Process Equipments

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• Production Capacity: 50
• Delivery Time: 70 Days

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PneumaticScaleAngelus’ unique CARR P6 Powerfuge System provides continuous-flow two-phase separation of solids and liquids at rates up to 60 liters/hour.

The P6 is designed for ease of operation, with sealed feed and drain lines allowing for aerosol-free operation. Similarly, no special tools are required to disassemble the system. Integrated turnkey systems incorporating feed delivery options, CIP and SIP skids, temperature control, and closed-loop centrate pumping under vacuum are available.

The P6 system meets cGMP requirements and has been validated to meet chemical and pharmaceutical industry protocols. The P6 is engineered to optimize ease of operation while maximizing throughput; each step in the process can be readily automated so that time spent on routine maintenance can be minimized.

Using an innovative design, the feed is introduced through a stationary pipe and accelerated to full rotational speed before entering the titanium-alloy bowl. In this system, centrifugal forces as great as 20,000g permit separation of even sub-micron particles.

Compressed solids are periodically removed with a fully-automated scraping cycle. After the solids have been discharged, automated CIP/SIP cycles can be performed via the PLC-controlled operating sequence.

• Drier solids and clear liquids
• Sealed automatic operation
• Full CIP/SIP designs
• cGMP construction
• Designs available for ASME-rated boundary, hazardous locations and aseptic operations

Additional Information:

• Production Capacity: 50
• Delivery Time: 70 Days

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• PneumaticScaleAngelus’ unique CARR Centritech P12 Powerfuge System provides continuous flow two-phase separation of solids and liquids at rates up to 500 liters/hour for batches up to 4000 liters.
• Using an innovative design, the feed is introduced through a stationary pipe and accelerated to full rotational speed before entering the titanium-alloy bowl.
• In this system, centrifugal forces as 20 000g permit separation of even sub-micron particles. Compressed solids are periodically removed with a fully automated scraping cycle.
• After the solids have been discharged, automated CIP/SIP cycles can be performed via the PLC controlled operating sequence.
• The P12 is designed for easy operation, with sealed feed and drain lines allowing for aerosol-free operation.
• Similarly, no special tools are required to disassemble the system. Integrated turnkey systems incorporating feed delivery options, CIP and SIP skids, temperature control, and closed-loop centrate pumping under vacuum are available.
• The P12 system meets cGMP and CE requirements and has been validated to meet chemical and pharmaceutical industry protocols.
• The P12 is engineered to optimize ease of operation while maximizing throughput; each step in the process can be readily automated so that the time spent on routine maintenance can be minimized.
• Unique SoftStream low-shear design
• Provides gentle separation with no cell damage
• 99% recovery of intact cells
• 99% reduction of solid load
• Up to 90% reduction in downstream ltration
• 20-fold concentration factor
• Medium-to-high-volume processing
• Flow rates up to 40 LPM
• Closed system design with CIP/SIP
• Concentrated cells and supernatant can be recovered without breaking containment
• Fully automated operation
• Integrates easily into automated processes

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• Production Capacity: 50
• Delivery Time: 70 Days

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DS PH – Pharma Grade Parts Washers are engineered and utilized for throughput, efficiency, and validatable cleaning and drying of various materials and components used in Biotechnology and Pharmaceutical Manufacturing processes, including laboratory glassware, filling line components, tools, tubing, TC fittings, valves and pump bodies, filter housings, reactor vessels, and miscellaneous equipment.

DS Series can be configured for different layouts and workflow requirements: single door or double door pass-through versions; with automatic motorized opening, vertical or horizontal sliding doors. Available also in hinged door version, full glass or stainless steel, to reduce footprint and ensure easy and safe access. Available in a wide range of chamber sizes, from 230 to 2,400 litres (8 to 85 cu ft), configurations and accessories to tailor each unit to the specific client requirements.

The design of the GMP range ensures self-cleaning of the chamber and pipework at each process stage, to prevent cross-contamination. Excellent cleaning and drying performance, combined with reduced process time and water consumption, characterize the DS series.

