ADVANCED ASEPTIC TECH HIGHLIGHTS
FEBRUARY 2014 ◗ pharmpro.com 31
AES “WOLF” TM - Walk-On Light
Fixtures for Cleanrooms
The AES “WOLF” TM is AES’ exclusive cleanroom flush walk-on light fixture, delivering the ultimate in safety and cleanliness. b These walk-on light fixtures are designed specifically
for integration into the AES 2” or 3” walk-on ceiling system.
A flush finish and built-in structural reinforcement assures
safe, easy servicing of lights and eliminates trip hazards or
risk of fall-through. The U.L. listed, IP65 rated units are built
to withstand the most stringent of cleaning protocols and
meets the highest cleanliness standards. b
◗ AES Clean Technology, Inc., Montgomeryville, PA 18936.
www.aesclean.com or call 888-AES-CLEAN
◗ INTERPHEX Booth No. 1753
Liquid Filling and Closing Machinery
groninger is a recognized global leader of specialized liquid filling and closing machinery to the pharmaceutical,
biotechnology, diagnostic, nutraceutical and cosmetic
industries. In addition to groningers’ two German sites,
we recently opened our newly build facility in Charlotte,
North Carolina. The 30.000 sqft facility is home for our
North American sales, service and spare-parts operations.
Nested, pre-sterilized object filling and closing machine
for syringes, vials and cartridges. Capable of 400 objects
per minute at a 100% IPC rate, contactless transport and
fully modular construction for scalability.
◗ groninger USA L.L.C., Charlotte, NC 28273.
www.groningerusa.com or call 704-295-9000
Modular Isolator System
The Pharmaceutical Safety Isolator Customized, PSI-C, is a modular isolator system with a
unique L-shaped flange,which allows to change the working equipment very quickly. The
short decontamination cycle and the return air filter (FIPA) makes it a universal, sterile work-space for aseptic and/or high active pharmaceutical products.
Modular isolator PSI-C endowed with fast and easy exchangeable filling equipment
The possibility of using an empty flange plate guarantees a maximum of flexibility
Aseptic production by H2O2 decontamination of the isolator
Fast H2O2 decontamination of the air lock < 20 min
Excellent operator safety by safe changeable return air filters FIPA
Suitable for many different sizes and types of presterilized packaging material
Small scale production of clinical samples or stability batches; Aseptic working conditions
with highest sterility assurance; Operator safety for working with toxic substances; Vial
filling, stoppering and capping; syringe filling, stoppering ; optional lyophilization process
aseptic and/or high active pharmaceutical products.
◗ SKAN US, Inc., Raleigh, NC 27617. www.skan.ch or call 866-381-7685
◗ INTERPHEX Booth No. 3628
Blow/Fill/Seal Aseptic Packaging
rommelag® is the primary innovator in Blow/Fill/Seal
(BFS) advanced aseptic packaging technology. rommelag®’s
bottelpack® BFS technology is regularly used to produce
aseptic products throughout the world: small volume
parenteral, large volume parenteral, inhalation drugs and
ophthalmic drugs. We provide our customers with custom
BFS container design, function and stability testing and clin-
ical trial filling services. Our contract manufacturing sister
companies’ holopack (Germany) and maropack (Switzerland)
enable us to be a one stop development packaging provider.
Maropack in Switzerland recently opened a BSL-2 facility which
has allowed BFS technology to be available to test biotech products.
This facility has been complemented with a technology development
by rommelag, a controlled temperature fill system that allows the product temperature to be
controlled all during the complete filling process. CoolBFSTM controls the product tempera-
ture during the aseptic filling process. BFS technology is moving into new areas though rom-
melag’s design and development skills. These developments fall in to three primary areas:
inserting a sterile device into an aseptically filled BFS container, creating a unique container
that supplies an aseptic liquid to a device and using a BFS container as a device. Containers
come in many sizes, from 0.05 mL to more than 1000 mL. rommelag® is developing its own
prefilled syringe design. The device will be produced in an aseptic BFS system that has an
integrated isolator for sterile needle supply.
◗ Rommelag USA, Inc., Evergreen, CO 80439. www.rommelag.com or call 303-674-8333
◗ INTERPHEX Booth No. 3528