PRODUCT GUIDE

Westech Instrument Services

Westech Scientific Inc
Dry Powder Inhaler
Mete red Dose Inhaler
Nasal Spray
Nebulizer
www.westechinstruments.com
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 CONTENTS
Inhaler Testing Categories
Dry Powder Inhaler

Mete red Dose Inhaler

Nasal Spray

Nebulizer

Automation

PRODUCTS
• Dry Powder Inhaler Testing......................................... 3
• Metered Dose Inhaler Testing..................................... 6
• Nebulizer Testing ........................................................... 8
• Nasal Spray Testing ...................................................... 9
• Impactor Accessories..................................................10

INSTRUMENT SERVICES
• Mensuration...................................................................11
• Recovery ........................................................................11
• Dynamic Calibration ....................................................11

AUTOMATION
• Novi Systems Ltd .........................................................12

Unibase Technology Limited, trading as Westech Instrument Services.

Unit 10, Rectory Farm Business Park, Upper Stondon, Beds
United Kingdom, SG16 6LJ
Registered Number - 07135475
Registered Address – 7 Village Square, Chelmer Village, Chelmsford, CM2 6RF, UK

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 PRODUCTS
Dry Powder Inhaler Application
A Dry Powder Inhaler (DPI) is designed t o deliver a precise measured dose of medication by breath activation . The test procedure me a s ures
aerodynamic particle size distributi on of the drug leaving the device and can define the manner in which the ae rosol deposits in the respiratory
tract during inhalation. Aerosol characterization is often used in judging inhaler performance and is particularly relevant in t he development of
inhalation formulations during research, production, quality assurance and equivalency testing. The results of characterizations using multi-stage
cascade impaction techniques are used for the determination of fine particle fraction or fine particle d o s e w hich may be correlated t o the d o s e or
fraction of the drug penetrating the lungs during patient inhalation. Other instruments collect and measure doses per container. Specified test
applications and various systems described meet both the pharmaceutical industry and its legislators.

Related References and Guidance Documents

United States P h a r m a c o p e i a 2007 ( U S P 30) Chapters 601, 905 & 1151 ( U S P )
E u ro p e a n P h a r m a c o p e i a 2 0 0 5 ( E P 5 ) C h a p t e r s 2 9 . 9 . 1 8 ( 0 671), (0523)

FDA Guidance for Industry - Metered Dose Inhaler (MDI) & Dry Powder Inhaler (DPI) Drug Products (October 1998)

Westech 8 Stage Cascade Impactor - Related Accessories

DPI Setup with
Preseparator
USP Apparatus 1 & 3
EP Apparatus D
W estech 8-Stage “Andersen Type” Multi -
jet, Non-Viable Cascade Impactor (ACI) &
High capacity preseparat or- Includes 8
serialized stages, f inal filter stage, b a s e
with metal h o s e barb, 3-p i e c e spring set,
silicone o-ring seals, dual o-ring style inlet
cone, stainless steel collection plate set
(6 Solid & 2 with Open-Center), operator
manual and complete mensuration
certificate report. Material options:
Aluminum, Stainless Steel or Titanium
60 & 90 L/minute Preseparators
To trap large ae rosols having greater
than a 10 µm ae rodynamic diameter,
the high-flow, high-capacity pre-
collector can be utilized. The t w o piece
assembly attaches atop the impactor t o
be held in place by the standard spring
clamps. Typically the 60 and 90 L/min.
designs match to the cor responding 60
and 90 L/min. conversion kits. Benef its
include the removal of non-inhalable
sizes and the prevention of collection
plate overload and possible fractionation and re-entrainment.
Westech designed and offers two kits allowing modification of the
Traditional flow to 60 and 90 L/min. Material options: Aluminum or
Stainless Steel.

High Flow Conversion Kits Induction Ports

USP Apparatus 1 • EP Apparatus D
60 & 90 L/minute adapter Kits The right -angled design is often
Pressure drop through a DPI should referred to as a “throat”. When
reach 4 kPa (40.8 c m H2O). The attached to the inlet cone of
technique inv olves operating the preseparator top, a gasket seal is
Andersen cascade impactor at higher flow formed allowing ae rosols to enter the
rates other than the standard of 28.3 impactor. Internally there should be a
L/min. Westech designed and offers two double tapper at the inlet reducing to
kits allowing modification of the traditional a straight bore around the leak -free
flow to 60 and 90 L/min. by adding and removing a few st ages . corner. Mouthpiece adapters would
Material options: Aluminum, Stainless Steel or Titanium. attach t o the inlet securel y holding the inhaler device. Material
options: Aluminum, Stainless Steel or Titanium.

