Cantium Scientific P0059 User manual
MicroBio Validation Kit
Operating Manual
MicroBio
Validation Kit
Model No. P0059
Operating Manual
"
This work is licensed under a
Creative Commons Attribution, Non-Commercial, ShareAlike 4.0
International License.
https://creativecommons.org/licenses/by-nc-sa/4.0/
Cantium Scientific Limited!
Clarendon Gardens!
Dartford!
Kent!
DA2 6EY
United Kingdom!
!
Tel: +44 (0) 1322 252000!
!
www.cantiumscientific.com!
February 2017 (Rev. 4)
Printed in England"
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2
Contents
Document Issue 5
Statement of Conformity 6
Warranty 7
Introduction 8
Kit Contents 9
Setting Up 10
Tube and head adaptor assembly 10
Preparing the air sampler 10
Validating the MB1 or MB2 bioaerosol sampler 11
Maintaining the Validation Kit 13
Additional Support 14
Calibration of the Validation Kit 15
Inspection Record 16
3
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4
Document Issue
Issue
Description
Date
Revision
By
Approved
1
First Issue.
06/05/2009
SNJP
DCP
2
Title modification. #
Web link update. #
Wording changes throughout
document.
04/11/2010
SNJP
DCP
3
Updated to reflect new
corporate logo.
06/02/2015
SNJP
DCP
4
Reformatting of manual.
03/02/2017
SNJP
DCP
5
Statement of Conformity
#
We certify that this product complies with EEC DIRECTIVE 2002/95/
EC the restriction of hazardous substances; commonly known as
the RoHS directive. The validation kit is designed and manufactured
under strict management systems compliant with ISO9001:2008
and calibration of the instruments is traceable to national standards."
6
Warranty
The manufacturer warrants this product to be free from defects in
materials and workmanship for 24 months from the date of
purchase.$
If your product is found to be defective within that period, please
contact Cantium Scientific Limited or your local distributor who will
arrange for repair of the instrument, or if necessary a replacement.
This warranty does not cover accidental damage, wear and tear,
consequential or incidental loss.
Damage caused by cleaning materials and methods not
recommended by the manufacturer, use beyond the specification,
use in wash down areas, or modifications without prior permission
from the manufacturer will invalidate the warranty.
This warranty does not affect your statutory rights.
7
Introduction
#
The MicroBio Validation Kit is the standard device used to validate
standard 100 litre per minute MicroBio MB1 and MB2 bioaerosol
samplers. It provides a simple and cost effective method to ensure
the MicroBio samplers are working at peak performance, requiring
the minimum of training to use."
This guide provides information needed to validate the MicroBio
MB1 and MB2 bioaerosol samplers and maintain the kit.
Instructional videos on how to use the equipment can also be found
on our website by visiting https://www.cantiumscientific.com/
products/validation-kit/ or visit our YouTube channel at
www.youtube.com/cantiumscientific. "
8
Kit Contents!
1. Calibrated flow tube (Part no. P0059M001)"
2. Sampling head adaptor (Part no. 0059M002)"
3. Contact plate"
4. Petri dish"
5. Trimmer screwdriver"
6. Padded plastic carry case"
7. User Guide (not shown in picture)"
8. Factory calibration certificate (not shown in picture)"
"
"
"
"
Figure 1: Kit Contents"
9
3
4
2
5
6
1
Setting Up
Tube and head adaptor assembly
The first step is to insert the calibrated flow tube (1) into the head
adaptor (2), as shown in figure 2. This forms the validation rig."
Figure 2: Tube and head adaptor assembly"
Preparing the air sampler
Fit the supplied Petri dish (4) or contact plate (3) into the MB1 or
MB2 bioaerosol sampler to be validated and fit the sampling head.
Then place the validation rig on top of the MB1 or MB2 sampling
head as shown in figure 3."
Figure 3: Fitting validation rig to the MB1/MB2
bioaerosol sampler"
10
Validating the MB1 or MB2 bioaerosol sampler!
Calibration and validation should be carried out in a controlled
environment and on a level surface. Air movement around the
calibration zone should be eliminated and ideally carried out in
normal atmospheric pressure of 1013 mbar at 20°C."
"
Figure 4: Location of adjustment screw hole"
Switch on the air sampler and set to take a volume of 400 litres.
