Fokus Reinraum

Aseptic Transfer Systems into and

out of Barrier Isolators and RABS
Dr. Hans-Jürgen Bässler, Frank Lehmann . SKAN AG, Allschwil (Schweiz)
Korrespondenz: Frank Lehmann, SKAN AG, Binningerstr. 116, 4123 Allschwil (Schweiz);
e-mail: frank.lehmann@skan.ch

Nur für den privaten oder firmeninternen Gebrauch / For private or internal corporate use only
Summary Key Words
The presented overview gives a picture of the actual technology in terms of continuous . Aseptic transfer; E-beam tunnel;
or batch wise transfer in and out of a containment isolator or RABS disregarding the hot air tunnel
purpose of the containment. . RTP systems; decontamination air lock;
During the past years, containment technology for aseptic production in the pharmaceu- aseptic liquid transfer systems
tical industry has developed in several ways to separate the product from the operator
and environmental influences. With the increasing importance of isolator technology,
there was a need for the development of aseptic transfer systems. Some of the transfer
systems are dedicated to a certain application like the transfer of plastic containers with
nested syringes with an E-beam tunnel, or glass objects with a hot air tunnel. Both are
used for the safe sterile transfer of large amounts of packaging material in a short time
into a filling line isolator.
The engineers have designed many different approaches for the aseptic transfer, but only
some of them came to market. There were developments with UV light, with pulsed light
and other, but in the end the E-beam technology was chosen to transfer nested syringes
into the filling line isolator by the manufacturers of sterile drugs. The hot air tunnel was
not specifically developed for the use with containment technology, but was adapted to
filling line isolators and became the transfer system of choice to bring in glass objects in
a sterile manner.
Some of the transfer systems are more commonly used like RTP systems, which can also
be applied bi-directional that means the transfer can be done in both directions in and
out of an isolator.
Furthermore transfer systems for the aseptic transfer of liquids in and out of a con-
tainment using the alpha/beta technology are available.

Introduction room technology are driving the active pharmaceutical ingredients

For the pharmaceutical industry of
the 21th century, containment sys-
tems for aseptic processes and the
handling of API`s become more
and more important. A modern iso-
lator, as it is used in the industry of
today, can be designed for product
and process protection and/or for
the protection of operators and the
environment. Additional safety fea-
tures and operating cost savings ver-
sus conventional approaches in clean
change to containment solutions.
Containments can be glove boxes,
isolators or closed RABS (Restricted
Access Barrier Systems). Isolators
have captured a firm position in the
pharmaceutical industry during the
past years.
The application for isolators
reaches from industrial research
and development via production of
pharmaceuticals, to laboratory use,
especially for the microbiological
quality control. In the production of
(API`s), many process steps are iso-
lated, to protect the operator and the
environment.
Further, in private and hospital
pharmacies, the individual patient
preparations are more and more pre-
pared in aseptic isolators for operator
and environment protection. For this
application, there is a need for simple,
fast and cheap transfer solutions.
An isolator or cRABS is a closed
system, which can only work, if mate-
rial liquid or solid can be transferred

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20 Lehmann and Bässler . Aseptic Transfer Systems © ECV . Editio Cantor Verlag, Aulendorf (Germany)
 etrate deeply into materials. The rays
utilized by E-beam tunnels are par-
ticle rays from electrons (ß-rays) or
positrons (ß+rays). In comparison to
Alpha and Beta rays, Gamma rays are
electromagnetic waves. Due to the
high energy, Gamma rays are rel-
atively dangerous and require exten-
sive shielding.
The accelerated electrons (Beta
radiation) are an ionizing radiation
and have a direct or indirect effect

