FABTECH TECHNOLOGIES PRIVATE LIMITED
About us
We're a biopharma engineering company, a small but essential piece of the massive life sciences ecosystem. By bringing together our customers, partners, industry thought leaders, regulators and governments, we affect a greater impact and bring our mission to life.
Products & services
AIR SHOWERS
Air Showers are specialised enclosed antechambers used to reduce cross-contamination within the facility. Depending on the application, they are integrated with the entry or exit air lock system of the production area. Our Air Showers use high-velocity HEPA filter jet streams in excess of 20 m/s to dislodge particles, dust, lint and other contaminants from clothing during entry or exit. 21CFR and GMP compliant, manual/microprocessor based control system to manage the entire cycle.
MIST SHOWERS
Integrated with exit airlock system in the production area, Mist Showers reduce cross-contamination within the facility. The mist formed during operation ensures removal of loose particles sticking to clothing which is discarded in a customised container. Contaminated water is discharged to kill tank – ETP via a closed loop system. A proper ventilation system is provided. The system is available in non-flameproof and flameproof execution. The design can be customised to suit specific applications and layouts.
DE-DUSTING TUNNEL
Arrest dust at source with Fabtech’s De-dusting Tunnel. Reduce dust levels, improve product quality and yield. Fabtech’s De-dusting Tunnels remove loose particles and dust that accumulate on raw material containers including drums, cartons, sacks and bags prior to sampling. The adjustable brushing system is designed to scrub containers of prefixed geometry. Loose particles are collected in a tray, and the filtration system picks up airborne particulates. 21CFR and GMP compliant, automated, mechanised system. Delivers consistent performance. Easy to maintain.
VERTICAL LAMINAR AIRFLOW SYSTEM
Our GMP/FDA complaint Vertical LAF systems provide product protection for workspaces of varying sizes including sampling, general process technology and sterile product filling. Product protection is ensured by means of targeted air flow – a clean and low-turbulence air flows vertically or horizontally onto the work area and is released back into the surrounding area at table height. The motor blower is statically and dynamically balanced so sufficient capacity and static pressure is maintained ensuring required airflow for the entire lifetime of the HEPA. Airborne particles are collected in a controlled manner and discharged.
LAMINAR AIRFLOW WORKBENCH
Our GMP/FDA complaint LAF workbenches provide product protection for small to medium-sized work processes on a laboratory scale. Product protection is ensured by means of targeted air flow – a clean and low-turbulence air flows vertically or horizontally onto the work area and is released back into the surrounding area at table height. The airflow is restricted at the back through a sheet metal cassette element and at the sides with polycarbonate panes. The motor blower is statically and dynamically balanced so sufficient capacity and static pressure is maintained ensuring required airflow for the entire lifetime of the HEPA. Airborne particles are collected in a controlled manner and discharged.
MOBILE LAMINAR AIRFLOW TROLLEY
Our GMP/FDA complaint battery operated LAF mobile trolleys provide product protection and sterile transport through cleanrooms of inferior classification. Product protection is ensured by means of targeted air flow – a clean and low-turbulence air flows vertically or horizontally onto the work area of the transfer cart and is released back into the surrounding area. The motor blower is statically and dynamically balanced so sufficient capacity and static pressure is maintained ensuring required airflow for the entire lifetime of the HEPA. Airborne particles are collected in a controlled manner and discharged. Safety functionality is monitored electronically.
SAMPLING & DISPENSING BOOTH
Fabtech’s Sampling & Dispensing booth is a GMP compliant LAF recirculation booth with product and protection. It features a recirculatory sub turbulent airflow system with upto 30% air bleed from the system. Clean and low-turbulence air flows vertically into the work area of the booth and is vacuumed out from the bottom collecting airborne substances in a controlled setting. It has an integrated exhaust air system that generates a slight negative pressure, permanently protecting the ambient area against cross contamination. Material can be loaded or unloaded for manual sampling using the high-speed lateral doors or automatic conveyor technology.
PASSBOX
Fabtech’s Dynamic Passbox is a GMP compliant system is used to transfer materials between classified areas. It has a re-circulatory air system with a certain percentage of air intake as fresh air to keep it under positive pressure. The material airlock serves as a barrier between greyroom and cleanroom It has a microprocessor-based controller to manage door interlock, UV light–hour metre, door open delay and other application based requirements. Validation is per IEST RP with air flow visualisation and specific execution based on application.
POSITIVE PRESSURE SYSTEM
Fabtech offers solution for any customised applications covering microbiology testing, testing of sterile products, cell therapy applications, sterile powder handling systems, R&D setup, aseptic process etc. These are re-circulatory in airflow management with integrated VHP system are available for both viable and non-viable particles. Integration of process equipment is 21 CFR compliant. PLC-based control system and custom built validation protocol.
NEGATIVE PRESSURE SYSTEM
Fabtech offers Negative Pressure Systems for custom applications across OSD, Injectable, QC including inline process, non- sterile powder handling, R&D and aseptic processes. Negative pressure is maintained from -30 to -20 Pa, to prevent particles from escaping the isolator. This serves as the physical barrier, but also a dynamic pressure barrier to protect the cleanroom from cross contaimination and maintain cleanliness. Supervisory Control and Data Acquisition (SCADA) compatible. Integration of process equipment is 21 CFR compliant. PLC-based control system and custom built validation protocol.
