Sample Collector FRL series

Instruction Manual
Document version: 3.0
Date: 2018-10-31
Document no.: 21853
File name: FRL_Manual_21853_En_V3.0
Language: English, translation of the original version
Page number: 28

Version table
Document
Date version* Amendment
2015-10-21 1.0
2016-03-09 1.1 New document no. (old no.:412-309-0001)
2017-03-02 1.2 Editorial revision
2018-02-14 1.3 General changes
2018-06-08 2.0 Shortened 50 ‘series
2018-10-31 3.0 Rack data

* When the document version X.Y is increased, X means a technical change and Y – a document amendment only.

Copyright
The material in this document is the intellectual property of ERWEKA. Any copy or reproduction of this
document or its parts without the written permission of and reference to ERWEKA is prohibited and will
be prosecuted according to the law. All trademarks are the property of their respective owners.

Copyright© 2018 by ERWEKA

Instruction Manual
Sample Collector
FRL series
Table of Contents

1 – Introduction 5
1.1 – About this instruction manual 5
1.2 – Service 5
1.3 – Hints and symbols 6
1.4 – Protection of the environment 6

2 – Safety 7
2.1 – Safety instructions 7
2.2 – Intended use 7
2.3 – Danger area 7

3 – Overview 8
3.1 – Description 8
3.2 – Device variants 9
3.3 – Designation 9
3.4 – Options 9
3.5 – Construction 10
3.6 – Type label 10
3.7 – Operation elements and connections 11
3.7.1 – Power and network 11
3.7.2 – Media 11
3.8 – Application areas 12
3.9 – Technical data 13

4 – Installation 14
4.1 – Storage and transport conditions 14
4.2 – Unpacking and checking 14
4.3 – Installation 14
4.3.1 – Positioning 14
4.3.2 – Acclimatization 14
4.3.3 – Required installation environment 15
4.4 – Inserting the rack 15
4.5 – Connecting and switching the device on 16
4.5.1 – Assembly of the media circulation 16
4.5.2 – Power and network connections 17
4.5.3 – Switching the device on/off 17

5 – Settings 18
5.1 – Configuration 18
5.1.1 – FRL-SERVICE menu (DT 82x and DT 161) 18
5.2 – Setting for rack change (25 ml) 19

6 – Performing the Test 21

7 – Cleaning 22
7.1 – Cleaning procedure 22
7.2 – Automatic cleaning 23

8 – Inspection and maintenance 24

8.1 – Check regularly 24
8.2 – In longer standstills 24
8.3 – Spare parts 24

Attachment 25
Terminology list 25
FRL series – Introduction 5

1 – Introduction
Thank you for purchasing the ERWEKA sample collector type FRL serie.

1.1 – About this instruction manual

This instruction manual supports you in work with your ERWEKA device. It describes the device, its operation and
gives you useful tips on its handling. Furthermore, read descriptions of installation and setting as well as detailed
step-by-step work operations in the present manual. Figures facilitate the understanding of processes described
here.

Read this manual completely before using the device and make sure you understand its content. The
instruction manual is a part of the product. Keep this manual in a safe place so that it will be available
for any questions at a later date. This is important for long-term and accurate function of the corre-
sponding device.

The FRL is used as a component in ERWEKA dissolution systems. It is used together with many components in the
system and can be controlled via ERWEKA Disso.NET.

Use this guide only in conjunction with the applicable technical documents of the connected devices.
Pay attention to the operation and safety precautions listed there.

The editorial team of ERWEKA appreciates your feedback regarding the present manual. Just send
an e-mail to quality@erweka.com with your topic and “technical documentation” as a subject. Your
feedback will also help us to meet our own high quality requirements.

1.2 – Service

Contact ERWEKA at support@erweka.com to order spare parts, in case of technical questions or possible repairs.
Please supply the following information:

• Type of the device (on the type label)

• Serial number of the device (on the type label)
• Short description of the case

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6 FRL series – Introduction

1.3 – Hints and symbols

WARNING indicates a possible hazardous situation which, if not avoided, could result in death or
serious injury.

CAUTION indicates a possible hazardous situation which, if not avoided, could result in moderate or
minor injury.

HAZARD of electric shock! Indicates a possible hazardous situation which, if not avoided, can lead
to injuries caused by electric shock.

This symbol indicates a possible hazardous situation which, if not avoided, can lead to equipment
damage.

