Prochrom® Hipersep M

Prochrom® Hipersep Systems by Novasep

Preparative HPLC systems - optimum performance guaranteed

1.Product Description

The HIPERSEP M (Pack 1 & Pack 2) is an automated high pressure solvent delivery module for preparative chromatography designed for cGMP operation. It is used to pump the mobile phase into the chromatographic column, inject the product to be purified into the column, detect and collect the fractions. It can be operated with the most common solvents used in chromatography.
MAIN CHARACTERISTICS
Flow Rate Range (L/h) 90 - 200
Typical Column Diameters Associated (mm)

200

300

450

Operating pressure (bar) 100
Operating Temperature (°C) 5 to 60
Norms ATEX Zone II (EU)
Class 1 Division 2 (US)
Weight Pack 1 / Pack 2
(Pumping skid + Electrical cabinet)
1620 kg / 2140 kg (EU)
3657 lb / 4817 lb (US)
Pumping skid dimensions DxWxH 1420 mm x 2915 mm x 2102 mm (EU)
55.9” x 121.5” x 87.9” (US)
Electrical cabinet dimensions DxWxH 400 mm x 800 mm x 1800 mm (EU)
 
ATEX Zone II Version
Class 1 Division 2 Version:

2.Product Specifications

Prochrom® Hipersep M specifications

Hipersep M
ITEM DESCRIPTION
Analogic Gradient
(1 to 9)
Binary analogic gradient working from 5 to 95 % in the dynamic range of the system flowrate, with an absolute accuracy of ± 1.0 %.
Four pneumatic 4-way ball valves used to select the solvents.
Mass flowmeter used to control the Eluent composition.
Two non return check valves.
Two pneumatic 2-way control valves used to adjust the Eluent composition.
Static Mixer (10) Static mixer used to mix the Eluent.
Additional inlet (11) Pneumatic 2-way ball valve. Used to pump additional solvent like washing solvent.
Recycling valves (12) Two pneumatic 3-way ball valve. Used to recycle the Eluent toward the Eluent pump.
Low pressure injection (13) Pneumatic 3-way ball valve. Used to inject large amounts of feed material using the Eluent pump.
Air sensor (14) Air switch. Used to detect air and to indicate there is no more feed material on the low pressure feed supply.
Eluent pump (15) 3-head membrane (PTFE) pump. Able to operate from 150 up to 500 L/h at 100 bar. Equipped with membrane failure indicators.
Pressure Transmitter (16) Used to monitor the pressure and secure the HIPERSEP Lab. It is also used in combination with the signal from pressure transmitter n° 24 to calculate the pressure drop across the Eluent filter (to detect filter clogging).
Purge Valve (17) Pneumatic 3-way ball valve. Used to prime the pump and/or purge the inlet lines.
Heat Exchanger (18) Temperature transmitter used to indicate the Eluent temperature after the heat exchanger.
Multi-tube heat exchanger (0.05 m²).
Filter (19) Low volume high pressure filter. Equipped with a SS316L frit with a 2 μm (relative porosity) mesh woven frit (5μm absolute porosity). A quick release chain eases the replacement of the frit.
Filter (19’) One low volume high pressure filter. Equipped with a SS316L frit with a 2 μm (relative porosity) mesh woven frit (5μm absolute porosity). A quick release chain eases the replacement of the frit.
Filter bypass (20 & 21) Two pneumatic 3-way ball valves used to bypass the filter.
High pressure injection (22) Air switch. Used to detect air and to indicate if there is no more feed material.
One 2-head membrane (PTFE) pump. Able to operate from 5 to 40 L/h at 100 bar. Equipped with membrane failure indicator.
One pressure transmitter, used to monitor the pressure and secure the pumping module.
One pneumatic 3-way ball valve. Used to prime the pump and/or purge the feed line.
One low volume high pressure filter. Equipped with a SS316L frit with a 2 μm (relative porosity) mesh woven frit (5μm absolute porosity). A quick release chain eases the replacement of the frit.
One pneumatic 3-way ball valve used to inject the feed material toward the column.
Eluent Flowmeter (23) Mass flowmeter used to control the Eluent pump.
Pressure Transmitter (24) Used to monitor the column pressure. It is also used, in combination with signal from pressure transmitter n° 16, to calculate pressure drop across the Eluent filter (to detect filter clogging).
Sample injection valve (25) Manual 3-way ball valve. Used to inject small quantities of feed. This injection mode is typically used to test the chromatographic column (efficiency).
Column bypass valve (26) Pneumatic 4-way ball valve used to bypass the chromatographic column.
Column backflush valve (27) Pneumatic 4-way ball valve used to revert the elution direction into the chromatographic column.
Pressure Transmitter (28) Used to monitor the column pressure. It is also used, in combination with signal from pressure transmitter n° 24, to calculate pressure drop across the column.
Detection (29)

Adjustable wavelength UV detector (190 – 740 nm) equipped with a full flow cell with an optical path length which can be adjusted to 0.50 mm, 1.25 to 2.00 mm.