Nur für den privaten oder firmeninternen Gebrauch / For private or internal corporate use only
on living cells. The DNA (Desoxyribo-
nucleic acid) in the cell nucleus is the
main target of the Beta radiation.
The major reaction is a single strand
or a double strand break of the DNA,
which is a serious damage to the cell.
Fig. 1: Different ways into and out of an isolator. A high dose of ionizing radiation
which is applied in the E-beam tun-
nel (Fig. 2), leads to a sudden death of
viruses and all types of vegetative
into or out of the isolator. The trans- active decay and the ability to pen- cells of bacteria, fungi, yeast and
fer of goods and tools in and out of etrate material. These are Alpha, their spores.
containment is an important process Beta and Gamma rays. Due to their The electrons are accelerated with
step and a critical procedure in con- electrical load and the relatively large a voltage of approximately 200 keV.
tainment technology. During the mass, Alpha particles do not pen- The amount of interaction between
past years, a large effort has been
made from the industry to improve
and develop transfer systems into
containment isolators, for the differ-
ent applications like product, opera-
tor and environmental protection or
a combination of both. As important
as the transfer into the containment
is the transfer out of containments.
The transfer can either be continu-
ous or batch wise. Figure 1 shows the
different transfer devices used typi-
cally with isolators for aseptic proc-
esses.

E-beam decontamination
tunnel
Electron beam decontamination for
packaging material is fast, reliable
and compatible with most materials
used in the pharmaceutical industry.
The decontamination method is
used for the outer surfaces of pre-
sterilized syringe containers (closed
plastic tubs) with nested syringes.
Fundamentally there are three
types of ionizing rays. These rays Fig. 2: E-beam decontamination tunnel with right and left shielding locks and three emitters
are divided by the amount of radio- in the middle (9).

TechnoPharm 3, Nr. 1, 20–27 (2013)

© ECV . Editio Cantor Verlag, Aulendorf (Germany) Lehmann and Bässler . Aseptic Transfer Systems 21
 Fokus Reinraum

E-beam and object is the absorbed
dose, defined as energy absorbed
per unit mass (4). The application
energy is at least 25 KGray on the
surface of the article.
The tubs are unpacked from their
outer bags, continuously transferred
into the E-beam tunnel, whereby the
external surface decontamination of
the tubs is achieved with the beta
radiation.
The radiation has to reach the en-
by hot air, up to 350 °C or 600 F in
a continuous process, to remove all
traces of organic substances from
them. The hot air is not only killing
bacteria, fungi, yeast and their
spores but removes also the endo-
toxins, the death residues of the de-
stroyed microbes. This is a crucial
step in production of quality glass
containers to feed them into a closed
containment.
For all process steps inside the
different hot air tunnel zones, de-
fined cleanroom conditions are
maintained according to ISO 5, re-
ferred to ISO 14644-1. Different
stages of differential pressures in
the zones are executed properly ac-
cording GMP rules. This pressure
level approach is designed in a way,
that very little of the expensive con-
ditioned clean room air must be dis-
carded. This contributes

