ÄKTAprocess 6 mm Std

Electrical documentation:

       System layout
       Cable diagrams
       Electrical schematic
       Grounding
       Wiring table

EC Declaration of Conformity in conformity with the following normative harmonized
standards;

       EN 61326-1 Electrical equipment for measurement, control, and laboratory use- EMC requirements

       EN 61010-1 Safety requirements for electrical equipment for measurements, control and laboratory use.

       EN ISO 12100 Safety of machinery. General principles for design. Risk assessment and risk reduction.
       2004/108/EC Electromagnetic Compatibility (EMC-Directive)
       2006/95/EC Low Voltage Directive (LVD)
       2006/42/EC Machinery Directive (MD)

Spare parts list
Assembly drawing
Bill of material

General specification comprising:
Technical data
System requirements
Material of construction
Tag numbering
Software function
Applicable codes and standards
Instrumentation and acceptance criteria
Operator interface
Interface points
Battery limit

P&ID
Functional test record

Software Configuration Description comprising:
Strategy information
Manual
Methods
Settings
Run data
Curves
Flow schemes
Alarm and warning messages
Watch analog and digital signals
Instructions for miscellaneous instruments air trap, buzzer etc.
Calibrating instructions in the strategy
META blocks in the strategy
Valve matrices

Software revision document
Wetted part list
Certificates
Tubing replacement drawing

User manuals and instructions for: 
Uv-monitor
Air-, level and pressure monitor
pH and conductivity monitor
Flow cell
Filter housing (optional)
AS-i/PROFIBUS Gateways
PC
Control unit
Flow meter
Frequency AC Drive
Pumps
Valves

ÄKTAprocess instruction manual
ÄKTAprocess operator console instructions
ÄKTAprocess safety handbook

BPG, Chromaflow, FineLINE 70-350 columns and ÄKTAprocess
All wetted parts of plastics/elastomers have been approved according to biological reactivity testing in vivo, USP class VI.

Systems
Systems must be cleaned and sanitized prior to storage. During storage, keep the system filled with 0.01 M sodium hydroxide or 20% ethanol solution.

¹ ÄKTAprocess is a versatile platform providing many configuration possibilities. For more information, read ÄKTAprocess Data File.

² Including keyboard and monitor.

Cleaning-in-place
Cleaning-in-place (CIP) removes precipitated material, strongly bound substances and other contaminants from the column bed without dismantling the column.
Regular CIP of the packed column between production batches ensures proper product quality and maintains expected medium and equipment life. An efficient CIP protocol depends on medium in use and the characteristics of the contaminants. Refer to the instructions for each medium, see our literature library.

Sanitization
Sanitization is the reduction of microbial contamination in the column and related equipment to an acceptable minimum. A specific sanitization protocol should be designed for each process according to the type of contaminants present.

Note: Always ensure that columns, systems and auxiliary components are compatible with the chemicals used.

Surface finish of wetted steel parts: Ra 0.5 µm (electropolished).

Sodium hydroxide is widely accepted for cleaning empty equipment, cleaning packed chromatography columns (cleaning-in-place , CIP), sanitizing and storing chromatography media and systems.

For CIP, sodium hydroxide has been extensively used to remove proteins and nucleic acids from ion exchange, hydrophobic interaction and gel filtration media. Its use with affinity media is restricted due to the limited stability of affinity ligands. If lipids are bound to a protein, an increased concentration of sodium hydroxide may be required for effective cleaning.

Sodium hydroxide is also effective for inactivating most viruses, bacteria, yeasts and endotoxins. It is common practice in industrial manufacturing to save time by adding salt, e.g. sodium chloride, to the sodium hydroxide solution to combine cleaning with sanitization as well. Since sodium hydroxide is a bacteriostat, it is also useful for storage.

The benefits of using sodium hydroxide include efficacy and low cost, plus ease of detection, removal and disposal.

Precautions
Always ensure that chromatography media, columns, systems and auxiliary components are compatible with sodium hydroxide at the concentration, time and temperatures used. Also keep in mind that sodium hydroxide may be corrosive to both metal and skin.

Compatibility with chromatography media
The concentration of sodium hydroxide used for CIP and/or sanitization will often depend on the level of contamination. For chromatography media, the ability to withstand stringent sanitizing conditions depends on the functional groups, attachment chemistries and the stability of the base matrices to alkaline conditions.
Table 4 in Application Note “Use of sodium hydroxide for cleaning and sanitizing chromatography media and systems” lists the general stability of a wide range of media as a function of pH.

Systems
In general, flushing with 1 M sodium hydroxide for 60 minutes at a moderate flow rate gives efficient cleaning and sanitization. However, system owners
must qualify a cleaning and sanitizing process that is suitable for the application of their system.

Make sure that the process control method for cleaning flushes all possible flow paths in the system. After cleaning, rinse the entire system with water or suitable liquid until the piping system is completely free from cleaning solution (instruments in the system can be used as detectors). Do not leave sodium hydroxide or other cleaning agents in the system.

Caution! pH electrodes are normally not compatible with cleaning solutions. Refer to the manufacturers’ manual in the documentation supplied with the system. If the pH electrode is not in the flow jacket during cleaning, be sure to mount a pH cleaning screw in order to avoid leakage.

ÄKTAprocess
1. Set the pressure for high alarm in the strategy to 1.5 x maximum operating system pressure.
2. Bypass columns with an in expandable tubing e.g. PEEK
3. Set UNICORN to:
a)disable all valve alarms
b)run tests with two different flow paths
flow path one:
airtrap in line
filter in line (if applicable)
column 1 in up flow position
column 2 in up flow position (if applicable)
pH probe mounted
flow path two:
bypass air trap
bypass filter (if applicable)
bypass column 1
bypass column 2 (if applicable)
mount the pH chip screw
4. Fill the entire system with test solution. Remove all pockets of air inside the piping.
5. Wait until the temperature of the system and test solution is stable.
6. Increase the test pressure slowly and steadily to system operating pressure + 10% by connecting one inlet to an external pump, opening the inlet valve and pumping slowly. Stop the pump when the test pressure is reached.
7. Close the valve.
Please Note that by closing the valve the pressure can rise significantly above the test pressure. If it’s the case the pump needs to be stopped at a lower pressure to reach the test pressure after closing the valve.
8. Let the pressure drop stabilize.
9. Start measuring when the pressure drop is constant (linear). Normally it should not be more than 0.15 bar over 30 minutes after the pressure has stabilized.