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 PRODUCTS
Dry Powder Inhaler Application
Westech 7 Stage Impactor (W7) - Related Accessories
DPI Setup with Preseparator
USP Apparatus 5 & 6 • EP Apparatus E
W estech 7-Stage Cascade Impactor with micro-orifice collector (W7) and high capacit y preseparator.
Multi -jet cascade impactor conforming t o critical USP & EP guidelines and stated dimensions with eight
removable impaction collection cups and convenient single tray design . Operational f l o w s range 15 - 100
L/ min. R e m ovable jet stages allow for easier cleaning, re-configuration and replacement .
Supplied w i t h full mensuration certificate package and operator manual.

Preseparator Induction Port

W7 high capacit y, high efficienc y
pre-collector traps large aero s ols w i t h
aerodynamic diameters greater than
10 – 15 µm dependent on flow rate.
The three piece assembly attaches to
the top of the impactor . T h e unit
removes non-inhalable sizes, prevents
stage 1 overloading and offers a sharp
reproducible cut point. Material: Nickel
Coated Alumin u m .
The right angled design is
often referred to as a throat.
When attached to the top
Of the W7 inlet, a friction
seal fit is established. A
mouthpiece adapter can
then be fitted to the port
inlet holding an inhaler in place. Materials: Stainless Steel, Titanium.

Collection Cups and Tray

The cups are actually impaction surfaces
located directly and precisely below the jets.
The bowl-like shape allows for use of liquid
collection substrates if needed and simple
direct recoveries . Held within a collection
tray, the eight cups can be inserted and Jet Stages
removed together as a unit allowing less Seven removable or replaceable jet stages press fit into the upper
confusion and faster s ample t hroughput. impactor body via precision o-rings. Each jet on each stage is a high
Additional cups and another tray will allow advance preparation quality machined opening meeting a critically specified diameter.
leading to higher productivity. Material: Stainless Steel Quality control is achieved by 100% mensurati on with certificates for
each st age. Material: Stainles s Steel

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 PRODUCTS
Dry Powder Inhaler Application
Other Impactors
Westech FPD Impactor - Rapid Screening
Westech fine particle dose impactor (FPD).
2 stage impactor with final filter for rapid
screening of F PD. Impactor incorporates unique
interlocking system (patent pending) for fast
assembly and disass embl y. Designed to hav e
cutpoints of 5 µm, 1 µm and a final filter w ith a
flow rate at 28.3 L/min. or 60 L/min. I m pactor
uses coated petri-dishes as collection media with
a cassette type filter holder. System allows for
rapid testing without intermediat e stages.

Multi - Stage Liquid Impinger Single - Stage Glass Impinger

USP Apparatus 4 • EP Apparatus C USP Apparatus A
The Astra Draco t y p e Multi -Stage Liquid Impinger The unit operates on the
(MSLI) is a versatile f i v e stage cascade principle of l iquid
impactor which can be used for determining impingement to divide the
the particle size (aerodynamic s i z e distribution) dose emitted from the
of inhalers. Four stages retain a small volume inhaler into respirable and
of liquid which in turn reduces particle b o u n c e non-respirable doses. The
and re-entrainment . The fifth and final stage larger, non-respirable,
aerosols impact on the
holds a filter to collect aerosols less than 1.7µm. m o u t h or pharynx and
The MSLI i s made of glass and in your choice of are swallowed. The
aluminum or stainless steel. appar atus is relatively
simple, easy to use and
Operational flow rates range from 30 to 100 L/min. A pplications include rugged in construction.
MDI, DPI, microbial and cell collection in nutrient media. Ideal for routine Quality
Control
applicat ions. The Single - Stage Glass Impinger comes complete with
a base plate and appropriate clamps, boss heads and fittings as
Dosage Uniformity standard.

