INSTRUCTION MANUAL

CRITICAL FLOW CONTROLLER

MODEL TPK & TPK-R

November 2020 TPK and TPK-R Rev 21 DT 121120

 INSTRUCTION MANUAL

The information contained in this document is subject to change without notice.

Copley Scientific Ltd. makes no guarantee of any kind with regard to this material,
including but not limited to, the implied warranties of merchantability and fitness for a
particular purpose.
Copley Scientific Ltd. shall not be held liable for errors contained herein, nor for
incidental or consequential damages in connection with the furnishing, performance
or use of this material.

No part of this document may be photocopied, reproduced or translated to another

language without the express consent of Copley Scientific Ltd.

Amendments
Revision 1 January 2006
Revision 2 June 2006
Revision 3 November 2007
Revision 4 March 2012
Revision 5 July 2013
Revision 6 August 2015
Revision 20 January 2020
Revision 21 November 2020
First Release
Change to reflect current format
Deletion in specifications
WEEE information added. FTV information added
TPK-R information added, photographs updated
Minor amendments
Detail Changes
TPK image change

© Copyright 2006 Copley Scientific Limited

Colwick Quays Business Park
Private Road No. 2, Colwick
Nottingham, NG4 2JY
United Kingdom

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 INSTRUCTION MANUAL

CONTENTS PAGE
1 Introduction ....................................................................................................... 4
1.1 The TPK and TPK-R .................................................................................... 4
1.2 General description and overview of operation ............................................ 5
2 Setting Up .......................................................................................................... 7
2.1 Location........................................................................................................ 7
2.2 Assembly ...................................................................................................... 7
3 Operation ........................................................................................................... 8
3.1 Determining the Test Flow Rate ................................................................... 8
3.2 Measuring Delivered Dose Uniformity of DPIs ............................................. 9
3.3 Measuring the Aerodynamic Particle Size of DPIs ..................................... 10
4 Maintenance and Cleaning ............................................................................. 12
4.1 Maintenance ............................................................................................... 12
4.2 Cleaning ..................................................................................................... 12
5 Specification .................................................................................................... 13
5.1 TPK and TPK-R General ............................................................................ 13
5.2 TPK and TPK-R Physical Dimensions........................................................ 13
5.3 TPK and TPK-R Operating Environment .................................................... 13
5.4 TPK and TPK-R Solenoid Valve ................................................................. 13
5.5 TPK and TPK-R Absolute Pressure Transducer ........................................ 13
5.6 TPK and TPK-R Differential Pressure Transducer ..................................... 13
5.7 TPK and TPK-R Timer ............................................................................... 13
6 Decommissioning, dismantling, disabling and scrapping. ......................... 14

7 Technical Support ........................................................................................... 15

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 INSTRUCTION MANUAL

1 Introduction

Copley Scientific confirm that providing the unit is operated in

accordance with the instructions contained in this manual, then the
Critical Flow Controller Model TPK (or TPK-R) is intrinsically safe to
operate.
At the same time, we should point out that in common with the majority
of laboratory equipment, we can bear no responsibility for any danger
or problems caused if safety precautions are not strictly observed.

1.1 The TPK and TPK-R

The TPK-R (‘Reversed’) is functionally identical to the TPK but designed to improve
connectivity between the critical flow controller and equipment such as the NGI by
having the inlet connector for the apparatus under test situated on the left-hand side
and the pump connector situated on the right-hand side. This instruction manual has
been produced with the TPK as the main subject but can apply equally to the TPK-R
by reversing any references to the left-hand or right-hand side. All of the comments
and information given in this instruction manual apply equally to both the TPK and
TPK-R.
LED Display

Timer P1, P2 and P3

buttons and LEDs

Flow control
Timer Button valve

Outlet connector
(to pump)

Figure 1.1 The TPK-R

P1 port

Inlet connector
(to test apparatus)

Figure 1.2 The TPK-R Inlet Connector

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1.2 General description and overview of operation

The Critical Flow Controller Model TPK is an instrument designed specifically for the
control of the critical parameters associated with dose uniformity and aerodynamic
particle size distribution testing of Dry Powder Inhalers (DPIs), in accordance with the
specifications laid down in European Pharmacopoeia Section 2.9.18 and the United
States Pharmacopoeia Section 601.

