Class A
EU GMP
AP-IS Aseptic Isolator
AP-IS is a Class A/ISO 5 cGMP-compliant isolation system designed specifically for quality control laboratories, pilot-scale pharmaceutical manufacturing facilities, and pharmacies.
It is a flexible machine that ensures optimal operating conditions for various applications, such as sterility testing and filling, fractionation, sampling, and aseptic product transfer.
GUARANTEED STERILITY
AP-IS ensures the highest air quality thanks to a perfect combination of design and construction strategies: engineered filtration (HEPA), an integrated VPHP system, and inflatable seals.
LAMINAR FLOW SYSTEM
A unidirectional airflow system with air recirculation within the work area, designed to maintain controlled environmental conditions and ensure high air quality.
AUTOMATIC LEAK TEST
An automatic leak-test system that performs an independent cycle on each chamber, in accordance with the pressure-varying method described in ISO 10648-2 (E) (5.2).
PROCESS FLEXIBILITY
Capability to develop a wide range of aseptic processes, such as aseptic filling, sterility testing, aseptic dispensing and sampling, and aseptic transfer.
MODULAR CONFIGURATION
AP-IS starts with a 3–4-glove work chamber, which can be configured with modules and options based on the requirements of each process to create a customized solution.
ERGONOMIC DESIGN
Optimal ergonomics to provide operators with comfortable working conditions and promote safety, operational continuity, and production quality.
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.
Features
Designed to ensure aseptic conditions and air quality control during pharmaceutical processes.
VPHP-Resistant Anemometer
VPHP-resistant rH% and T° sensor.
Interior LED Lighting System
Virtual Private Network (VPN) connection
Features
Human-Machine Interface
The HC-IS is controlled by a Siemens S7-1500 series PLC and a 12-inch Siemens SIMATIC HMI, featuring touchscreen technology, a widescreen TFT color display, and user-friendly graphics.
The operator interface, developed by Tema Sinergie, offers simple and intuitive operation, 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.
Features
Transfer Chamber
Feature
Transfer Chamber
cGMP Class A/ISO 5 process chamber equipped with an anemometer for air velocity control and an integrated temperature and relative humidity (rH%+T) sensor, both resistant to VPHP.
VENTILATION
Unidirectional flow system with air recirculation.
FILTRATION SYSTEMS
Engineered filtration system consisting of High-Efficiency Particulate Air (HEPA) pre-filters and Ultra Low Penetration Air (ULPA U15) unidirectional and return filters.
AUTOMATIC LEAK TEST
The compounding production isolator is equipped with an automatic leak test system that can be performed routinely; it runs an independent cycle on each chamber in accordance with the pressure variation method described in ISO 10648-2 (E), clause 5.2.
BIODECONTAMINATION
Integrated vaporized hydrogen peroxide bio-decontamination system for very rapid bio-decontamination cycles (complete 20-minute cycle in the Rapid Gas pre-chamber, including full venting).
Removable electrical compartment
Dashboard
Integrated, sliding electrical compartment made of AISI 304 stainless steel, housing the electrical components and providing direct access for all maintenance operations.
Additional Features
Safety Sensors
Closing of visual/access panels with built-in safety sensors
Additional Features
LED Lighting System
Features
Inflatable Seals
Inflatable seals made of FDA-approved Bio-Guardian® white silicone, with antibacterial inhibitors.
Features
Room Layout
Made of AISI 316L stainless steel, with a Mirror Brite interior finish (< 0.3 μm) and a Scotch Brite exterior finish (< 0.8 μm).
Features
Built-in VPHP Generator
Integrated vaporized hydrogen peroxide bio-decontamination system for rapid bio-decontamination cycles (20 to 50 minutes, depending on the type of load).
1/4
additions
Process Chamber: Equipment and Add-ons
Maximum flexibility for integrating dedicated process equipment into the system.
Robotic Filling Systems
The system can be integrated with robotic systems within the process chamber for the aseptic filling of various types of containers, including vials, syringes, bottles, eye drop dispensers, nasal sprays, and bags.
This integration enables the creation of an all-in-one solution optimized for the aseptic filling of small batches.
Peristaltic Pumps
The system can be integrated with peristaltic pumps within the process chamber for performing sterility tests and quality control (QC) activities.
This integration enables the creation of an all-in-one solution specifically designed for sterility testing and QC applications.
RTP Transfer Ports
Option to integrate rapid transfer ports (RTP) to enable the transfer of materials into and out of the isolator while maintaining aseptic conditions and process environment control.
Customized Systems for Sampling Operations
The ability to integrate custom-built systems and devices for sampling activities within the process chamber, configured to meet the specific needs of the process.
This integration enables the creation of a custom all-in-one solution for applications under aseptic conditions, ensuring operational flexibility and control of environmental conditions during sampling activities.
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Robotic Filling Systems
The system can be integrated with robotic systems within the process chamber for the aseptic filling of various types of containers, including vials, syringes, bottles, eye drop dispensers, nasal sprays, and bags.
This integration enables the creation of an all-in-one solution optimized for the aseptic filling of small batches.
Additional Modules
Recommended Accessories
Hyper
Integrated 6-log bio-decontamination system.
AGLTS 2
Automatic Glove Leak Test System.
ZEROC
Automatic integrity verification system for Alpha and Beta rapid transfer systems (RTP).
Accessories
Hyper
HYPER® is a vapor-phase hydrogen peroxide (VPHP) generator specifically designed to perform biodecontamination processes in clean, controlled environments used for medical, pharmaceutical, and biological applications.
The bio-decontamination process is effective against a wide range of microorganisms. The processes can be validated using Geobacillus stearothermophilus as a biological indicator to consistently achieve a 6-log reduction in spores.
CYCLE DESCRIPTION
The bio-decontamination process is a dry procedure that prevents VPHP from condensing on treated surfaces.
HYPER uses a low-temperature bio-decontamination method, during which a 35% aqueous H₂O₂ solution is rapidly vaporized via a preheated air jet, which penetrates the chamber saturated with VPHP.
To minimize operator exposure to liquid hydrogen peroxide during handling of the bulk product, HYPER® uses specially designed disposable containers that hold 3,000 ml of 35% hydrogen peroxide (H₂O₂).
Accessories
Configuration Details
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.
Accessories
Configuration Details
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.
DATA MANAGEMENT
Supervision, Control, and Data Acquisition System.
Accessories
DATA MANAGEMENT
AP-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.
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 process of dispensing radiopharmaceuticals, 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 disposable 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
OTHER Pharmaceutical Isolators
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