pall,颇尔,PKP层析系统,

pall,颇尔,PKP层析系统

Delivering Process-Scale Performance and Enabling True Linear Scale-Up at Pilot Scale

The ability to transition from pilot-scale chromatographic processes to final process-scale without loss in separation performance is the foundation of 颇尔’s PKP chromatography systems.The easy-to-use software and flexible component combinations, along with the precision instrumentation, enable systems that encompass a flow range of 3 to 150 L/h for optimum gradient performance and true linear scale-up in a compact footprint.

特点

• 模块化系统设计
• Scalable automation and design
• 不锈钢结构符合 cGMP 规范
• Minimized hold-up volume
• Full system drainability (manual)
• Dual 4-piston diaphragm pumps
• Optimized clean-in-place (CIP) design

颇尔的 PKP 层析系统是标准模块化自动化系统，设计用于执行所有类型的低压柱生物层析（如离子交换、亲和性、混合模式、疏水作用、分子排阻和羟基磷灰石）和膜层析。这些系统适用于小规模生产或工艺优化，以及根据 GAMP 指引制造生物治疗分子。

Base Unit System Overview

1. Conductivity meter
2. Flow meter
3. Bubble trap [option]
4. Display panels of conductivity, temperature, and pH measurement
5. Reset button
6. Emergency stop button
7. Display panel of the UV measuring instrument
8. Pump
9. Pressure sensor (post column) [option]
10. pH meter
11. UV instrument
12. Fraction outlets

PKP 系统自动化软件控制

• Intuitive recipe creation enables smoother scale-up
• 在操作过程中，批量或半自动化模式为用户带来了更多灵活性
• 快速的检测仪响应可清晰地展示工艺条件、设定点和警报
• 颇尔分析工具可实现 HETP 计算、峰对称性及迁移分析等。
• 批次比较，监测工艺重现性
• 选择独立检测仪曲线使监管意见书的批量数据报告的灵活性更大
• 符合 21 CFR 第 11 部分
• High flexibility and ease of use in recipe creation
• "Smooth transition" / gapless recipe execution
• Recipe export/import fuctionality
• Standalone recipe editor available
• Batch schedule functionality
• Configurable batch report

颇尔 Analytic Tool

颇尔 analytic tool enables calculation of column evaluation parameters such as:HETP, peak asymmetry, and transition analysis.Configurable to meet user requirements for batch data reporting and comparison.

PKP Chromatography System Overview

	PKP2	PKP3
Diameter, ID mm (in.)	4.57 (0.18)	7.75 (0.3)
Pump Flow Rate (L/h)	1 - 100	1 - 150
Maximum Pipe Velocity (m/s)*	1.7	1.0

Gradient/In-line Dilution	5 - 95% > 60 L/h 10 - 90% > 30 L/h 20 - 80% > 15 L/h**
Process Connection	Inlets 4# (12 max) / Outlets 4 (14 max) #Per pump
Column Flow Control	forward, reverse, by-pass
Uncrated Weight	80 Kg (176 lb)
Maximum Operating Pressure	6 barg (87 psi)
Maximum Temperature	2 - 60 ºC (36 - 140 ºF) for production; up to 80 ºC (176 ºF) for CIP
泵	2 x four-piston diaphragm
Dimensions WDH, mm (in.)	600 x 600 x 1500 (23.6" x 23.6 x 59)

**Maximum limited by pipe velocity (< 2 m/s)
#Limited by minimum pump flow rate (50 mL/hr)

PKP System Standard Options

• Bubble trap including by-pass valve block, vent valve and level switches
• Additional inlets and outlets
• In-line filter, including by-pass valve block
• Air sensor at inlet
• Pre-column conductivity
• Post-column pressure sensor
• Second wavelength
• Mobile stainless steel trolley
• Drip trays for inlets and outlets