This symbol indicates a possible hazardous situation. Information from the respectively accompany-
ing documents is necessary in this place to proceed further. Pay attention to the safety precautions
listed there.

This symbol indicates information that will ensure smooth work processes.

Disso.NET
This symbol provides you with information to be considered when operating the system with
Disso.NET.

This symbol provides you with additional useful information.

1.4 – Protection of the environment

Note that product residues must be properly disposed of in accordance with the respective valid environmental legis-
lation. According to the valid EC directives all the electrical parts (electrical scrap) must be disposed of appropriately.

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FRL series – Safety 7

2 – Safety
2.1 – Safety instructions

To guarantee the health and safety, read the following safety instructions before using the device.

WARNING Hazard when handling with media! Wear the personal protective outfit and glasses, if nec-
essary. The safety regulations for working in the laboratory must be observed.

HAZARD of electric shock! Electric devices are to be plugged into safety sockets only. Use the
delivered power cable. The voltage of the existing power supply has to meet the requirements of the
type label. Before installation works always switch the corresponding device off and disconnect it
from the rear panel.

Damages due to operator error! ERWEKA devices should be operated by qualified and trained per-
sonnel only.

Pay attention to the on-site safety instructions for work in the laboratory and with the laboratory equipment!

2.2 – Intended use

The ERWEKA sample collector should be used only for collecting samples during dissolution tests of tablets, dragees,
oblongs and other formulations. The requirements for installation environment defined by ERWEKA shall be met. The
installation and operation of the device in a potentially explosive atmosphere (explosive areas) is not permitted.

ERWEKA devices should not be used for processing:

• Products that are easily flammable or explosive

• Products that develop vapours which may create flammable or explosive mixtures in combination with air
• Products that release harmful or poisonous substances

The device should be operated and maintained only as intended and in accordance with the instructions presented
in this manual.

2.3 – Danger area

The spindle drive moves the filling unit together with the energy chain with the media hoses during operation. The
spindle is visible through a gap at the rear side of the device.

CAUTION
Danger of seizing! Movable rotating parts! Do not reach this area when operating! Wear protective
clothing and follow safety instructions. Wear clothes with tight-fitting sleeves. Bind long hair together.
Do not wear ties, long chains, bracelets or scarves. The device should be operated by trained,
authorized personnel only.

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8 FRL series – Overview

3 – Overview
3.1 – Description

The sample collector FRL is a laboratory device for collecting media samples, which are taken during a dissolution
test from the dissolution medium for the purpose of a later analysis.

It consists of a rack holder with rack and collection containers, a filling unit and a spindle drive. The media hoses to
the filling unit are carried along within an energy chain of the movement.

The racks are designed for storing glass tubes with 10 ml or 25 ml capacity as well as HPLC vials with max. volume
of 1.5 ml and 4.0 ml. For HPLC vials, a refrigerated rack is available to store temperature sensitive samples. The FRL
can be equipped with various racks and needle stations to fill HPLC vials or glass tubes.

The electric spindle drive (x/z-driven) moves the filling unit over the collection containers. The control causes the
change of the row of collection containers to be filled within a certain temporal frequency or a certain sample volume.

A container for waste material is on the left side. Additionally this container can include two tanks for substitution and/
or dilution medium (opt.). These both tanks can be refilled via integrated peristaltic pumps from external containers
automatically. The container can be easily removed for cleaning.

The dosage of sampling is carried out with a pump and/or a valve station. After the end of the filling or rinsing time,
the valves are opened and the sample volume is filled into the collection containers. The HPLC-membrane piercing
to use vials is realized with a second spindle drive (z-axis). Split septum piercing is possible.

In order to keep the media volume in the vessels automatically constant during several sampling steps, as well as to
prevent sample carryover, a substitution station is optionally installed. For replacement, the sample tubes are moved
into a container with substitution medium. The sample pump feeds the substitution medium back into the respective
vessels. Sampling hoses and sampling tubes are cleaned.

The device corresponds to the regulations of USP, DAB, EP.

Dosage accuracy and dilution

In the case of dissolution systems with a peristaltic pump, the filling tubes (needles) of the FRL move to the height
level of the sample quantity to be filled. Once the desired sample quantity has been reached, the remaining medium
is returned to the vessels of the dissolution tester.

