싸토리우스 코리아

Multi-Use Batch Chromatography Systems

Companies may want to maximize utilization of their facility and existing assets while non-value-added activities are being eliminated. Risks in operations and failure in supply must be prevented. Fully automated system platforms with proven scalability, accompanied by extensive service pre and post-sales, can reduce process costs for large scale manufacturing facilities. PK Systems offer reliable standard and customized stainless-steel based solutions, drainable flow path, with or without steaming in place. High precision sensors allow for wide operational flow rates and in-line dilution options.

Find the Right Solution for Your Chromatography Process

PKP and PK systems have identical performance yet differ in flexibility.

Attributes	PK System	PKP System
Scale of operation	Platform for commercial manufacturing	Platform for Pilot scale operation, scale up/down studies
Automation	Focus on robust operation; Includes Uninterruptable Power Supply (UPS)	Increased flexibility as needed for pilot studies and scale; Analytical Tool
Mobility	≥990x1300mm; 250kg	600x600mm; 80kg on a mobile cart
	Learn More	Learn More

PK Chromatography System

PK Chromatography Skid

PK Chromatography systems provide an established portfolio of standard and customized products from clinical development to commercial manufacturing. The systems cover a full range of applications with the highest standards in design and operation. Besides isocratic separations, they are much better equipped than SU-Systems to run gradients, dilute product in-line and make buffers. PK Systems comprise bubble trap, pre-column air detection, and up and downflow operation for column operation and can also be optimized for membrane chromatography.

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Key Features:

Stainless steel construction offering robust production at clinical or small scale
Automation and data analysis ensure cGMP compliance
Smaller footprint for easier maneuverability
Seamless scale up to larger PK systems

The PK systems are available in 2 configurations based on your chromatography requirements.

System	PKP2	PKP3
Diameter	3/8“(9.525 mm)	1/4“(6.35 mm)
Flow rate (L/h)	1 – 150	1 – 100
Process Connection	Inlets 4 (12 max) / Outlets 4 (14 max)
Column Connection	1 (down-flow/up-flow/ by-pass)

Description

PK Chromatography Systems for the Biopharmaceutical Industry

PK chromatography systems cover a full range of applications with the highest standards in design principles and operating protocols.

We provide process solutions with both standardized and fully customized products, and offer comprehensive local support wherever the location.

Each PK 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 PK 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

Applications

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

Specifications

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
Documentation	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	Yes

System Sizes


System	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.) Sanitary Clamp	18 mm (0.75 in.) Sanitary Clamp		38 mm (1.5 in.) Sanitary Clamp
Dimensions	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


Description	Specification
Pumps	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
Filter	Pre-column, 0.2 µm Pall standard, with by-pass
Air sensor	Sample feed, pre-column

Instrumentation


Item	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 %
Conductivity	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


Item	Material
Pipework	Stainless steel 316L
Pumps	Stainless steel 316L, EPDM, Santoprene, Polypropylene
Valves	Stainless Steel, EPDM
Bubble trap	Acrylic, Stainless steel 316L, EPDM
Filter	Polyethersulfone, PVDF or as specified
Instrumentation	Stainless steel 316L, Titanium, EPDM, PVDF, Quartz, Glass
Elastomeric seals	EPDM or silicone

Performance

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.

PK Chromatography System

PKP Skid

pkp-chromatography-system-b-0000201-white-sartorius

PKP systems are a platform for small scale operation and process optimization. While keeping design and certification principles equivalent to the PK portfolio, programming flexibility and data analysis are enhanced. PKP operations can be linearly scaled to the PK portfolio.

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Key Features:

Reliable monitoring and control of process conditions through standardized instrumentation
Minimizes dead-legs and hold-up volume through sanitary multi-port valve technology and flow through instrumentation
Two-pump gradient and in-line dilution for precise in-line mixing and step/ gradient formation
Consistent scale and easy maintenance

The PKP systems are available in multiple configurations based on your flowrate requirements.

System	PK10	PK25	PK50	PK300	PK500
Diameter	¼’’	½ ’’	¾’’	1’’	1 ½’’
Flowrate (L/h)	10 – 100	25 – 400	50-1200	100 – 2800	300 – 5000

Description

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 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.

Features

Modular system design
Scalable automation and design
Stainless steel construction is cGMP compliant
Minimized hold-up volume
Full system drainability (manual)
Dual 4-piston diaphragm pumps
Optimized clean-in-place (CIP) design

Applications

PKP chromatography products, a family of standard modular automated systems, are designed to perform all types of low pressure column biochromatography (e.g., ion exchange, affinity, mixed mode, hydrophobic interaction, size exclusion and hydroxyapatite) and membrane chromatography. These systems are suitable for small-scale production or process optimization, in addition to manufacturing biotherapeutic molecules according to GAMP guidelines.

Specifications

Base Unit System Overview

Conductivity meter
Flow meter
Bubble trap [option]
Display panels of conductivity, temperature, and pH measurement
Reset button
Emergency stop button
Display panel of the UV measuring instrument
Pump
Pressure sensor (post column) [option]
“pH” meter
UV instrument
Fraction outlets

PKP System Automation Software Controls

Intuitive recipe creation enables smoother scale-up
Batch or semi-automated mode allows users greater flexibility during operation
Rapid instrument response provides clear visual display of process conditions, set points, and alarms
Analytical Tool enables calculation of HETP, peak asymmetry, transition analysis, etc.
Comparison of different batches to monitor process reproducibility
Selection individual instrument curves enables greater flexibility in batch data reporting for regulatory submissions
21 CFR part 11 compliance
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

Pall Analytic Tool

Pall 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)	3-100	3-150
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
Pumps	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


	Type	Measuring Range/Accuracy
Flow Measurement	Magnetic-Inductive	System range ± 0.5% MR
Air Sensor	Ultrasound	N/A
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	Glass
Flowmeter	316 L/PFA liner
Pump Diaphragms	Santoprene
UV-Windows	Sapphire
Conductivity Body	PEEK

Ordering Information

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, 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

PKP chromatography systems can help you optimize your process requirements. For additional information, or to order a PKP chromatography system, please contact you local Sartorius representative.

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Application Options for PK Chromatography Systems

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