Close up03 I 2020 - Uhlmann Pac-Systeme
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03 I 2020 up
Person- and
product-protectors
Anyone visiting the solid dose production facilities of a Mexican pharmaceutical manufacturer in
Tlajomulco near Guadalajara will find no sign of bodyguards, no stout, black-suited men with headphones and reflecting sunglasses.
Two integrated high-containment lines are to be found instead: one that meets protection level OEB3 for the
production and packaging of immunosuppressants, and one that fulfills OEB5 protection requirements for oncological products. Both result
from a joint project executed by the Excellence United partner companies Fette Compacting, Glatt, and Uhlmann.
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“ Cooperating with Excellence United, The Mexican pharmaceutical company
awarded a contract for two complete
our long-term customer has a competent high-containment lines for tablet produc- Safe and consistently
tion in August 2018, and Excellence United
partner for the entire process from production is currently implementing this joint
productive – even with
to packaging on high-containment lines – project. The lines each incorporate a Glatt
OEB5 containment
granulator, a Fette tablet press, and –
one-stop supply and services. to package the highly toxic solid dose
products – a Blister line BEC 300 plus an
Andrés Garcia, Managing Director Fette Compacting Mexico
Uhlmann Labeling Platform ULP. The
Uhlmann specialists fitted each BEC 300 the active ingredients, and equally reliable
blister machine with a customized con- protection of the product against contami-
tainment system. nation from outside or caused by other
substances.
Left: Tablet or capsule feeding using a containment SimTap
Whether it is just for packaging or, as in
feeder in a closed restricted-access barrier system (cRABS) the case of this customer, for an integrated Simulate, optimize, and engineer. To en-
Center: The sealing station is also in the cRABS zone and
line including granulation, tablet pressing, sure accurate customization of the separate
ensures operator protection. and packaging, the key criterion of every line components from Glatt, Fette, and
Right: Airlocks and “intervention gloves“ provide double
containment solution is protection: Uhlmann in accordance with the specific
protection for format changeovers. reliable protection of the operator against requirements, all the process steps were
Video on an
exemplary BEC 300
containment solution
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first jointly defined with the customer. A
kick-off meeting was also held in Tlajomulco
to clarify the Uhlmann share of the pro- The basis:
“ Process-integrated, full-scale
containment – with a strong alliance
Andrés Garcia, Managing Director Fette Compacting Mexico, on the benefits
of a network of excellence for complex projects
ject. Various videos demonstrating setup, Mr. Garcia, Fette has already supplied the Mexican pharmaceutical company with
cleaning, and troubleshooting procedures
well-proven and flexible 17 tablet presses and was the main contact for the two containment lines. Why did you
were presented. According to Uhlmann immediately think of the Excellence United partner companies in this case?
project manager Emanuel Wegis, this ap- On the one hand, we wanted to offer our customer all components in the same top quality
proach is “good practice where containment as expected of us. On the other hand, streamlined organization with clear-cut areas
solutions are concerned. Using practical of responsibility was a key issue – particularly in view of the complexity of the project.
examples, we are able to accurately analyze to these stringent stipulations regarding Consequently, we considered the lines to be a viable contract for the alliance from the out-
the individual specifications beforehand. operator protection, flexibility is a key set. Together with Glatt and Uhlmann, we engaged in intensive discussions and workshops
Furthermore, we always carry out a risk factor. The line is to seal tablets or capsules to convince the decision-makers of the synergy effects of this collaborative
assessment. In addition to taking operator in film blisters, and package them in project management.
protection into account, we also consider cartons – in six different configurations.
production-relevant factors such as batch Nevertheless, a project of this scope needs someone to “pull the strings”.
sizes, materials, and many other aspects.” Flexible combination: Blister line BEC 300. What was the situation here?
Consequently, the Uhlmann specialists Obviously, a major criterion for the customer was to have a central contact.