In combination with an ERWEKA syringe pump (SP) and an optional 3-section container (instead of standard 2-sec-
tion), the FRL 720 allows a dilution of the collected samples with an accuracy of ± 0.1 ml. Therefore a 1:1 or even
1:2 dilution (5 ml : 5 ml, 10 ml : 10 ml, 5 ml : 10 ml) can be obtained in combination with 10 ml or 25 ml glass tubes.

The dilution of the samples in the FRL 820 is also done with the syringe pump. It takes the sample from the test sta-
tion into the collection container with an accuracy of better than ± 0.1 ml. The syringe pump then takes the required
dilution liquid from the reservoir and injects it into the sample (accuracy ± 0.1 ml). The maximum dilution ratio is 1:10.

FRL with integrated valves

The 7-channel FRL 724 with a 3-way solenoid valve per channel was designed to be combined with the peristaltic
or piston pump in a USP 4 offline dissolution system and achieves a dosage accuracy of ± 0.5 ml. The medium is
pumped in a closed loop from the vessels to the FRL and back into the vessel until the media hoses are completely
filled. Only then the valve is switched over and the sample is filled in glass tubes or HPLC vials. In combination with
a USP 4 offline dissolution system, the 3-way valves operate as a “splitter” to collect an average of the flow-through
medium from the flow-through cells.

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FRL series – Overview 9

3.2 – Device variants

FRL x20/x24

FRL 624 FRL 720 FRL 820 FRL 720 - 2 FRL 724 FRL 824
Available channels 6 7 8 14 7 8
Max. capacity 26 sample 26 sample 26 sample 13 sample 26 sample 26 sample
(not for 25 ml intervals of 6 intervals of 7 intervals of 8 intervals of 14 intervals of 7 intervals of 8
glass tubes) test stations test stations test stations test stations test stations test stations
Glass tubes      

Vials      
Integrated 3 way
 — — —  
valves

FRL x50/x54

The devices of the 50 ‘series are built smaller, so that they can be placed offset by 90 ° on a laboratory bench. All
functions are identical with the devices FRL x20 / x24 (see also 3.9 Technical Data).

For two-row sample collectors (FRL x20-2 / x24-2 and FRL x50-2 / x54-2), the spacing of the needles in
the filling unit must be changed depending on the rack used (see 5.2 – Setting for rack change (25 ml)).

3.3 – Designation

Example Meaning
FRL 720-2 7 2 0 -2
For 7 test stations Standard No integrated valves Double row (7 x 2 test stations in total,
each second row is a rack interval)
FRL 854 8 5 4
For 8 test stations Shortened Integrated valves Single row (8 x 1 test stations in total,
each row is a rack interval)

3.4 – Options

FRL racks

• 26 x 8 / 12 ml glass tubes, 250 glass tubes included

• 18 x 8 / 25 ml glass tubes, 150 glass tubes included
• 26 x 8 / 1.8 ml HPLC vials
• 26 x 8 / 4.0 ml HPLC vials
• Recalibration rack for HPLC vials (1.8 ml/ 4.0 ml/ 10 ml)

Media substitution

The medium is exchanged by means of a 2-section container whose substitution medium section is constantly re-
filled by two 1-channel peristaltic pumps from an externally heated or unheated flask. This feature permits a) nearly
unlimited amount of substitution media and b) sucking from a heated container not to lower the media temperature
inside the test station by cold replacement media.
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10 FRL series – Overview

Dilution

3-section container. In addition to waste and substitute medium, a tank for diluting medium is also provided. For this
the dissolution system must be operated with a syringe pump (ERWEKA SP).

Titanium

To prevent corrosion, also within the filling tubes, the filling tubes are available in titanium (for FRL 820/ 824/ x54).

3.5 – Construction

5
6

Fig. 1 FRL 724

1) Filling unit
2) Covered spindle drive with mobile media hoses
3) Rack with collection containers
4) Rack holder
5) Media connections
6) Container for waste and opt. substitute and/or dillution medium
7) Adjustable foot, 4 pieces

3.6 – Type label

The type label is placed on the rear panel of the device and looks as follows:

Typ: Device type

Serial No: Serial number *
PN: Rated output in volt-ampere [VA]
ERWEKA GmbH • D-63150 Heusenstamm • Germany IN: Nominal current in ampere [A]
Typ: Serial No: xxxxxx.xxxx U: Voltage in volt [V]
PN : VA IN : A U: V F: Hz F: Frequency in hertz [Hz]

* The last 4 digits of the serial number show the calendar week (CW) and the year of manufacture of the device, e.g. xxxxxx.3217 means that the device has
been manufactured in the 32th CW 2017.

