Hospital validation

Hospital Validation

air control in surgery rooms

© 2010 Topas GmbH

 Hospital validation

A surgery room as a clean room facility

DIN 1946 – 4: German Standard

Ventilation and air conditioning - Part 4:
Ventilation in buildings and rooms of
health care, 12/2008

similar european and international standards

and guidelines (SWKI 99-3, GOST R 52539-2006)

validation of air ventilation systems in hospitals

increased health risks at hospital operations

from particulate contaminations

validation of the efficiency of low-turbulence

displacement flow unit installed above the
operating table

verification of the particle number which is

able to enter the critical protective area

© 2010 Topas GmbH

 Hospital validation

A surgery room as a clean room facility

HS-Luftfilterbau GmbH

© 2010 Topas GmbH

 Hospital validation

validation measurements according to DIN 1946-4

the concept of protection factor measurements

standardised test procedure

high reliability verified by scientific institutions

measurements under real hospital conditions

test procedure independent of different flow profiles

consideration of flow interferences and heat sources (lamps, dummies)

simulation of external and internal particle penetration

reliable test procedure with a minimum effort

© 2010 Topas GmbH

 Hospital validation

validation measurements according to DIN 1946-4

definition and determination of a protection factor
simulation of external and internal particle penetration
Reference surgery room: 10m², 0,3m/s laminar air flow

particle source particle measurement

© 2010 Topas GmbH
 Hospital validation

validation measurements according to DIN 1946-4

simulation of a constant “particle background” from a constant particle penetration

particle production rate: constantly generated during the whole test procedure
Q c 
V  c  A  v  6,3 109 P/min
Ref Aerosol Aerosol Ref Ref Ref

protection factor: determination at 3 positions, minimum value

cX
SG X  log cX: average concentration at measuring position
c Ref cRef: reference concentration 35,3E6 P/m³ (1E6 P/ft³)

SG > 5: excellent protection

SG  0: laminar flow not working properly

SG < 0: external particle contamination, e.g. from the ventilation

requirements on class Ia surgery room:

SG > 4: without lamps
SG > 2: with lamps

© 2010 Topas GmbH

 Hospital validation

validation measurements according to DIN 1946-4

general requirements
high primary air flow rate
homogeneous distribution to six aerosol ejector positions
reliable particle production rate, monitored continuously by a particle counter

required test equipment

aerosol generator
particle counter
aerosol distribution system
aerosol dilution system for monitoring
particle production rate

© 2010 Topas GmbH

 Hospital validation

required test equipment

Aerosol Generator ATM 226 Particle Counter LAP 340

atomizer aerosol generator clean room particle counter
adjustable particle production rate PC interface
designed for mobile use designed for mobile use
designed for clean room applications

Air flow rate 0 ... 300 l/h Flow rate 1 cfm / 28,3 lpm
DEHS mass flow 0 … 2.5 g/h Measuring range 0,3 … 10 µm
Particle output > 108 P/cm³ Size channels 16
Reservoir for test liquid 80 ml Max. concentration 35 P/cm³
Maximum counter pressure 0.2 bar Measuring time 1 s … 99 h
Measuring modes single, continuous
© 2010 Topas GmbH
 Hospital validation

required test equipment

Aerosol Distribution and Dilution System ADD 536

new patented Topas development
Topas ADD 536
blower unit: Aerosolverteil- und
Verdünnungssystem
filtered air for adequate aerosol outlet feeding
Aerosol-
continuous flow rate measurement outlet 4 5 6
auslass 1 2 3

aerosol mixing
aerosol generator + filtered air
dilution
Verdünnung particle
Partikelzähler
100k counter
aerosol distribution
homogeneous to 6 aerosol outlets Aerosol-
distribution
verteiler
laminar flow conditions
Misch- Aerosolgenerator
aerosol generator
mixing
aerosol dilution kammer

sampling from the distributor

Volumen-
adjustable dilution ratio up to 1:100.000 flow rate
strom- blower
Gebläse-
measurement
messung Filtereinheit
unit
direct connection of a particle counter
continuous monitoring of particle
production rate Steuerung/Bedieninterface
control interface