Instrument Specifications

	机型	Measuring Range/Accuracy
Flow Measurement	Magnetic-Inductive	System range ± 0.5% MR
Air Sensor	Ultrasound	不可用
Pressure Sensor	Piezoresistive Transducer	-1 - 9 bar ± 0.5% MR
Temperature Sensor	Resistance Thermometer Pt1000	0 - 100 ºC (32 - 212 ºF) ± 0.5 ºC (32.9 ºF)
Conductivity Measurement	Conductive	0 - 200 mS ± 5% MR
pH Measurement	Potentiometric	0 - 14 ± 0.14 pH unit
UV Measurement	Absorption Measure	0 - 3 AU ± 1% Reproducible 0 - 2 AU with 2 Wavelengths Optical path length 2 mm

Table of Wetted Components

Process Wetted Parts	Materials
Bubble Trap End Plates, Pump Pistons, Pressure, pH/Cond/UV Flow Cell, Pipework, Valve Bodies, Conductivity Probe Electrodes	316 L stainless steel (Ra ≤ 0.8 μm, electropolished)
Tri-clamp Gaskets, Valve Diaphragms, Bubble Trap Seals, Pump Seals/Check Valves, Instrument Seals, and Filter Seals	FDA conforming EPDM
Air Sensors	316 L stainless steel
Bubble Trap Tube	Borosilicate glass (HALAR* coated for shatter protection)
pH Probe	玻纤
Flowmeter	316 L/PFA liner
Pump Diaphragms	Santoprene
UV-Windows	Sapphire
Conductivity Body	PEEK

Chromatography Systems for Scale-Up

The PK solution platform and PKP chromatography system range incorporate proven component technology, delivering accurate precision gradients as well as in-line buffer dilution.Maintaining the performance necessary to make your chromatography process consistent from batch-to-batch and optimal at pilot and manufacturing scales.Covering a range from 1 - 4000 L/h, 颇尔’s PK and PKP systems ensure robust operation and flexibility for all biochromatography applications.These systems can be used with Resolute chromatography columns as well as Mustang® chromatography membrane capsules.

PK System Range

系统	PK10	PK25	PK50	PK100	PK300
Flow Range (L/hr)	3 - 150	10 - 600	20 - 1200	60 - 2000	100 - 5000

Chromatography Columns for Production

Resolute® DM and DP columns are ideally suited for process purification in the biopharmaceutical industry.A patented nozzle valve provides all column functions required for packing, unpacking, and running of the column in a closed system.Standard column diameters range from 280 mm to 1200 mm – all with selectable bed heights from 100 mm up to 600 mm.Resolute FM columns are purpose-designed glass columns for the manufacturing of clinical batch material or small scale production.Column diameters are 100, 140 and 200 mm with a bed height span of 100 mm to 460 mm.Based on established and well-proven design, the Resolute column range provides improved column performance and true linear scalability combined with reproducible column packing methods for today’s high performance media.

Resolute FM Column Range with Corresponding PKP Systems

膜层析

Mustang® Ion-exchange Membrane Chromatography Capsules deliver a flexible solution in bioprocessing, with scalable devices that can be used either as single- or multiple-use products.High volumetric flow rates lead to increased throughput, and the simple, easy-to-use compact design enables reduced buffer consumption in addition to overall process economic improvements.Mustang membrane products are ideal for efficient contaminant removal and capturing large target molecules (plasmid DNA, viral vectors, etc.).

层析介质

A large range of scalable, high productivity sorbents are available as ion exchangers (Q, and S HyperCel, Q, CM, DEAE and S Ceramic HyperD®) and mixed-mode sorbents (MEP, HEA, and PPA HyperCel).Please contact your local 颇尔 Life Sciences representative for additional information.

颇尔’s PKP chromatography systems are supplied with a comprehensive documentation package.To support validation efforts and efficient commissioning, IQ and OQ protocols are available as an option.In addition, 颇尔 also can provide support for execution of the protocols.

PKP system documentation includes:

• User manual
• Materials data sheets
• Certificate of conformity
• Comprehensive parts list and certification
• Mechanical and electrical diagrams
• Spare parts recommendation
• Maintenance recommendation

颇尔 can help you optimize your process requirements.

pall,颇尔,PKP层析系统