tire surface of the article to be decon-
taminated. Therefore, usually two or
three E-beam emitters are positioned
symmetrically to the conveyor belt
(3).
Immediately after passing the E-
beam emitter, the syringe container
will enter a pressure zone with di-
rected air flow as it is required for
GMP production. The pollutants,
which are generated by the radiation
(NOx) are removed locally. The de-
creasing pressure between the isola-
tor and E-beam tunnel assures that
no pollutants will reach the filling
zone of the isolator.
To protect the operator and the
environment from radioactive emis-
sions, the E-beam tunnel is com-
pletely covered with a lead shielding.
The syringe tub input and output
area is protected by shielded doors,
which are interlocked, so that one
door is always closed.
The automation concept provides
an individual control and monitoring
of each individual syringe tub. There-
fore some tubs, which are not suc-
cessfully decontaminated, can imme-
diately move backwards to pass thru
once again the radiation source.
Hot air sterilization and
depyrogenation tunnel
A hot air sterilization and depyroge-
nation tunnel (Fig. 3) is used to
transfer continuously large amounts
of heat resistant material like glass
containers, vials, syringes, carpules
or ampoules in the aseptic filling
area of a containment isolator. The
glass objects will be sterilized and
depyrogenated and siliconized (6)
Nur für den privaten oder firmeninternen Gebrauch / For private or internal corporate use only
significantly to energy
savings in this process
step.
Decontamination
air lock
An airlock is a chamber
of different sizes, which
can be decontaminated
with gaseous hydrogen
peroxide or another dis-
infectant. The airlock is a
pass through for prod-
uct, material, tools and
Fig. 3: Hot air sterilisation tunnel (Bausch + Ströbel). monitoring material into
an aseptic isolator or
closed RABS (5).
The decontamination
The washed objects are, in most system uses hydrogen peroxide
cases, automatically loaded from the (H2O2) for the decontamination of
washing machine into the infeed of the material. The H2O2 should allow
the tunnel. On a conveyor belt, they a reduction of 106 spores of geobacil-
are guided through the heating zone. lus stearothermophilus in a conven-
In the first zone, the glass body com- ient time, including the flushing of
ing from the wet cleaning, is dried the chamber down to at least 1
under clean room conditions and ppm H2O2 residual concentration (8).
conditioned by slowly heating up to The total cycle time should not ex-
about 80 °C. ceed 20 minutes, otherwise the pro-
The sterilization, depyrogenation ductivity of the isolator or RABS is
and the burning in of the silicone of limited.
the objects takes place in the second The airflow in the decontamina-
zone. The defined, validated and con- tion airlock is directed from top to
trolled sterilization parameters are down and the air inlet as well as the
temperature and time, which must air outlet is protected by a HEPA
be held usually at 280 to 350 °C, for (H14) filter. During the decontamina-
at least 5 to 10 min. This time can be tion process the air is not moving in
shorter if the temperature is higher. the airlock. The decontamination
This is followed by the cooling of agent is vaporized with two or three
the sterilized and depyrogenated evaporators directly into the
glass objects in the third zone, to a chamber. After a short residence
temperature level which is usually time, which is validated for killing
less than 30 °C, which is not critical 106 spores of Geobacillus stearother-
for the bottled product to be filled. mophilus, the air lock purges the

TechnoPharm 3, Nr. 1, 20–27 (2013)

