Sie sind auf Seite 1von 4

Product Information

StripTabsTM line by Romaco Siebler

Pharmaceutical technologies by Romaco in one line

The new Siebler StripTabsTM line unites the


technology of the FrymaKoruma, Siebler
and Promatic brands from the machine
construction specialist Romaco to form an
innovative machine concept. The new
TM
StripTabs form of application is being
produced on this Romaco pharmaceutical
line for the first time.

Innovative medical form of application: StripTabsTM

The new StripTabsTM form of medical application is primarily used for


hormonal and pain therapies. Furthermore, these film tablets are also suitable
as carriers for active ingredients used in treating migraines or throat and
pharyngeal diseases. StripTabsTM also represent an attractive medical
application for companies supplying agents to treat potency problems.

The filmy strip tablets, each approximately 60 to 100 micrometers thick, are
taken orally but not swallowed. The medication, 20 by 30 millimeters in size,
dissolves on the tongue within a few seconds. Direct absorption of the active
ingredients by receptors inside the mouth leads to extremely rapid
distribution of the active ingredient in the body, comparable to an injection.

The chemical composition of the StripTabsTM is based on a starch and polymer


solution, which provides the tablets with their extremely fine film
characteristics. Furthermore, depending on the formulation, the respective
active pharmaceutical ingredients (API) are added to the pharmacological
matrix at different levels of concentration. The StripTabsTM solution is
manufactured using a homogenized mixing procedure, which guarantees an
extremely high degree of dosing accuracy.

The StripTabsTM are packed in soft aluminum foil packages provided with
opening aids. The peelable primary packaging allows safe removal of the film
tablets, either by hand or tongue. Once sealed, the applications will keep for
up to three years. Romaco also supports users of this new pharmaceutical
StripTabsTM technology by developing individual formulations. The complete
supplier Romaco locates suppliers of raw materials and manufacturers of
pharmaceutical formulations.

The FrymaKoruma vacuum processing plant

The liquid pharmaceutical mass for manufacturing the StripTabsTM is produced


in the vacuum processing unit from Romaco FrymaKoruma by using a
homogenizing procedure. The active pharmacological ingredients are added to
the matrix in the first production stage and homogenized to form a bubble-
free solution. To do this, the different raw materials are sucked directly into
the mixing zone of the homogenizer and processed immediately. Both dry and
liquid components can be added in up to five different product feeds. The
powerful homogenizer is located directly below the tank and is designed in
accordance with the rotor-stator principle. The high peripherical speed of the
rotor generates extremely powerful shearing forces through the simultaneous
counter-forces of the stator. These achieve ideal dispersal results with fine
distribution of particles in the micrometer range and below. Depending on the
application, the stator can optionally be moved out, which makes it possible
to flexibly control the shear energy impact. This provides high pump
performance with a simultaneous gentle circulation of the product mass.

After homogenization, the product optionally passes through an internal


(short loop) or external (long loop) recirculation pipe into the vessel of the
vacuum processing machine. The short route, through the so-called short
loop, is suitable for the production of smaller batch sizes, for example. The
short loop is additionally of great benefit in processing mixed ingredients that
tend towards a more pronounced formation of bubbles. This prevents foaming
of the pharmaceutical solution and unwanted air inclusions. Very large
preparations can also be homogenized quickly and effectively using the long
loop, with the contra-directional stripper stirrer in the tank providing good
macro-mixing. In this way, the machine meets all the requirements for
installation in zones which are potentially explosive, as well as for sterile
production in clean room areas.

The Siebler HM 2/500 heat sealing machine

In the Siebler HM 2/500 heat sealing machine, the StripTabsTM are cut to size
and sealed in strip packaging suitable for pharmaceutical use. This eight
meter-long machine was designed specially for the primary packaging
processes of pharmaceutical film tablets. With a maximum output of 1,500
items per minute, the HM 2/500 seals the StripTabsTM in light-tight and
moisture-proof soft aluminum film packaging. The applications are fed to the
ten-line hot-sealing process on film with a sealing width of up to 500
millimeters. The absolute reproducibility of the sealing parameters is
guaranteed by optimal pressure and heat distribution across the whole width
of the film. The sealing temperature is kept constant through a precision
control system, which is operated by several high-performance cartridge
heaters. Integrated sensors additionally provide continuous monitoring of the
heat-sealing processes.

The machine has an impressive innovative cutting system, equipped with a


precision fluting station. This type of stamping processes the pharmaceutical
matrix directly on the carrier film. Cutting out is performed by a cutter block
that does not allow any tolerance in the cut. Once stamping is complete, the
applications are released from the carrier film using a sharp-edged dispensing
tongue. A rotating shuttle system picks up the cut StripTabsTM and passes
them individually to the primary packaging film. As an option, the production
sequence can be additionally monitored by a digital camera system, which
detects any irregularities in the product early on and rejects the relevant
applications. The HM 2/500 meets all the conditions of “Good Manufacturing
Practices” (GMP) and can be operated in all classes of clean room. A surface
finish specifically designed for pharmaceutical use simplifies and accelerates
the otherwise expensive cleaning processes.

The Promatic P 91 intermittent motion cartoner

The Promatic P 91 intermittent motion cartoner takes the StripTabsTM in their


primary packaging directly from the Siebler HM 2/500 stacking station. The
cartoner, designed with a maximum output of 100 cartons per minute, is
designed so that any format changes required can be carried out directly by
the shift personnel. In the case of small batch sizes in particular, this
accelerates the sequences, providing a consistent production flow. The
machine is operated using a touch screen, which monitors individual
production stages fully automatically, and adjusts them if necessary. All of the
secondary packaging processes are flexibly and efficiently controlled in this
way.

The balcony structure and compact design of the P 91 cartoner allow good
access to all machine parts. This makes loading with folding cartons and
cleaning much easier. Actuators and a venturi vacuum unit reduce noise
exposure for the operating personnel and protect machine parts. Signs of
wear are reduced by the use of toothed pulleys during product transfer.
Safety friction clutches additionally protect the machine against mechanical
overload. Thus the cartoner has an impressively high level of capacity
utilization with a simultaneously low outlay for maintenance.

In this way, the Siebler StripTabsTM line brings together the skills of the
Romaco Group in the areas of Processing and Packaging. The development of
the StripTabsTM in association with the whole manufacturing and packaging
process is proof of the powers of innovation of this complete supplier to the
pharmaceutical industry.

The Romaco Group

Romaco is one of the world’s leading suppliers of machines and installations


for process engineering and packaging. Subdivided into the areas of
Processing and Packaging, the company develops technical solutions for the
pharmaceutical, cosmetic and food industries. The Romaco Group, with its
headquarters in Karlsruhe (Germany), is part of the listed US group Robbins &
Myers Inc. (Dayton, Ohio). Romaco is represented in four European locations
in Germany, Switzerland and Italy through a total of seven brands. Bosspak,
Macofar, Noack, Promatic, Siebler and Unipac represent the Packaging
business area; the Processing sector is covered by the FrymaKoruma brand.
Currently, more than 50,000 Romaco machines are in use in over 130
countries. About 500 employees look after and supply more than 100 markets
around the world.

Das könnte Ihnen auch gefallen