Products

Barrier Isolation Technology

When building and designing custom sterility and protection solutions for the pharmaceutical industry, particularly when dealing with operator safety, a thorough experienced consultative approach is essential. This is the main reason you need a partner that you can trust, a partner who understands the local regulatory guidelines for sterile products, safety and health needs defined under Control of Substances Hazardous to Health (COSHH) and Occupational Safety and Health Act (OSHA), and this is how ACIC and Tema Sinergie support you.

If your pharmaceutical project requires a contained environment around a particular manufacturing process or manipulation of products in aseptic or hazardous environments, our barrier isolators create the perfect physical auto-containment. The only access the operator has to the inside of the barrier is utilizing gloves. Our turn-key equipment packages are completed with full implementation of appropriate cGMP/GAMP documentation, including IQ/OQ packages, FDS, HDS, SDS, P&ID, and all industry standards ensuring compliance, control, and validation of data submittals.

We provide the full range of equipment including barrier isolators, restricted access barrier systems (RABS), laminar flow hoods, and integrated custom automation solutions for aseptic pharmaceutical manufacturing.

Product Lines

Click for Aseptic Processing Isolator

Aseptic Processing Isolator

click for Bio-Decon Pass Through Chamber

Bio-Decon Pass Through Chamber

click for Cell Culture Isolator System

Cell Culture Isolator System

click for compact larimar flow isolator

Compact Laminar Flow Isolator System

click for Compounding Isolator

Compounding Isolator Production

click for dispensing isolator systems

Dispensing Isolator

click for high containment isolators

High Containment isolator systems

click for ABS - Restricted Access Barrier System

RABS – Restricted Access Barrier System

click for Sterility Testing Isolator System

Sterility Testing Isolator System

Aseptic Processing Isolator

Tema  Sinergie provides a comprehensive range of totally contained aseptic solutions, fully compliant with the strictest cGMP and international regulations, and can service the pharmaceutical, biological and hospital industries worldwide.

Typical applications are: Aseptic Filling, Sterility Testing, Aseptic Dispensing & Sampling, and Aseptic Transfer. Upgradable cost-effective standard and fully customized isolator systems are available according to the specific process.

Some advantages of using isolator systems compared to the traditional cleanroom include:

  • GMP Class A ISO 5 contained enclosure
  • Recirculation unidirectional flow airflow system
  • Integrated Gasified Hydrogen Peroxide Bio-decontamination Systems
  • Controlled reliability of the process
  • High quality product with total efficiency
  • Increased safety through reduced contamination risks, and consequently increased patient safety
  • Full process equipment integration

 

Aseptic Processing Isolator System (AP-IS)l

The AP-IS 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
Guaranteed AsepsisModular Based ConfigurationAutomatic Leak TestEase of Maintenance
Ergonomic DesignGlove Integrity TestData ManagementEnergy Saving
  • Complete documentation package according to Tema Sinergie standards
  • Complete validation package, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
  • Installation Qualification/Operational Qualification (IQ/OQ) protocols and execution upon request
  • Performance Qualification (PQ) protocols and execution upon request

Bio-Decon Pass Through Chamber

Active Bio-decon Pass Through Chambers

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
Guaranteed AsepsisMaximum SafetyAutomatic Leak TestEase of Maintenance
Standard DesignData ManagementEnergy Saving

 

Active Bio-decon Walk-In Pass-Through Chambers

Walk-In dimensions Pass Through Chambers for aseptic transfer of materials in the cleanroom

With Active Bio-decon Walk-in Pass-Through Chambers, materials are sterilized in the Pass-Through Chamber by means of an integrated Bio-decontamination system.

The integrated ventilation system of the chamber guarantees a pressure cascade between the adjoining rooms and the chamber itself. This cascade preserves the asepsis of materials after termination of the bio-decontamination process prior to extraction into the cleanroom.

Custom designed to fit individual applications.

 FJALAR KRISTJANSSON – Chief Operating Officer, Alvotech

“Tema Sinergie has developed a custom-designed Walk-in Active Bio-decon Pass Through Chamber for our facility in Reykjavik and delivered two of those to us.

It is a pleasure to see how precisely and efficiently the Pass-Through Chambers work, and they are just a pure joy to look at!

We have appreciated how Tema Sinergie professionally dealt with each step of the project through friendly correspondence and cooperation from the initial phases of the project through on-site installation and validation of the equipment. The chambers are currently in complete operational readiness, and successfully support our aseptic processing.”

