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The concept and design of a manufacturing system using
Spectrum's hollow fiber modules for applications with specific
requirements must be conducted through intensive consultation
and discussion with Spectrum's production management and
process application specialists. A design engineer assures that specific customer requirements are
compatible and are incorporated into the constraints of the system design.
A team of specialized engineers (mechanical, automation, validation, etc.) all contribute to the creation of
the manufacturing filtration system in an ISO 9000 certified environment, complying with cGMP regulations.
Incorporating the customer's specific requirement, detailed engineering drawings of the system are then issued for
the customer's approval. In addition, validation protocols for the Installation Qualification and the Operation
Qualification are generated and executed in accordance and approval by the customer's QC department.
Required automation is designed and engineered according to cGMP and 21CFR part
11 regulations. A Factory Acceptance Test (FAT) according to
an approved protocol finalizes this process.
After the FAT is successfully completed, the filtration system will then be prepared for shipment to the customer.
After assurance of necessary facility utilities, our specialized service engineers will perform the Site
Acceptance Test (SAT) according to a pre-approved SAT protocol. During the SAT, operator training is
conducted on the new filtration system. Once the SAT is successfully completed, the system will then be
turned over to the customer for manufacturing operation.
The custom system configuration depends on the process specifications and desired operation as deemed by the customer.
Since most biopharmaceutical processes involve sensitive biological components, sanitary rotary lobe pumps are used
for the circulation required for the gentle filtration achieved with Spectrum's hollow fiber tangential flow membranes.
System flow control can include diaphragm shut-off valves, and automated sanitary valves to control and regulate
circulation and filtrate flows as well as back pressures and TMP.
In addition to pressure transducers and flow meters, optional equipment can be installed such as temperature sensors,
conductivity meters, pH probes and mass-flow controllers. The system can also be equipped with different types of
processing reservoirs with or without temperature control jacketing. The extent of automation can range from total
manual operation to complete system automation with full data acquisition and SCADA process control systems. In essence,
JM Separations can implement a variety control options for a customized filtration system as deemed necessary by the
process application and the operation parameters.
JM Separations offers service and maintenance contracts for all their filtration installations. The contract
can be modified to the specific requirements of the customer. The service and maintenance work will be conducted by
cGMP certified service engineers according to the regulations compliant with the biopharmaceutical industry.
The service engineers will perform the calibration of the system instrumentation using certified equipment.
Should your process application need to be scaled-up to a manufacturing level, contact your local process
specialist, Spectrum in U.S.A / Canada and JM Separation in Europe. Together with Spectrum, JM Separations can
design, engineer, install and service a customized filtration system that perfectly suits your manufacturing needs
and take full advantage of the benefits of Spectrum's disposable hollow fiber membrane filters.
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Advantages of Disposability
- Easier FDA Validation
- Saves Money & Time
- No Cross-Contamination
- Less Down-Time
- Low Shear
- Directly Scalable for Production
- Easy Retrofit for other HF Modules
Applications
- Cell Washing
- Protein Purification
- Virus Purification
- Lysate Clarification
- Macromolecule Isolation
- Microparticle Diafiltration
- Viral Vector Concentration
- Fermentation Harvesting
- Antibody Production
- Viral Clarification
- E. coli Concentration
- Desalt & Buffer Exchange
- NanoParticle Diafiltration
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