22 Lehmann and Bässler . Aseptic Transfer Systems © ECV . Editio Cantor Verlag, Aulendorf (Germany)

Fig. 4: Decontamination air lock with short
decontamination cycle (SKAN AG).
H2O2 from the chamber with sterile
filtered fresh air.
Air locks with an integrated de-
contamination system can be used
to transfer goods aseptically into
containments and out of contain-
ments. Pharmacies in hospitals, or
private pharmacies, produce many
aseptic preparations for parenteral
nutrition or cytotoxic infusions indi-
vidually for patients. Due to the in-
dividuality and the short shelf life of
the solutions, they will be produced
aseptically, shortly before their appli-
cation to the patient. Decontamina-
tion air locks can also be attached to
filling line- or sterility testing isola-
tors to enhance the efficiency of the
installation.
The airlock can be loaded from
the environmental clean room (class
D). By closing the outer door, the
inflatable gasket of the door is auto-
matically inflated and the door is
TechnoPharm 3, Nr. 1, 20–27 (2013)
© ECV . Editio Cantor Verlag, Aulendorf (Germany)
tight. Now the decontamination
cycle, which runs automatically, can
be started. The outer and the inner
door of the airlock are interlocked.
The inner door to the isolator can
only be opened, if the outer door is
closed and a validated decontamina-
tion cycle has been performed with-
out any alarm. The inner door to the
isolator is a sliding door, so there is
no space in the isolator blocked by
the door opening.
For the decontamination air lock,
an IQ/ OQ, decontamination cycle
development and microbiological
performance qualification has to be
performed. During OQ the inlet and
outlet filters are tested for their re-
tention rate and the tightness of the
filter seal. A visualization of the lam-
inarity of the airflow in the chamber
can be of interest. All sensors are cal-
ibrated.
For the cycle development with
hydrogen peroxide, a standard load
has to be defined for the airlock. In
this standard load, biological indica-
tors have to be placed for the estima-
tion of the D-value of the lock
chamber. The distribution of the
H2O2 in the load can be determined
by using chemical indicators on the
defined places. A temperature and
humidity distribution study during
the process of decontamination can
help to find locations where the gas
distribution is not optimal.
Fig. 5: PVC collar with RTP for mobile transfer
isolator (SKAN AG).
Lehmann and Bässler . Aseptic Transfer Systems
Transfer isolator
Transfer isolators are commonly
used for the mobile transfer of tools
and other material from an autoclave
to an isolator, if large amounts of
material have to be transferred. The
isolator support structure is
mounted on casters, so the isolator
can be moved. To be able to be con-
nected with filling line isolators or
other immobile isolators or RABS,
Nur für den privaten oder firmeninternen Gebrauch / For private or internal corporate use only
they have installed on the front side
rapid transfer ports with a flexible
PVC collar to be connected with
the fixed RTP flange on the isolator
(Fig. 5). The stored material can be
transferred to the filling line isolator,
if the docking is accomplished.
To be free to move, they have a
battery buffer or if possible, a long
connecting cable to the power
supply, so they can operate in pos-
itive pressure during the movement.
Mostly, they are decontaminated
with an external H2O2 decontamina-
tion system or like in Figure 6 with an
integrated H2O2 decontamination
system. For the decontamination
process, the isolator is moved to a
fixed location, where the exhaust air
in the aeration phase of the decon-
tamination cycle is removed into a
dedicated waste air system.
The control system in a simple
transfer isolator with external H2O2
decontamination can be a common
pressure controller. The control sys-
tem in a transfer isolator with inte-
grated decontamination system is
more complicated and mostly based
on a PLC system.
Rapid transfer port (RTP)
Rapid transfer port (RTP) technol-
ogy provides the means to move
material into and out of an isolator
or RABS without breaking the con-
tainment. There are many different
rapid transfer ports on the market
with different technologies for the
transfer. The most widespread is
the RTP technique of Getinge-La
Calhène (Fig. 7). It has become an
industry standard worldwide and is
23
 Fokus Reinraum

used in pharmaceutical and life

science applications.
The transfer port system is based
on the interaction of two separate
units: Alpha and Beta unit each,
fitted with a door, a lock and a sealing
function. The Alpha flange is
mounted in the isolator wall while
the Beta flange seals off a container
or a transfer isolator. Both compo-
nents can be joined together by rota-
tion, with the help of embedded bay-

Nur für den privaten oder firmeninternen Gebrauch / For private or internal corporate use only
onets. Now the two doors are assem-
bled and can be opened. A rapid
material transfer between the vessel
and the containment is possible,
without breaking the integrity of
the containment. Between the com-
ponents, are pointed tapered seals
that form the interface. Thus, the un-
clean outsides of the containers are
sealed to each other. When the door
is opened, the impure port covers are
sealed together and can be swivelled
into the containment inside. In addi-
tion, the alpha-flange is fitted with a
mechanical safety lock, which pre-
vents the opening of the door in the
absence of containers and a removal Fig. 6: Transfer isolator with integrated H2O2 decontamination system (SKAN AG).
of the same with the door open.
The weakness of the system for
aseptic transfers is the so-called
“Ring of Concern”. For this reason which allows the gassing of the critical sterilized endless tubular film. Bag
the circumferential seal construction sealing surfaces with the door open. sealers with two seal lines and a
is meant, at the converging faces a The RTP containers are available in parting line are used to bring out
space can occur, a contamination, for stainless steel, aluminium and plastic. small product amounts rapidly from
example from bacteria and therefore The stainless steel and aluminium the containment. The length of typ-
a microbiological contamination of containers can be autoclaved. They ical endless tubular film is between 2
the isolator inside can happen. RTP have a Tri Clamp in the bottom, and 40 m.
systems must be visually checked on where a hydrophobic filter can be
a regular basis for damages to the connected for the steam exchange. Rapid aseptic liquid
seals. In addition, there are test sys- Beta-flanges made of plastic, com- transfer system
tems for pressure testing of the beta bined with sterilized disposable bags
flanges for tightness. (beta-bags) of PE are often used to Aseptic transfer systems are used to
For everyday use, the heavy weight supply ready to use caps and transfer fluids from the preparation
of the stainless steel components, stoppers. For the sterile product in- vessel to the isolator chamber. There
and the relatively forceful tightening feed, these bags are equipped with an are different autoclave-able reusable
of the containers for the bayonet fit- inner film tube, which may, after the systems and pre-sterilized single-use
ting to connect to the alpha flange flanging be pulled out to cover the systems available.
has to be considered. For docking critical seal of the RTP. A reusable RTP container for liq-
lifting aids are available. For reasons Beta flanges with canisters or uid transfer (Fig. 8) is treated to-
of germ growth, it is prohibited to sterile PE bags also can be used for gether with the preparation vessel
lubricate the gaskets with silicone oil. discharging small amounts of prod- with steam. Therefore the RTP dou-
Blind covers (false containers) will uct as well as for to dispose the ble door on the container is secured
be connected during H2O2-decontam- waste out of the isolator. Beta with an additional pressure cover
ination of the isolator on the RTP port flanges can also be equipped with and then the hose from the prepara-

