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Flexible containment solution featuring Lugaia SafeFlex isolator in a cleanroom setting – equipped with continuous liner, glove ports, control panel, and stainless steel transfer hopper for safe handling of highly active substances.

The Lugaia SafeFlex Isolator

Name: The Lugaia SafeFlex Isolator
Brand: Lugaia

Flexible containment solution

Our flexible isolators can be easily customized to meet customer requirements. We can design systems adapted to local conditions in regard to dimensions, connectivity and ergonomic requirements.

Connect the container

Drums in various dimensions can be docked or exchanged to the isolator free of contamination by means of Double O-Ring technology.

Media feed supplied via special interfaces in the isolator foil

When dismantling the isolator, it is possible to undock them without contamination. (power cables, air connections, connections for liquids, etc.)

Magnetic Base Plate

The stainless-steel base frame has a rustproof, magnetic work platform.

Ease of use

The properties of the SafeFlex Foil allow a good view inside, as well as optimal freedom of movement.

Filter Unit H14

Each isolator comes with at least one H14 filter which allows the system to breathe.

Integrable systems

Depending on the application and needs, customer equipment such as scales and stirrers can be provided and placed inside.

Tabs with incorporated snap fasteners

Allow for an easy and quick attachment to the base frame of the isolator.

Isolator dispensing with integrated ventilation technology

Ejection from isolator via continuous liner

Isolator with double chamber system and integrated ventilation technology

Isolator dispensing with integrated scale

Isolator filter dryer drain

SafeFlex Isolator for portioning

Features:

- With barrel connection, continuous liner and integrated weighing system

- Transfer into a bag system, such as the SafePort TransferBag

- Balance decoupling via drop port

Isolator with filling in SafePort TransferBag

Customized SafeFlex isolator for stirring liquids in a closed environment

Overhead and magnetic stirrer

SafeFlex isolator with a mobile ventilation unit, designed for dispensing processes

Key features of the customized solution:
- Tailored OEB5 single-use isolator
- Continuous liner port for CLS 700-250: enables equipment and waste entry/exit
- Lugaia ventilation technology Premium: Mobile Ventilation Unit with pressure test, inerting and evacuating mode - implemented with control buttons as requested by the customer.
- Hydraulic height adjustment
- Double filter H14 exhaust air isolator and double filter H14 pressure measurement isolator
- H14 supply air filter isolator
- Lifting rollers for easy movement
- TriClamp 4’’ interface
- Inner pocket isolator
- SafeSeal Toolset shelf
- Fold-down table: secured with ball lock pins

Dispensing

Exhibition SafeFlex Isolator

This equipment offers advanced features to enhance safety and efficiency in pharmaceutical manufacturing, including ventilation technology, gloves made from various film materials, drum connection, safeport connection, linerport CLS 600-250, weighing system, filter housing, zipper and swivel casters with brakes.

The advantages of the SafeFlex Isolator:

High product and personal protection
Easy handling
Universal usability
Foil with high tear resistance
High quality
Lower investment costs compared to rigid systems
Elimination of cleaning and validation costs
Integrable in existing systems
Gamma or x-ray sterilization possible
Containment can be done quickly and can be adjusted flexibly afterwards

The basis for the isolator system is provided by the stainless-steel base frame. The flexible isolator is made using easy-to-use tabs and snap fastener. The magnetic base plate on the bottom of the isolator provides a fixed and leveled platform.

Different configuration options:

stepless height adjustment
Storage options for equipment
Platforms
Different grounding points
Casters and stands in various designs

The optionally available Lugaia ventilation technology will carry out a pressure test. After finishing a production batch and necessary change of the isolator, the negative pressure will be interrupted and the enclosed air will be evacuated.

The flexible isolators can be customized to customer requirements and needs and adapted to local conditions and they can be equipped with different customer-specific dockings (e.g. with special gloves and CLS Continuous Liner for the inward and outward transfer of equipment and product.) There are also docking options for containers such as drums, connections for transfer systems (SafePort TransferBags or RTP Ports) and interfaces for media feed. Direct machine and system connection options can also be implemented on request.

Possible uses for SafeFlex Isolators:

Sampling
Weighing
Lyophilization
Filter change
Dismantling
Emptying
Reactor feeding / filling

Possible uses for local containment:

(direct docking to the process equipment without its own frame)

Filter change
Sampling
Enclosure of cleaning equipment (CIP und WIP)
Maintenance purposes/dismantling

SafeFlex Isolator System Explainer Video

Documents

Product Brochure Lugaia SafeFlex Isolator System

Back

FAQ - Frequently Asked Questions

Are there different types of gloves?

Yes. Custom designs are possible.

Can equipment be locked either inside or outside of the Isolator?

Yes, in combination with the Lugaia Continuous Liners, locks can be closed in both directions.

Can flexible isolators be operated under negative and positive pressure?

Yes. With the Premium ventilation unit, flexible isolators can be operated in both negative and positive pressure modes. The Eco ventilation unit is designed by default for a specific negative pressure; operation in positive pressure mode is available as an option. The appropriate operating mode depends on the requirements of the respective containment process.

Can the interior of the Isolator be operated inertly?

Yes, Lugaia ventilation technology offers an inerting mode.

Can the Isolator be operated in negative pressure?

Yes, in combination with the Lugaia ventilation technology, the Isolator can be operated in negative pressure or optionally in positive pressure.

For which containment applications is the Premium ventilation unit suitable?

The Premium ventilation unit was developed for demanding containment applications in the pharmaceutical, biotechnology, and life sciences industries. Typical applications include sampling, weighing, filling, powder handling, and maintenance and decontamination processes. The system ensures controlled airflow and stable pressure conditions within the flexible isolator.

For which containment level can the SafeFlex Isolators be used?

Most often with containment level OEB5. Higher containment levels are possible with double-barrier systems.

How do I find the right ventilation system for my flexible isolator?

The choice of the appropriate ventilation system depends on the requirements of the specific containment process. For applications that prioritize reliable pressure maintenance and reduced technical complexity, the Eco ventilation unit is the ideal choice. If functions such as inerting, advanced monitoring, negative and positive pressure operation, or an ATEX-certified version are required, the Premium ventilation unit is the more comprehensive solution. Lugaia supports you in selecting and designing the appropriate ventilation technology for your flexible isolator system.

How will I be alerted if the limit values for the pressure and / or the oxygen content inside the isolator are exceeded?

There is an acoustic and visual alarm. Then there is an automatic self-regulation of the ventilation unit.

Is it possible to inert the flexible insulator?

Yes. The Premium ventilation unit features an inerting mode with oxygen measurement. This provides a function for applications that require controlled inerting. The Eco ventilation unit does not include an inerting function.

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