Protection, efficiency, and flexibility. recommended a Blister line BEC 300 as the We only managed to win this project for Excellence United because we had
The outcome of this analysis was that the basis for the container lines. Well-proven in previously successfully implemented other projects for the company. As a
line for the packaging of oncological prod many practical applications and offering a result, we were always the main contact and coordinated the project.
ucts must meet the requirements of the stable process, the BEC 300 is ideal for the
second highest protection level OEB5 variable processing of standard-shaped solid Cue coordination: What about support services?
for highly toxic products. One way of illu dose products. Common forming materials The same as for the entire project – should difficulties with a machine
strating this is to extrapolate the toxic ex- are used to package small to medium-sized arise, the customer first approaches us, and we organize service
posure to the volume of the Empire State batches of up to 70,000 packs. In addition, technician support. As an Uhlmann sales and service partner in
Building: no more than one twentieth of a number of BEC 300 blister machines Mexico, we are well acquainted with machines from Laupheim.
a teaspoon of the toxic substance is per- have already been upgraded to customized However, as containment solutions are involved here, we
mitted in the whole building. In addition containment solutions. immediately consult the Uhlmann specialists.
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Negative and positive pressure. The cus
tomized pressure zone and climate control
concept, based on an air management
unit, is a central element of containment.
Positive air pressure protects the products
against cross-contamination when a prod
uct changeover takes places. Negative air
pressure prevails at the positions where
the operator engages in the process, and
“
where the most dust occurs – usually in
the area of the fill section. In addition,
there are specific extraction points for this Every containment solution is
dust, such as at the tablet feeder. Filters
for supplied and extracted air are also an
customized. The specifications always
integral part of a containment system. The vary and are always very complex.
supply air filters ensure the required air
purity, while the extraction air filters pro- A lot of know-how is needed – and
tect the outside area from contamination.
A cooling circuit maintains a constant
that can only be built up through many
temperature during the packaging process. successfully implemented projects.
Sensors continually measure the tempera-
ture as well as the humidity. Emanuel Wegis, Project Manager Uhlmann Customized Packaging Systems
Air management unit
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Active flap for filling of the product-feeder hopper
close-up online
Safe zone between feeding and transfer
The benefits of containment Issued by:
to the cartoner. The solid dose products Uhlmann Pac-Systeme GmbH & Co. KG
compared to cleanroom packaging:
formed by the Glatt granulator and the Plenty of know-how Chief editor:
Fette tablet press are forwarded to the line Marion Neubrand
in drums. A lift raises these to the hopper
from many successful Phone: +49 7392 702-8648
• Operators can work without neubrand.m@uhlmann.de
special protective overalls and can of the feeder. A passive flap in the drum
containment projects Concept and realization:
take regular breaks base and an active flap in the top of the Volker Laucher Grafik Design,
Stuttgart, Germany
• No time-consuming entry and hopper engage and tightly link the two
Text:
exit of persons and materials elements. The flaps open, allowing the Marisa Arzt, Stuttgart, Germany
• Cross-contamination is reliably products to flow into the hopper – an air- Translation:
ruled out tight process without any operator contact. in the blister pockets to keep dust to a Rosemary Sack, Stuttgart, Germany
• Less floor space required for The flaps then close and the lift removes minimum. Sealing of the blisters also takes Photos:
dreiM, Munderkingen (p. 1, 2, 3, 4, 5);
a line the empty drum. place in the cRABS zone, likewise inspec Ernst Fesseler, Bad Waldsee, Germany (p. 4);
• Clearly reduced effort for format tion of the products. Only the camera is dewessa/stock.adobe.com (intro photo)
Double protection also prevails during for- positioned outside the zone to simplify
changeovers and cleaning
mat changeovers and replacement of the cleaning. Faulty blisters are removed via a
• The more product changeovers, BEC 300
air filters. The operators work in a negative special magazine, from which the operator Compact, added-value
the sooner a return on invest-
combination
pressure zone and all intervention is carried can also access IPC blisters.
ment is secured
out through ports with integrated gloves.
• Future-oriented solution due to
greater line flexibility The last step of this tailored solution is CONTAINMENT
Product feeding takes place in a cRABS product transfer to the cartoner using a Uhlmann white paper
on the subject
(closed restricted-access barrier system) conveyor. Subsequent handling continues
zone. This area of the blister machine is “normally”: carton printing, filling, check-
enclosed, forming the greatest possible weighing, and the application of tamper- CLOSE BY THROUGHOUT
THE WORLD
barrier to outside. A containment SimTap evident labels using the Uhlmann Labeling Your contact person
around the globe
places the capsules or tablets individually Platform.
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