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FRL series – Overview 11

3.7 – Operation elements and connections

3.7.1 – Power and network

The main switch as well as power and network connections are located on the rear panel of the device.

1 2 3 4 5

1) RS 232 interface (PC/DT)

2) RS 485 interface, 2 pieces (f./m.)
3) Pump connection (RS 232)
4) Power connection
5) Main switch
6) Fuse T1A

3.7.2 – Media

The media connections are on the rear panel of the device. The optional connections, e.g. for substitute medium,
are located additionally in the front below the rack. The container with the waste and optional tanks has direct
connections for cleaning. All connections are labeled.

3
4

1) Connections of the sampling hoses of individual dissolution test stations

2) Peristaltic pump, for substitution medium and/or dilution medium (opt.)
3) Connection for cleaning of tanks with dilution and substitution medium (opt.)
4) Connection for cleaning of waste tank

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12 FRL series – Overview

3.8 – Application areas

Offline system; FRL with valves (only substitution is possible, dilution is impossible):

Dissolution test Pump FRL with valves Needle

station IPC / PVP station

Offline system; FRL without valves (substitution and dilution are possible):

Dissolution test Pump FRL without valves

station SP

On-Offline system; FRL with valves (dilution is impossible):

Dissolution test Pump UV / VIS FRL with valves Needle

station IPC / PVP station

Off-Online system; without valve station (dilution is possible, online measurement of diluted samples is impossible):

Dissolution test Pump UV / VIS

station SP

FRL without valves

Off-Online system; with valve station (dilution and online measurement of diluted samples are possible, diluted
samples go via valve station into waste after measurement):

Dissolution test Pump UV / VIS VS Waste

station SP

FRL without valves

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FRL series – Overview 13

Dual Offline System

The dual offline system has special hose connections. A pump takes samples from two testers, so
there is no return hose in the sampling station. The medium exchange in the test station takes place
through the sampling probes.

USP 4 Systems
For information on USP 4 systems, refer to the USP 4 System Manual.

3.9 – Technical data

FRL x20/x24 FRL x50/x54

Dimensions:
Height [mm] 650 583
Width [mm] 800 515
Depth [mm] 500 702
Weight:
[kg] 25
Voltage:
100 - 240 VAC ±10%; 50 / 60 Hz
Fuses:
115 V / 250 V; 2 x 3,15 A
Safety:
Protection class I / EN 61140
Protection type IP 21 / IEC 529
Interfaces:
RS 232 (two), RS 485 (one)
Cover material:
lacquered metal

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14 FRL series – Installation

4 – Installation
4.1 – Storage and transport conditions

The device should not be exposed to punches and vibrations.

Temperature and humidity should not exceed or fall below the values defined by ERWEKA
(see 4.3.3 – Required installation environment).

4.2 – Unpacking and checking

After receipt of the delivery, check the packaging and the device for transport damage.

On some packages you can see indicator labels, which change their colors in case of improper transporting. Check
these labels for discoloration.

If undue transporting or any damage is evident, take a photo of this and send it to our ERWEKA Service
immediately.

4.3 – Installation

4.3.1 – Positioning

Position the device on a horizontal, plane, stable surface, e.g. on a laboratory table, and pay attention not to displace
it during the operation.

Use the adjustable feet to set the appropriate height and a horizontal plane position of the device.

For ease-of-use and accessibility, when positioning the device ensure that there is sufficient distance
towards walls, cabinets or other fixed components of the facility.

Besides sticking to the requirements for installation environment defined by ERWEKA, avoid the following:

• Heat (heating, insolation)

• Direct draft through open windows, doors or air conditioning and ventilation systems
• Vibrations
• Dampness

Do not place any objects on the device!

4.3.2 – Acclimatization

If a cold device is moved to a warm environment, condensation may occur. Therefore you should allow the device to
acclimatize for approximately two hours at room temperature, leaving it unplugged.

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FRL series – Installation 15

4.3.3 – Required installation environment

Ambient temperature in operation: +10°C to +30°C

Storage and transport temperature: + 5°C to +40°C
Relative humidity: 25-80% no condensation

4.4 – Inserting the rack

Various racks are available to store the samples in the FRL. The racks differ according to the number, arrangement
and size of the holes for the collection containers. Collection containers can be HPLC vials or glass tubes of differ-
ent volumes. Depending on the collection containers you wish to take with the FRL you must mount a corresponding
rack on the FRL rack holder.