TechnoPharm 3, Nr. 1, 20–27 (2013)

24 Lehmann and Bässler . Aseptic Transfer Systems © ECV . Editio Cantor Verlag, Aulendorf (Germany)

Fig. 7: Endless liner system (Getinge-La Cal-
hène).
tion vessel is connected with the tube
clip of the RTP container. The hose
coming from the preparation vessel
in the RTP container is open and the
steam can reach the interior of the
RTP container before it leaves the
RTP container through a valve or hy-
drophobic filter. After a successful
SIP (sterilization in place) and cool
down, the system is operational. If
the preparation vessel is ready for
the transfer, the RTP container can
be docked on the alpha flange of the
isolator.
After opening the double door
RTP, the open hose end can be taken
out and is connected to the feeder
tank in the isolator.
Biosafe Transfer System
(Sartorius Stedim)
The unique design of the single-use
Biosafe transfer system (Fig. 9) ena-
bles the secure transfer of compo-
nents (stoppers, caps, QC test de-
vices, etc.) and powder while main-
taining the integrity of the critical
area (isolator or RABS). Packaging
in single-use Biosafe bags sterile
and ready-to-use, eliminates issues
with cleaning, sterilization and main-
tenance.
The Biosafe port is integrated in
the isolator wall. Prior to the connec-
TechnoPharm 3, Nr. 1, 20–27 (2013)
© ECV . Editio Cantor Verlag, Aulendorf (Germany)
tion of a pre-sterilized bag with
stoppers for example, the pins on
the Biosafe connector are in “out”
position. This is the proof that it
has not been used before. The dock-
ing is secured by magnetic guidance
on the Biosafe port. Further, the mag-
netic connection is secured by me-
chanical locks. When the docking is
completed, the double door is
opened either from inside or outside
the critical area. Now the aseptic
transfer of components, fluids or
powder can start. A Biosafe port with
outside opening lever is the best
choice to prevent air turbulences
and ergonomic issues in RABS and
isolators with directed airflow.
When connected to the Biosafe
port, the dummy service connector
allows the door to be opened for
the H2O2 decontamination of the
critical area and the inner side of
the Biosafe port, as well as mainte-
nance operations like gasket replace-
ment.
The Biosafe ports are delivered as
manually operated ports, as auto-
mated ports or as Biosteam port,
which can be sterilized in place hold-
ing a pressure from 1 to 6 bar and a
temperature of 130 °C.
Fig. 8: RTP container for liquid transfer (Getinge-La Calhène).
The mouse hole
Mouse holes are openings in the shell
of the isolator or RABS, which allow
the continuous transfer of intermedi-
ate- or finished goods between differ-
ent pressure zones in the isolator or
out of the isolator. The isolator sys-
tem can be equipped with pneumat-
Lehmann and Bässler . Aseptic Transfer Systems
Nur für den privaten oder firmeninternen Gebrauch / For private or internal corporate use only
Fig. 9: Biosafe transfer system (Sartorius).
ically sealed mouse holes, which are
used for infeed and unloading of the
packaging material and the finished
product. The protection of the criti-
cal area in the isolator is given by
means of a pressure cascade. That
means a directed overflow is in the
direction of the area with less protec-
tion requirements. To keep the air
volume loss low, the open area is
minimized with a tailor-made face-
plate. If very large containers must
pass through the mousehole, it may
be advantageous to minimize the
opening with an automated sliding
door, which closes the mouse hole
faceplate after each passing through
of a container (Fig. 10).
The mouse holes are locked and
sealed airtight by an inflatable gasket
during de-contamination. The gas-
kets are equipped with a pressure
sensor. If the pressure of the gasket
falls below a defined minimum pres-
sure the gasket is automatically pres-
surized again, by a pulse of com-
25
 Fokus Reinraum