Dosage Unit Sampling Apparatus

USP Apparatus B
For inhalers containing multiple doses, a test for delivered-d o s e uniformity
over the enti re contents is requi red. The test also measures total discharges
claimed by the product label . The sample collection system utilized is the Dry Powder Related Accessories
D U S A collection tube. Primary parts include a fine particulate filter holder,
main chamber with side pressure tap, end cap sets (solid and with vacuum Critical Flow Controller
hose connector), gasket seals and an inlet to hold the preferred mouth USP Apparatus B
piece adaptor. Popular closures techniques include the quick turn bayonet - Establishing the requi red
style or scre w-style cap. Custom designs available while following critical pre s s ure drop, flow rate
guidelines . Material options: Delrin or Teflon. and subsequent powder
sampling volume is best
managed by a timed
sequence controller.
Simply attach a suitable
vacuum pump and
impactor or DUSA assembly, set the measured air flow rat e and
input required timing durations.

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 PRODUCTS
Metered Dose Inhaler Application
A metered-d o s e inhaler (MDI) i s most often a drug solution or suspension formulation and propellant . Designed t o deliver a precise measured
dose of medication under pressure, the devices h a v e a long reliable history . The required test procedure measures aerodynamic particle s i z e
distribution of the drug leaving the device and can define the manner in which aerosols deposit in the respiratory tract during inhalation.
Aerosol characterization i s often used in judging inhaler performance and i s particularly relevant in the development of inhalation formulations
during researc h , production, quality assurance and equivalency test ing. The results of characterizations using multi-stage cascade impaction
techniques are used for fine particle fraction or fine particle d o s e determination which may be correlated t o the lung penetrating d o s e by t h e
drug during inhalation. Other instrum ent s collect and measure doses per co ntainer. Specified test a pplications described meet both the
pharmaceutical industry and its legislators.

Related References and Guidance Documents

United States P h a r m a c o p e i a 2007 ( U S P 30) Chapters 601, 9 0 5 & 1151 ( U S P )
E u ro p e a n P h a r m a c o p e i a 2 0 0 5 ( E P 5 ) C h a p t e r s 2 9 . 9 . 1 8 ( 0 671), (0523)
F D A G u i d a n c e f o r I n d u s t r y - M e t e r e d D o s e I n h a l e r ( M D I ) & D r y P o w d e r I n h a l e r ( D P I ) D r u g P ro d u c t s ( O c t o b e r 1 9 9 8 )

MDI Setup Westech FPD Impactor - Rapid Screening

USP Apparatus 1 • EP Apparatus D Westech fine particle dose impactor
Westech 8-Stage “Andersen Type” Multi-Jet (FPD). 2 Stage impactor with final filt er
Non-Viable Cascade Impact or (ACI)-Includes: for rapid sc reening of FPD. I mpactor
8 serialized stages, final filter stage, b a s e incorporates unique interlocking system
with metal hose barb, 3-piece spr ing set , (patent pending) for fast assembly and
silicone o-ring seals, dual o-ring style inlet disassembly. Designed t o have cutpoints
cone, stainless steel collection plate set (6 of 5 µm , 1 µm and a final filter with a
Solid & 2 with Open-Center), operator floe rate at 28.3 L/min. or 60 L/min.
manual and complete mensuration certif icate Impactor uses coat ed petri-dishes as
report. Material options: Aluminum, Stainless collection media with a cassette t y p e
Steel or Titanium filter holder System allows for rapid
testing without intermediat e stages.

Single - Stage Glass Impinger Multi - Stage Liquid

USP Apparatus A Impinger
The unit operates on the principle of l iquid i m p i n g e m ent t o divide the USP Apparatus 4 • EP Apparatus C
d o s e emitted from the inhaler into respirable and non -respirable doses . The Astra Draco type Multi -S t age Liquid
The larger, non-res pirable, aerosols impact on the mouth or pharynx and Impinger (MSLI) i s a versatile f i v e stage
are swallowed. The apparatus is relatively simple, easy t o u s e and rugged cascade impactor which can be used fo r
in construction. Ideal determining the particle size (ae ro-
for routine Quality dynamic size distribution) of inha lers.
Control applicati ons . Four stages retain a small volume of
liquid which in turn reduces particle
The Single - Stage b o u n c e and re-entrainment. The fifth
Glass Impinger comes and final stage holds a filter t o collect
complete w i t h a b a s e aerosols l e s s than 1.7 µ m . The MSLI i s
plate and appropriate made of glass and in your c h o i c e of
clamps, boss heads aluminum or stainless steel. Operational flow rates range from 30
and fittings as to 100 L/min. Applications include MDI, DPI, microbial and cell
standard. collection in nutrient media.

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 PRODUCTS
Metered Dose Inhaler Application
MDI Setup without Induction Port
USP Apparatus 5 & 6 EP • Apparatus E
W estech 7-Stage Cascade Impactor with micro-orifice collector (W7) and high capacity
preseparator. Multi-jet cascade impactor conforming t o critical USP & EP guidelines and
stated dimensions with eight removable impaction collect ion cups and convenient single
tray design. Operational flows range 15 - 10 0 L/min. Removable jet stages allow for
easier cleaning, re-configuration and replacement. Supplied w i t h full mensuration
certificate package and op erator manual

Induction Ports Collection Cups and Tray

USP Apparatus 1 • EP Apparatus
The right-angled design is
often referred t o a “throat”.
W hen attached t o the inlet
cone or preseparator top,
an o-ring seal is formed
allowing aerosols t o enter
the im pact or. Internall y
there should be a doubl e
tapper at the inlet reducing t o a straight bore around t he leak-f ree c orner.
Mouthpiece adapters would attach to the inlet securely holding the inhaler
device. Material options: Aluminum, Stainless Steel or Titanium.
The cups are actually impaction
surfaces located di rectly and precisely
below the jets. The bowl -like shape
allows for u s e of liquid collection
substrates if needed and simple direct
recov eries. Held within a collection
tray, the can be inserted and removed
together as a unit allowing less conf usion and faster sample
throughput. Additional cups and another tray will allow
advance preparation leading to higher productivit y.
Material: Stainles s Steel

Jet Stages

Westech 8-stage impactors are

specifically designed to meet the
highest criteria laid down in the
various Pharmacopoeia (e.g. United
Seven removable or replaceable jet stages press fit into the upper impactor
body via precision o-ring seals. Each jet on e a c h stage i s a high quality
States Pharmacopiea Chapter
machined opening meeting a critically specified diameter. Quality control is <601>; European Pharmacopoeia
achieved by 100% mensuration wit h certificates for e a c h stage.
Material: Stainless Steel
Chapter 29.9.18 for characterizing
aerosol clouds emitted by inhalers

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 PRODUCTS
Nebulizer Testing
A nebulizer typically “atomizes” a solution into a fine mist. Various models are available from a traditional jet nebulizer using
compressed air to newer designs using ultrasonics and electronic control sensors. These generated aerosols are often a formulation of
an active drug suspension. Test procedures should measure aerodynamic particle size distribution from the mouthpiece with a cascade
impactor suited to determine total drug mass released from the aerosols, quantity per impactor stage, mass median aerodynamic
diameter and geometric standard deviation. A collection chamber should be considered with suggested guidelines of not less than 0.5
liters and with an unobstructed path length of not less than 13 cm from the mouthpiece. Specified test applications and various
systems described meet both the pharmaceutical industry and its legislators.

Reference
• C E N : E u ropean Committee for Standa rdization, prEN 13 544 -1 “Respiratory therapy equipment -Part 1: Nebulizing syst e m s and their components”
• Original 298X-CEN modifications developed with co -operation b y Westech I n s t r u m e n t s ( U K )
• ”Cascade Impaction of Nebulized Aerosol”, Dr J. H. Dennis et al, D D L -1 4 , L o n do n , 2 0 0 3

