Grade 2
ISO 10648-2 standard
HC-IS Dispensing Isolator
Compliant with GMP, Class 2, the isolation system for dispensing (Manufacturing) is designed to ensure operator protection when handling highly potent active pharmaceutical ingredients (HPAPIs) during pharmaceutical manufacturing operations.
Used in contexts of:
MAXIMUM SAFETY
Very strict containment levels, thanks to the perfect combination of design and manufacturing strategies.: inflatable seals, negative pressure gradient, and H14 HEPA filters.
AUTOMATIC LEAK TEST
An automatic leak-test system that performs an independent leak test cycle for each chamber according to the pressure change method (5.2) ISO 10648-2:1994(E).
EQUIPMENT INTEGRATION
Maximum flexibility to integrate key process equipment into the system, such as static dryers, reactors, scales, and Split butterfly valves for High-Containment applications (HCSBv).
PROCESS FLEXIBILITY
Capability to perform a wide range of contained processes, such as transfer, manual sampling, weighing, and fractionation of highly potent active pharmaceutical ingredients (HPAPIs), including cytotoxic compounds.
EASY MAINTENANCE
Direct access to the panel for on-site maintenance.
VPN connection for support and remote updates.
LIFETIME ENERGY SAVINGS
Thanks to the new sustainable low-voltage fans, the insulator has very low energy consumption throughout its entire life cycle.
MODULAR CONFIGURATION
HC-IS starts with a 3–4-glove work chamber, which can be configured with modules and options to meet the needs of each process, ultimately creating a custom solution.
ERGONOMIC DESIGN
Optimal ergonomics to provide operators with comfortable working conditions and promote safety, operational continuity, and production quality.
Features
Designed to ensure operator protection when handling highly potent active pharmaceutical ingredients (HPAPIs), including cytotoxic agents and potentially hazardous compounds.
Features
Human-Machine Interface
The HC-IS is controlled by a Siemens S7-1500 series PLC and a 12-inch Siemens SIMATIC HMI, featuring touch technology, a widescreen TFT color display, and user-friendly graphics.
The operator interface, developed by Tema Sinergie, allows for simple and intuitive use, thanks in part to the “one-touch” function and the ability to retrieve saved work programs.
- Touch panel
The interface reliably records all relevant data from the current process. - User-friendly
Intuitive graphics, designed to assist the operator. - Data management
Flexibility in data management and archiving.
Handles with built-in safety sensors
Features
LED Lighting System
Features
Removable electrical compartment
A compact, integrated, sliding control module made of AISI 304 stainless steel, housing the electrical and pneumatic components, provides direct access for all maintenance operations.
Alternatively, a monolithic, sliding external control module made of AISI 304 stainless steel is available.
Features
WASH-IN-PLACE (WIP)
Manual and automatic Wash-In-Place system for cleaning processes, which improves safety for operators involved in the production of potentially hazardous compounds and reduces the risk of cross-contamination.
Features
Inflatable Seals
The system is equipped with inflatable and/or static seals made of FDA-approved EPDM (Ethylene Propylene Diene Monomer) to ensure a Class II seal (ISO 10648:2).
Additional Features
Integrated continuous bag liner system
Features
Process Chamber
VENTILATION
Process chamber equipped with a turbulent-flow ventilation system that ensures a negative pressure gradient between the chambers and the laboratory environment.
FILTRATION SYSTEMS
The high air quality of the isolated environment is ensured by High Efficiency Particulate Air (HEPA H14) filters.
MATERIALS
Constructed of AISI 316L stainless steel, with a Mirror Brite interior finish (< 0.3 μm).
AUTOMATIC LEAK TEST
The compounding isolator is equipped with an automaticleaktest system that can be performed routinely; it carries out an independent cycle on each chamber, in accordance with the pressure variation method described in ISO 10648-2 (5.2) (E).
Features
Transfer Chamber
Features
Inert Gas Distribution System
The dispensing isolator (Production) is equipped with an integrated inert gas distribution system (e.g., nitrogen, supplied by the customer), as an alternative to ventilation using compressed air or air drawn from the laboratory. This system simultaneously allows the chambers to be inerted and keeps the oxygen concentration inside the chambers below 2%, thereby protecting specific products from oxidation.
Additions
Process Chamber: Devices and Equipment
Maximum flexibility for integrating key process equipment into the system.
High-precision scale
Reactor
A lined vessel for the preparation of blended products, integrated into the isolator to ensure complete containment of the production process.
Mechanical integration, via an EPDM membrane, to enable weighing procedures using integrated load cells. Integrated WFI and nitrogen circuits managed by the isolator’s PLC, which allows for the preloading of recipes for fully automated process management.
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Dose Preparation and Multiple Simultaneous Infusions
A high-containment manual split valve (HCSBV) and an IBC container enable a weighing and splitting process with complete containment.