pressed air. The time to inflate the The system from

gasket and also the pulses used to SKAN AG consists of
keep the gasket inflated are moni- a funnel mounted on
tored to detect if the gasket leaks. the isolator wall
The mouse holes cannot be equipped with three
opened when the gasket is inflated. inflatable gaskets and
The mouse hole is equipped with a two covers for the in-
proximity switch to monitor the side and the outside.
mouse hole cover position. In phases, (5) The inflatable gas-
for which it is defined that H2O2 is in kets hold the cartridge
the isolator chamber, it is not possi- with the liner in posi-
ble to open the mouse holes. If the tion and seal the car-

Nur für den privaten oder firmeninternen Gebrauch / For private or internal corporate use only
isolator system is in a phase for tridge to the environ-
which it is defined that no H2O2 is ment. The cartridge
in the isolator chamber and the iso- holds a PE liner with
lator system is in the status “decon- Fig. 10: Mouse hole with laminar flow protection (SKAN AG). a 500 mm diameter.
The usable diameter
Mouse holes of the cartridge is 190 mm.
with a local ex- The sterile liner transfer system is
haust (also called double packed in PE foil and gamma
“active mouse sterilized. Before inserting in the fun-
hole”) may be nel, the outer foil will be removed
used, when no and the cartridge is placed in the
air flow over the decontamination airlock of the isola-
process air in tor. After the decontamination cycle,
another isolator the cartridge is moved to the main
area or pressure chamber and the second PE foil is
zone is desired. removed. Now the cartridge is ready
They are installed, to be positioned in the funnel.
for example, in The funnel is decontaminated to-
systems in which gether with the isolator chamber,
active or toxic leaving the inner cover open and
Fig. 11: Liner transfer system for the aseptic transfer of goods out of an substances are the outer cover closed. After decon-
isolator.
processed. In this tamination and transfer of the car-
case, the process tridge into the isolator, the cartridge
taminated”, the mouse hole gaskets air is sucked from both sides of the is pushed into the funnel up to the
deflate automatically. mousehole and discharged in be- outer cover. The inflatable gaskets
Mouse holes in isolators can be tween through a HEPA filter. In are inflated, so that the outer cover
operated manually by an operator safety-critical zone transitions, the can be erased. The liner can now be
or automatically. If automatically, correct functioning of
the mousehole cover is closed by a the air flow has to be
pneumatic cylinder and kept close by visualized in opera-
a return spring even in the case of tion mode of the sys-
power loss. tem.
As the mouse holes are open dur-
ing “production” mode and therefore Liner transfer
represent an opening of the isolator system (LTS)
to the surrounding room, a unidirec-
tional Air Flow Unit (LAF) is installed There are different
over the mouse holes to protect this sterile liner transfer
opening from passing particles from systems (Fig. 11) avail-
the environmental room. To ensure able on the market.
proper protection, the mouse hole They can be used for
does not open until the LAF is run- the aseptic transfer
ning at the defined speed of normally out of a containment
0,45 m/s. isolator. Fig. 12: SART liquid transfer system (Sartorius Stedim).