Equipment - Impactors
Marple 290X-CEN Series CEN prEN 13544-1
The Marple Series 290 Cascade Impact or
has been re-specified w i t h development
assistance from Westech Instruments.
Originally a personal sampler for healt h
and safety monitoring, the 298 is now a
device currently validated for u s e in the
pharmaceutical i ndustr y. Accurate
aerodynamic particle
size distributions range
from 0.4 to 21 microns
with a nominal flowrate
of 2 L/min. Cutoff
diameters have been
independently validated
using dynamic
calibration techniques.
USP Apparatus 1 • EP Apparatus D
W estech 8-Stage “Andersen Type”
Multi -jet, Non-Viable Cascade
Impactor (ACI) - Includes 8 serialized
stages, final filter stage, b a s e with
metal hose barb, 3-piece spring set,
silicone o-ring seals, dual o-ring styl e
inlet cone, stainless steel collection
plate set (6 Solid & 2 with Open-
Center), operator manu al and
complete mensuration certificate
report. Material options: Aluminum,
Stainless Steel or Titaniu m
15 L/Minute Delrin Impactor
“New Exclusive” W estech 8-Stage “Andersen Type”
cascade impactors manufactured
from Aluminum or Stainless Steel
exhibit thermal effects wh en used t o
m e a s ure the particle size distri bution
of droplets f rom nebulisers. W e
solv ed this concern by developed a
high grade plastic (Delrin® ) 8-stage
impactor, based on the well
characterized Andersen Cascade
Impactor (ACI), operating at 15 L/min.
allowing the whole output of the
nebulizer to be taken directly into the
impactor. This avoids the need for
the dilution, cooling or f l o w by -pass
techniques currently employed by
alternative devices potentially
distorting the particle size distribution
of the emitted aerosol. Static electricity problems are of no concern
with the typically moist nebulizer sample st ream. The overall inst ru-
ment shape is very familiar to ACI users complete with standard
stainless steel 81 mm diameter impaction plates, a plastic inlet cone,
jet plates, final filter holder and standa rd sized O-ring seals. Del rin®
acetal resin properties are dimensional stability, stiffness and
corrosion resistance.

USP Apparatus 5 & 6 • EP Apparatus E

W estech 7 -Stage Impactor with mic ro-orifice collector ( W-7). Multi-jet
cascade impactor that conforms to crit ical USP & EP guidelines and stated
dimensions. Eight removable impaction collection cups and single tray
design. Operational flow rate 15 - 100 L/min. Removable jet stages for
easier cleaning, con figuration and replacement . Supplied with operator
manual and complete mensuration certificate report.

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 PRODUCTS
Nasal Spray Testing
A nasal spray typically “atomizes” a solution into a coarse mist into the nose. These aerosols are often a formulation of an active
drug suspension. Common test procedures should measure aerodynamic particle size distribution and determine inhalable and
respirable sizes with a cascade impactor. A collection or expansion chamber contains the mist for better recovery. Specified test
applications and various systems described meet both the pharmaceutical industry and its legislators.

Reference
• FDA Guidance for Industry - Nasal Spra y, Inhalation Solution, suspension & spray drug p roducers (July 2002)
- Nasal a e r o s o l s and nasal sprays for local action (April 2003)
• E u ropean pharm acopeia 2 0 0 5 -Nasal preparation (0776)
• United States Pharmacopeia 2007 (usp 36) chapters <601> <905> <1151>

Equipment - Impactors
USP Apparatus 1 • EP Apparatus D (without Port)
Westech 8-Stage “Andersen Type” Multi -jet, Non-Viable Cascade Impactor (ACI)
(Custom arrangements available, see page 3 for full description).

USP Apparatus 5 & 6 • EP Apparatus E

W estech 7-Stage Impactor with mic ro-orifi c e collector ( W-7).
See page 4 for description.

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 ACCESSORIES
Impactor Accessories
Waste Shot Collector
Westech has partnered with N ovi
Systems to offer the original “Waste
Shot Collect or” (W ASC). The WASC is
Used to trap the particles emitted from
pharmaceutical inhalers of both liquid
and powder type aerosols emitted
from Metered D o s e (MDI) & Dry
Powder Inhalers (DPI).
During routine testing of M D I and DPI
inhalers, there is a need to fi re shots to
waste e.g. there may be a need t o
analyze only the last f e w doses of shots of each inhaler. It is therefore necessary t o actuate the inhaler
many times prior t o any testing. Dose wasting i s usually done in an exhaust hood or f u m e cupboard. Westech offers
The W A S C offers the ability to actuate the inha ler within the lab without the need of an expensive
exhaust system. The collector is small enough to fit on a b e n c h and is powered by compressed air custom design
typically accessible in most labs.
Features and Benefits services for many
• B e n c h top system (no need for f u m e cupboard or complicated extraction systems)
• HEPA filter retains 99.97% of particles over 3 µm
inhaler testing
• Disposable filter canister products including
• Thousands of shots per filter canister
• Adjustable flow rate up to 200 L/min. DUSA’s, Induction
Ports and
Digital Flow Meter Mouthpiece
Digital Flow Meter with adaptor: 0- 300 L/min. +/ - 2% of reading of air
and oxygen. AC adapter, RS 232 & Analog interface cables, particulate Adaptors.
filter, manual, NIST-Traceable calibration certificate. R e s p o n s e t i m e 4
m s t o 63% of full scale flow.