The heating elements, located in the sump, are pharma industry compliant, sanitary and dead leg free, fabricated from AISI 316L (1.4404) stainless steel and electro-polished. They may be connected to plant steam in the Steam heat exchanger version or directly to plant power in the Electrical heat exchanger version.

Steelco GMP washers are designed, manufactured, validated, and documented according to the latest global practices and standards to facilitate customer compliance with current Good Manufacturing Practices (cGMPs).

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• Production Capacity: 50
• Delivery Time: 70 Days

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Features:

• Consistency
• Robustness
• High performance

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• PneumaticScaleAngelus unique Viafuge V12 Cell Separation System offers a major breakthrough in gentle cell separations, with no damage at medium to large-scale production levels.
• The continuous Viafuge V12 allows аfor rapid cell harvesting and supernatant clarifications with unsurpassed viability, 99% recovery of intact cells, and up to 90% reduction in filtration needs.
• With flow rates up to 40 l/min and variable speed drive, the Viafuge V12 versatile performance characteristics enable the optimization of specific applications. Closed system operation allows recovery of concentrated cells and clarified supernatant without breaking containment.
• Using an innovative patented design, the Viafuge V12 introduces feed into the SoftStream accelerator through a stationary pipe, where is is accelerated to full rotational speed under low shear before entering the titanium-alloy bowl.
• Cells are then concentrated along a gentle path between the core and the bowl wall. The clarified supernatant is continuously discharged by gravity at atmospheric pressure.
• Periodically, the concentrated cells are automatically recovered from the Viafuge V12 for collection, and the cycle is repeated to process the remainder of the feed batch.
• Upon completion of the separation process, automated CIP/SIP cycles may be performed via the PLC-controlled TrueClean operating sequence.
• The Viafuge V12 facilitates cGMP compliance by offering a simple sanitary design including strategic placement of sprayballs and jets, ASME-rated configurations for steam sterilization and a flexible CIP/SIP software program.

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• Production Capacity: 50
• Delivery Time: 70 Days

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• CARR Centritech’s new UniFuge from PneumaticScaleAngelus utilizes a gamma irradiated, single-use module that requires no CIP and no SIP. All process-contact surfaces are easy to install and are 100% replaceable after each run.
• Low shear harvesting of mammalian and insect cells is possible, and minimal reduction in viability of recovered cells is achievable. Since the cells are not lysed, production of cell debris in the centrifuge is minimized, making the UniFuge an excellent choice for both cell recovery or centrate clarification.
• UniFuge modules are readily tube-welded to your single-use bioreactor connections (customer-specified single-use connectors available upon request). The UniFuge is completely automated with exible cycle parameter entry.
• The feed suspension is gently pumped to the module and the cells settle to the outer radius while the clear supernatant is continuously discharged. Once the module has filled with cells, the controller stops the rotor and discharges the cells. This cycle is repeated until the bioreactor volume has been processed.
• Single-use disposable module
• No CIP or SIP necessary
• Fully automated
• High cell recovery rates
• Mammalian and insect cell processing
• Integrated trolley
• Intuitive software
• Low shear processing
• Minimal reduction in viability of recovered cells
• State-of-the-art manufacturing facility in Clearwater, Fla., USA

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• Production Capacity: 50
• Delivery Time: 70 Days

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Simple Operation

Cells are concentrated at the bowl wall while clarified supernatant is continuously discharged throughout the separation process. Once the bowl fills with cell concentrate to a capacity of 1.3 L, a simple manifold system and concentrate pump is utilized to recover the cells without breaking containment. Subsequent cycles are performed for recovery of larger batch sizes.

Improved Product Processing

Cellular damage can result in release of intracellular material such as DNA, which may increase downstream processing and in some cases impact product purity. Because the Viafuge Pilot is gentle to cells, damage is minimized from the start of the process. For supernatant recovery applications, ltration requirements downstream may be reduced. For cell harvesting applications, intact cell recovery will be increased.

Low-Shear Design

The Viafuge Pilot’s unique design minimizes shear forces on cells. Incoming feed is matched to the bowl hub’s rotational velocity, allowing fast, efficient harvesting of even the most shear-sensitive cells without causing cell damage.