1
B

Fig. 2 FRL with rack for 1.8 ml vials (skewed view from the front)

1) FRL 820
2) Rack for 1.8 ml vials

The rack [2] is placed with its holes on the four bolts [A] of the rack holder.

The oblong holes of the rack [B] must be located on the left from the front when inserting the rack!

By default the front of the racks is labeled at delivery.

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16 FRL series – Installation

4.5 – Connecting and switching the device on

See also 3.7 – Operation elements and connections.

CAUTION
Lay the cables so that not to stumble over them!

HAZARD of electric shock! Electric devices are to be plugged into safety sockets only. Use the
delivered power cable. The voltage of the existing power supply has to meet the requirements of the
type label.

4.5.1 – Assembly of the media circulation

Make the necessary hose connections between the FRL and the neighboring system components. Ensure that
the system components are positioned on a plane surface.

All hose connections are numbered.

Refer to the system manual of the used dissolution system for information on the media hose
connections.

Make sure that the individual hose lines are not damaged. When connecting the hoses pay attention to the following:

• Do not bend the hoses

• Do not kink the hoses
• Do not allow hoses to become caught
• Hoses must be able to move freely during operation
• Carefully tighten hose connections by hand
• Screw fittings into coupling pieces of the same length

Damaged or faulty screw connections can cause leaks or air in the system. Carefully tighten the hose
connection by hand. Screw fittings into coupling pieces of the same length.

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FRL series – Installation 17

4.5.2 – Power and network connections

1. Plug the device (connection on the rear panel) into a safety socket. Use the enclosed power cable.

2. Establish the network connections between the FRL and the other components of your dissolution system.

All network connections were numbered by the manufacturer. Each connector has a label indicating the port to which
it is connected.

ERWEKA accepts no liability in case of wrong connection!

Defective devices are to be opened by the ERWEKA authorized staff only.

Refer to the system manual of the used dissolution system for information on the system connections.

Disso.NET
For system control via ERWEKA Disso.NET refer to the guide of the used software version.

4.5.3 – Switching the device on/off

Switch the device on (I) and off (0) using the main switch on the rear panel of the device.

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18 FRL series – Settings

5 – Settings
5.1 – Configuration

The FRL can be controlled in different ways. The device configuration of your FRL depends on the system and used
system control.

Configuration via the ERWEKA software Disso.NET

Disso.NET
For system control via ERWEKA Disso.NET refer to the guide of the used software version.

Configuration via the FRL menu of an ERWEKA dissolution tester (DT 82x and DT 161)

The functions of the fraction collector (FRL) and syringe pump are controlled in the configuration menu of the
dissolution tester (DT 82x and DT 161). To do this, use the following menu items:

• FRL-SERVICE - for manual control of the fraction collector (cleaning of the sampling station and probes,
switching positions of the valves)
• Setting pump - to configure the pump operation

Read the system manual of the used dissolution system and the instruction manual of the dissolution
tester for more information.

5.1.1 – FRL-SERVICE menu (DT 82x and DT 161)

This section is valid for operating the FRL together with one of the aforementioned DT devices. The FRL-Service menu
is an item of the user interface of the DT 82x and DT 161x. It is used to check the valve operation and to clean the
hose system.

To open the menu, select FRL-SERVICE in the Configuration menu and press Enter. The following screen appears:

After you have opened the FRL-Service menu, you can perform the following actions:

Menu item Key Function

Valve to Control of the valves of sample pump with the number keys.
0 Valve goes to the position 0, hose from syringe to sampling station is open.
1 Valve goes to the position 1, hose from syringe to FRL is open.
2 Valve goes to the position 2, flushing pipe is open.
3 Valve goes to the position 3, air from the syringes is released.
Syringe down 4 Syringes are placed in the lower position.
Syringe up After the syringes have been positioned down, this message will be shown on the dis-
play. Press ENTER to move syringes to the initial position again.
Homeposition 5 FRL needles are returned to the initial position.
Abort with CL Abort with CL.