Guaranteed Asepsis

Maximum Safety

Automatic Leak Test

Ease of Maintenance

Standard Design

Data Management

Energy Saving

 

  • Complete documentation package according to Tema Sinergie standards
  • Complete validation package, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
  • Installation Qualification/Operational Qualification (IQ/OQ) protocols and execution upon request
  • Performance Qualification (PQ) protocols and execution upon request

Custom-designed Active Bio-decon Pass Through Chambers

Fully Custom-designed Active Bio-decon Pass Through Chambers according to user requirement

This equipment enables the aseptic transfer of material into cleanrooms.

Materials are sterilized in the Pass-Through Chamber by means of an integrated Bio-decontamination system.

The integrated ventilation system of the chamber guarantees a pressure cascade between the adjoining rooms and the chamber itself. This cascade preserves the asepsis of materials after termination of the bio-decontamination process prior to extraction into the cleanroom.

Custom designed to fit individual applications.

Guaranteed Asepsis

Maximum Safety

Automatic Leak Test

Ease of Maintenance

Custom Design

Data Management

Energy Saving

 

  • Complete documentation package according to Tema Sinergie standards
  • Complete validation package, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
  • Installation Qualification/Operational Qualification (IQ/OQ) protocols and execution upon request
  • Performance Qualification (PQ) protocols and execution upon request

Cell Culture Isolator System

The CC-IS is a Cell Culture Isolator cGMP Class A/ISO 5 system specifically designed to provide the users with a cell culture environment that is safer than environments on traditional biosafety cabinets, clean booths, or standard cleanrooms, by eliminating any risk from human contamination of cell cultures.

The Cell Culture Isolator CC-IS is intended to perform cell & gene autologous therapy activities, which include activation and transduction process of non-infectious viruses, viral vectors, that might becomes infectious or overexpressed.

Cell Culture Isolator System (CC-IS)

Centrifuge: An integrated centrifuge allows to run the spin cycle on a multitude of cell culture containers and conical tubes for cell passage, and process a wide range of plates and racks for cell culture analysis.
The centrifuge is available with refrigeration capability, and a temperature range of -20° C to +40° C.
The centrifuge is integrated into the working place of the Process Chamber.

Incubator: An integrated incubator, monitored and controlled through the isolator HMI, guarantees optimal environmental conditions for cell cultures, such as controlled Temperature (T), Humidity (rH%), Carbon Dioxide (CO2) and Oxygen (O2).
The incubator is integrated into the back wall of the isolator; an inflatable seal made of FDA-approved White Silicon Bio-Guardian® guarantees the tightness with the Process Chamber.

Refrigerator: An integrated refrigerator, monitored and controlled through the isolator HMI, keeps media and other reagents cool (0 – 20° C).
The refrigerator is integrated into the back wall of the isolator, an inflatable seal made of FDA-approved White Silicon Bio-Guardian® guarantees the tightness with the Process Chamber.

Microscope: An integrated microscope for brightfield live-cell imaging can be used in routine cell culture processes to monitor cell proliferation, motility and morphology.
The microscope is integrated into the working place of the Process Chamber.

  • 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
  • Control Cabinet made of AISI 316L stainless steel
  • View/Access panel latches with integrated safety switches
  • LED lighting system
  • Integrated process equipment, such as incubator, centrifuge, refrigerator, and microscope
  • Safe change (Bag-In/Bag-Out) filtering units for the process environment
  • Integrated systems (RTP) to transfer solid and liquid products without breaking the aseptic containment
  • Integrated Flexicon® PD12 Series Peristaltic Pump for flexible and reliable filling processes

Modular Based Configuration: The Cell Culture Isolator is based on a versatile modular concept: the base isolator can be easily expanded with additional Process Chambers and Transfer Chambers. This makes CC-IS perfectly suitable for every need and process. A selected group of available options may be added at a future date.

Guaranteed Asepsis: The Cell Culture Isolator CC-IS assures the highest air quality for the isolated environment thanks to:
– an engineered filtration system composed of High-Efficiency Particulate Air (HEPA H14) inlet, unidirectional downflow, and exhaust filters
– Single-pass 100% extraction airflow to avoid potential contamination of the process environment
– HYPER, Tema Sinergie’s integrated Vapour Phase Hydrogen Peroxide (VPHP) bio-decontamination system for very fast bio-decon cycle (Rapid Gas Chamber complete cycle last in 30 minutes, full aeration included)
– inflatable seals made of FDA-approved White Silicon Bio-Guardian®, with anti-bacteria inhibitors.

Automatic Leak Test: The Cell Culture Isolator CC-IS is equipped with a routine automatic leak testing system that performs an independent leak test cycle for each chamber according to the pressure change method (5.2) ISO 10648-2(E).