Flexible Optimization

Flexible operating conditions offer optimization for specific applications with a flow rate range of 0.1-4.0 L/min and a relative centrifugal force range of 500- 10,000g. For mammalian cell culture, concentration to 2.5 ↔ 10⁷ cells/ml can be achieved.

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• Production Capacity: 50
• Delivery Time: 70 Days

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• PneumaticScaleAngelus’ unique CARR P18 Powerfuge System provides continuous-flow two-phase separation of solids and liquids at rates up to 1700 liters/hour for batches up to 10,000 liters.
• Using an innovative design, the feed is introduced through a stationary pipe and accelerated to full rotational speed before entering the titanium-alloy bowl.
• In this system centrifugal forces as great as 20,000g permit separation of even sub-micron particles. Compressed solids are periodically removed with a fully-automated scraping cycle.
• After the solids have been discharged, automated CIP/SIP cycles can be performed via the PLC-controlled operating sequence.
• Drier solids and clear liquids
  • Sealed automatic operation
  • Full CIP/SIP designs
  • cGMP construction
  • Designs available for ASME-rated boundary, hazardous locations and aseptic operations
  • State-of-the-art manufacturing facility located in Clearwater, FL.
• The P18 is designed for ease of operation, with sealed feed and drain lines allowing for aerosol-free operation. Similarly, no special tools are required to disassemble the system.
• Integrated turnkey systems incorporating feed delivery options, CIP and SIP skids, temperature control, and closed-loop centrate pumping under vacuum are available.
• The P18 system meets cGMP and CE requirements and has been validated to meet chemical and pharmaceutical industry protocols.
• The P18 is engineered to optimize ease of operation while maximizing throughput; each step in the process can be readily automated so that time spent on routine maintenance can be minimized.

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• Production Capacity: 50
• Delivery Time: 70 Days

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Sterile continuity is the vision. The SPE Series is ideal for treating closures for containers normally used in the pharmaceutical industry, where continuous sterility has to be maintained between different phases. The pharma grade closure processing system fully integrates all the phases of the treatment in an all in one solution:

• Pre-treatment handling
• Washing, rinsing & siliconizing
• Sterilization, drying and cooling
• Sterile delivery

Compatible with different loading/unloading systems, the unit can also be interfaced with vaporized hydrogen peroxide isolator.

Flexibility and versatility characterize the series devices, available in five models with five different chamber capacities – with a chamber volume ranging from 40 to 240 litres (1.4 to 20 cu ft). The high-quality AISI 316 L chamber with a round cross-section and two torispherical heads ensures an even distribution of load in separate baskets for optimized final results. In addition, Steelco produces a “Closure washer” version (SPE-W series) that only provides washing, rinsing, siliconizing, drying, and cooling phases.

The SPE Series is designed, manufactured, validated, and documented according to the latest global practices and standards to facilitate customers’ compliance with current Good Manufacturing Practices (cGMPs).

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• Production Capacity: 50
• Delivery Time: 70 Days

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The AMS Series of Pharmaceutical Grade Steam-Air Mixture sterilizers is a range of autoclaves designed for terminal sterilization using steam air mixture technology. Specially designed for the treatment of pharma grade materials and products that must be dry and arranged for further handling promptly after cooling, this sterilization method avoids any damage to pressure and heat-sensitive materials.

An optimal air ventilation maintains the temperature uniform in the sterilizing chamber during all process phases. These features make it suitable for sterilizing liquids in sealed or heat-sensitive containers, such as bottles, ampoules, vials, semi-open containers, bags, blister packs, prefilled syringes, pouches, contact lenses, and large sizes and small-volume parenteral (LVP and SVP).

Flexibility and versatility characterize the series devices available in different chamber sizes – chamber volume ranging from 830 to 25.000 litres (29 to 883 cu ft). The chamber is equipped with horizontal sliding double doors and the movement is controlled by an electromechanical device. The door tightness is guaranteed by gasket in Silicon FDA compliant swallowtail pneumatically pressurized by compressed air.