ATEX Zone II Version: One purged box and its pressure switch providing explosion proof area for the UV detector.
Class 1 Division 2 Version: The UV detector is located into the electrical cabinet attached to the pumping skid.

Check valve (30) Spring loaded check valve to generate a small pressure drop after the UV cell in order to avoid any degassing in the UV cell.
Collection valve (31) Pneumatic 2-way ball valve (normally open). Used to perform the collection. Typically defined as waste valve.
Collection valve (32 to 35) Pneumatic 2-way ball valve (normally closed). Used to perform the collection.
Collection valve (36 to 40) Five pneumatic 2-way ball valves (normally closed). Used to perform collection.
Air Pressure Switch (41) Pneumatic pressure switch. To secure the use of the HIPERSEP in case of too low air pressure.
Air pressure regulator (42) Pneumatic pressure regulator used to adjust the air supply pressure for the HIPERSEP Lab II.


3. Automation

The Control Module provides an interface between the system and the Operator. A Programmable Logic Controller (PLC) is used to control the Solvent Module. A computer is used for the operator interface through the control software so called HIPERSEP SC software. It provides automated and safe operation of the Solvent Module under cGMP conditions.
The PLC Controller: A slot Programmable Logic Controller (PLC WinAC™ 412 SIEMENS) ensures real-time operation, high availability (reliability) and a high degree of safety. It is plugged into the computer. Communication between the PLC and SCADA (Supervision Control And Data Acquisition) is based on OPC.
Operator Interface: A SCADA is used for the operator interface and historical data logging through the Automation software. It is based on the iFIX™ software package and runs under WINDOWS XP.
Description of the Software
The HIPERSEP SC software, is divided into various modules for the ease of operator interface, cGMP operation of the chromatography step and safety.
MODULES DESCRIPTION
User Access The User Access Module is used to define access rights of the users for the protection of the system. The password and Username strategy are managed by the operating system.
Historical Module The Historical Module is used for logging and viewing the data acquired during the HIPERSEP operation.
Batch Management The Batch Management module allows the user to create, stop and recall a batch record file with corresponding alarms and events.
Graphics To trend chromatographic relevant process parameters such as UV signals, flowrate, pressure drop, temperature, etc. Additionally, the user can compare chromatograms from various cycles within a run. Graphics is also used for testing the column. It can calculate the chromatographic peak parameters: retention time, plates count (column efficiency) and peak asymmetry for up to two test compounds
Recipe The Recipe Module is used to create the base parameters of the method (Recipe Identification, Recipe Duration, Eluent Gradient Parameters, Event Configuration, Fraction Collection).
Manual Operation The Manual Module is typically used for the priming, testing or flushing of the Solvent Pumping Module elements or chromatographic operations requiring user interface.
Automatic Operation The Automatic Mode runs the chromatographic separation in an attended mode as defined in the Recipe. Recipes may be linked. For example, the user can run five cycles of a given separation recipe and then run one cycle of a regeneration recipe and then run again five cycles of the separation recipe.
Supervisor Access The Supervisor level access is typically used during the optimization of operation parameters or manual user interface during fraction collection.
Operator Access The Operator level access is typically used for operation of the unit under the strictest GMP conditions.
Alarms The alarm data and event data are stored in RDM (Relation Database Management). This data can be recalled from batch management module.
Reserved Parameters This module has restricted user access. It contains all critical parameters, which could affect safety, validation or mechanical operation of the chromatographic unit. Alarms can be inhibited. Alarm management, like alarm inhibition, is controlled from this module.
Maintenance This module is often used for maintenance operations. Any action can be made with all the interlock protections disabled. Accordingly, the module must be operated with very high caution. This module has restricted user access. To activate a given the desired element of the unit, the user must click on the corresponding icon on the synoptic diagram.