The Critical Flow Controller Model TPK incorporates the following components (see
also Figure 1.3 – items highlighted in red):

 An in-built differential pressure meter, for measuring the pressure drop over
the inhaler (P1).
 A timer controlled two-way solenoid valve to control flow duration.
 A flow control valve to adjust flow rate.
 Absolute pressure meter for measuring absolute pressures at points P2 and
P3, immediately upstream and downstream of the flow control valve.
 An ON/OFF switch on the rear panel.
 An outlet hose connector on for connecting to the vacuum pump.
 An inlet hose connector for connecting to the test apparatus.
 A small pressure port for measuring the differential pressure P1.
 A timer which can be set up to 999.9 seconds for controlling the two-way
solenoid valve.
 P1, P2 and P3 buttons with corresponding LEDs.
 LED display for displaying pressure (in kPa).
 Timer button for starting the timer.

Figure 1.3 Schematic Layout of the TPK and TPK-R

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 INSTRUCTION MANUAL

The Critical Flow Controller Model TPK and TPK-R comprises the parts described in
Figure 1.4 and Figure 1.5 below:

LED Display

Timer
P1, P2 and P3
buttons and LEDs

Flow Control Timer Button

Valve

Outlet
Connector
(to pump)

Figure 1.4 The TPK

P1 port

Inlet connector
(to test apparatus)

Figure 1.5 The TPK Inlet Connector

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 INSTRUCTION MANUAL

2 Setting Up
2.1 Location
 Site the TPK on a level surface capable of withstanding the weight of the unit (see
specification).
 Ensure that the TPK is readily accessible to the user and placed at a convenient
height for access to the on/off switch, the inlet and outlet connectors, and the front
panel.
 Ensure that the TPK is in a clean and dust-free environment.
 Minimise as far as possible the distance between the TPK, vacuum pump and
test apparatus in order to reduce the tubing length between each item.

Before using the TPK, ensure that there is no damage as a result of

transporting or locating the TPK in its position of use. Report damage
immediately to your supplier and do not attempt to use the TPK, until
permission has been received from the supplier.

The TPK contains sensitive pressure measurement sensors. Operating

the TPK in a non-laboratory (or dirty) environment, and not taking
adequate precautions to filter out drug particles prior to entry into the
TPK, may result in damage to the TPK sensors.

2.2 Assembly
 Once in position, plug the mains cable into the socket on the rear of the TPK and
switch on.
 Allow 15 minutes after switching on for the electronics of the TPK to stabilise
before use.
 The flow inlet (on the right panel) will have a small (12 mm O.D.) hose connector
in position. This is for connection directly to the test apparatus (cascade impactor
or dosage unit sampling apparatus) using suitable tubing.
 If the TPK is being used with a Next Generation Pharmaceutical Impactor (NGI)
then it may be necessary to replace the small hose connector with the large (17
mm O.D.) hose connector supplied with the TPK.

NOTE: A 24mm spanner/wrench will be required for changing hose connectors – not
supplied.

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 INSTRUCTION MANUAL

Before using the TPK, ensure that the mains power supply is correct
for the TPK being used. Details of the TPK voltage and frequency can
be found on the specification label on the rear panel of the TPK.
Incorrect mains power supply could cause irreparable damage to the
TPK.

3 Operation
NOTE: It is highly recommended that test monographs contained within European
Pharmacopoeia Section 2.9.18 and the United States Pharmacopoeia Section 601
are used in conjunction with this instruction manual.

3.1 Determining the Test Flow Rate

Use the Critical Flow Controller Model TPK in conjunction with the Sampling
Apparatus for DPIs and a suitable vacuum pump to perform this test.

 Connect the TPK to the Sampling Apparatus for DPIs as shown in Figure 3.1.

Vacuum
Pump TPK P1 Port

Note: This schematic is designed as a guide to the

Sampling
assembly of the apparatus. Please refer to the test Apparatus for
monograph (e.g. USP or EP) for further guidance. DPIs
Figure 3.1 Determining the Test Flow Rate – DUSA for DPIs

 Insert the inhaler into the inlet of the sample tube of the Sampling Apparatus
for DPIs, using a suitable mouthpiece adapter.
 Connect the tube marked P1 from the TPK to the pressure tap marked P1 in
the sample tube of the Sampling Apparatus for DPIs.
 Switch on the vacuum pump.
 Set the timer to a high value (e.g. 500 seconds) and then open the two-way
solenoid valve by pressing the “Timer” button.
 Press the "P1" button and adjust the flow control valve until the differential
pressure on the LED display indicates 4.0 kPa.
 Press the "P2" button and then the "P3" and note the respective readings on
the LED display.
 P2 must not be less than 2 x P3 for sonic flow to occur. If sonic flow is not
achieved then do not proceed with the test.
 Replace the inhaler with a suitable flow meter and flow meter adapter and
then measure the flow rate (Q) as shown in Figure 3.2.

