Is Lugaia registered with EcoVadis?
Yes, Lugaia was awarded the bronze medal by EcoVadis in 2024. Find out more here.
Home of Containment Solutions
Swiss Quality
FAQ - Frequently Asked Questions
Answers to frequently asked questions
Here you will find answers to the most frequently asked questions.
For which containment level can Continuous Liners be used?
Product group:
Continuous Liner System CLS/CLCC
Product:
Continuous Liner
OEB5 in combination with our SafeSeal closure system.
What types of film materials for Continuous Liner are available?
Product group:
Continuous Liner System CLS/CLCC
Product:
Continuous Liner
An antistatic LDPE with FDA approval or a pure LDPE with FDA EP and USP approval is used as standard. Foil material with conductive properties or customized foils are also available.
Are the continuous liners manufactured in a clean room?
Product:
Continuous Liner
Yes, we have the option of manufacturing the continuous liner in the ISO 8/7/5 cleanroom. Continuous liners for secondary packaging are usually produced in ISO 8 cleanrooms. For primary packaging accordingly ISO 7 or ISO 5.
Does Lugaia also offer the Carrier System for the Continuous Liner?
Product group:
Continuous Liner System CLS/CLCC
Product:
Continuous Liner
,
Liner carrier CLS
,
Liner carrier CLCC
Yes, Liner Carrier systems with various interfaces are possible as well as Liner Carrier systems with RTP Beta ports.
What are the advantages of the folded Continuous Liner?
Product group:
Continuous Liner System CLS/CLCC
Product:
Continuous Liner
Lugaia’s special axial folding makes it possible to provide maximum film capacity in the smallest possible space. This reduces the frequency of changing the Continuous Liner pack to a minimum, thereby saving you time and money.
Which Continuous Liner sizes are available?
Product group:
Continuous Liner System CLS/CLCC
Product:
Continuous Liner
The smallest Continuous Liner has a diameter of 190mm with increasing gradations up to a diameter of 700mm. As a rule of thumb, the size of the Continuous Liner is adapted to the container (drum).
Can Continuous Liners be sterilized?
Product group:
Continuous Liner System CLS/CLCC
Product:
Continuous Liner
Yes, by means of gamma or X-ray radiation.
Are your products suitable for sterile production?
Product group:
General
Radiation sterilization is possible on customer request.
What industry requirements do the products meet?
Product group:
General
Our technologies have the necessary certifications for the pharmaceutical, biotechnology, and life science’s industries. All components are manufactured in an ISO8 / 7/5 clean room and remain in this environment until final packaging and delivery.
What is the main application of Lugaia products?
Product group:
General
Production of active ingredients in powder form (API’s, HPAPI’s).
Can single-use containments also be used for liquid media?
Product group:
General
Yes. If you are interested, please contact us directly via e-mail at anfrage@lugaia.ch.
What documentation is included in the delivery?
Product group:
General
Batch-related manufacturer certificate, declaration of conformity, special certificates on request
Isolator: Additional technical documentation and operating instructions.
For which containment level can SafeSeal closure system be used?
Product group:
SafeSeal Closure System
Product:
SafeSeal Crimp
OEB5 in combination with our film systems.
Can the SafeSeal Toolset be used for all closure sizes?
Product group:
SafeSeal Closure System
Product:
SafeSeal Crimp
,
SafeSeal Toolset
Yes, can be used for sizes S, M, and L.
Which SafeSeal Crimp fits which film size?
Product group:
SafeSeal Closure System
Product:
SafeSeal Crimp
The correct closure size is determined on the basis of the film diameter and film thickness. Please contact us for more information.
Are the SafeSeal Crimps liquid or gas-tight?
Product group:
SafeSeal Closure System
Product:
SafeSeal Crimp
No, the Crimps are powder-tight according to Containment Level OEB5.
For which closure sizes can the pneumatic tool be used?
Product group:
SafeSeal Closure System
Product:
Pneumatic Tool
Available for size M & L
Is the pneumatic tool suitable for ATEX areas?
Product group:
SafeSeal Closure System
Product:
Pneumatic Tool
Yes, the pneumatic tool is operated pneumatically and is suitable for ATEX.
Can the pneumatic tool be integrated into existing systems?
Product group:
SafeSeal Closure System
Product:
Pneumatic Tool
Yes, the mounting of the pneumatic tool is designed in a customer-specific manner.
What are the dimensions of a standard Isolator?
Product group:
SafeFlex Isolator System
Product:
SafeFlex Isolator
Because each Isolator is customized to meet individual needs and requirements, there are no standard sizes. If you are interested, we look forward to discussing your dimensions and details in order to design your best containment solution.
What film material is the SafeFlex Isolator made of?