TechnoPharm 3, Nr. 1, 20–27 (2013)

26 Lehmann and Bässler . Aseptic Transfer Systems © ECV . Editio Cantor Verlag, Aulendorf (Germany)
drawn out; the transfer system is [4] Urano, S. Wakamoto, I. Yama-
kawa, T. Electron Beam Steril-
ready to be used. With the liner ization System; Mitsubishi Heavy
transfer system it is possible to trans-
Industries Ltd. Technical review
fer material out of an isolator or Vol. 40 No.: 5 (Oct. 2003)
[5] Bässler H.-J. und Lehmann F.; Semiauto-
RABS in an aseptic way. matisches aseptisches Füllen; Techno-
Pharm 2 Nr. 4, 260 – 265 (2012)
[6] Mundry T. Einbrennsilikonisierung bei
Aseptic Rapid Transfer pharmazeutischen Glaspackmitteln- An-
System (SART) from alytische Studie eines Produktionspro-
Abgelegt auf: zesses;
F:\GK\ECV\Satz\TechnoPharm\TP_2013-01\Anzeigensatz-keine-Druck-PDFs\optima-junior_tp-2013-0
Sartorius Dissertation an der Mathematisch
Zuletzt gesichert: 21.01.13 (09:58:01 Uhr)
Naturwiss. Fakultät der Humboldt Uni-
versität Berlin (1999)
[7] Gail L, Gommel U, Hortig HP. Reinraum-
technik (VDI Buch), chapter “Isolator-
technik in der chemisch-pharmazeut-
ischen Industrie und Lebensmitteltech-
nik”. Berlin: Springer Verlag; 2012.
[8] Krebsbach T. und Böttcher F. Leistungs-
qualifizierung von Steriltest-Isolatoren;
Pharm.Ind. 74 Nr. 3 469-476 (2012)
[9] SKAN AG, Electron Energy brought to
Perfection, E-Beam brochure, 2012

The aseptic, liquid transfer

between a containment isola-
tor and the environmental
clean room can be performed
by using the SART (Fig. 12)
system. The system consists
of an external port, an inter-
nal port, made from stainless
steel 316L and a disposable
connection device made from
PBT Celanex grade (Polybuty-
lene terephthalate) with the
brand name Gammasart
ATD. Applying the RTP tech-
nology at the port as well as
the disposable connector, the
principle of the connection is
based on the alpha-beta con-
cept using four V-shaped pro-
files matching exactly on the
„Kleine Fehler? Mag ich
tip. A mechanical interlock an Menschen. An Anlagen
helps to avoid accidental
opening, if the ADT connec- von OPTIMA schätze ich
tor is not in place. The con-
nector can either be Gamma
dagegen Perfektion.“
sterilized or autoclaved. The
connector can be opened and Birgit Breitmoser
closed several times without Technische Zeichnerin
(Maschinenbau)
a fresh sterilization.

Fachliteratur
[1] Sigwarth, V. und T. Huber;
Trends bei der Entwicklung
von Isolatoren für die phar-
mazeutische Industrie;
Pharm. Ind. 71, Nr. 2, p 334 –
344 (2009)
[2] Zandbergen, J.-E. und Monge,
M. Disposable Technologies
Mit einer Abfüllanlage von OPTIMA sind Sie von vornherein
for Aseptic Filling; BioProcess

International 4: p 48-51 (June
2006)
[3] Sigwarth, V., Lehmann, F.;
Boesiger, A.: Dekontamina-
tionsprozesse und -Systeme
bei der Abfüllung genesteter
Fertigspritzen – Isolatorsys-
teme und Elektronen-
strahltunnel Pharm. Ind. 70
Nr. 10 p. 1277 – 1288 (2008)
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