 3arm or 5arm base unit

·         Trolley light inductive

·         Trolley compact with 3arm or 5arm base unit

·         Trolley compact plus

·         Trolley maxi with integrated SS box for scanner and printer

Fixed workstation

·         Floor and ceiling mount Pedestal

·         KIS stand

SS Tablet is a ideal solution mobile computing in GMP environments. It is easy-to-clean with stainless steel housing, fully enclosed and without gaps and edges -fulfilling IP65 requirements. It is equipped with IP65 rated on-off button and magnetic charging port.

 

Standard configuration :-

MICROSOFT Surface Pro with 12.3 inch, 128GB memory, 4 GB RAM, Core m3 processor, Windows 10, WiFi, 3G and Bluetooth

MICROSOFT Surface Pro with 12.3 inch, 128GB memory, 8 GB RAM, Core i5 processor, Windows 10, WiFi, 3G and Bluetooth

Custom stainless steel cases e.g. Apple,Lenovo on request.

Compressed Air is a form of stored energy that is used to operate machinery, equipment or processes. Compressed Air & Nitrogen gas Testing is simply a standardized test that can be used to analyse the quality of air &      detect any kind of contamination present in it. A Sterile enviourment is essential in the pharmaceuticals industries. Any contaminates in the compressed air & Nitrogen gas such as Oil, Moisture and Solid Matter can cause process disruptions, production shutdown & expensive product recalls.  So manufacturing units can take no chances, demanding the high quality of air at all the times without any question. 

mk teknology1 has understood the importance of product risks by monitoring the air against quality standards, testing, giving accurate results and advising the risk factor to the clients.Mk teknology1 carried all the tests which are mandatory to check for quality of air & Nitrogen Gas. All the tests, testing methods along with standard guidelines are mention below:  

A) Type of Tests – Non Viable Particle count test , Dew point Test, Oil Mil Test, Moisture Test , Oxygen Test, Carbon Dioxide Test, Carbon Monoxide Test , Sulphur Dioxide Test , Nitrogen Oxide+ Dioxide Test ,Viable Test, Hydrocarbon Test , Solid Particulate Matter & Odour Test.

B) Testing Method – Laser Particle Counting, Condensation Method, Thimble Method, Gas Analyser, Detector Tubes, Gas Chromatography, Oxygen Analyser.

C) Guidelines References - ISO 8573, USP, EP, BP, ISO 14644, EU-GMP.