Product group:
SafeFlex Isolator System
Product:
SafeFlex Isolator
Due to the impressive mechanical properties (tear resistance) of the film, we use an antistatic polyurethane (PU) for the SafeFlex Isolators.
For which containment level can the SafeFlex Isolators be used?
Product group:
SafeFlex Isolator System
Product:
SafeFlex Isolator
Most often with containment level OEB5. Higher containment levels are possible with double-barrier systems.
Are there different types of gloves?
Product group:
SafeFlex Isolator System
Product:
SafeFlex Isolator
Yes. Custom designs are possible.
Can the Isolator be operated in negative pressure?
Product group:
SafeFlex Isolator System
Product:
SafeFlex Isolator
Yes, in combination with the Lugaia ventilation technology, the Isolator can be operated in negative pressure or optionally in positive pressure.
Can the interior of the Isolator be operated inertly?
Product group:
SafeFlex Isolator System
Product:
SafeFlex Isolator
Yes, Lugaia ventilation technology offers an inerting mode.
Can equipment be locked either inside or outside of the Isolator?
Product group:
SafeFlex Isolator System
Product:
SafeFlex Isolator
Yes, in combination with the Lugaia Continuous Liners, locks can be closed in both directions.
For which containment level can TransferBag systems be used?
Product group:
TransferBag System
Product:
TransferBag
OEB5 in combination with the SafeSeal closure system
Are the Transfer Bags available with different connections?
Product group:
TransferBag System
Product:
TransferBag
Yes, the SafePort connection system is used optionally with TriClamp or O-ring connections for high containment applications.
Which film materials are available for the Transfer Bags?
Product group:
TransferBag System
Product:
TransferBag
An antistatic LDPE with FDA approval or a pure LDPE with FDA EP and USP approval is used as standard. Foil material with conductive properties or customized foils are also available.
Are there Transfer Bag standard sizes?
Product group:
TransferBag System
Product:
TransferBag
For manual handling, volumes of 5-40 liters are available as standard. Special sizes possible on request.
How is the SafePort system cleaned at the end of the process?
Product group:
TransferBag System
Product:
SafePort Bag
Using a special cleaning bag or integrated CIP nozzles in the SafePort connection head.
How many SafePort bags can be connected per passage?
Product group:
TransferBag System
Product:
SafePort Bag
A maximum of 20 bags can be connected.
Is there also a simple ventilation device only for negative pressure operation?
Product group:
SafeFlex Isolator System
Product:
Ventilation technology
Yes, we also offer a model for negative pressure operation only (without pressure test, without automatic inerting process, and without system monitoring via O2 measurement).
How will I be alerted if the limit values for the pressure and / or the oxygen content inside the isolator are exceeded?
Product group:
SafeFlex Isolator System
Product:
Ventilation technology
There is an acoustic and visual alarm. Then there is an automatic self-regulation of the ventilation unit.
Are both the new and the old SafeStick still available?
Product group:
TransferBag System
Product:
SafeStick
Yes, both versions are still available.
Is the SafeStick liquid and gas tight?
Product group:
TransferBag System
Product:
SafeStick
Yes, the SafeStick is both liquid and gas-tight in connection with our film system.
In what lengths are the SafeSticks available?
Product group:
TransferBag System
Product:
SafeStick
Custom lengths up to 900mm available.
For which SafeSeal closure sizes is the protective cap & hanging system available?
Product group:
SafeSeal Closure System
Product:
Protective Cap & Hanging System
For sizes M & L
Do you need an additional tool to close the cable tie?
Product group:
SafeSeal Closure System
Product:
Protective Cap & Hanging System
A standard cable tie tool can be used here.
What weight is the suspension system designed for?
Product group:
SafeSeal Closure System
Product:
Protective Cap & Hanging System
Up to 20kg.
What is the difference between Toolset Type 90 and Toolset Premium?
Product group:
SafeSeal Closure System
Product:
SafeSeal Toolset
Typ90 is made of standard tool steel and the handles are made of plastic. Toolset Premium is completely stainless steel with handles made of anodized aluminum. Due to its corrosion resistance, the Premium Toolset is also ideally suited for cleaning and washing processes in the Isolator.
Can the same tool set be used for all crimp sizes?
Product group:
SafeSeal Closure System
Product:
SafeSeal Toolset
Yes, for size L you only have to remove the spacer bolt from the press tool. The cutting tool is the same for all of them. Both sets can be used for all sizes of SafeSeal closures.
Is the opener part of the tool set?
Product group:
SafeSeal Closure System
Product:
SafeSeal Toolset
,
SafeSeal Opener
No, the opener is available as a separate accessory.
For which sizes is the opener available?
Product group:
SafeSeal Closure System
Product:
SafeSeal Opener
There is one opener per SafeSeal size (L, M, S).