CLOSED LOOP GRANULATION
Fabtech’s innovative closed granulation line is an efficient production plant consisting of a mixer granulator, fluid bed dryer, vacuum transfer system and miller. Different parts of the line are directly connected to each other and provide best production results on the basis of their optimum adaptation. The line offers advantages like low space occupation, increased productivity due to fast product transfer, less human intervention and high yield rate. The different combinations of plant elements allows completely closed and contained product transfer on the basis of hazardous nature of product along with the highest assurance of cleaning.
CONTAINED PROCESSING
Fabtech’s Containment Solution covers the entire end-to-end process from sampling, dispensing, granulation (high shear mixer, pelletisation, drying and blending), compression, coating and primary packing either in blister, bottle or strips for potent molecules. We offer complete in-house turnkey design, manufacture, installation, validation and execution of the entire project. Our offerings include the entire granulation segment, coating and encapsulation. Solutions are available for R&D, pilot and commercial batch sizes. Validated for OEL compliance post routine validation.
FLUID BED PROCESSOR
Fabtech’s Fluid Bed Processors are designed to carry out multiple processes like drying, granulation/agglomeration and coating. This efficient combination model of the dryer, processor and coater in one single machine offers the flexibility of choice while executing each function powerfully. As several ingredients can be mixed, granulated, and dried in the same vessel, the material handling and process times are shorter as compared to other wet granulation processes. In addition to granulation for tabletting, the fluid-bed top spray method produces highly dispersible granules with a characteristic porous structure that enhances wettability. The system allows for easy validation and cleaning and can be integrated with high containment isolation systems while maintaining the safety of the operator at all times. This system is GMP compliant, easy to handle and clean. 21 CFR Part 11 compliant.
SINGLE POT PROCESSOR
Fabtech’s Single Pot Processor combines different unit operations of the pharmaceutical production process. Dry mixing, liquid addition, wet granulation, drying and sizing of the granules are all done in one compact machine. It requires less floor space, operators and support as compared to other alternatives. The swinging bowl design ensures uniform drying and mixing. The hermetic design enables high containment processing of potent solid dosage formulations and the inbuilt WIP system ensures quick product changeover. PLC based control system for process monitoring. 21CFR part 11 compliant. Operational SCADA software with IPC operating panel for data security. Available in ATEX version for operation in hazardous area.
HIGH SHEAR MIXER
Fabtech’s High Shear Mixer Granulator (also known as Rapid Mixer Grinder) has an ergonomic, compact design that allows for efficient performance of dry mixing and wet granulation processes. It delivers homogeneous mixing, even binder distribution, wetting and granule size growth through a controlled process. The result is a homogeneous product, stabilised by lower heat transfer with excellent colour distribution and rapid drying. The four-blade impeller design makes for better dry mixing of powder and faster processing. Mixing, massing and granulation are all performed in minutes. Our High Shear Mixer is GMP compliant, easy to handle and clean in place system. Unique chopper design ensures effective reduction of oversized agglomerates, . 21 CFR Part 11 compliant.
VIBROSIFTER
Fabtech’s Vibrosifter is a compact and portable design based on the ‘gyro’ principle. The gyratory motion comes from a specially designed gyro motor, fitted underneath the vibrating assembly which is isolated from the base by means of specially designed springs. The adjustable vibratory motion efficiently sifts extraneous or oversized particles, agglomerates or fines generated during processing to produce precise particles in the desired size ranges and also allows for dust free sifting. The IPC bin and hopper are designed to connect, preventing dust generation during the transfer and sifting process. This system is GMP compliant, easy to handle and clean, with easy access to all exposed areas, and corners minimising the risk of cross-contamination. Available in multiple mesh sizes to suit individual processing needs. 21 CFR Part 11 compliant.
DRY CO-MILL WITH VTS
Fabtech’s dry co-mill is used milling and sizing operations. Particle size distribution (PSD) is tightly contained with sieve, depending on the screen and impeller choices. The milling is efficient with higher output and less fines and no dusting of material. Dried granules are transferred to dry co mill through vacuum transfer system and after milling to bin blender by gravity. The compact design is easy to clean and operate. The mill works on forced pressure and generates very little heat.
MULTI-MILL
Le multi-broyeur de Fabtech est idéal pour la granulation, le mélange, le déchiquetage, le hachage et la pulvérisation à grande vitesse d'une large gamme de matériaux humides et secs. Il utilise une force variable avec des lames de marteau qui ont à la fois des bords de couteau et d'impact tournant avec l'écran pour contrôler la réduction de taille. La direction de la lame peut être modifiée à l'aide d'un interrupteur inverseur pour le fonctionnement du marteau ou du couteau. Il propose plusieurs combinaisons d'écrans et de vitesses. Il a une zone d'ouverture de tamis plus élevée pour un plus grand débit et un tamis perforé au bas de la chambre de pulvérisation pour le contrôle de la taille et de la finesse des granulés. Nous proposons également des broyeurs Co-mill et coniques utilisant les mêmes principes de force variable.
SQUARE BIN BLENDER (CONTA
Fabtech’s Bin blenders are used to mix powders or work granules with tumbling. Bin blenders are widely used due to the flexibility they offer with different capacities, closed loop material transfer and better mixing efficiency. Bin blenders also allow for improved material handling both upstream and downstream. This operator friendly system, is easy to install, dismantle and clean.
AUTOCOATER
Fabtech’s Autocoater is a wet or organic coating machine for production processes, that allows precise control of the critical variables of coating and ensures product quality and repetitiveness. It features a coating solution container and a peristaltic pump with pressure controls for differential pressure filters control. It unique design offers mixing efficiency and coating uniformity. It GMP design is an in-wall design concept that has four user levels, JOG function for heating and cooling cores and an automatic washing system.
