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maintenance

the magazine for all instrument users

Sanofi-aventis:
The story of
a long-term
partnership

today
Issue 4 06/2009

IFS 5.0:
Are you ready?

Energy monitoring
Counting the cost of steam

How to draw a
metrological plan

Maintenance publications
issued recently
The Maintenance Guide - new release: this manual is the reference
text for your production, metrology and maintenance teams. Its
content has been updated and the new issue is available from
07/2009. Keep a copy on your desk all year round!
Maintenance Actions is a handy collection of information sheets
dealing with a specific subject of direct relevance to your day-today operations. Each sheet gives you option for immediate action.
We publish several sheets each year.
Recent issues:
Need a quick repair time?
We can work on this together (03/2009)
International Food Standard 5.0 Passing the audit with process instrumentation (06/2009)

the magazine for all instrument users

In this issue:

p. 4

Energy monitoring - Counting the cost of steam

p. 7

Efficacy and confidence: the pillars of our


long-term relationship with Sanofi-aventis

p. 9

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How to draw up a metrological plan

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p. 3

The Main

IFS 5.0 - are you ready?

ated

2009 Upd

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Trends, solutions, shared experiences


Everything you need to get the best
out of your installed base!

+Hauser

p. 11

Endress

Revitalize your installed base

tions
ce Guid

Find all these documents


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www.products.endress.com/maintenance_publications

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Maintenance Today - Issue 4 - 06/09

IFS 5.0 - Are you ready?


Version 5.0 of the International Food Standard
(IFS) has numerous consequences for installed
instrumentation, the associated documentation and
the metrology. Which concrete actions shall now
implement agrofood companies?

Following the example of the life sciences industries,


the process instrumentation must now be given periodic
checks and calibrations. To be compliant, the agrofood
company must first clearly identify the measuring and
monitoring devices required to ensure compliance with
product requirements and record them on a document.

More and more distributors now require food


tranformation companies to comply with the last
version (5.0) of the IFS - which now includes particular
requirements regarding process instrumentation.

Check and calibration of the instrumentation


In a second step, all these measuring devices shall
be checked under a monitoring system at specified
intervals in accordance with defined standards/
methods. The results of the checks shall be documented
and corrective actions carried out, where necessary.

The first point directly concerns the selection of the


instrumentation. Devices that are in contact with
the product shall be suitably designed and specified
for an hygienic use, as for the life sciences industry.
Before commissioning, it shall be verified that the
instrumentation fits for its defined purpose.
Implementing a monitoring plan
Once in operation, the measurement instrumentation
must be periodically monitored in accordance with
a predefined plan. Scope and frequency of the audits
shall be determined by risk analysis. Anyway, internal
audits shall be carried out at least once a year in
all departments. Any deviation and the associated
corrective actions shall be documented.
In circumstances where the control of process and
working environment parameters (temperature, time,
pressure, chemical properties etc.) is essential to ensure
the product requirements, such parameters must
be monitored and recorded continuously and/or at
appropriate intervals.

Maintenance Today - Issue 4 - 06/09

The calibration status of the measuring devices shall


be clearly identified (by means of a labelling at the
machine or on a list of test devices).
Finally, it should be noted that any analyze that
would be important for the food safety - calibration
in particular - must be conducted by an ISO 17025
accredited laboratory.
For the past year we have supported IFS
managers from several companies to draw up
a process instrumentation monitoring plan,
implement the appropriate solutions and thus
pass the IFS audit. Keen to know more? Attached
to this magazine, you will find a flyer that gives
further information.

International
Food Standard
Substituting to version 4.0
from January 2008,
the IFS 5.0 includes no
more recommendations,
but only requirements.
Six new KO criteria have
been added to the four
existing ones.
This version includes
the new requirements
of the Global Food
Safety Initiative
(GFSI) Guidance
Document Version 5.
Thus IFS reaches its
objective of meeting
all internationally
harmonized
requirements, and to be
a worlwide recognized
reference for food quality
and safety.
At the end of October
2007, 7300 companies
were IFS certified
throughout the world.