The AMS Series of Pharma Grade Steam-Air Mixture Sterilizers is designed, manufactured, validated, and documented according to the latest global practices and standards to facilitate customers’ compliance with current Good Manufacturing Practices (cGMPs).

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• Production Capacity: 50
• Delivery Time: 70 Days

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Compact laminar flow isolator system.

The Compact Laminar Flow Isolator System is a modular cGMP Class A/ISO 5 isolator system specifically designed for safe handling of hazardous compounds (Chemotherapy, Oncological Applications) in hospital pharmacies and small laboratories.

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• Production Capacity: 50
• Delivery Time: 70 Days

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The containers are fed automatically from an upstream machine or manually using trays. Subsequently the containers enter the single frame tube into 3 major zones: a) infeed, b) sterilization, c) cooling zone. The sterilization is performed using hot air, which is heated by an electric heating coil and constantly recirculated. Heat resistant high-capacity particle filters guarantee a Class A (100) clean room specification. The filters are mounted without a gasket to minimize generation of particles. The cooling zone gently cools down the containers before they are automatically transferred to a machine downstream.

Main Features:

• Air convection pre-heating and sterilizing zone for energy efficiency and gentle heating of the containers
• Integrated transport belt with automatic tensioning and monitoring of the belt position
• Temperature and differential pressure indicators ensure ideal and repeatable machine settings
• Optimum temperature distribution is achieved by using multiple sensors and control stations
• Collection system for broken glass
• System control and monitoring of all process-relevant data via PLC
• User-friendly touch screen operation

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• Production Capacity: 50
• Delivery Time: 70 Days

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WHEN THE HIGHEST OPERATOR PROTECTION IS REQUIRED.

The High Containment Isolator System (HC-IS) is a GMP Class 2 modular HPAPI containment enclosure designed for the most challenging containment levels during manipulations of potentially hazardous compounds for Research & Development, Production and QC.

CONFINE THE PROCESS, NOT YOURSELF!

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• Production Capacity: 50
• Delivery Time: 70 Days

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AP-IS Series | Aseptic Processing Isolator Systems

The Aseptic Isolator, AP-IS Series, is a cGMP Class A/ISO 5 isolator system specifically designed for R&D, batch scale pharmaceutical production and pharmacies.

It’s a flexible equipment that guarantees the best working conditions in different applications such as Aseptic Filling, Aseptic Dispensing & Sampling and Aseptic Product Transfer.

• Fully PLC controlled isolator system
• Modular configuration concept of the system
• Integrated VPHP generator (HYPER) and distribution circuit
• VPHP resistant anemometer
• VPHP resistant relative humidity and temperature (rH%+T) sensor
• Integrated Sliding Control Cabinet made of AISI 316L stainless steel
• View/Access panel latches with integrated safety switches
• LED lighting system
• Manipulation of viruses and vaccines

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• Production Capacity: 50
• Delivery Time: 70 Days

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The Modular Aseptic Containment Isolator System

The Aseptic Containment Isolator System is a modular cGMP Class A/ISO 5 isolator system specifically designed for the Sterile processing of High Potent Active Pharmaceutical Ingredients (HPAPIs).

• Fully PLC controlled isolator system
• Modular configuration concept of the system
• Integrated manual & automatic Wash-In-Place (WIP)
• Integrated VPHP generator (HYPER) and distribution circuit
• VPHP resistant anemometer
• VPHP resistant relative humidity and temperature (rH%+T) sensor
• Integrated Sliding Control Cabinet made of AISI 316L stainless steel
• View/Access panel latches with integrated safety switches
• LED lighting system

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• Production Capacity: 50
• Delivery Time: 70 Days

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• HEPA filtration
• Facilitate the isolation of a product or process while providing the required condition for a sterile / aseptic environment
• Provides a comprehensive range of personnel and product protection in addition to protection for the surrounding work areas and environment

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The AGS Series of sterilizers using Ethylene Oxide represents the best relationship between engineering and quality price, operating running costs, and, most important, the safety of the system and operators. AGS Series has been designed for low-temperature sterilization of heat-sensitive products according to the EN 1422 Standards for the medical processing industry, such as plastic syringes, perfusion sets, dialysis cartridges, heat-sensitive rubber products, and specific surgical instruments.

