PK Chromatography Systems for the Biopharmaceutical Industry
颇尔’s chromatography systems cover a full range of applications with the highest standards in design principles and operating protocols.
我们提供标准化和完全定制产品的工艺解决方案，并在任何地方提供提供全面的本地支持。
Each 颇尔 System is Designed to Provide:
- Conformance to critical industry standards
- Reduction in time spent in process development and manufacturing applications
- Optimum flexibility for changing process demands
- Run-to-run reproducibility
- Wide performance operating range
- Efficiency of installation and ease of use
Features of 颇尔's Chromatography Systems
Process Performance
- Precision gradient with two pumps
- Broad system flow range for ion exchange, affinity, hydrophobic interaction and gel permeation applications
- Consistent system layout allows true linear process scale-up
- Forward/reverse and column by-pass control
- Low system hold up volumes
High Quality Material and Components
- Stainless steel (316L) pipework and internal surface finish to 0.4 µm (16µ-inch) + electropolish ensures system cleanability
- In-line sanitary grade system
- Full material certification package
GAMP Compliance
- Design in accordance with GAMP guidelines, to ensure that process and regulatory requirements are met
- Documentation and protocols include DQ, IQ/OQ and FAT to verify compliance to requirements
- Designed for full CFR21 Part 11 compliance
Flexible and Proven, User-friendly Software
- Operations by selection of pre-configured protocols
- Automation using convenient and flexible recipes
- Password controls to set different user levels
- Override of automated functions where required
- Simple but comprehensive intuitive screen display with touch screen and keyboard operation
Real-time Data Viewing, Data Storage and Analysis
- High quality instrumentation and signal generation
- Clear visual display of process conditions, set point and alarms
- Data point acquisition and recording
Simple System Intergration
- Industry standard platform running on Microsoft Windows OS
- Optional interfaces to allow master control or data acquisition
- Segmented system control and operator interface hardware
Safety and Ease of Operation
- Orientation friendly layout with easy component access and industry standard terminations
- IP/NEMA rated
- Easily-tranportable systems with locking adjustable castors
- Complete pre-column air detection
- Hard-wired back-up features
- Internal UPS included for safe shut-down and restore automation
PK 层析系统
View additional chromatography systems.
Application Options for PK Chromatography Systems
- Single feed pump
- Buffer in-line dilution
- Pressure control
- Integration with single-use technology
- Segregated bubble trap and filtration
- Increase number of inlets and outlets
- Integration with column technology
- Gradient accuracy to +/- 1 %
- Steam-in-place design
- Integration with Mustang® technology
- Temperature control
Hardware Features and Benefits
| Sanitary Multi-port Valve Technology |
Reduces dead-legs to a minimum Compacts flow path |
| 316L Stainless Steel Wetted Flow Path |
Robust, chemically-resistant flow path In-line valve fabrication minimizes clamp connections |
| Two-pump Gradient and In-line Dilution |
Precise in-line mixing Fast accurate step and gradient formation |
| Designed for CIP |
Turbulent Flow velocities achievable in pipe work Extended temperatures possible |
| Flow through Instrumentation | Instrumentation flow cell in-line, eliminating dead-legs and minimizing hold-up volume |
| Industry Standard Instrumentation | Reliable monitoring and control of process conditions |