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 INSTRUCTION MANUAL

P1 Port
TPK

Note: This schematic is designed as a guide to the

Sampling Flow Meter
assembly of the apparatus. Please refer to the test Apparatus for
monograph (e.g. USP or EP) for further guidance. DPIs
Figure 3.2 Measuring the Test Flow Rate – DUSA for DPIs

NOTE: If 4 kPa cannot be achieved at P1 (in the case of extremely low resistance
inhalers) before a flow rate of 100 L/min is exceeded, then adjust the flow control
valve to achieve a flow rate of 100 L/min.

NOTE: The purpose of the absolute pressure measurements (P2 and P3) is to
ensure that critical or sonic flow conditions exist in the flow control valve so that
the flow rate through the particular test apparatus remains constant and
unaffected by fluctuations in the pump.

NOTE: If the vacuum pump is fitted with an unregulated vacuum inlet, then use
this to bypass the flow control valve that may be fitted to the pump. If sonic flow is
still not achieved, then a more powerful vacuum pump, or a secondary pump,
may be required. Contact Copley Scientific for further details.

3.2 Measuring Delivered Dose Uniformity of DPIs

 Using the predetermined flow rate (Q) and the TPK timer controls, adjust the
test flow duration to give an inspiration volume of 4 L.

NOTE: Calculate the test time (T) such that 4 L of air is drawn through the inhaler
(i.e. T = 240/Q).

 Replace the inhaler and discharge the powder into the Sampling Apparatus for
DPIs, by activating the timer controlled solenoid valve, by pressing the "Timer"
button.
 Repeat as necessary to achieve the minimum recommended dose.
 Assay the contents of the Sampling Apparatus for DPIs for drug after rinsing
the filter and interior with a suitable solvent.

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 INSTRUCTION MANUAL

3.3 Measuring the Aerodynamic Particle Size of DPIs

Use one of the current USP or EP specified cascade impactors for DPIs, in
conjunction with the Critical Flow Controller Model TPK and a suitable vacuum pump,
to perform this test.

 Connect the TPK to the cascade impactor and attach a suitable flow meter to
the inlet the induction port as shown in Figure 3.3.

Flow Meter
Adapter

Flow Meter
TPK
Cascade
Impactor

Note: This schematic is designed as a guide to the

assembly of the apparatus. Please refer to the test
monograph (e.g. USP or EP) for further guidance.

Figure 3.3 Measuring the Aerodynamic Particle Size of DPIs – Flow Rate Determination

 Switch on the vacuum pump.

 Set the timer to a high value (e.g. 500 seconds) and then open the two-way
solenoid valve by pressing the “Timer” button.
 Adjust the flow control valve until the flow rate as measured by the flow meter
is equal to “Q” as determined in Section 3.1.
 Press the "P2" button and then the "P3" and note the respective readings on
the LED display.
 P2 must not be less than 2 x P3 for sonic flow to occur. If sonic flow is not
achieved then do not proceed with the test.

NOTE: The purpose of the absolute pressure measurements (P2 and P3) is to
ensure that critical or sonic flow conditions exist in the flow control valve so that
the flow rate through the particular test apparatus remains constant and
unaffected by fluctuations in the pump.

NOTE: If the vacuum pump is fitted with an unregulated vacuum inlet, then use
this to bypass the flow control valve that may be fitted to the pump. If sonic flow is
still not achieved, then a more powerful vacuum pump, or a secondary pump may
be required. Contact Copley Scientific for further details.

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 INSTRUCTION MANUAL

 Close the solenoid valve by setting the timer back to “0.0”

 Remove the flow meter.
 Using the predetermined flow rate (Q) and the TPK timer controls, adjust the
test flow duration to give an inspiration volume of 4 L.

NOTE: Calculate the test time (T) such that 4 L of air is drawn through the inhaler
(i.e. T = 240/Q).

