VWR Pinocchio Super Petri Validated User manual

VWR®Pinocchio Super
INSTRUCTION MANUAL
European catalogue numbers:
710-0950 Pinocchio Super Petri
710-0949 Pinocchio Super Contact
710-0955 Pinocchio Super Petri Validated
710-0951 Pinocchio Super Contact Validated
Version: 2.2
Issued: July 2016

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Legal address of manufacturer
Europe
VWR International S.r.l.
Via San Giusto, 85
20153 Milano (MI)
Italy
+ 39 023320311
http://it.vwr.com
Country of origin: Italy

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Table of contents
Warning 4
Safety information 4
Installation 5
Intended use 7
Specifications 7
Instructions for 8
Maintenance 10
Technical service 11
Warranty 11
Equipment disposal 12
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Warning
PLEASE READ THE INFORMATION CONTAINED IN THIS MANUAL BEFORE USING THE UNIT.
THE MANUFACTURER DOES NOT ACKNOWLEDGE ANY RESPONSIBILITY FOR AN IMPROPER USE
OF THIS EQUIPMENT AND NOT FOLLOWING THESE DIRECTIONS FOR USE.
Using this manual will help you use this instrument efficiently. The manual should be kept in a convenient
place near the instrument for ease of use.
Safety information
Please follow the guidelines below, and read this manual in its entirety to ensure safe operation of the unit.
Use the device just for the indicated purposes
The device must be correctly installed according to manual instructions, before starting any operation
Use original spare parts and accessories for any replacement
If this device is used with extremely high pressurised gas you must connect a reducer to the inlet in
order to have a maximum of 6 bar to the inlet
Avoiding damage to the instrument
Be aware that pressure applied to the inlet is lower than 6 bar.
Avoiding damage to operator
Do not use this device with gas with an oxygen concentration more than 21%.
Do not use this device with gas harmful for humans or the environment.
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Installation
The compactness of “Pinocchio Super II” sampler enables the device to be located where space is limited.
The simple construction coupled with simple operation enable accurate reports on air–gas microbiology
quality. The unit can be completely dismantled for easy cleaning and autoclave sterilisation. The pressure
gauge and the airflow meter are not autoclavable. Follow the schematic drawing for assembly. All
connections are “quick disconnect”.
Connect the unit to the desired point of sampling using suitable sterile tubing. The inlet gas valve should be in
a closed position.
ASSEMBLING
1) Connect the inlet splitter to the basement according to the following picture.
2) Connect the pressure gauge to the base according to the following picture.
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3) Connect the elbow arm to the base according to the following picture.
4) Connect the flow meter and its holder to the base according to the following picture.
5) Connect the sampling arm and its holder to the base according to the following picture.
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Intended use
The “Pinocchio Super II” microbiological gas sampler is a portable instrument for determining the level of existent
microbiological contaminants in the compressed gas of aseptic manufacturing operations.
For laboratory use only. Not intended for any animal or human therapeutic or diagnostic use.
Specifications
HxWxD 245x400x200 mm
Weight 5 kg
Construction Stainless steel / anodized aluminium
Airflow meter 50/400 litres
Operating temperature 10 .... 40 °C
Electrical power supply N/A
Compressed air Max. inlet pressure 6 bar
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Overview
The Pinocchio Super II microbiological gas sampler is a portable instrument for determining the level of
existent microbiological contaminants in the compressed gas of aseptic manufacturing operations.
An official validation of the Pinocchio Super II air sampler is required as part of an inspection. The flow meter
should be calibrated by an official agency at regular intervals (usually every year). Official validation of the
flow meter can also be performed by VWR INTERNATIONAL customer support service.
Instructions for use
PREPARATION
1) Connect the unit to the desired point of sampling using suitable sterile tubing. The inlet gas valve should
be in a closed position.
2) Insert an identified contact plate or Petri dish with sterile medium in the Pinocchio funnel housing and
screw it to the conical head. Do not connect to the Pinocchio Super II.
AIRFLOW ADJUSTMENT
3) Fully open the flow meter knob (pos. “C” Figure 1).
4) Fully close the D and D2 valves.
5) Fully open the D1 valve.
6) Open the line of compressed air or gas.
7) Start opening the D valve slightly, ensuring that the manometer is not indicating a pressure greater than 6
bar.
8) Open the D valve until you see the desired airflow on the flow meter, the suggest value is 100 l/min (210
SCFH). The purpose of this operation is to obtain a known volume of air, without contaminating the sampling
circuit.
C
D
D1
D2
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COMPRESSED GAS SAMPLING
9) Connect the Pinocchio funnel to the Pinocchio Super II.
10) Fully close the (D1) valve.
11) Fully open the (D2) valve and start the count down.
12) Close the inlet gas valve after 10 minutes (or when 1000 litres of air is collected).
13) Unscrew the head and transfer the contact plate (RODAC) or Petri dish to a laboratory for incubation.
The Pinocchio Super II is now ready for a new test.
Count the Colony Forming Units in the plate at the end of incubation time and report the results as CFU/1000
litres of gas/compressed air.
SAMPLING DATA RECORDING
If the sampling data needs to be recorded, replace the plate housing with a SAS Super air sampler and start
from point 4 to 6.The time will be regulated by the sampler timer.
CALIBRATION
The airflow meter can be officially calibrated each year.
CLEANING & STERILISATION
The unit can be dismantled for easy cleaning and autoclave sterilisation.
IMPORTANT NOTE!
AIRFLOW METER AND PRESSURE GAUGE ARE NOT AUTOCLAVABLE.
D
D2
D1
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CONVERSION TABLE “SCFH” TO LITRES PER MINUTE
The meters airflow readings should be translated into litres per minute. Follow the reported table.
Maintenance
Daily cleaning of the instrument will prevent most future faults. It is possible to clean the instrument with a
mild detergent and a soft wet cloth.
WARNING
Do not use any cleaning product containing halogens or other aggressive substance to clean the
instrument. Usage of these products can cause rust.
SCFH l/min
150 70,8
160 75,5
170 80,2
180 85,0
190 89,7
200 94,4
210 99,1
220 103,8
230 108,5
240 113,3
250 118,0
260 122,7
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