Ease of Maintenance: A remote control module made of AISI 316L stainless steel allows direct access for all maintenance operations.
A Virtual Private Network (VPN) connection allows secure and private communication via Internet network and provides remote access for assistance, updates, and maintenance anytime, everywhere.

Ergonomic Design: Maximizing the operators’ effectiveness is essential to minimize any risk of accidents, remove unscheduled downtime and boost production quality. Operators have assured the most comfortable working conditions by the outstanding ergonomics of the Cell Culture Isolator CC-IS.

Glove Integrity Testing: The Cell Culture Isolator CC-IS can be equipped with an integrated Automatic Glove Leak Testing System (AGLTS) which performs an independent leak test cycle for each glove mounted on the isolator system according to the Positive Pressure Decay Method described in the international standard ISO 14644-7 Annex E.5. Wireless Wi-Fi data transmission based on a TCP/IP protocol. Recognition of the glove to be tested by means of Radio Frequency IDentification (RFID) Technology. Detection of holes down to 100μm diameter.

Data Management: The Cell Culture Isolator CC-IS can also be upgraded with an Integrated Supervisory Control And Data Acquisition (SCADA) – iFIX with Historian Data Management Software (DMS) from GE Digital. DataWall, a software application developed by Tema Sinergie for data management, is also available upon request.

Energy Saving: Thanks to the new sustainable low voltage ventilation fans, the isolator has a very low energy consumption throughout its life.

  • Complete documentation package according to Tema Sinergie standards
  • Complete validation package, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
  • Installation Qualification/Operational Qualification (IQ/OQ) protocols and execution upon request
  • Performance Qualification (PQ) protocols and execution upon request

Compact Laminar Flow Isolator System

Aseptic Containment Isolator Systems suitable for a safe handling of hazardous compounds (Chemotherapy, Oncological Applications).

Increased operator safety with better ergonomics into CGMP Class A/ISO 5 isolated environments. Fully integrated Bio-decontamination system to allow 6-log bacterial reduction.

 

Compact laminar flow isolator system (CLF-IS)

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.

  • Fully PLC controlled isolator system
  • Modular configuration concept of the system
  • High Efficiency Particulate Air (HEPA H14) filtration
  • Unidirectional Air Flow
  • Achievable positive/negative pressure gradient
  • View/Access panel latches with integrated safety switches
  • LED lighting system
  • Increased operator safety with better ergonomics
  • Compact dimensions allow easy handling through standard doors and elevators in hospitals and pharmaceutical companies

Optional Integrated Equipment

  • Integrated VPHP generator (HYPER) and distribution circuit
  • VPHP sensor for TLV environment (safety sensor)
  • Integrated Non-viable (Particle) monitoring system
  • Integrated Automatic Glove Leak Testing System (AGLTS)
  • Front Sliding Shield for operator protection for radiopharmaceutical applications
  • Shielded working area for operator protection for radiopharmaceutical applications
  • External Catalytic Unit for H2O2 break down

Guaranteed Asepsis

Isolator Configuration

Automatic Leak Test

Ease of Maintenance

Ergonomic Design

Glove Integrity Testing

Maximum Safety

Energy Saving

  • Complete documentation package according to Tema Sinergie standards
  • Complete validation package, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
  • Installation Qualification/Operational Qualification (IQ/OQ) protocols and execution upon request
  • Performance Qualification (PQ) protocols and execution upon request

Compounding Isolator Production

Compounding Isolator

HC-IS Series

GMP Class 2 containment enclosure designed for the most challenging containment levels during manipulations of High Potent Active Pharmaceutical Ingredients (HPAPI) for compounding activities.

  • Fully PLC controlled isolator system
  • Integrated Wash-In-Place (WIP)
  • Integrated inert gas distribution system
  • Handles with integrated safety switch
  • Sustainable low voltage ventilation fans
  • LED lighting system
  • Integrated sliding control module
  • Virtual Private Network (VPN)
  • Integrated continuous liners
  • Integrated IP69 Weighing Scale and Operator Terminal
  • Integrated 50lts Jacketed Preparation Vessel
  • Rapid Transfer Port (DPTE 190-XS)

Maximum Safety

Isolator Configuration

Automatic Leak Test

Glove Test Integrity

Integrated Wash-In-Place (WIP)

Integrated Inert Gas Distribution System

Ease of Maintenance

Contained Process

Energy Saving

Integrated Process

 

 

  • Complete documentation package according to Tema Sinergie standards
  • Complete validation package, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
  • Installation Qualification/Operational Qualification (IQ/OQ) protocols and execution upon request
  • Performance Qualification (PQ) protocols and execution upon request

Dispensing Isolator

Dispensing Isolator

HC-IS Series

The Dispensing Isolator is a GMP Class 2 containment enclosure designed for the most challenging containment levels during manipulations of potentially hazardous compounds for production activities.