Continuous Bag System
Suitable for transferring any type of material, such as filters, bags, bottles, etc. The 200-mm port is made of AISI 316L stainless steel and is equipped with a continuous plastic bag to ensure safe and efficient transfer operations. Alternatively, a 300 mm port is available.
Depending on the isolator’s configuration, the continuous bag system can be installed on a side flange (recommended position) or on the isolator’s work surface.
SHR 500
The SHR 500 is a manually operated sealing/cutting system consisting of a sealing bar with a 12-mm heating element that operates at low voltage (24 V max) and a counter bar with a cold wire—0.9 in diameter (not electrically connected).
This type of sealing prevents any contamination at the top of the bag, unlike standard pulse sealers.
A dual timer allows for separate adjustment of both the sealing time and the cooling time, enabling the seal to set before the jaws are released.
The sealer is supplied with a dedicated ergonomic cart.
High-precision scale
Configuration
Process Equipment Integration
Maximizing operator protection is the primary feature of a containment isolator. Tema Sinergie HC-IS ensures extremely rigorous containment levels (≤50 ng/m³) thanks to the perfect combination of design and manufacturing strategies. The system is equipped with inflatable and/or static seals made of FDA-approved EPDM (ethylene-propylene-diene monomer) to ensure a Class II air seal (ISO 10648:2). The HC-IS is therefore the ideal adaptable solution for various applications, such as product transfer, manual sampling, weighing, and dispensing of highly potent active pharmaceutical ingredients (HPAPIs).
A compact, integrated, sliding control module made of AISI 304 stainless steel, housing the electrical and pneumatic components, allows direct access for all maintenance operations. Alternatively, a monolithic, sliding external control module made of AISI 304 stainless steel is available. A Virtual Private Network connection enables secure and private communication over the Internet, making remote access, support, updates, and maintenance possible at any time, from anywhere.
Thanks to the new sustainable low-voltage fans, the insulator has very low energy consumption throughout its entire lifespan.
The system is based on a versatile modular design: the isolator’s basic configuration consists of a single process chamber, which can be easily expanded with additional chambers and/or transfer chambers. This makes the HC-IS perfectly suited to any requirement and process. A selection of available options can be added at a later date.
The HC-IS is equipped with an automatic routine leak test system, which performs an independent test cycle for each chamber in accordance with the pressure-change method (5.2) specified in ISO 10648-2:1994(E).
Settings and Customization
CRP Compact is highly customizable to meet specific production needs, vial types, and capping strategies.
Precise
It can be used to process a very wide range of radiopharmaceuticals in vials, always in full compliance with the latest GMP specifications.
Multitracer
It can be used to process a very wide range of radiopharmaceuticals in vials, always in full compliance with the latest GMP specifications.
Automatic
It automates the entire radiopharmaceutical dispensing process, minimizing the need for manual intervention by the operator.
Compact
Thanks to its compact size, it can be installed in any type of shielded laminar-flow chamber equipped with a well for a calibrator and a remote gripper.
Open-Vial Filling Station
The refilling station is equipped with a 0.22 µm filter that sterilizes the radiopharmaceutical at the end of the dispensing line.
Capping Station
Crimping Station
Capping Station
Push-Fit Capping Station
The Plus version of the CRP Compact features a vial closure system with push-fit caps.
Disposable Plate Kit
Removable anodized aluminum plate, equipped with a dedicated mounting slot for quick, secure, and error-proof installation of the single-use kit.
External scale
High-precision external scale for weighing the stock solution.
Built-in scale
High-precision scale integrated into the filling station for weight-controlled dispensing.
Bubble Point Sensor
Additional Modules
Recommended Accessories
AGLTS 2
Automatic Glove Leak Test System.
ZEROC
Automatic integrity verification system for Alpha and Beta rapid transfer systems (RTP).
DATA MANAGEMENT
Supervision, Control, and Data Acquisition System.
Additional Features
AGLTS 2
Integrated Automatic Glove Leak Test System (AGLTS), which performs an independent test cycle for each glove mounted on the isolator, in accordance with the positive pressure decay method described in the international standard ISO 14644-7, Annex E.5.
Wireless data transmission via Wi-Fi based on the TCP/IP protocol. Identification of the glove to be tested using radio-frequency identification (RFID) technology. Detection of holes with diameters up to 100 μm.
Additional Modules
ZEROC
ZEROC is the new RTP tester developed to perform a fully automated, comprehensive integrity test on rapid transfer ports (Alpha component) installed on isolators or RABS and their enclosures (Beta component).
It is an extremely versatile system capable of performing accurate and repeatable tests based on the pressure drop method.
Additional Features
DATA MANAGEMENT
The HC-IS can be integrated with a supervisory control and data acquisition (SCADA) system—iFIX—along with GE Digital’s historical data management (DMS) software.
DataWall, a software application developed by Tema Sinergie for data management, is also available upon request.
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