 Insert the mouthpiece of the primed/loaded inhaler into the inlet of the
induction port using a suitable mouthpiece adapter as shown in Figure 3.4.

Vacuum
Pump TPK

Note: This schematic is designed as a guide to the

Cascade
assembly of the apparatus. Please refer to the test Impactor
monograph (e.g. USP or EP) for further guidance.

Figure 3.4 Measuring the Aerodynamic Particle Size of DPIs – Testing

 Discharge the powder into the Sampling Apparatus for DPIs, by activating the
timer controlled solenoid valve, by pressing the "Timer" button.
 Repeat as necessary to achieve the required number of doses.
 Assay the contents of impactor in accordance with the impactor
manufacturer's instructions, in conjunction with the USP and EP monographs.

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4 Maintenance and Cleaning

4.1 Maintenance
Other than routine cleaning, there are no regular maintenance operations that need
to be performed by the user.

Operational verification during calibration can be aided by the ‘Flow Time Verification
Kit’ which measures the actual duration that the vacuum is present on the inlet to the
TPK (or TPK-R). Please contact Copley Scientific Ltd. for details.

4.2 Cleaning

Disconnect from the mains power supply before cleaning.

The manufacturer will take no responsibility for damage to the

case/components of the TPK (or TPK-R) caused by the use of
aggressive solvents or non-approved cleaning materials.

 The metal case and front panel can be cleaned with mild soapy water, taking care
not to allow water to run down the sides of the machine or through any of the
apertures/sockets/switches in the case.
 Dry immediately after cleaning.
 Internal cleaning is not required.

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5 Specification
5.1 TPK and TPK-R General
230 V, 50 Hz 110V, 60 Hz
Mains supply See specification label See specification label
Class I - MUST BE Class I - MUST BE
Isolation classification
EARTHED EARTHED
Fuse 1 x 2 A (Type T) 1 x 2 A (Type T)

5.2 TPK and TPK-R Physical Dimensions

Dimensions (wdh) 370 x 220 x 230 mm
Mass 7.5 kg

5.3 TPK and TPK-R Operating Environment

Operating Temperature 10 C to 30 C
Relative Humidity 25 to 65 %

5.4 TPK and TPK-R Solenoid Valve

Opening time 25 ms
Closing time 25 ms

5.5 TPK and TPK-R Absolute Pressure Transducer

Range 0 to 100 kPa
Resolution 0.1 kPa
Repeatability < ± 0.1% FSD
Long term stability < ± 0.2% FSD / 6 months

5.6 TPK and TPK-R Differential Pressure Transducer

Range 0 to 100 kPa
Resolution 0.1 kPa
Repeatability < ± 0.1 % FSD
Long term stability < ± 0.2 % FSD / 6 months

5.7 TPK and TPK-R Timer

Range 0 to 999.9 s
Resolution 0.1 s
Operating Mode Elapsed Time
Accuracy ± 0.005 % ± 30 ms (max.)

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6 Decommissioning, dismantling, disabling and scrapping.

With suitable care this equipment should provide you with years of reliable operation.
At the end of its useful life the equipment should be dismantled and disposed of in an
appropriate manner.

Information concerning dismantling, disabling and scrapping can be obtained by

contacting Copley Scientific Limited; See below for contact details:

Copley Scientific Limited.

Colwick Quays Business Park
Private Road No. 2, Colwick
Nottingham NG4 2JY
Tel: +44 (0)115 961 6229
Fax: +44 (0)115 961 7637
e-mail: support@copleyscientific.co.uk

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7 Technical Support
Should you have any queries, or require technical information regarding the Critical
Flow Controller Model TPK, or any other equipment we supply, please do not
hesitate to contact us.

For details of your local distributor please consult our web-site:

www.copleyscientific.com

Or alternatively you can contact us at the address below:

Copley Scientific Limited.

Colwick Quays Business Park
Private Road No. 2, Colwick
Nottingham NG4 2JY
United Kingdom

Tel: +44 (0)115 961 6229

Fax: +44 (0)115 961 7637

e-mail: support@copleyscientific.co.uk
web site: www.copleyscientific.com

Copley Scientific AG
Erlenstrasse 27
Postfach 152
CH-4106 Therwil
Switzerland

Tel: +41 (0)61 725 25 35

Fax: +41 (0)61 721 31 87

e-mail: service@copleyscientific.ch
web site: www.copleyscientific.com

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