The isolator system is equipped with a turbulent air flow system, and constantly guarantees a negative pressure gradient between the chambers and the lab environment. The high air quality of the isolated environment is assured by High Efficiency Particulate Air (HEPA H14) filters.

  • Fully PLC controlled isolator system
  • Integrated Wash-In-Place (WIP)
  • Handles with integrated safety switch
  • LED lighting system
  • Integrated compact control module
  • Virtual Private Network
  • Integrated weighing scale with operator interface
  • Integrated High Containment Split Butterfly Valve (HCSBV)

Maximum Safety

Isolator Configuration

Automatic Leak Test

Glove Test Integrity

Integrated Wash-In-Place (WIP)

Ease of Maintenance

Contained Process

Energy Saving

  • Complete documentation package according to Tema Sinergie standards
  • Complete validation package, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
  • Installation Qualification/Operational Qualification (IQ/OQ) protocols and execution upon request
  • Performance Qualification (PQ) protocols and execution upon request

Dispensing Isolator (QC Lab)

HC-IS Series

GMP Class 2 containment enclosure designed for the most challenging containment levels during manipulations of High Potent Active Pharmaceutical Ingredients (HPAPI) for analysis/quality control activities.

  • Fully PLC controlled isolator system
  • Integrated Wash-In-Place (WIP)
  • Integrated inert gas distribution system
  • Handles with integrated safety switch
  • Sustainable low voltage ventilation fans
  • LED lighting system
  • Integrated sliding control module
  • Virtual Private Network (VPN)
  • Integrated continuous liners
  • Integrated High Precision Weighing Scale and Operator Terminal

Maximum Safety

Isolator Configuration

Automatic Leak Test

Glove Test Integrity

Integrated Wash-In-Place (WIP)

Integrated Inert Gas Distribution System

Ease of Maintenance

Contained Process

Energy Saving

 

 

 

  • Complete documentation package according to Tema Sinergie standards
  • Complete validation package, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
  • Installation Qualification/Operational Qualification (IQ/OQ) protocols and execution upon request
  • Performance Qualification (PQ) protocols and execution upon request

Dispensing Isolator (Production)

HC-IS Series

GMP Class 2 containment enclosure designed for the most challenging containment levels during manipulations of High Potent Active Pharmaceutical Ingredients (HPAPI) for production activities.

  • Fully PLC controlled isolator system
  • Integrated Wash-In-Place (WIP)
  • Integrated inert gas distribution system
  • Handles with integrated safety switch
  • Sustainable low voltage ventilation fans
  • LED lighting system
  • Integrated sliding control module
  • Virtual Private Network (VPN)
  • Integrated continuous liners
  • Integrated IP69 Weighing Scale and Operator Terminal

Maximum Safety

Isolator Configuration

Automatic Leak Test

Glove Test Integrity

Integrated Wash-In-Place (WIP)

Integrated Inert Gas Distribution System

Ease of Maintenance

Contained Process

Energy Saving

 

 

 

  • Complete documentation package according to Tema Sinergie standards
  • Complete validation package, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
  • Installation Qualification/Operational Qualification (IQ/OQ) protocols and execution upon request
  • Performance Qualification (PQ) protocols and execution upon request

High Containment isolator systems

The primary characteristic of a Containment Isolators system is maximizing operator protection: Tema Sinergie Containment Isolator systems have been designed for handling high potent compounds and offer guaranteed high levels of user protection.

Operator safety is crucial due to the potentially dangerous nature of the products.

Tema Sinergie Containment Isolators systems, thanks to a perfect combination of design and manufacturing strategies, assure a 100% OEL5 (≤50 ng /m3).

Product Transfer, Manual Sampling, Weighing and Dispensing operations of High Active Pharmaceutical Ingredients (HAPIs) are some of the default activities our Containment Isolators are designed for, to cover a wide range of processes, from HPAPI synthesis to final formulation for both R&D and production.

Various solutions for chemical synthesis and manufacturing processes that comply with user requirements are available, such as standard and custom-designed Multi-stages Containment Isolator Systems in compliance with Class 2 leakage testing according to ISO 10648-2.

Explosive proof (ATEX) compliant applications available.

Full integration of process equipment, such as Vacuum Dryers, Reactors, Weighing Scales, and High Containment Split Butterfly Valves (HCSBv) possible.

