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Distributed in Europe by JM Separations  This Product is available in Europe, exclusively through JM Separations, BV For additional information please contact: JM Separations, BVP.O. Box 6286 5600 HG Eindhoven, The Netherlands  |
Finally, an "OFF-THE-SHELF", cGMP tangential flow filtration system designed for the
pharmaceutical and diagnostic industries featuring automatic pressure and flow controls
for processing up to 5.000 liters. Instead of contracting expensive outside services and
engineering firms to consult, design, engineer, manufacture and install a custom, mid-range
production system that could take up to a year of your valuable time, Spectrum introduces
the KrosFlo Pharma System that is available in JUST 6 WEEKS! The
cGMP system complies with FDA regulations and is supplied
with a complete cGMP documentation package, including
test protocols for processing therapeutic biopharmaceuticals.
Ideal for production volumes of 50 to 5.000 liters, the KrosFlo Pharma System features a
single standard design with the flexibility for a variety of build options.
The various combinations of these standard options, allows
Spectrum to offer 12 different system models that are readily available "OFF-THE-SHELF".
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The KrosFlo Pharma System is available in three capacity designs depending on the process volume:
| Single KrosFlo Plus | 50 - 1.000 L |
| Dual KrosFlo Plus | 100 - 2.000 L |
| Single KrosFlo MAX | 200 - 5.000 L |
Each capacity design can be combined with one of two Flow-path types for use with either disposable HF modules or re-use (SIP) HF modules:
Clean-in-Place (CIP)
Steam-in-Place (SIP)
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The process is driven by one of three capacity pumps with
option head flush system for diagnostic applications.
The Flush System consists of pump head with double
mechanical seals, SS manifold for flushing and override
flow sensor to prevent dry operation of lobe pump.
50 LPM with or w/o Flushing
100 LPM with or w/o Flushing
200 LPM with or w/o Flushing
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All 12 KrosFlo Pharma System designs feature a "slide-lock" manifold to accommodate HF filters ranging
from 1-5 ft in length, including 14 sizes & types of Spectrum HF modules:
| KrosFlo Plus (3 sizes) | CellFlo® (3 sizes) |
| KrosFlo MAX (3 sizes) | CellFlo MAX (3 sizes) |
| KrosFlo SIP (2 sizes) |
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The System is controlled via a programmable PLC, Siemens C7-613 Controller. Since the PLC
has 5 input/output accesses, the system can be operated under manual or semi-automatic control.
The system can also interface with a data acquisition network.
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The 12 standard KrosFlo Pharma Systems are specifically designed for complete FDA compliance and to meet the needs of the various process applications:
- Standard AC pump drive motor (460VAC, 3 phase, 60HZ)
- Reducer between drive & pump for increased torque at low RPM's w/ high pressure
- Standard frequency converter for stabilizing pump speed
- Sanitary Rotary lobe pump (50, 100, or 200 LPM)
- Standard CIP or optional SIP flow-path with height adjustment
- Sanitary 316 SS manifolds for 3 system capacities:
- Single KrosFlo Plus
- Dual KrosFlo Plus
- Single KrosFlo MAX
- 3.1B certified & foreseen piping & welds
- Carting design w/ locking swivel wheels
- Inlet & outlet electronic pressure transducers
- High/Low pressure alarm w/ auto shut-off
- Sanitary back-pressure membrane-valve (manual)
- Sanitary "zero-deadleg" drain-valve (manual)
- Automated Operator Interface Terminal (OT) w/ PLC
- Complete cGMP Documentation & Validation Package
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All 12 standard systems offer semi-automatic processing, ideal for validated processes:
- Operator Terminal (OT) w/ 3 operating modes
- Manual Control
- Automatic Pressure Control
- Automatic Flow Control
- Programmable PLC (Seimens C7-613 Controller) with 5 input/output accesses
- 3 accesses for standard system:
- Inlet pressure
- Outlet pressure
- Pump drive control.
- 2 accesses can be used for system options:
- Flow transmitter
- Permeate pressure
- ph Meter
- Conductivity meter
- Temperature
- Permeate IR detection
- Data Acquisition
- Software and PLC complies w/ 21-CFR, part 11 Regulations.
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