Induction Port Caps

Cap Seal for Induction Port/throat (Teflon) w i t h t w o internal seals
(silicone rubber). Suited as an end closure for solution rinse/ recovery
& port storage.

Carrying Case
Black, ultra high impact carrying c a s e. Unbreakable, watertight, airtight,
dustproof, chemical resistance and corrosion proof. Neopre n e O-ring Mouthpiece adapter
1 / 4 " seal and AB S latches . Includes an automatic purge valve. High
density tear-away f o a m interior allows you t o safely transport or ship Mouthpiece adapters customized to
your lab supplies worry free f r o m damage. particular Inhalers are available upon
request. Their purpose is to prov ide an
airtight seal between the mouth of the
test apparatus and the inhaler being
O-Rings tested
O-rings c o m e in both Buna and silicone rubber. W e offer different sets
for all versions of the ACI and for all other W estech I mpactors.

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 SERVICES
Impactor Mensuration & Instrument Service

IVIS System
Impactor Visual Inspection System by Westech
Instruments for quality control and verification of
Cascade Impactor characteristics.

A PC driven laboratory instrument:

• Camera with telecentric lens
• Stage Location and Orientation platform
• Hardware an d Electronics
• Software and Data Processing
• Single or Multi measurement options
• System Calibration and Certified Standards
• Installation and Training

Mensuration Service
Westech Instruments provides 100% jet hole verification of Cascade Impactors.
Service qualifications include being an instrument manufacturer, possessing
accurate mechanical documents of tolerances and specifications and an
understanding of USP / F D A requi rements:

• Printed and Authorized reports and graph

• ”As Found” and “Final” results available
• Basic stage handling and recovery included
• Includes F D A or user defined tolerances
• Other statistical d a t a available

Recovery Services
Impactor evaluations can result in Failed
Reports. Special cleaning and handling
techniques best unde rstood by Westech can be utilized to
resolve many stage failures. Estimates to repair or replace
are always discussed.

Dynamic Calibration
A detailed traceable characterization i s available for both
the Andersen t y p e and Maple 290 Series Cascade Impactor s at various flow rates . The approach is for
determination of aerodynamic diameters for which there i s a 50% collection efficiency . By exposing the
impactor to multiple known size ranges, a recovery is reportable to compa re with theo retical diameters
specific to the impactor. Standards used are preformed fluorescent -labelled monodisperse polystyrene
latex mic rospheres and monodisperse methylene blue pa rticles. Typical test flows: 28.3, 60, 90 (ACI) or
2 L/min (Marple 290). Enquire on other flow rates.

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 AUTOMATION
Impactor Automation Systems
Novi Systems Limited
Westech Instrument Services is the worldwide, exclusive agent for Novi Systems
Limted, who provide a complete range of custom engineered systems used for
inhaler testing.

Automation of the Andersen

Typical Novi products include the ICTUS – a proven, dedicated system for the
complete automation of Andersen and Andersen-type impactors including:
• Preparing the impactor
• Weighing
• Collection plate coating
• Washing and drying the impactor
• Critical flow control
• Leak testing
• Waste shots
• Electronic signatures

The ICTUS custom engineered Automation System

is capable o f testing up to 30 inhalers in 24 hours.

Automated Collection Plate Coating

Automated and Semi Automated Collection Plate systems
offer a unique ablilty to increase throughput in any inhaler
testing facillty whilst improving the overall consistency and
quality of the coating itself – up to 1500 plates a day can be
accomodated .

Automated Shot and Waste System for MDIs

An intregrated system for MDI
s hot weight and wasting
includes shaking and firing,
transfer to a dedicated balance
and work flow control, and
enhances the ability to test
MDI’s in a efficient and
effective approach

Novi Systems Ltd.

Novi is a dedicated custom
engineering company with
long term experience in the
design and development of
automation systems for use in
the pharmaceutical industry
particularly involved in the automation of impactors and
related devices used in inhalation and inhaler testing.

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