How to draw up
a metrological plan

The last two articles


in the Maintenance
Today illustrated
the beneficial role of
metrology in terms
of ensuring optimum
functioning of the
production process.
Implementing a
metrological plan can
even help production
companies to increase
profit. Providing,
of course, that a
methodological
approach is adopted

Many companies are now in the habit of


calibrating their instruments once a year,
although there is perhaps no need to pay the
same degree of attention to every measuring
point. In many cases, it is sufficient to focus
on the instruments that play a critical role.
Marianne Hatterer, you are in
charge of developing services at the
Endress+Hauser Group, and have
helped your clients to implement a
metrological plan on many occasions.
What are the factors to bear in mind
when defining which measuring
points to include?
To start out on the best basis, you should
begin by noting every measuring instrument
on the plant. Identify and make a list of all
the equipment parts and all the instrumentrelated systems. This list should also
include details such as a description, local
information, working range and history,
and any other points that provide a better
understanding of the parts function.
The first stage in any analysis of the data
gathered is to identify which instruments
are critical to the application, the
production environment and operator
safety. This calls for teamwork. We
will set up a meeting with the Head of
Metrology (or Quality, depending on the
case), the Head of Production - who has
in-depth knowledge of the process and
the related instruments - and the Head of
Maintenance. Besides generally being the
person in charge of calibration, the Head of
Maintenance will also be able to contribute
what they know about the process
environment, the condition of the installed
instruments, the type of maintenance work
carried out and, finally, any limitations
imposed by the plant in terms of servicing.

Marianne Hatterer
using Endress+Hausers
calibration and
maintenance mangement
software CompuCal

Maintenance Today - Issue 4 - 06/09

Four categories of critical importance


Instruments should be classified according to one
of the four categories of critical importance below:
Instruments critical for the product:
instruments that, if defective, may have a direct
impact on product quality
Instruments critical for the process/
system: instruments that, if defective,
may have a direct impact on process or system
performance, without affecting the quality of
the final product, or safety
Instruments critical for safety /the
environment: instruments that, if defective,
may have a direct impact on operator safety, or
the environment
Non-critical instruments: instruments
that, if defective, are thought not to have any
impact on product quality, process or system
performance, safety or the environment.

With this working group, we will start from


the finished product - and the tolerance
permitted in relation to its quality - and
go back through the various stages in
the production process. At each stage,
we will look at the instruments in place
and ask ourselves: Does this instrument
impact on the quality of the product (or
any intermediary product), on process
functioning or on operator safety?
Why start with the finished product?
Users frequently define Maximum
Permissible Errors (MPE) on the basis
of the instruments they purchase, when
what should be most important are the
application specifications in relation to the
quality of the finished product. Tolerances
at all levels of the process should be
defined in relation to desired results. In the
context of instrumentation, MPEs express
defined tolerances for the function being
monitored. Taking it a step further, MPEs
should provide a basis for deciding what
instruments to install, not vice versa!

Maintenance Today - Issue 4 - 06/09

Lets take a simple example to illustrate this


thinking: a good biscuit should be cooked
to just the right degree, be tasty and the
right size. The first thing to look at, then,
is the cooking phase and the parameters
impacting on the result: essentially cooking
time and oven temperature in this case. The
next stage is to try to identify the elements
likely to influence the quality of the pastry,
e.g. quality and quantity of ingredients and
adherence to the recipe instructions.
The relative importance of some of these
parameters will help identify measuring
points that merit particular attention in
relation to metrology. Having defined
parameters in terms of their importance
for the product, this step is repeated with
regard to the process, and then with regard
to operator safety. On completion of this
first stage of analysis, the working group
will have compiled a list of instruments
ranked in order of critical importance, i.e.
high, average, low, and a list of noncritical instruments.
The primary benefit of this work?
Instruments classified as non-critical do
not require any metrological monitoring
in particular, hence there is no need to
continue periodic calibration. As long as
the user can prove to the auditor that these
instruments have no impact whatsoever on
the quality of the finished product, they are
entirely at liberty to decide they no longer
require calibration.
In many cases, the second benefit is a
reappraisal of the choice of instruments in
the context of the application. A Ferrari is
not the ideal car for an uphill race, and may
even cause lots of problems. The same goes
for the instruments you employ.
How to define the calibration frequency
of instruments deemed critical?
The ideal calibration frequency should
be just what it takes to guarantee the
instrument specifications in the context of
the production process. To achieve that,
we will consider both the factors in favor of
frequent calibration and those against it.