This range of Ethylene Oxide sterilizers are available in two versions:

• AGS series | Pressure sterilization program – up to 10% of Ethylene Oxide, with the remaining 90% made of inert gas (normally Nitrogen)
• AGS-E series | Vacuum sterilization program – up to 90% of Ethylene Oxide, with the residual 10% made of inert gas (normally Nitrogen)

Following customer requests, dedicated chambers for separate processes can be supplied: Pre-conditioning, Sterilization, and Degassing chambers.

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• Production Capacity: 50
• Delivery Time: 70 Days

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Dynamic Pass Boxes are aseptic architectural systems utilized to prevent contaminants from leaking into aseptic suits. They are used for aseptic transfer of materials into and out from the critical process environments.

Basic Principles:

• Dynamic airflow provides an airflow barrier during material transfers to prevent contaminants from entering into controlled environments.
• Vertical airflow purges any trace contaminants that could have entered the pass box after material transfer.
• Airflow set at dual re-circulatory on both sides.

Features:

• Modular and easy-to-clean design
• HEPA/ULPA primary filter is of  knife-edge gel seal design
• Sentinel(TM) microprocessor controller with audio/visual alarms for downflow velocity and filter loading
• Red/Green indicators for all operational parameters
• Emergency stop
• Food-grade FDA-approved, USP Class 6-compliant airtight seals
• Toughened safety glass
• Airtight pharma-grade latches with electromagnetic interlocks
• Stainless steel hinges
• Fully rounded interior corners with enhanced perforated grille system for full downflow in critical corners
• Port for particle counter probe
• Port for upstream PAO concentration
• Pressure-tested as per ISO standards

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Nesting/re-nesting machines allow for quick and precise loading of syringes into nests, for further processing or storage. The syringes are fed automatically from an upstream machine using a slide, while the tubs are fed manually or automatically on a conveyor belt.

Using vacuum technology, a cleanroom robot picks up one row of syringes and places them into the nest. Once the nest is full, it is picked up by the robot and placed into the tub. The tub is then automatically transferred to the end of the machine.

Main Features:

• Up to 12,000 pc/h
• Safety system to stop the upstream machine if infeed track is full
• Robot controller for monitoring and control of all machine functions

De-Nesting machines are quick and safe solution for unloading nested syringes. The syringe tubs can be fed manually or automatically from an upstream machine. A cleanroom robot separates the syringes from the trays and places them onto a discharge slide.

Empty tubs are automatically transferred and stacked at the end of the main transport system, while nests are stacked by the robot, using vacuum technology

Main Features:

• Up to 12,000 pc/h
• Equipped with a security system for triggering an automatic machine stop of the upstream machine if infeed track is full
• Easy access to all working stations

Additional Information:

• Production Capacity: 50
• Delivery Time: 70 Days

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Additional Information:

• Production Capacity: 50
• Delivery Time: 70 Days

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Available in single or double door pass-through hinged door version, the devices feature chamber volumes from 330 to 10.000 liters (11.7 to 353 cu ft). On request and previous Steelco approval shall be possible to require customized chamber dimensions.

Steelco’s GMP depyrogenation ovens and dry heat sterilizers are designed, manufactured, validated, and documented according to the latest global practices and standards to facilitate customer compliance with current Good Manufacturing Practices (cGMPs).

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• Production Capacity: 50
• Delivery Time: 70 Days

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Automatic Glove Leak Tester

The most advanced GMP compliant glove leak tester for isolators and RABs in the pharmaceutical industry, developed in compliance with the international standard ISO 14644-7 Annex E5.

A SMART GUARDIAN FOR YOUR BARRIER ISOLATION TECHNOLOGY

It’s advanced. It’s automatic. It’s above everything you have used so far.

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• Production Capacity: 50
• Delivery Time: 70 Days

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Pass Through Chambers for aseptic transfer of materials in the cleanroom

Active Bio-Decon Pass Through Chambers can be used for multiple applications, such as aseptic transfer of materials into cleanrooms or decontamination of equipment from BSL-1 through 4 organisms prior to extraction from the facility.