| Conformance to ASME, BPE | Major components designed for conformance to BPE for inherent sanitary design |
| FDA Conforming Non Metallic Parts | Validation and compatibility with pharmaceutical manufacturing requirements |
| System Drain | Post-pump system fully drainable for storage |
| Diaphragm Pump (4-piston) | Pump head design gives virtually pulsation-free flow |
| No Manual Pump-stroke Adjustment | Fully automated control – repeatable setting with reduced operator intervention |
| System Validation | Testing protocols, including DQ, IQ/OQ and FAT support, for fast track validation and system start-up |
| 文件材料 | Comprehensive support documentation in accordance with GAMP guidelines |
| Easily Accessible Parts | Easy maintenance and replacement |
| Standard Skid Range uses Consistent Layout Philosophy and Components | Consistent scale-up |
System Ratings (Applicable to All)
| Working Pressure | 6 barg (87 psig) |
| Working Temperature | 2 - 60 oC |
| Surface Finish | Internal:0.4 µm (16 µ-in.) Ra + Electro-polish |
| Operating Environment |
Temperature and Humidity: 30 oC maximum, 95% humidity |
| Electrical Ratings | IP54/NEMA 13 |
| Electrical and Safety Approvals | CE and UL |
| Quality Systems | ISO 9000 |
| Design Standards | ASME BPE, GAMP |
| CFR 21 Part 11 Compliance | 是 |
System Sizes
| 系统 | PK10 | PK25 | PK50 | PK100 | PK300 |
| Flow Range (L/H) | 10 – 100 | 25 – 400 | 50 – 1000 | 300 – 4000 | |
| Piping id | 4.6 mm (0.18 in.) | 12.5 mm (0.5 in.) | 15.7 mm (0.62 in.) | 34.8 mm (1.4 in.) | |
| Pipe Connections |
6 mm (0.25 in.) Sanitary Clamp |
12.5 mm (0.5 in.) |
18 mm (0.75 in.) Sanitary Clamp |
38 mm (1.5 in.) Sanitary Clamp |
|
| 尺寸 |
900 mm x 1300 mm x 1400mm (35 in. x 51 in. x 55 in.) |
950 mm x 1300 mm x 1400mm (37 in. x 51 in. x 55 in.) |
950 mm x 1300 mm x 1400mm (37 in. x 51 in. x 55 in.) |
- | |
| Uncrated Weight | 250 kg (550 lbs) | 275 kg (606 lbs) | 300 kg (660 lbs) | - | |
General Specification
| 描述 | 规格 |
| 泵 | Two x Four -piston diaphragm pump |
| Gradient/In-line dilution capability | 5 to 95 % typical (see diagram) |
| Inlets including product sample | 8 |
| Outlets including waste | 4 |
| Column flow control | Forward, reverse, by-pass |
| Bubble trap | Automated vent control, with by-pass |
| 过滤器 | Pre-column, 0.2 µm 颇尔 standard, with by-pass |
| Air sensor | Sample feed, pre-column |
检测仪
| 项目 | Position | Range | Accuracy |
| Flow meter | Post-column | 0 - 1,500 L/H | ± 1 % (of reading) |
| Pressure transmitter | Pre and post-column | 0 - 6 bar (0 - 87 psi) | ± 0.5 % |
| 电导率 | Pre and post-column | 0 - 200 mS | ± 2 % |
| Temperature | Pre-column with post-column option | 0 - 100 °C | ± 0.5 % |
| pH | Pre-column with post-column option | 0 - 14 pH | ± 1 % |
| UV | Post-column | 0 - 5 AU, 280 nm | ± 2 % (± 1% typical) |
Wetted Material List
| 项目 | Material |
| Pipework | Stainless steel 316L |
| 泵 | Stainless steel 316L, EPDM, Santoprene, Polypropylene |
| Valves | Stainless Steel, EPDM |
| Bubble trap | Acrylic, Stainless steel 316L, EPDM |
| 过滤器 | Polyethersulfone, PVDF or as specified |
| 检测仪 | Stainless steel 316L, Titanium, EPDM, PVDF, Quartz, Glass |
| Elastomeric seals | EPDM or silicone |
Gradient Capability
The turn down ratio (maximum flow divided by minimum flow) of the pump determines system gradient and in-line dilution capabilities.
The diagram shows the coverage for the PK50 system within the flow range of the system pumps. Due to large turn down, the pumps are capable of 5 – 95 % mixing over a wide flow range.
The gradient is feedback controlled using the pre-column conductivity transmitter.
