PK Chromatography Systems

PK Chromatography Systems for the Biopharmaceutical Industry

Pall’s 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 Pall 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 Pall'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 Chromatography System

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
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

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. 

 

 

 

 

 

Please contact your Pall Representative for ordering information.