The key factor, of course, is the desired


measuring precision which is closely
linked to the Maximum Permissible Error
tolerated in order to guarantee the quality
of the final product. But decisions will
also be influenced by the varying nature
or condition of the product in contact
with the instrument, the continuity (or
discontinuity) of the process, the relative
severity of the ambient conditions or
the presence of CIP (Cleaning in Place).
Similarly, considerations such as whether
the instrument is used continuously or at
intervals, time available for calibration,
ease of disassembly and possibility of
on-site calibration will also influence
calibration plans. And an analysis of
calibration history will obviously allow
frequency to be adjusted in relation to any
non-conformities that are identified.
A final parameter to consider when
deciding whether to reduce the frequency
of calibration is the risk associated with an
excessively long period without calibration.
It is useful at this point to remember that
the purpose of calibration is to certify the
quality of the products that have already
been manufactured, not of those yet to be
manufactured. Will non-conformities be
detected if the instrument is not calibrated
for a certain time? Will the production
operator, wanting to compensate for a
production non-conformity, add too much
raw material or modify the process, thereby
causing additional costs? This is why the
interval between two calibrations rarely
exceeds two or three years in the case of
critical apparatus.

Why do companies tend to opt for


a one-year interval?
It must be something to do with a natural
biological rhythm that suits everyone, more
or less, auditors included! Because there
is no mention of one-year intervals in any
regulations. The only stipulation is that the
calibration interval must be determined
as a function of statistical factors. And as
auditors are not necessarily calibration
specialists, no one will ask any questions if
you calibrate once a year. But if you opt for
a longer interval, you will need arguments
in support of your decision.
Despite being the usual practice, one-year
intervals are not necessarily a good thing.
Whereas a flowmeter can go for two
or even three years without calibration
(depending on the application), a year
is generally too long in the life of a pH
measuring device.
What can Endress+Hauser do
for companies with a metrology
department?
As an instrument manufacturer, we apply
our measuring systems know-how to our
clients application conditions. And we have
tools to implement, in the initial phase,
our method for drawing up a metrological
plan, then for implementing the plan itself.
We help our customers achieve dynamic
management of their installed instruments,
i.e. we ensure they are capable of planning,
triggering and documenting maintenance
and calibration operations.

Endress+Hauser software solutions


to serve metrological activities
CompuCal is a high performance system
to efficiently maintain and calibrate your on-site
instrumentation
www.endress.com/urlurlurl
W@M - Life Cycle management is an open
and flexible information platform with on-site
tools and services supporting you along the life
cycle.
www.endress.com/urlurlurl

At the operational level, we bring our


skills, mobile equipment and accredited
laboratories to bear in carrying out
calibration work in combination with
customers own resources.
Finally, our contribution helps the Head of
Metrology to emphasis the importance of
process optimization to their team. For in
many cases, metrology is still perceived as
a burden, even if those in the life sciences
or the agroalimentary industry are more
aware than others of its benefits in terms
of process control. And with the current
context making it more necessary than ever
to economize raw materials, energy and
water, an ever-growing number of industry
practitioners now have a better appreciation
of the role of metrology in cost control.

In the next issue:


Laboratory or on-site calibration?

Inventory of critical devices


in a pharmaceutical plant

Maintenance Today - Issue 4 - 06/09

Image courtesy of Byworth Boilers

Energy monitoring

Counting the cost of steam


Endress+Hauser combines high
quality measurement with unique
tools and services to guarantee a
precise and sustainable calculation
of steam usage this is the first such
solution of its kind in the world.
Due to the environmental and economic
issues, focus is shifting more and more
to energy measurement, balancing and
invoicing. This applies in particular to
steam. But up to now, there has been no
solution that, for example, allows steam to
be measured in a verifiable manner.
An unstable medium
Steam is not subject to legal metrology
controls since it is an unstable medium
and cannot be traceably calibrated using a
weighing scale. In other words, there are
no clearly defined requirements according
to the verification ordinance that stipulate
measurement technology, accuracy,
maintenance intervals etc.
Therefore, when it comes to balancing
and invoicing, disagreements are almost

