Flexible solutions for pharmaceutical processing

FAQs – General Questions

What is the VarioSys® principle? How does VarioSys® work?

VarioSys® is an all inclusive system designed to provide maximum flexibility in pharmaceutical production. It is suitable for a wide range of applications so that the manufacturing of clinical samples, as well as the production of batches, is possible in one line. Machine modules made by Bausch+Ströbel or Harro Höfliger interlink with a SKAN isolator system on a “lock and key” principle. The “lock and key” principle allows modules to be interchanged at any time.
Pharmaceutical production can be extended by adding a suitable freeze dryer made by GEA. All FDA requirements for pharmaceutical production are met. Each partner has long-standing experience and advanced technologies for your benefit.

Why is the L-flange called L-flange?
The Pharmaceutical Safety Isolator with L-flange (PSI-L), is a modular isolator system with a unique
L-shaped flange made for VarioSys®. It allows miscellaneous process equipment to be exchanged very quickly. The short decontamination cycle and the optional return air filter (FIPA) make this a universal, sterile workspace for aseptic and  toxic/potent pharmaceutical products.

Which containers can be processed?
Vials, syringes and ampoules composed of glass or plastic (ampoules glass only), can be processed. Bulk cartridge process in pipeline. Proven and processed, Ready to Use (RTU), containers from BD, Schott and Ompi.Processing of other RTU containers may be supported. Please seek additional info.

Is VarioSys® available for nested processes or also for bulk processes?
Yes. Bausch+Ströbel production modules are designed for filling and closing all common primary packaging components used in the pharmaceutical industry. Bulk components can be processed by washer/tunnel or de-nested from RTU packaging.

Are there semi-automatic/table-top machines available on a VarioSys® module?
Yes, semi-automatic and table-top machines (resistant to VHP) are available for the following:
 • Filling precise volumes of liquid and powder products
 • Closing containers
The use of semi-automatic machines in the PSI-L isolator promises maximum flexibility in small batch production.

How is the outfeed with bulk components?
The outfeed is a mobile, single tray loader.

How is the outfeed with tubs?
The tub moves on a mobile roller track. Mobility is simply derived by the exchange between the roller track and tray loader.

What is the total height/footprint of the machine?
Width isolator (per PSI-L): 1.90 m
Depth isolator with B+S module: 1.50 m
Height isolator: 3.00 m (less then 10 feet)
Space above is not required since the machine modules within the PSI-L are self-contained.

Can the VarioSys move to different location, lines, and countries?
Yes, modules can be transported to different locations, lines and countries worldwide.
Also with the standardized isolator size and the electric infrastructure (VSE90100), a worldwide module exchange is possible.

In which clean room class can VarioSys® be installed?
Cleanroom class ISO 7 and 8 (class C and D) are possible. The lyo chamber could be also located in class ISO 7. The lyo has an ISO 7 surround- housing.

Is VarioSys available with other isolator or freeze dryer vendors?
No, VarioSys is only available with privileged and selected partners.

How many operators are required to operate a VarioSys® line?
Depending on batch size and selected process, the number of operators varies from min. 2 to max. 4.
With the Automatic De-Nester (DDM9105) or washer/tunnel as feeding machines and the disposable hopper system (BZV8110), the number of operators is reduced from 4 to 2.

Is the rear wall freely configurable? Is access to the machine possible from both sides?
The rear wall is dedicated for process-related installation of RTP ports (e.g. product supply, product circulation, stopper and cap supply).

How many gloves are needed for one PSI-L module?
Per mock-up studies, four glove ports are recommended at standardized positions.

Is VarioSys® available without glove ports?
Glove ports do help operate the VarioSys® when in a semi-automatic working mode or for trouble-shooting in order to save product. An option to work with non-permanent gloves can only be installed if an emergency occurs.

What time does a module exchange require?
It takes approx. 30 minutes to exchange modules, e.g. to switch from a vial process to a syringe process. The time required for a VHP cycle is to be added.

Can the machine handle a nitrogen atmosphere for products that are oxygen-sensitive?
Either we could offer nitrogen overlay with dispensing needles or the full chamber is loaded with nitrogen.

Is operation of the modules outside the isolator possible?
Production outside isolator is not possible due to safety reasons. Power up and jog button operation is possible outside the isolator. A special provision/docking station is necessary.

There is a risk of cross-contamination even after VHP runs. However, with VarioSys® it is possible to prevent cross-contamination by using one module for each product (dedicated customer, patient,  product modules). CMOs use dedicated modules per customer.

What is the VSE90100?
Supply and control unit to support up to 4 VarioSys® modules:
This is the central infrastructure cabinet for all modules (see schematic).

 • Central HMI

 • Central power supply

 • Central vacuum supply

 Central safety monitoring
The machine-dedicated functions are integrated directly on the module.

Where is the VSE90100 located?
The VSE cabinet can be positioned in the clean room or outside/mezzanine (technical area). Cable length max. 35m (100 feet).

How are the modular machines supplied with power?
Coded power plugs can easily be connected on the rear side of the module/L-flange. Plugs are connected to the centralized supply and control unit/VSE. All connections are standardized for simple plug and play.