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FRL series – Settings 19

Cleaning and rinsing the hose system

1. Open the valves in position 0.

2. Lower the syringes by pressing the key 4.

3. Put the valves into position 2.

4. Press Enter to release the medium.

The cleaning of the sampling station should be carried out in a special cleaning container. In this case,
the sampling probes are fixed in the outer sections of the container and the return hoses are fixed in
the inner section. The sampling station can be rinsed without the cleaning container.

5.2 – Setting for rack change (25 ml)

For two-row sample collectors (FRL x20-2 / x24-2 and FRL x50-2 / x54-2), the distance of the needles in the filling
unit must be changed if changing from 1.8, 4 or 10 ml racks to a 25 ml rack.

Changing the setting to 25 ml rack

HAZARD of electric shock! Before installation works on electrical devices, always switch the device
off and disconnect it from the power supply.

CAUTION
Risk of injury! Assembly work on the device may only be performed by trained personnel.

1. Loosen the eight Allen screws [A] of the housing, four on each side, see Fig. 3.

8xA

Fig. 3

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20 FRL series – Settings

2. Remove the housing.

3. Loosen the two knurled nuts [B], see Fig. 4.

3xC

2xB

Fig. 4

4. Loosen the three cylinder head bolts [C], see Fig. 4.

5. Rotate the distance block [D] by 90°, see Fig. 4 and Fig. 5.

D D

Fig. 5

6. Tighten the three cylinder head bolts [C].

7. Tighten the two knurled nuts [B].

8. Mount the housing by fastening it with the Allen screws [A] again, four each side, see Fig. 3 on page 19.

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FRL series – Performing the Test 21

6 – Performing the Test

Before performing the test, make sure the device is properly positioned, connected and configured
according to your specifications.

Danger of collision! Make sure that the correct rack (the one actually used) is selected in the device
configuration.

Control via dissolution tester

Refer to the instruction manual of the used dissolution tester for more information.

Control via Disso.NET

Switch the device on before starting the software (see 4.5.3 – Switching the device on/off).

Disso.NET
Refer to the guide of the used software version for more information.

During the operation

CAUTION
Danger of seizing! Movable rotating parts! Do not reach this area (top and rear panel of the device)
when operating! Wear protective clothing and follow safety instructions. Wear clothes with tight-fitting
sleeves. Bind long hair together. Do not wear ties, long chains, bracelets or scarves. The device
should be operated by trained, authorized personnel only.

Pulling and rotating the sampling system during operation or cleaning must be avoided as this can
lead to damage.

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22 FRL series – Cleaning

7 – Cleaning
Ensure that the device is cleaned regularly. The device is to be cleaned after each test and at least once a week.
Spilled media must be removed immediately. Read the following instructions carefully before starting the cleaning.

WARNING Hazard when handling with media! Wear the personal protective outfit and glasses, if nec-
essary. The safety regulations for working in the laboratory must be observed.

HAZARD of electric shock when cleaning the electric devices! Disconnect the mains supply for
cleaning the electric devices. Switch the device off and unplug it for cleaning. Clean the electric
instruments without liquids.

Note that product residues must be properly disposed of in accordance with the respective valid
environmental legislation.

7.1 – Cleaning procedure

1. Disconnect the mains supply and all device connections.

2. Remove the rack with the collection containers. Remove the collection containers and empty them.

3. Clean the collection containers e.g. with Hellmanex® II, which must be mixed with water (1:50), in order to obtain
an effective cleaning solution for quartz and glass cuvettes. Clean for 15 minutes with the aqueous cleaning
solution and rinse thoroughly with water (about 15 minutes). Observe the manufacturer’s instructions for proper
handling of the cleaning solution.

Incorrect measurement results due to dirty or damaged optical components. Pay attention to the
cleanliness of the glass tubes and HPLC vials. Clean carefully and thoroughly. All impurities must be
removed completely without damaging the sensitive and high-quality optical components.

4. Remove the waste container (opt. substitution and dilution medium) and empty it.

5. Clean the container with a special detergent for acrylic glass and rinse it with warm water thereafter.

6.
The container is made of high-grade acrylic glass and therefore is sensitive to the aggressive cleansing
agents. Do not use organic solvents (e.g. ethanol or methanol) because this causes damage. Use only
a special cleansing agent for acrylic glass.

Acrylic glass can be scratched during the dry cleaning with the present dust particles. That’s why wipe the acrylic
glass always with a damp cloth. The best way is to have special microfiber clothes at hand that you can damp with
the lukewarm water.

