Ready for take off

ÄKTA™pilot FLIGHT COUPON

AIRPORT
2.0 The new sanitary ÄKTA design
system for process development
and small scale production
GO TO GATE
3.0 Flow scheme
Flow rate: 4–400 (800) ml/min. Capacity for 2–10 g production Phase I-II
Pressure: 20 bar – Makes it possible to use small bead media for polishing
Hygienic design – Smooths the path to cGMP

• All wetted parts are easy to change – Fast and convenient validation.
• Gradient pump/Sample pump – Both with same flow specifications.
• Two columns in single or serial positioning – For higher flexibility and increased capacity.
• Fraction valve and Fraction collector interface – Capable of collecting fractions in any
size of vessel.
• Air trap. Filter optional – Full protection of columns.
• Bench top design – Fits in to small spaces and is easily moved.
SECURITY CHECK
4.0 Sanitization study
Microbial challenge test with introduction of high concentration of contamination.
Proofs of cleaning.

CFU counted for E. Coli, Pseudomonas aeruginosa, Staphylococcus aureus and

Pichia pastoris.

Swab, streak test and direct contact tests for sanitization proof of flow through
components.
A SAFETY ON BOARD
5.0 Sanitary components
The ÄKTA design platform now offers a system with fully sanitizable components

The pump heads

• The pump has a high resistant seal. Withstands 20 bar and is solvent resistant.
Sanitary designed rinsing system to avoid contamination and pump damage.

The valve
• The valves are designed with an actuator moved diaphragm for optimal sanitization,
built in a block of four valves to minimize hold up volumes and dead volumes.

The UV cell with the sanitary fittings

• The O-ring in the fitting and the sanitary designed UV cell ensure that no dead spaces
occur in the flow path. Three wavelengths measured simultaneously using fiber optics.
B PRE-FLIGHT CHECK LIST
6.0 cGMP/IQ/OQ
Validation documentation & services

Fast Trak™ Validation offers a number of specialist services, including:

• Installation and Operational Qualification Packages (IQ/OQ), consist of professionally
developed templates that will facilitate equipment qualification.

• Change Control Procedure (CCP) Documents. Changes to software and hardware systems
in a regulated environment must be carefully evaluated, verified, documented and
reviewed. Fast Trak Validation Service provides documents and advice on how to perform
upgrades, verify function, as well as implement changes to computer controlled systems
marketed by Amersham Biosciences.

• Standard Operating Procedures (SOPs). These procedures are fully developed for
immediate use. They describe how to use and maintain the system and equipment during
regular operation.
CLIMBING TO ALTITUDE
7.0 Protein purification on ÄKTA pilot FLPilot3SS OUR C E3OS 10 cm 004:1_UVI_280rm FLPilot3SS OUR C E3OS 10 cm 004:1_Cond
FLPilot3SS OUR C E3OS 10 cm 004:1_Fractions FLPilot3SS OUR C E3OS 10 cm 004:1_Logbook
FLPilot3SS OUR C E3OS 10 cm 004:1_UV3_410rm
mAU
Lysozyme
The chromatogram shows excellent performace using ÄKTA pilot 600

FineLine™ Pilot 35, SOURCE ™ 30S, 9 cm bed height, 87 ml column volume 500

Starting buffer (A): 20 mM Na2HPO4 pH 6.8.

400
Elution buffer (B): 20 mM Na2HPO4 pH 6.8 + 0.5 M NaCl.
Flow: 180 cm/h, 29 ml/min. 300

Gradient: 20 – 80% B over 15 column volumes.

Sample: Lysozyme 10 mg/ml, Cytochrome C 0.4 mg/ml, BSA 1 mg/ml. 200

100
Cytochrome BSA

0
Waste F2 F3 F4 Waste
0 200 400 600 800 1000 1200 1400 ml
FLIGHT CONTROLS
8.0 UNICORN™
UNICORN – a faster, more intelligent way of working. UNICORN on ÄKTA pilot for any
purification task, at any scale

UNICORN gives you a common control platform and one common user interface for all scales
of operation. This software with networking capabilities puts you in total control from lab-
scale research to full scale production, UNICORN offers functions that are vital in R&D and
production. Method wizard and scouting functions simplify purification tasks, while the ability
to generate customized reports and documentations saves time. UNICORN is also supplied
with comprehensive documentation that helps to fulfill regulatory requirements.
PASSPORT CONTROL
9.0 UNICORN/FDA 21 CFR Part 11
UNICORN Control System version 4.1, can be used in an FDA 21 CFR Part 11 compliant
enviroment. Support is provided for Electronic signature and Electronic records.

