Product Details:
Usage/Application | Airflow pattern visualization as per ISO 14644 |
Model Name/Number | TEK1 WFG |
Brand | TEK1 |
Features | Has highest mist density among peers, more than 6000 ml / hr. -twice the flow of our competitors. |
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:
Usage/Application | Used to collect the steam,condensate from pure steam generator for analysis of bacterial endotoxins |
Brand | TEK1 |
Features | Complete SS 316 make body,telescopic tripod stand with Teflon foot print & maximum condensate yield |
Model Name/Number | TEK1-PSS |
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:
Brand | CLiMET INSTRUMENTS CO., USA |
Usage/Application | Pharmaceutical grade and autoclavable high pressure diffuser for viable and nonviable sampling |
Air Flow | Can be used with 1 CFM, 50 LPM, 75 LPM or 100 LPM air particle counter and microbial air sampler |
Model Name/Number | CI302 High Pressure Diffuser |
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:
Model Name/Number | CI302 High Pressure Diffuser |
Usage/Application | Pharmaceutical grade and autoclavable high pressure diffuser for viable and nonviable sampling |
Brand | CLiMET INSTRUMENTS CO., USA |
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:
Model Name/Number | CI-99A |
Usage/Application | Microbial Air Sampler for fixed locations sampling in Isolators, RABS etc. to comply with ISO 14698 |
Brand | CLiMET INSTRUMENTS CO.,USA |
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:
Usage/Application | Generates Polydispersed submicron oil Aerosols for HEPA and ULPA Integrity Test as per ISO 14644-3 |
Model Name/Number | AG-1800 |
Air flow range | 1,500-65,000cfm(42-1,839.5m3/min) |
Aerosol type | PAO, DOP etc. |
Product Details:
Usage/Application | Generates Polydispersed submicron oil Aerosols for HEPA and ULPA Integrity Test as per ISO 14644-3 |
Model Name/Number | AG-60 |
Air flow range (Built in Pump) | 50 - 2,000cfm/min(1.4-56.6m3/min) |
Air flow range (external air source) | 50 - 4,725cfm/min(1.4-133.7m3/min) |
Product Details:
Usage/Application | Generates Polydispersed submicron oil Aerosols for HEPA and ULPA Integrity Test as per ISO 14644-3 |
Model Name/Number | AG 230 |
Air flow range | 50 - 8,100cfm (1.4-229m3min) |
Aerosol type | PAO, DOP, Polydispensed |
Product Details:
Testing Type | TEK1 |
Brand | TEK1-PSQT |
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:
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:
Model Name/Number | CI-90A |
Brand | CLiMET INSTRUMENTS CO.,USA |
Features | CLiMET has built in mass flow controller for highest consistency of sample volume |
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.
Product Details:
Usage/Application | HEPA Integrity Test as per ISO 14644-3 in Clean Rooms, LAB, Bio safety cabinets, Glove boxes etc. |
Model Name/Number | DP-30 Aerosol Photometer |
Shape | Rectangular |
Features | User friendly Interface with Portable Scan Probe and easy to trace measurement result |
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.
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.
Product Details:
Unit Pack Size | 10-20 ltrs |
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.
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 technologyDiode 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.
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.
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:
Model Name/Number | Fixed and Trolley versions |
Usage/Application | Cleanroom workstation for using in GMP grade areas for computing |
Range | 17" to 55" |
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