This will allow sufficient operating time for validation/calibration to
be performed. Now start the sampler."
NOTE: MB2 users will need to initiate sampling operation before
fitting the validation rig to the MB2 sampler.
11
The float will rise in the validation rig. Hold the validation rig down
firmly onto the MicroBio sampling head or alternatively use quick
grip clamps (not supplied) to hold in place. The float should centre
on the circle printed on the glass tube indicating a flow rate of 100
litres per minute. Approximately 20 seconds should be allowed for
the float to stabilise."
NOTE: It is important not to obstruct the exhaust vents of the MB1
or MB2 sampler or the bottom of the glass tube of the flow rig
during the validation test.
If the validation kit does not indicate correct flow, first check the rig
is held firmly down and repeat the test. If the test fails a second
time, the sampler should be returned to Cantium Scientific Limited
or your local distributor for calibration. It is possible for users to
adjust the flow if required by turning the adjustment screw, located
as shown in figure 4, using the screwdriver supplied (5). The
adjustments should always be made slowly. Self adjusting will
invalidate the calibration certificate provided with the sampler."
Once adjusted, allow approximately 1 minute and observe that the
float remains predominantly within the 100 litres per minute circle.
There may be some occasional fluctuation of the float. The air
sampler can now be considered validated."
If it is not possible to increase or decrease the flow rate to 100 litres
per minute, this may indicate a fault in the air sampler. For service,
contact Cantium Scientific Limited or your local distributor."
12
Maintaining the Validation Kit
#
Due to the nature of variable area flow meters, as used in the
validation kit and the product being manufactured to precise
standards, annual calibration is not required. Regular inspection is
needed. It is recommended that the validation kit is returned to
Cantium Scientific Limited or an appointed re-seller for full factory
inspection every five years."
When not in use, the kit should always be stored in the padded
carry case and kept in a clean dry environment. The kit should be
cleaned with a soft dry cloth. Inspection should include the
following checks:"
1. Ensure the orange coloured seals in the head adaptor (2) are
clean, secure and level."
2. The calibrated flow tube (1) fits securely into the adaptor
head (2)."
3. Looking into the bottom of the glass tube check the white
PTFE stopper is in-line with the direction of the tube and not
at an angle restricting flow. If not, this can be moved into
position using small pliers or tweezers."
4. The glass tube is parallel with the longer white plastic tube.
If not, this can be moved into position by hand, as the
silicone rubber fitting does allow a small degree of
movement."
5. The glass tube is firmly fitted into the silicone rubber fitting."
If required, the kit can be returned to Cantium Scientific Limited or
your local distributor for independent verification."
13
Additional Support
#
Further support for using the validation kit and the MicroBio MB1
and MB2 bioaerosol samplers can be obtained from Cantium
Scientific Limited or your local distributor."
Documentation to support IQ/OQ/PQ for use within pharmaceutical
and related industries is available upon request by contacting
Cantium Scientific Limited or your local distributor. Or visit our
website at https://www.cantiumscientific.com/support/information"
14
Calibration of the Validation Kit
#
Calibration of the validation kit shall only be undertaken by Cantium
Scientific Limited. It is recommended this is done at five yearly
intervals.#
Variable area flow meters impose a restriction on air flow. This will
cause a reduction in the normal flow of air through the MB1 and
MB2 bioaerosol samplers. Through experimentation during
development, this restriction is known at various set-points on the
tube scale and is compensated for on the flow markings on the
tube. "
The exact printing position on each tube is adjusted to take into
account the equivalent true flow based on the known restrictions.
Once printed, the tube is calibrated for life and no further
adjustments are necessary."
Five year inspections will check the scale against the known
restrictions using the same flow meter rig used during manufacture.
This rig is a calibrated secondary standard held by the glass flow-
tube manufacturer."
For calibration, please arrange through your local distributor or
directly with Cantium Scientific Limited."
15
Inspection Record
Year
Date
By
Seal
Check
Head/
Tube
Fit OK
PTFE
Stoppers
OK
Glass
Tube Fit
OK
1
2
3
4
5
RETURN FOR 5 YEAR CALIBRATION
6
7
8
9
10
RETURN FOR 5 YEAR CALIBRATION
11
12
13
14
15
RETURN FOR 5 YEAR CALIBRATION
16
17
18
19
20
RETURN FOR 5 YEAR CALIBRATION
16
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