© 2010 Topas GmbH

 Hospital validation

required test equipment

Aerosol Distribution and Dilution System ADD 536

aerosol outlet
aerosol penetration of the test environment
simulation of real particle flow profiles within a surgery room
isothermal flow profile: no heat convection effects
laminar flow profile: no impulse kinetic effects

room flow profile

ca. 0,3 m/s

kinetic
energy
9:1
aerosol outlet v2
Ekin  m 
0,1 m/s 2

no influence of the existing flow profile from the test aerosol penetration

© 2010 Topas GmbH

 Hospital validation

required test equipment

Aerosol Distribution and Dilution System ADD 536

open dilution closed dilution

filtered air flow flow rate given by the particle counter
aerosol injection no additional air flow
sampling for analysis 1. flow: Capillary with controlled Dp
(-) Dp dependency 2. flow: HEPA filter
(-) high external air flow required (-) continuous Dp regulation required
(-) high external diluted aerosol flow resulting (-) continuous HEPA filter loading

(-) limited one-step dilution ratio

(-) dilution ratio fixed to a certain particle counter flow rate

combination of both principles

high single-step dilution ratio
adjustable dilution ratio and flow rate depending
on the connected particle counter
© 2010 Topas GmbH
 Hospital validation

required test equipment

Aerosol Distribution and Dilution System ADD 536

homogeneous aerosol distribution

continuous monitoring of the particle production rate

designed for mobile use

dilution ratio adjustable to the particle counter

Default setting: 1:100.000
flow rate up to 28,3 l/min
particle counter
flow rate up to 5 l/min
aerosol generator
filtered air flow >100 l/min

aerosol outlet 6 Stück, Ø 65mm

tubing to the outlet 6 x 4m

power supply 230 V AC, 100 W

dimensions 250 x 340 x 330 mm
(B x T x H)
weight 8,5 kg

© 2010 Topas GmbH

 Hospital validation

validation of the test equipment

adjustable dilution of the primary aerosol concentration from the connected aerosol generator
adjustment to the coincidence concentration of the connected particle counter

counting rate of a particle counter at different

dilution ratios (x1000) of the ADD 536
counting rate [#/cf]

time [s]

© 2010 Topas GmbH

 Hospital validation

validation of the test equipment

no effect of the chosen dilution ratio to the measured particle size distribution
no particle deposition, no agglomeration = basic requirements for a test aerosol

Particle size distribution (DEHS) after dilution by the ADD 536 (V=10.000 to
500.000) compared to a cascaded dilution system (V=100.000)
relative frequency

Reference:
closed dilution system, cascaded
2x 1:100 + 1x 1:10
particle size [µm]

© 2010 Topas GmbH

 Hospital validation

test procedure

placing and connecting the instruments

placing the aerosol outlets

starting up the instruments

setting up the reference particle production

rate at the aerosol generator

particle measurement at 3 positions

within the protective area

determination of the protection factor

(1) aerosol generator

(2) aerosol distribution and dilution system
(3) aerosol outlet
(4) particle measurement

© 2010 Topas GmbH

 Hospital validation

test software CREWin

designed to perform test strictly according to DIN 1946-4
guides the operator step by step through a validation measurement

particle source

particle measurement

visualization of the measurement setup

data acquisition + documentation

© 2010 Topas GmbH

 Hospital validation

test software CREWin

application of different aerosol generator and particle counter models
fully automated data acquisition and test protocol generation

© 2010 Topas GmbH

working steps

adjustment of the particle production rate at the aerosol generator

© 2010 Topas GmbH
 Hospital validation

test software CREWin

complete documentation of all test results
particle production rate for each single measurement
protection factor for each single measurement, average and minimum values

© 2010 Topas GmbH

validation
protocol

© 2010 Topas GmbH

 Hospital validation

further potential applications for the ADD 536 system

validation of aerosol generators
start-up behavior, working range depending on parameter settings, long-term stability
reduced experimental setup, mobile use

14

13
x106 [#/min]

test duct 12

11 ADD 536
6
rate x10

10
production rate

aerosol dilution
9
generator aerosol
P artikelproduktions

8 particle
generator
dilution counter
7

6
particle

particle 5
counter
4

3
0 5 10 15 20 25 30 35 40 45 50 start-up of two aerosol generators
Z eit [min]
time [min] dilution ratio 1:100.000

© 2010 Topas GmbH

 Hospital validation

further potential applications for the ADD 536 system

validation/calibration of determination of the coincidence

dilution systems concentration of particle counters

ADD 536 ADD 536

1:10.000 … 1:500.000 1:10.000 … 1:500.000

dilution system dilution system

1:10 / 1:100 1:10

aerosol aerosol
Particle particle
generator generator
counter counter

adjustable dilution ratio to perform particle
counter measurements with/without the dilution
system under test
gradual reduction of the dilution ratio at the ADD 536
calculation of primary aerosol concentration
comparison with an additionally diluted aerosol

reduced experimental setup without any test duct, suitable for mobile use
no different aerosol generators or dilution systems required

© 2010 Topas GmbH