inevitable. For this reason, steam consumers


are calling more and more for a verifiable
method of invoicing steam, which is
acceptable to both steam producers and
consumers. Operators of steam generators
are required by the conditions of emissions
trading to balance the steam quantities
produced in a clean and verifiable manner.
Inaccuracy is the main issue
To calculate the steam mass flow rate,
pressure, temperature and flow are
measured. Three sensors are therefore
needed, each of which will have an
inherent inaccuracy. This makes it difficult
to predict the total system uncertainty
under operating conditions. This is
important, for example, in the auxiliary
circuits in chemical parks, which were
designed many decades ago to allow for
high throughput and high rates of flow.
Nowadays these circuits are often operated
at the very low end of their operating
range, which is completely different to
the original design operating point. This
can have a huge impact on the total
performance of the measuring point, with

unaccounted steam usage amounting to


several thousands of euros per month.
An aggravating factor is that the steam
producer must remove the measurement
technology used in order to either upgrade
equipment or calibrate the components.
This results in downtime and additional
costs. Up to now, there has been no
measurement technology that facilitates
inline testing.
This is unique: Endress+Hauser now
provides its customers with a convenient
all-round package for verifiable steam
invoicing. It consists of four parts:
1) Application-optimized
measurement technology
Flow measurement using the principle of
vortex shedding is ideal for the reliable
and long-term stable measurement of
volume flow in steam applications. This
robust measuring principle is widely
accepted. In addition to tried and tested
measurement technology for pressure,
temperature and flow, an external energy

Maintenance Today - Issue 4 - 06/09

Three sensors provide an energy manager with flow, temperature and pressure - just the right combination of high
quality instruments! The RMS621/RMC621 energy manager calculates the quantity of gases, liquids and water vapor
consumed.

With Fieldcheck, flowmeters are monitored while they


are installed, without any disruption to the process.

monitoring system from Endress+Hauser


calculates the quantity of steam consumed.
The cost-saving complete solution is
universally applicable.

their steam customers. The customers were


querying the measurement technology
and the measuring solution. The invoiced
amounts were allegedly much too high.
With Endress+Hausers solution, they were
able to prove using traceable standards
that the measurements were correct.
The feedback confirmed that the solution
deals effectively with all of the points
necessary to verify optimum performance,
starting with the measurement, including
uncertainty calculation and regular testing
during operation.

2) Real-life calculation of
total accuracy for the entire
measuring point
Endress+Hauser has now made it
possible to calculate the maximum total
uncertainty under process conditions,
i.e. even in unfavourable operating
conditions which, experience has shown,
result in maximum measured errors. This
calculation takes into account all the
factors relevant to the process that can
influence the measurement error of the
steam measuring point.
Using our solution, the user receives
a traceable calculation of the overall
performance, of the steam measuring
point, taking current operating conditions
into account.
3) On-site calibration to guarantee
verifiable measurement results
All Endress+Hauser sensors are
calibrated prior to delivery using
accredited calibration rigs. We are also an
independent calibration partner, accredited
in accordance with ISO/IEC 17025 for
providing onsite calibration services for
flow, pressure and temperature. To ensure
that the theoretically calculated accuracy
of the entire measuring point can also be
verified on a practical level, we provide a
continuous, on-site calibration solution for
sustained testing of steam systems.
Each component can be tested by carrying
out individual calibrations using traceable
calibration instruments. In line calibration

for the flowmeter can be facilitated by


short-term operation in a bypass. For
pressure and temperature measuring
devices and for the external calculator,
traceable calibration instruments are used.
The onsite calibrations are carried out
by trained and certified calibration
technicians in accordance with SOP
(Standard Operating Procedures).
Calibration logs provide the user with
continuous verification of the calibration
results and, for the first time, with a
statement of the real total accuracy of the
measuring point.
4) Verification without removing the
measuring device
We also offer our FieldCheck test and
verification tool. This monitors and
verifies Endress+Hauser flowmeters while
they are installed, without any disruption
to the process. This solution is the first
of its kind to enable inline verification
directly during operation - a huge
advantage for steam producers.
What makes our solution stand out from
the rest? As far as the measurement
technology itself is concerned, all suppliers
are fundamentally similar. However,
we believe that only Endress+Hauser
is currently in a position to carry out a
traceable calibration and process checks.
Most importantly, as an accredited
calibration service provider with verifiable
on-site calibration, we are well ahead of
the game.

Everyones desire is to pay only


for what they get without ongoing
discussions on steam balancing and
invoices. Endress+Hauser can help.

