Maximator® high pressure extruder

This continuous high pressure extruder (HPE) allows rapid and reproducible large-scale production of unilamellar liposomes by filter extrusion over polycarbonate membranes.

FAQ

What is required for installation of the Maximator HPE?

The device comes as a ready-to-use unit which only has to be connected to compressed air or nitrogen via the polymer hose included in the delivery (via plug-in nipple).

Is electricity required to operate the Maximator HPE?

The standard unit (HPE 12.0 - 100) does not use any electricity unless you choose to supply the compressed gas needed to drive the pump via an air compressor which is not part of the unit.
However, if CE certification is required an emergency stop switch which requires electricity has to be added due to European regulations (model HPE 12.0 - 100 CE).

How is the propellant gas supplied to drive the high-pressure pump in the Maximator HPE?

Typically air or nitrogen from gas bottles or standard gas lines as available in most labs is used to drive the pump. The required working (i.e. propellant gas) pressure is obtained by adjusting the reduction valve in the control device of the unit.

What documentation is provided along with the Maximator HPE?

The unit is delivered with a comprehensive instruction manual, technical drawings (without dimensions) and parts list.

What kind of certificates are provided along with the Maximator HPE?

The model HPE 12.0 - 100 CE comes with an EC Declaration of the manufacturer according to the EC Machinery Directive 2006/42/EC or a declaration of incorporation in case of the standard model HPE 12.0 - 100.

What is the minimum liposome batch size which can be extruded with the Maximator HPE 12.0 - 100?

Due to the void volume of the unit as well as product losses which result when using different filter stages (i.e. pore sizes) for sequential extrusion the minimum recommended batch size is approximately 50 - 75 ml.

What is the maximum liposome batch size which can be extruded with the Maximator HPE 12.0 - 100?

The unit was originally designed for the production of liposomes up to the liter scale (0.1 - 3.0 liter) which should be sufficient for formulation development and initial (pre-) clinical testing. However, some clients routinely use the Maximator HPE 12.0 - 100 for the production of batches > 10 liters especially when only a single extrusion step (i.e. filter pore size) is required.

What are the maximum product flows which can be achieved with the Maximator HPE 12.0 - 100?

The product flow is dependent on the capacity of the propellant gas source, the required operating pressure and product characteristics.

What ist the highest operating (i.e. extrusion) pressure that can be used with the Maximator HPE 12.0 - 100?

The required/resulting operating pressure is a function of formulation properties and filter pore sizes. The unit allows extrusion of extremely concentrated and viscous preparations at pressures up to 120 bar if needed, but can of course be used at any pressure below the maximum as required (see also next question).

What ist the lowest operating pressure that can be used with the Maximator HPE 12.0 - 100?

As a rule of thumb x bar inlet pressure (i.e. working or propellant gas pressure) will result in x times 46 bar operating pressure due to the pressure ratio (approximately 1:46) of the employed high pressure piston pump. Therefore, the lowest extrusion pressure one can theoretically use is approximately 4.6 bar which is obtained when the working pressure (i.e. propellant gas) is adjusted to 0.1 bar by the reduction valve of the control device.

Does the Maximator HPE require any routine maintenance?

No special maintenance is needed. General maintenance instructions are included in the standard instruction manual.

Are there any wearing parts in the Maximator HPE which need to be exchanged on a frequent basis?

Except for the seals in the high-pressure pump the Maximator high pressure extruder does not have any wearing parts which need to be exchanged. Typically the seals last for several years.

Is a test device available which can be provided for initial testing?

We do not routinely provide our Maximator HPE for external testing. However, we offer to process test suspensions (preferably placebo preparations) provided by you with our in-house test device according to your extrusion protocol and to provide the respective samples and results to you. Alternatively, someone from your team can visit us to perform such tests in our lab.

Do you have a Maximator HPE for the production of larger liposome batch sizes?

High pressure extruders for larger batch sizes are available upon request and have to be customized according to your specific requirements (e. g. DQ).

Do you have a Maximator HPE for the production of smaller liposome batch sizes?

Smaller units for the production of liposome batch sizes below 50 ml (= minimum recommended batch size for Maximator HPE 12.0 - 100) are not available due to technical/practical limitations.