UNICORN is the control system for ÄKTA systems, BioProcess™ Systems and
OligoProcess™ Systems.

UNICORN has undergone an independent audit by Weinberg Associates certified for use in a
compliant and confirmed GMP-environment. The new Electronic Signature System utilizes
a dual password confirmation and documenting locking scheme.

The automatic audit trail system comprises complete documentation of the runs, such as
raw data, method used, calibration, logbook etc, presented as a result file. There is also
an Audit Trail Function for tracking data changes, user actions and fraud control on both
a global and a system level. These functions are appropriate, compliant and applicable
to the above guidelines.
C COUPON
10.0 Yes, please send me more information about:
ÄKTA pilot
ÄKTA explorer
Name:

Organisation:
Job title:

Department:
Fast Trak
Fine LINE columns
Address:
UNICORN
Bio Process
SOURCE™
City & State: Zip/Post code:

Simply fax back to Country:

your nearest
Amersham Biosciences Phone: Fax:
sales office,
see back cover e-mail:
INFORMATION DESK
11.0 Contact Amersham Biosciences UK Limited
Amersham Place, Little Chalfont,
Buckinghamshire HP7 9NA, England.
Amersham Biosciences AB
Björkgatan 30,
SE-751 84 Uppsala, Sweden.
Amersham Biosciences Europe GmbH
Munzinger Strasse 9,
D-79111, Freiburg, Germany.
Asia Pacific France Portugal
Tel: +852 2811 8693 Tel: 0169 35 67 00 Tel: 21 417 7035
Fax: +852 2811 5251 Fax: 0169 41 9677 Fax: 21 417 3184
Australasia Germany Russian & other C.I.S. & N.I.S.
Tel: +61 2 9899 0999 Tel: 0761 4903 401 Tel: +7 (095) 232 0250,956 1137
Fax: +61 2 9899 7511 Fax: 0761 4903 405 Fax: +7 (095) 230 6377
Austria Italy South East Asia
Tel: 01 576 0616 20 Tel: 02 27322 1 Tel: 60 3 8024 2080
Fax: 01 576 0616 27 Fax: 02 27302 212 Fax: 60 3 8024 2090

Amersham Biosciences K.K Belgium Japan Spain

Sanken Building 3-25-1, Tel: 0800 73 888 Tel: 81 3 5331 9336 Tel: 93 594 49 50
Hyakunincho, Shinjuku-ku, Fax: 03 272 1637 Fax: 81 3 5331 9370 Fax: 93 594 49 55
Tokyo 169-0073, Japan. Canada Latin America Sweden
Tel: 1 800 463 5800 Tel: +55 11 3667 5700 Tel: 018 612 19 00
Amersham Biosciences Corp.
Fax: 1 800 567 1008 Fax: +55 11 3667 87 99 Fax: 018 612 19 10
800 Centennial Avenue,
PO Box 1327, Piscataway, USA. Central, East, South East Europe Middle East and Africa Switzerland
Tel: +43 1 982 3826 Tel: +30 (1) 96 00 687 Tel: 01 802 81 50
Fax: +43 1 985 8327 Fax: +30 (1) 96 00 693 Fax: 01 802 81 51
Denmark Netherlands UK
Tel: 45 16 2400 Tel: 0165 580 410 Tel: 0800 616 928
Fax: 45 16 2424 Fax: 0165 580 401 Fax: 0800 616 927
Finland & Baltics Norway USA
Tel: +358 (0)9 512 3940 Tel: 2318 5800 Tel: +1 800 526 3593
Fax: +358 (0)9 512 1710 Fax: 2318 6800 Fax: +1 877 295 8102
ÄKTA, Fast Trak, FineLINE, SOURCE, UNICORN, BioProcess, OligoProcess and Drop Design are trademarks
of Amersham Biosciences Limited. Amersham and Amersham Biosciences are trademarks of Amersham plc.
All goods and services are sold subject to the terms and conditions of sale of the company within the
Amersham Biosciences group that supplies them. A copy of these terms and conditions is available on request.
© Amersham Biosciences AB, 2002 – All rights reserved.