Confidentiality level: xxx

STANDARD OPERATING PROCEDURE

CODE XXX

Sonicator

Author: Accepted:
dd Mmm yyyy dd Mmm yyyy

Name of responsible analyst Name of approver

Responsible analyst Approver/Position
Pharmaceutical Testing Laboratory Pharmaceutical Testing Laboratory

Version Number XX
Supersedes version: XX
Dates of validity: dd Mmm yyyy –
dd Mmm yyyy

Name of Manager
Quality Manager

Distribution list:

Replaced by version: XX

1. Objective
Standard Operating Procedure Version No XX
CODE XXX Sonicator Dd Mmm yyyy Confi Level XXX

The obtain a clear and detailed procedure in operating an ultrasonic cleaner or sonicator.

2. Responsibility

1. The person assigned to be in charge of this instrument should follow the instructions in
this procedure. Any changes should be reported to the head of the laboratory. Proper
revisions should be done immediately upon approval of the head of the laboratory.
2. The person assigned to be in charge of this instrument should train staff and students
on the operation of this equipment and to ensure adherence to the working instruction.

3. Definitions

Sonication The act of applying sound energy (usually of the ultrasound type)
to agitate particles in a sample. [1]

4. References

 Crest PowerSonic User Manual [1]

5. Procedures

  Steps
START-UP
Check that the main connection, which must be equipped with a protective earth
1
conductor, conforms with the data on the rating plate of your cleaner.
2 Set up the sonicator on a firm, dry and level base.
Fill the tank with water.
3
Note: The liquid level should be approximately 1” – 1 ¼” from the top.
4 Please take note of the respective safety regulations for handling chemicals.
Connect the sonicator to the main connection and switch on the power switch located at
the side. When the sonicator has been switched on, the green indicator light in the
5
switch is lit. The sonicator is now ready for operation.
Note: Ensure without fail that you use the correct power cord for the socket outlet.
OPERATION
1 The sonicator has a digital interface panel which enables settings and its operation. The
ff. settings are possible:
 Sonic turn-on duration from 1 to 99 minutes in steps of 1 minute or continuous
operation,
 Bath temperature in steps of 1C (33F) to 80C (176F).
Standard Operating Procedure Version No XX
CODE XXX Sonicator Dd Mmm yyyy Confi Level XXX

 Sonic power in nine steps from approx. 40% to 100% of max. output power.
The sonicator can also be operated in degas mode for degassing of fluid. During the
degas mode, the sonic is switched ON and OFF in short intervals. This causes the
2
entrapped air to form into larger bubbles during the acoustic cavitation of the fluid. The
bubbles can then rise freely to the surface in pauses between the acoustic cavitations.

Operating and display elements of the sonicator are the following:

 Sonic – the sonic is switched ON and OFF by means of this button. The
operating status ‘Sonic On’ is indicated by the illumination of the red light-
emitting-diode (LED) on this button.
 Heater – the heating is switched ON and OFF by means of this button. The
operating status ‘Heating On’ is indicated by the illumination of the red LED on
this button.
 Degas – the degas mode is switched ON and OFF by means of this button. The
operating status is indicated by the illumination of the red LED on this button.
3  Time – when the sonic is switched OFF, the preset sonication time is shown in
minutes in this display. When the ultrasound is switched ON, the remaining
sonication time is shown and the dot in the display blinks to indicate the preset
sonication time is running.
 Temperature – in the sonication mode, the current bath temperature is shown in
C in this display. If the preset temperature has not been reached, the decimal
point in the display blinks; the bath is being heated. Once the preset temperature
has been reached, the decimal point will stay lit all the time. During the process
of ‘Setting the bath temperature’, the target temperature for the cleaning bath is
shown in the display.

SETTING THE CLEANING/SONICATION TIME

4 With the sonic off, press the ‘Select’ button.
The ‘Time’ display blinks. The desired cleaning time can be set in steps of 1 to 99
5
minutes by means of the ‘+’ and ‘-‘ buttons.
Once the desired time has been set, stop pressing the ’+’ and ‘-‘ buttons and wait until
6
the display stop blinking (approx.. 3 sec). The value has now been stored.
The timer function can be rendered inoperative by pressing the ‘-‘ button until two
7
horizontal lines are shown in the display. With this continuous operation mode is active.
SETTING THE BATH TEMPERATURE
With the sonic off, press the ‘Select’ button until the ‘Temperature’ display blinks. The
desired bath temperature can be set in C (max. 80C) by means of the ‘+’ and ‘-‘
buttons.
8
Note: The bath temperature rises considerably with lengthy ultrasonic operation. If the
bath temperature reaches approx. 90C, the heater and the ultrasonic are switched off
for safety reasons.
Once the desired temperature has been set, stop pressing the ‘+’ and ‘-‘ buttons and wait
9
until the display stops blinking (approx. 3 sec). The value has now been stored.
SETTING THE SONIC POWER
10 The output sonic power can be varied/set during the sonic switched ON or OFF
Standard Operating Procedure Version No XX
CODE XXX Sonicator Dd Mmm yyyy Confi Level XXX

condition.
Ultrasound ‘OFF’:
 With the sonic switched off, press the ‘Select’ button until the ‘Power’ display
blinks. The desired power can be set in steps of 1 – 9 using the ‘+’ and ‘-‘
11 buttons (max. power = step 9).
 Once the desired power has been set, stop pressing the ‘+’ and ‘-‘ buttons and
wait until the display stops blinking (approx. 3 sec). The value has now been
stored.
Ultrasound ‘ON’:
 With the sonic switched on, press the ‘Select’ button until the ‘Power’ display
blinks. The desired power can be set in steps of 1 – 9 using the ‘+’ and ‘-‘
12 buttons (max. power = step 9).
 Once the desired power has been set, stop pressing the ‘+’ and ‘-‘ buttons and
wait until the display stops blinking (approx. 3 sec). The value has now been
stored.
UTRASONIC CLEANING
Immerse the parts to be cleaned into the bath, whereby the distance of the parts to be
1
cleaned from the bottom of the tank must be approximately 13mm (1/2”).
Set the required cleaning time and temperature for the cleaning process and the
ultrasonic power as well.
Note: The parameters ‘Cleaning time’ and ‘Sonic power’ depend on a great extent on
2 the cleaning fluid, temperature, type of soiling as well as on the degree of soiling of the
parts to be cleaned. The time can vary from a few seconds to a few minutes. An
optimum combination of the parameters may have to be determined through
experiments.
3 Start the cleaning operation by switching on the sonic.
After cleaning, remove the parts from the bath with care. We recommend rinsing the
4
parts in clean water.
5 Disconnect the cleaner from the main power when not in use.
When the sonic cavitation in the bath becomes noticeably weaker or the fluid is very
6
dirty, the cleaning bath should be changed.

6. Distribution and Retrieval

DISTRIBUTION RETRIEVAL
Standard Operating Procedure Version No XX
CODE XXX Sonicator Dd Mmm yyyy Confi Level XXX

CONTACT
NAME No. SIGNATURE DATE SIGNATURE DATE
           
           
           
           
           
           
           
           
           
           

7. Revision History

Date/Initials* Version Section, page: Change / Reason to change** New version

Dd Mmm yyyy/XXX

*Initials of the person making the change

**When not self-evident