A relevant contribution
to energy monitoring
The biggest part of the energy involved
in the process of a brewery is for steam
production. The measurement concept
has immediately convinced us. And
thanks to Endress+Hausers calibration
service, the precision of the measured
values and the process safety are now
proven and ensure the permanent
efficiency of our energy monitoring.
Hartmut Sturhann, Energy Manager,
Beck & Co brewery, Bremen (Germany)

For further information:


contact us at 00 xx xx xx xx

Tangible results
Endress+Hauser was requested by a well
known energy supplier to assist in finding
a solution to avoid regular discussions with

Maintenance Today - Issue 4 - 06/09

Efficacy and confidence: the pillars of our


long-term relationship with Sanofi-aventis
At the Montpellier (France) research and development
site, Sanofi-aventis decided several years ago to outsource
metrological operations in order to concentrate on
its core businesses and activities. Endress+Hauser
suggested and supplied exactly the right services to
meet Sanofi-aventis expectations.

Regulatory requirements (laboratory controls, on-site inspections),


uncompromising health specifications and business goals all
impose the highest standards of vigilance and monitoring at all
stages of the drug manufacturing process. All drugs marketed
by Sanofi-aventis must be manufactured in line with both the
European and American pharmacopoeias. The company also has
to prove the conformity of its metrological operations with the
ISO 17025 standard.
At the Montpellier site, Sanofi-aventis decided to outsource
metrological operations in order to concentrate on its core
businesses and activities - whilst still of course retaining
responsibility for, and management of, these activities.
Keen to entrust this metrology and quality-related work to a
reliable external company specializing in the pharmaceutical
industry, Sanofi-aventis chose Endress+Hauser.
For Yvon Sales and Jean-Pierre Montseny, Manager and Deputy
Manager of the Metrology Department, choosing the right service
provider was all-important. They explain how, in time, a service
provider becomes a real partner: Everyone involved must be
perfectly acquainted with the specific requirements (GMP, GLP,

The third-largest pharmaceutical Group worldwide,


Sano-aventis has one of its biggest research and
development sites in Montpellier (France). The
Montpellier site, which employs 1800 people, covers
every stage in the research and development cycle: from
understanding illnesses and their biological foundations
right through to launching new drugs.

Maintenance Today - Issue 4 - 06/09

GCP) of the pharmaceutical industry. As far as metrology is


concerned, COFRAC accreditation for the relevant parameters
is a prerequisite. After that, we attach great importance to the
expertise and dependability we can expect from Endress+Hauser
metrologists. Their experience and intimate knowledge of both our
equipment and our site ensures maximum reactivity: they have
become almost part of our company. Last, but not least, we require
autonomy and flexibility. For example, the plant scheduled for
attention may not always be available as planned, so engineers have
to be able to adapt and work on something else instead.
Providing real support to the metrological team
The story began in 1993: The very first metrology contract focused
on implementing processes and on training operators working on
the pilot project (chemical development, micro-production).
In 1995, Endress+Hauser was involved in implementing Sanofiaventis metrology processes and operations from the day the
Metrology Department was set up, which allowed the two
companies to move forward in the same direction.
Over the years, further contracts were signed for numerous areas
of the site. Each year, Sanofi-aventis draws up a metrology plan
for Endress+Hauser, thereby providing long-term transparency in
relation to work carried out by engineers on the site.
Services provided by Endress+Hauser
Three Endress+Hauser engineers are available to Sanofi-aventis
to work on over 1000 instruments: in addition to dealing
with emergencies and technical problems, they also carry out
cartography (OQ/PQ), check laboratory equipment (ovens, heating
chambers, environmental test chambers, incubators, autoclaves),
processes and reference standards (temperature, hygrometry,
electricity). Endress+Hauser takes care of critical operations where
all risk of error has to be completely ruled out.
All metrology operations are now 100% under control. Thanks
to the certificates guaranteeing the traceability required during
inspections, Sanofi-aventis knows it is well prepared for audits!
The focus is now on optimizing processes and calibration
intervals in order to avoid needlessly excessive attention to
quality. Looking at the bigger picture, Endress+Hausers task
is to streamline the field metrology by adapting it to new
internal and external requirements - which we can sum up as
continuing to develop together.