In both cases, materials are sterilized in the Pass Through Chambers by means of the integrated VPHP system.

• Fully PLC controlled
• Integrated VPHP generator (HYPER) and distribution circuit
• VPHP resistant relative humidity and temperature (rH%+T) sensor
• View/Access panel latches with integrated safety switches
• LED lighting system

Additional Information:

• Production Capacity: 50
• Delivery Time: 70 Days

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• Processes various Syringe and Safety Device Sizes
• Reduced tooling for quick and easy size changeover
• Rejects nonconforming containers automatically
• Type 212 machine features a labeling station

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• Production Capacity: 50
• Delivery Time: 70 Days

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• FDA and USP class 6 silicone seal
• Class 1 leaktightness
• 0.5µm surface rugosity
• Limited extractables
• Fewer particles generated during connection
• No hidden surfaces
• No liquid retention
• Limited condensation
• Smaller ring of concern

Designed to improve ergonomy during production and simplify maintenance:

• Easy connection from the bottom
• Reduced rotation torque
• No mechanical jamming
• No bearings
• Easy replacement of the seal
• Ergonomic handles
• Reduced footprint in washers and autoclaves
• Replaceable connection lugs

Developed in compliance with FDA 21CFR & USP Class VI

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• Production Capacity: 50
• Delivery Time: 70 Days

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Designed specifically for parenteral products applications, the Betacleanbags™ can be used for many more.

The Betacleanbags™ are compatible with other brands.

Whether you are already in production or are planning a new project, in which you need to transfer stoppers, media plates, liquids, cleaning kits or vials or eliminate waste, our Betacleanbags™ are the solution to your problems.

Contact us and let’s discuss how the new advanced Betacleanbags™ can give you the edge.

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• Production Capacity: 50
• Delivery Time: 70 Days

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With a revolutionary seal design – our Easy-GlideTM system – a new sterility assurance with new safety locks, ABC Transfer® Alpha Ports are cGMP assured.

• FDA and USP class 6 silicone seals
• No hidden surface
• Smaller ring of concern
• Class 1 leaktightness
• 0.5µm surface rugosity
• Easy cleaning operations
• Limited extractables
• Fewer particles generated during connection
• Fixed seals
• No filters
• External opening to protect your process

With the ABC Transfer® Alpha Port, you are in full control of your ergonomic options.

You can select the internal opening or the external opening option or combine both, as you see fit. It is even possible to operate one option and upgrade to an other one while you perform your annual summer shut down maintenance, at a later stage.

Such is the flexibility of the ABC Transfer® Alpha Port modular design.

• Ergonomic internal opening lever
• External opening lever
• Large range of levers and handles
• Programable door opening
• Reduced rotation torque
• Weight reduced by 30%
• Easy seal replacement
• Modular construction for simplified maintenance

Additional Information:

• Production Capacity: 50
• Delivery Time: 70 Days

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Sterility Testing Isolator

The Sterility Testing Isolator is a cGMP Class A/ISO 5 custom-designed isolator system specifically designed for Sterility Testing, according to customer’s requirements.

These parameters were pinned out to bestow the safest and most ergonomic working conditions during Quality Control Operations.

• Fully PLC controlled isolator system (Siemens S7-1500)
• Integrated VPHP generator (HYPER) and distribution circuit
• Integrated VPHP sensor for TLV monitoring (safety sensor)
• Integrated VPHP sensors for chambers’ concentration monitoring (High / Low values)
• Integrated Non-viable (Particle) monitoring
• Integrated Viable (Microbial) monitoring
•  Rapid Transfer Ports (mod. DPTE 190-XS)
•  VPHP resistant anemometer
• VPHP resistant relative humidity and temperature (rH%+T) sensors
• Integrated Sliding Control Cabinet made of AISI 316L stainless steel
• View/Access panel latches with integrated safety switches
• LED lighting system

Additional Information:

• Production Capacity: 50
• Delivery Time: 70 Days

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Restricted Access Barrier Systems

As people are the greatest source of contamination during aseptic manufacturing of drugs, reducing personnel interventions into the process zone has significant impact on the quality of the final product.
From small to large batch production systems our proficiency extends to all fields that require particular attention to asepsis during filling processes for both non-toxic sterile and cytotoxic products which require totally enclosed environments.

Tema Sinergie develops custom-designed barrier systems by directly managing the integration activities with a party machine manufacturer and the end user.

Specific equipment can be also supplied along with the barrier system, such as Preparation Isolator Systems, Unidirectional Airflow carts, Active Bio-decon Pass Through Chambers, Sterility Testing Isolators to perform all the process steps.

Our equipment are designed to meet all existing requirements for aseptic processing. A RABS provides protection by delivering a physical and aerodynamic barrier over a critical process zone with easier access to the process in the event a human intervention is required.

Tema Sinergie can develop different kinds of RABS.

• Open Passive RABS: barrier system which utilizes existing cleanroom overhead air supply systems to deliver HEPA filtered air over a critical process before returning air back into the clean room.
• Open Active RABS: barrier system which has an integrated ventilation system to supply HEPA filtered air over a critical process before returning air back into the clean room.
• Closed RABS: a positive pressure barrier system which has an integrated ventilation system to supply HEPA filtered air over a critical process, which can pass through return filters before being recirculated. Closed RABS can also be integrated with a Vapour Phase Hydrogen Peroxide (VPHP) bio-decontamination system to provide with a fully CGMP class A/ISO 5 environment.

Additional Information:

• Production Capacity: 50
• Delivery Time: 70 Days

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Automatic Filling and Capping Machine in aseptic conditions

AseptiFill is the Aseptic Filling and Capping Machine specifically designed for Pharma & Biotech companies, focused on small batch production of injectable products for pre-clinical and clinical trial studies.
Suitable for Ready-To-Use (RTU) vials ISO 8362-1 and RayDyLyo® push-fit caps.

Ease of integration in aseptic isolator system manufactured by Tema Sinergie.

• Fully PLC controlled filling and capping machine
• cGMP Filling and Capping
• Volumetric filling with 100% weight check
• GAMP 5 compliant
• 21CFR Part 11 compliant

Additional Information:

• Production Capacity: 50
• Delivery Time: 70 Days

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The ONE platform is Solaris’ ultimate entry level system. It offers multiple autoclavable single-wall vessel sizes from 2 up to 10 L total volume.

The system is 100% configurable, built with high quality components, and offered at a competitive price.

Solaris ONE Features and Benefits

• 5 different volumes (2 L, 4 L, 6.5 L, 8 L, 10 L) and 2 different ratio H/D.
• Single-wall borosilicate glass vessel, with thermoregulation performed through heating blanket and cooling finger.
• Microbial (Toro sparger, Rushton impellers, baffles) and cell cultures (Sintered sparger, Marine impellers, baffles caps) configurations available.
• Basic measurement and control options, including temperature, pH, dO2, antifoam and level.
• Modbus digital sensors reduce background noise and guarantee quick response time.
• Suitable for batch, fed-batch and continuous processes.
• Compact stainless-steel cube PCS, that can be equipped with up to 4 fixed speed Watson Marlow peristaltic pumps WM114 type.
• Powerful and accurate (1 RPM) brushless motor.
• Different gas mixing strategies with up to 4 rotameters (and/or up to 5 TMFC).
• Choice between single or multi-feed connectors.

·         Light version of LEONARDO 3.0 software licence included in the equipment supply (USB flash key), to be installed on customers’ personal computers (Optionally Solaris can provide a PC).

• Data extraction in .csv format.

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At ABC Transfer, we design handling, quality control and sterilization accessories to help your production crews manage the daily requirements of sterile production.

Designed to improve ergonomics and sterility assurance during production and maintenance:

• Handling accessories
• Sterilisation containers
• Baskets, holding and dispensing accessories
• Drawers
• Handles and levers
• Leak testers

Additional Information:

• Production Capacity: 50
• Delivery Time: 70 Days