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FRL series – Cleaning 23

7. Wipe the device with a soft and slightly damped cloth.

Do not use a wet cloth but slightly damped one. Do not add any chemical cleansing agents to the
cleaning water. For the lacquered housing parts use no cleansing agents which attack this material.

In case of heavy contamination, use a damped cloth and dab the cleaned areas dry.

7.2 – Automatic cleaning

The autosampler is cleaned by the dissolution system with a suitable cleansing agent e.g. dissolution media or deter-
gents. These detergents should be able to dissolve residual particles resulting from the active ingredients or another
drug compound.

For system control via dissolution testers refer to the instruction manual of the dissolution tester (see
also Cleaning and rinsing the hose system on page 19).

Disso.NET
For system control via ERWEKA Disso.NET refer to the guide of the used software version.

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24 FRL series – Inspection and maintenance

8 – Inspection and maintenance

Ensure that the device is regularly inspected and maintained in a clean condition.

HAZARD of electric shock! Before installation work on electrical devices, always switch off the device
and disconnect it from the power supply.

To ensure a long lifetime of your devices and systems, we recommend a regular maintenance
performed by our service staff.

8.1 – Check regularly

Regularly check hose connections for leak tightness and fixed placement.

The fittings are manually tightened. This is sufficient to establish a tight connection.

Do not seal with the sealing material or PTFE band.

8.2 – In longer standstills

• Switch the device off.

• Disconnect the device from the power supply.
• Disconnect all device connections.
• Dismount additional components.
• Empty and rinse all containers and hoses.
• Clean the device thoroughly.
• Store the device, its components and instruction manual. See the storage conditions defined by ERWEKA
in 4.3.3 – Required installation environment.

Non-compliance with the instructions given above can lead to damages.

8.3 – Spare parts

Electronic and mechanical replacements are to be made by the ERWEKA personnel or approved by
ERWEKA.

Only original spare parts or components released by ERWEKA should be used. Only repairs or changes on the device
performed by the ERWEKA technicians or approved explicitly by ERWEKA are to be made.

21853-3.0
FRL series– Attachment 25

Attachment
Terminology list

Notion / Abbreviation Explanation

DAB German Pharmacopoeia

Display LC or LED display

Dissolution test Test of formulation dissolution in certain media under specified conditions

e.g. for example (exempli gratia)

EP European Pharmacopoeia

Fig.  Figure (picture, illustration)

HPLC High performance liquid chromatography

i.e. that is, in other words (id est)

LC Liquid crystal

LED Light-emitting diode

Medium Fluid environment in the test vessel to dissolve the product

USP U.S. pharmacopeial convention

UV/Vis ultraviolet light/ visible light

Vessel test container, beaker

Vial phial, small container, in which the samples are stored

21853-3.0
Certificate of Compliance for
Konformitätserklärung für

Sample collector, FRL serie

We, ERWEKA GmbH, declare under our sole responsibility that the product to which this declara-
tion relates is in conformity with the following EU-Directives and harmonized standards:

■ Low Voltage Directive (LVD) 2014 / 35 / EU

■ Safety requirements for electrical equipment for measurement, control and laboratory use; EN 61010-1
■ Electromagnetic Compatibility, (EMC) Directive 2014 / 30 / EU
■ Electrical equipment for measurement, control and laboratory use; EN 61326-1

Wir, die ERWEKA GmbH, erklären in alleiniger Verantwortung, dass das Produkt, auf das sich die-
se Erklärung bezieht, mit folgenden EU-Richtlinien und harmonisierten Normen übereinstimmt:

■ Niederspannungsrichtlinie 2014 / 35 / EU
■ Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte; EN 61010-1
■ Elektromagnetische Verträglichkeit, EMV-Richtlinie 2014 / 30 / EU
■ Mess-, Steuer-, Regel- und Laborgeräte, EN 61326-1

Heusenstamm, 09.03.2016

Manfred Koller
-CTO-

ERWEKA GmbH · Ottostr. 20-22 · 63150 Heusenstamm · Germany · Tel: +49 6104 6903-0
Fax: +49 6104 6903-40 · E-mail: info@erweka.com · www.erweka.com
Managing Director & CEO: Werner G. Müller, Claudia Müller, Manfred Koller · District court Offenbach HRB 2382
ERWEKA GmbH · Germany
Email: info@erweka.com
www.erweka.com