Yvon Sales,
Head of Metrology

10

Endress+Hauser has made qualified metrological engineers available to


us on a permanent basis, which is very important for us, acknowledge
Yvon Sales and Jean-Pierre Montseny. And the fact that these engineers
are familiar with our site is a huge advantage: it means we can ask them
to handle problems related to critical operations. The engineers are always
with us swiftly in an emergency or if we have technical problems, and never
get in the way of any of the other site operations. Endress+Hausers prompt
response is much appreciated: having a service provider nearby means we
can be more flexible in our daily organization. We are very satisfied with
the relationship of confidence that has been established and we recommend
Endress+Hauser to other companies without hesitation.

Jean-Pierre Montseny,
Assistant Head
of Metrology

Maintenance Today - Issue 4 - 06/09

Revitalize your installed base

Ever conscious of our commitment to anticipating your


needs and to bringing you all the benefits of state-of-the-art
technology, Endress+Hauser attaches great importance to
on-going development of its instrument range and continuous
support of your installed base.

Withdrawn product

Promass 80/83 M

Type of product

Mass flowmeter

Date of discontinuation

12/2009

Successor

Depends on the application:

Successor advantages

Are you affected by the upcoming discontinuation of any of


these products (see adjacent)? We can help you decide on
the best solution for you.

Promass 80/83F
Promass 80/83I
Promass 80/83S
CNGmass

Mechanical compatibility *

No

Functional compatibility *

* = Please contact us
= Full compatibility
= Partial compatibility
= No compatibility

Promass 84M

Soliphant FTM260

11500Z/11500ZM

Deltapilot S DB50/DB50x

Mass flowmeter

Level measurement for solids

Capacitance HT probe

Hydrostatic pressure measurement

12/2010

12/2008

12/2008

12/2009

Depends on the application:

FTM20/21

FMP45/FTL71

FMB70

Promass 84F
Promass 84I
Promass 84S
CNGmass

Cost reduction
Fit for higher grain sizes

Robustness
Easy to install

Increased precision

No

Yes

Yes

Yes

Yes

Deltatop/set DPX1X/DPX5XD

TMT184

RIA250

Pressure sensors

Temperature transmitter

Process display

09/2008

03/2009

10/2009

Deltatop DOXX/DPXX

TMT84

RIA45

Compact version
Additional features

Dual sensor input


Advanced diagnostics functions
Increased precision

Dual input
Linearization and Differential functions
Min and max values storage

Yes

Yes

Yes

Yes

Yes

Yes

Maintenance Today - Issue 4 - 06/09

Our phase out policy


Endress+Hauser are
committed to the long term
support of all our products.
We undertake to support and
service our products for a
period of ten years after notice
of product withdrawal.
This covers where possible
availability of spare parts.
However we reserve the right
to propose alternative solutions
including replacement products,
if deemed appropriate.

11

New products
New product

Deltabar M PMD55

RIA46

Type of product

Differential pressure sensor

Field digital display

Recorder

Launch date

05/2009

07/2009

xx/2009

Advantages
For further information
please call: 03 89 xx xx xx

Compact version
EExd
Local configuration
Integrated Flow-level-pressure function

Identical to RIA45 + field box

Memograph M

High quality TFT display


256 MB internal memory for data storage
(enough for 3 years)
special software for batch management
remote alarm

Need to check the status of your products?


New Device Viewer

Promag 10/50D

Liquiphant density

Electromagnetic flowmeter

Density measurement

09/2009
DN25, 40, 50, 80
Completes the Promag range

Q4/2008
Density measurement with Liquiphant M
and FML621 controller for temperature
compensation
FML platform can handle 5 measurement
points
High accuracy and repeatability

Micropilot M FMR244

ISE electrodes

Level radar for solids

For ammonium and nitrate

Q4/2008
New HF module (+35 dB) specially
designed for the measurement on solids
New advanced dynamic software

Q4/2008
Combined electrode
New technology allowing the monitoring
of ventilation basins in waste water treatment plants and thus energy savings

Part of the Life Cycle Management concept, the W@M


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12.06/I.I.

Instruments International
Endress+Hauser
Instruments International AG
Kaegenstrasse 2
4153 Reinach
Switzerland
Tel. +41 61 715 81 00
Fax +41 61 715 25 00
http://www.endress.com
info@ii.endress.com

CM 004H/29/ae/06.09
PF/INDD CS2