Client's Requirements Analysis

Version: June 17 / 06

Name of the company:

...Name of the contact person:

Address: City:

Zip Code:

Street and House no.:

Post Office Box:

Building:

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Phone:

Sequip has made the experience that we can save our clients a non negligible amount of cost and time if we get as much answers as possible for the accompaning circumstances of your future application / implementation of Sequip in situ systems for PAT, under your special conditions.

More than 4000 different products have already been measured successfully by Sequip for our customers!

In order to ease up the assessment of our questionnair we divided it into 5 sections in which the different questions are classified. These are:

  • Motive driven aspects
  • Applicational aspects
  • Sensor depending aspects
  • Electronics and software depending aspects
  • Special requests

Section 1

What are your main objectivesbecause an inline / in situ particle system size measurement is considered…

1.

2.

3.

4.

5.

What are your main expectations ofan inline / in situ particle system size measurement…

1.

2.

3.

4.

5.

*Some of the questions may appear repeatedly in different sections. This is due to ..their correlation to the topic of the corresponding section.

1.1 What objective is to be achieved with
the measurement?
1.2 What is your biggest interest: to
detect fine - middle or coarse
fraction shifts?
1.3 What do you consider as the
absolute necessary resolution?
1.4 What is the really necessary min/max
dynamic measuring range
1.5 How many months do you expect
should remain between two
maintenance intervals?
1.6 What is the targeted date of
installation of the measurement
system
1.7 Would it be interesting to you to
reduce the price by a delivery time
extension?

Section 2

2. 1 What product/material is planned to
be measured?
2. 2 For granulates and/or dry
dispersions: how much residual
moisture is left inside %?
2. 3 What are the colors of the carrying
and the disperse phase?
2. 4 What is the color/opacity of the
particles:
under dry condition
dispersed in liquid
2. 5Are the particles visible under the
microscope in dry and/or wet
condition?
2. 6Are there air bubbles under
measuring condition? If yes, what
could be the approximate size?
(direct influence on the reflective behavior of the
laser beam - possibility to filter out)
2. 7Is the measurement intended for
batch or continuous process?
2. 8What is the relation of fine to
coarse material in %ige?
2. 9What is the relative/absolute portion
of fine particles of <100nm size in
%ige
2.10 What is the really necessary
min/maxdynamic measuring
range?
2.11On how many mounting points
would you like to perform in situ
measurement:
simultaneously during one
measurement lapse of time?
as a total for the complete
project?
2.12 After how many seconds/minutes/
hours do you need a new re-
freshed measurement update?
2.13 How long do you consider one
measurement cycle to continue?
2.14 What number of different particulate
elements (droplets, needles, cubes,
spheres, algues, bacteria’s, etc.)
does the formulation contain you
would like to be measured?
2.15 What are (is) the dimension(s) or
volume of the reactor/pipeline

Section 3

3. 1 Are the particles visible under the
microscope in dry and/or wet
condition?
3. 2 Are the droplets visible under the
microscope?
3. 3 How do the particles look like: ie.
spherical, longish, cubic, cone-
shaped, needle-like or different?
(important for determination of length, surface and/or
volume weighting)
3. 4 Do you already have pictures taken
of a. m. particles/droplets; either
with microscopic and/or in situ video
examination / measurement?
3. 5 In case your answer to 3.4 is yes: is
is it possible to make those pictures
confidentially available to Sequip?
3. 6What are the approximate sizes of
the particles/droplets?
3. 7 Do the particles tend to build
soft or rigid agglomerates
during the process?
3. 8What is the x.y.z. ratio of one single
particle of your agglomerated
structure
3. 9What are the min/max sizes of the
particles/droplets/agglomerates?
3.10At what temperatures is your
product/suspension/powder
/emulsion to be measured?
3.11At what process pressure will be
measured?
3.12What is the safety pressure value
for the pipeline/reactor? Please
specify if possible into:
Inspection . .
Continuous .
Max. admissible..
Vacuum
Is the pressure static or dynamic?
3.13Which certificates (pressure) need
to befulfilled in case?
3.14To what "g" force(s) will the
reactor/pipeline be exposed?
3.15Is the exposure by vibration or
shockwave?
3.16What is the pH value of the medium
to be measured?
3.17Do you consider necessary any
special raw materials for the
construction of the medium touched
side of the sensor?
3.18Is the medium possibly conductive
or causing electrostatic charges at
any times?
3.19Is ATEX protection of the sensor
necessary? Please also refer to
item no. 4.9 up to 4.15
3.20Which sensor materials are
specified by your engineers for:
Sealings and O-rings
Outside sensor protection
inside pipeline and/or reactor
3.21 Do you intend to install the
measurement system at your site
or somewhere else?
In case the system will NOT remain
at your site: which would be the
address of the intended place of
mount?

Section 4

4. 1 What are the properties of the
particles (if known): ie. smooth,
coarse, structured, rippled, porous
etc.(regards the back reflective behavior of the laser
beam)
4. 2 What is the specific weight of the
particles?
4. 3 Are there specified measuring time
cycles indicated? If yes
4. 4 After what period of time do you
need an updated distribution?
4. 5 What measuring time cycles fit best
for a process control engineering?
4. 6 What is your analytical objective for
the particle/droplet measurement?
length diameter, surface
(decrease/increase), fractions, pre
set measuring range, "D"-value?
4. 7At what ambient temperatures
is the electronic box going to be
exposed?
4. 8 Which certificates need to be
fulfilled in case?
4. 9 Do you need QM according to FDA
Title 21 CFR Part 11?
4.10 Do you need a GMP certificate?
4.11 Do you need validation of
manufacturing according to ISO ?
4.12 Do you need calibration of the
appliance according to ISO 9001?
4.13 Special other/supplementary safety
requirements of your company?
4.14 Does the electronic box need
certified ATEX/ULprotection?
4.15 Does the sensor need certified
ATEX/ULprotection?
4.16 At what velocity in m/sec do the
particles or droplets move inside the
medium?
4.17What is the density in vol. % and/or
weight % or thedistance of the
particles/droplets toeach other in
µm inside the medium?
4.18What is the viscosity in mPas of the
medium?
4.19What is the size range of possible
air bubbles during the measurement
process?
4.20Is the measurement intended in
batch or continuous process?

Section 5

5.1 Do you consider special security
features regarding the
measurement?
5.2 How many installation points do you
like to perform:
5.3 Comments/Suggestions: