TQM at Rhône-Poulenc Rorer Weighing with complete confidence

On site
TQM at Rhône-Poulenc Rorer
Weighing with complete confidence
Rhône-Poulenc Rorer’s Le Trait works has ISO 9002 certification
and complies with GMP. It also meets the extremely rigorous
standard laid down by the American Food and Drug Administration (FDA). We went along to ask how weighing was helping them
to achieve this Total Quality objective.
Rhône-Poulenc Rorer’s Le Trait works
are situated near Rouen
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“We received advice from
METTLER TOLEDO on everything
from the purchase of the
weights used for inspection
In the Metrology laboratory, René
Ferquin showed us a full set of calibration weights. “We received advice from
METTLER TOLEDO on everything from
the purchase of the weights used for
inspection work to the methods
employed in carrying out that work.
Procedures for verifying and validating
the models had to be put in place and
the company did, obviously, offer us
guidance on the choice of equipment.
Our relationship developed into a partnership, in the true sense of the word,
and we are still very pleased about the
way this relationship has progressed.”
“The formulations that are
going for manufacture are made
up at the Weighing Centre”
The Weighing Centre is a clean area
which bears a striking resemblance to a
strong room. It is here that the starting
materials, either in powder or liquid
form, are unpacked and weighed, after
which staff get to work on making up
the formulation prior to re-packing.
In the Metrology Laboratory, there is a
whole range of METTLER TOLEDO Class E 2,
F1 and M1 weights and masses. There are
several balances that are used to carry out
checks on the masses used in our work.
René Ferquin
Metrology Manager
Rhône-Poulenc Rorer
Jean-Baptiste Brisson, the Manager in
charge of preparation work and of the
LOVENOX line, explained to us that
“weighing takes place twice: first in the
clean room then outside to check the
weight after re-packing.”
The METTLER TOLEDO balances are
connected to a terminal which ensures
that the formula can be traced back to
its source.
The Weighing Centre is in a
controlled-atmosphere area and
is equipped with a balance that
can weigh items of up to 60kg x
1g and one of 400g x 0,01g
balance. The same equipment is
used outside, but with the addition of a 4kg balance. All this
weighing equipment is linked to
the METTLER TOLEDO terminal.
“Soon, we will have software
that we will be able to use for
computer-aided formulation”
As part of its PRIZEM Project, the RhônePoulenc Rorer Group has developed new
software that will safeguard the formulation and provide a real-time total
stock overview.
The METTLER TOLEDO balances with
which the Le Trait works has already
been validated with these arrangements
in mind.
Jean-Baptiste Brisson added: “METTLER
TOLEDO balances can be wired up even
to the most highly-specialised dataprocessing systems.”
On site
tinuously on a GARVENS checkweigher.
subsidiary specialising in dynamic
weighing). This machine checks that
the two syringes are, in fact, present in
the box, along with the accompanying
leaflet. If the balance detects a problem,
the box is rejected from the production
line so that it can be checked manually.
The weighing assists in three stages in the fabrication line of Lovenox
“We inspect the bottles every
10 minutes”
Inspection procedures are exactly the
same, whether it is the clean production
area used for the manufacture of nasal
solutions or a sterile area used to
prepare collyria? “An operator takes
samples every 10 minutes. He then
carries out two checks. First, he verifies
the amount of torque required to unlock
the caps, then he weighs the liquid. For
the latter operation, the bottle is
weighed whilst full, then again once it
has been emptied, using a METTLER
TOLEDO balance, accurate to the nearest milligramme. The results are then
entered into batch records.” “We are
really looking forward to the arrival of
the SQC 14, which will enable us to
achieve optimum reliability in recording the results and will allow us to
dispense with paper altogether,” says
Lionel Quinton, the Pharmacist in
charge of aseptic allocation.
“The new LOVENOX production
lines consists of two sections,
each 38 metres long!”
In technological terms, the production
line for LOVENOX (an anti-thrombotic
product) really does break new ground,
since it allows syringes to be sterilised,
filled and sealed in a continuous operation, under insulated conditions in a
sterile environment. The packing line,
which features an integral three-stage
weighing facility, covers everything from
clarity inspection to palletisation.
Quantitative verification
Finally, the palleting machine packs the
boxes into cartons. The balance stores
the weight of the filled carton and the
check is carried out by means of differential verification, based on this nominal weight.
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Monitoring of filling
Once the syringes have been filled, the
linked up to a balance offering accuracy
to the nearest milligram, is used to carry
out a statistical check. The self-calibrating PR303M balance was chosen for the
excellent reliability and reproducibility
it offers.
Sorting and rejection of
‘non-standard’ product
Once packing and labelling have been
completed, the cases are weighed con-
Equipped with a METTLER TOLEDO load
cell, this tank has been converted into a
The operator carries out two checks, the
amount of torque required to unlock the
caps and the weight of the liquid
The checkweigher
secures a continuous flow of 6000
Reader Service No. 5