HC-IS

High Containment Isolator System

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.

  • Modular based configuration of the system
  • Fully PLC controlled isolator system
  • Integrated Wash-In-Place (WIP)
  • Handles with integrated safety switch
  • LED lighting system
  • Integrated compact control module
  • Virtual Private Network

Maximum Safety

Modular Configuration Based

Automatic Leak Test

Glove Test Integrity

Integrated Wash-In-Place (WIP)

Ease of Maintenance

Data Management

Energy Saving

  • Complete documentation package according to Tema Sinergie standards
  • Complete validation package, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
  • Installation Qualification/Operational Qualification (IQ/OQ) protocols and execution upon request
  • Performance Qualification (PQ) protocols and execution upon request

RABS – Restricted Access Barrier System

RABS

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, and Sterility Testing Isolators to perform all the process steps.

Our equipment is 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 Vapor Phase Hydrogen Peroxide (VPHP) bio-decontamination system to provide with a fully CGMP class A/ISO 5 environment.

Guaranteed Asepsis

Maximum Safety

Automatic Leak Test

Ease of Maintenance

Custom Design

Data Management

Energy Saving

 

  • Complete documentation package according to Tema Sinergie standards
  • Complete validation package, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
  • Installation Qualification/Operational Qualification (IQ/OQ) protocols and execution upon request
  • Performance Qualification (PQ) protocols and execution upon request

Sterility Testing Isolator System

The ST-IS (Sterility Testing Isolator) is a cGMP Class A/ISO 5 modular isolator system specifically designed for Sterility Testing, which guarantees the safest working conditions during Quality Control Operations.

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

Guaranteed Asepsis: The ST-IS assures the highest air quality of the isolated environment due to:
– an engineered filtration system composed of High-Efficiency Particulate Air (HEPA H14) inlet, unidirectional down flow, return, and exhaust filters;
– Our integrated Vapour Phase Hydrogen Peroxide (VPHP) bio-decontamination system for very fast bio-decon cycle;
– inflatable seals made of FDA-approved White Silicon Bio-Guardian, with anti bacteria inhibitors.

Data Management: The ST-IS can also be upgraded with an Integrated Supervisory Control And Data Acquisition (SCADA) – iFIX with Historian Data Management Software (DMS) from GE Digital. DataWall, a software application developed by Tema Sinergie for data management, is also available upon request.

Modular Based Configuration:The system is based on a versatile modular concept: the base isolator configuration is composed of a single 4-gloves working chamber which can be easily expanded with additional chambers/airlocks. This makes ST-IS perfectly suitable to every need and process. A select number of available options may be added at a future date.

Automatic Leak Test: The ST-IS is equipped with a routine automatic leak testing system which performs an independent leak test cycle for each chamber according to the pressure change method (5.2) ISO 10648-2(E).

Glove Integrity Testing: The ST-IS can be equipped with an integrated Automatic Glove Leak Testing System (AGLTS) which performs an independent leak test cycle for each glove mounted on the isolator system according to the Positive Pressure Decay Method described in the international standard ISO 14644-7 Annex E.5. Wireless Wi-Fi data transmission based on a TCP/IP protocol. Recognition of the glove to be tested by means of Radio Frequency IDentification (RFID) Technology. Detection of holes down to 100μm diameter.

Ergonomic Design:Maximizing operators’ effectiveness is essential to minimize the risks of accidents, eliminate unscheduled downtime and boost production quality. Operators are assured the most comfortable working conditions by the outstanding ergonomics of the isolator.

Ease of Maintenance: An integrated sliding control module made of AISI 316L stainless steel, containing electrical and pneumatic components, allows direct access for all maintenance operations. A Virtual Private Network (VPN) connection allows a secure and private communication via Internet network and provides remote access and assistance, updates and maintenance anytime, everywhere.

  • Fully PLC controlled isolator system
  • Modular configuration concept of the system
  • Integrated VPHP generator and distribution circuit
  • VPHP resistant anemometer
  • VPHP resistant relative humidity and temperature (rH%+T) sensor
  • External monolithic Control Cabinet made of AISI 304 stainless steel
  • View/Access panel latches with integrated safety switches
  • LED lighting system
  • Rapid Transfer Port
  • External sliding shield
  • Compact Sterility Testing Isolator System (CST-IS) is also available.
  • Complete documentation package according to Tema Sinergie standards
  • Complete validation package, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
  • Installation Qualification/Operational Qualification (IQ/OQ) protocols and execution upon request
  • Performance Qualification (PQ) protocols and execution upon request