Telstar is an international company that offers complete aseptic production systems for pharmaceuticals using their proprietary technology. They provide barrier systems that protect products from contamination during all process stages. Their systems are designed and manufactured according to relevant quality and regulatory standards and can include isolators, transfer systems, control systems, and sterility testing equipment. Telstar works with clients globally to design customized, high-quality solutions for sterile manufacturing processes.
In a nutshell, Flexible Isolators are soft walled containment systems often used as alternatives to rigid isolators. They come in a couple options: flexible and semi-flexible. Flexible Isolators are commonly used in industries such as biotech, pharmaceutical, healthcare and universities to protect workers and/ or their process from the external environment.
At Aseptic Technologies we developed and manufacture innovative solutions for aseptic filling operations. Our equipment and devices are designed to provide safer & easier sterility assurance for aseptic fill and finish of biologicals, potent drugs and products requiring cryopreservation.
This write up shows that Therapure offers fill/finish services for their client's bulk drug substance either produced off-site or as an add-on to Therapure's own cGMP manufacturing services. Therapure is an ideal partner for biotech companies as they can provide this integrated service from manufacturing to fill/finish to storage and distribution of finished product.
In a nutshell, Flexible Isolators are soft walled containment systems often used as alternatives to rigid isolators. They come in a couple options: flexible and semi-flexible. Flexible Isolators are commonly used in industries such as biotech, pharmaceutical, healthcare and universities to protect workers and/ or their process from the external environment.
At Aseptic Technologies we developed and manufacture innovative solutions for aseptic filling operations. Our equipment and devices are designed to provide safer & easier sterility assurance for aseptic fill and finish of biologicals, potent drugs and products requiring cryopreservation.
This write up shows that Therapure offers fill/finish services for their client's bulk drug substance either produced off-site or as an add-on to Therapure's own cGMP manufacturing services. Therapure is an ideal partner for biotech companies as they can provide this integrated service from manufacturing to fill/finish to storage and distribution of finished product.
Nine sunplus systems presentation for modular operation theatreSamsonZhu
Nine Sunplus Systems, a leading manufacturer in China who provides innovative solutions and products for operation theatres, hybrid operating rooms, ICU/NICU units, surgical preparation rooms and other hospital areas. We design modular OT and manufacture medical equipments for hospitals on the basis of accumulated experience since 2005: modular wall panel systems, surgical scrub sinks, control panel, X-ray viewer, Laminar airflow, peripheral lights, pressure relief damper, return air grills, OR doors, medical trolleys, OT furniture and customized products. We integrate solution for complete integration of devices and medical image management enhances workflow efficiency and improves patient care in the OT.
Positioned as micro centrifuge, MCV and refrigerated MCR stand out with excellent feature and versatility. MCV and MCR have a capacity of up to 44 x 1.5/2.0ml and can accommodate 12 x 5ml reaction tube or 4 x 8-pcr strips per run. With hematocrit rotor, it can accommodate 24 x capillaries per run for the determination of the hematocrit value.
It is designed with compact size to save space in the lab and with low noise performance that is preferred in any working area. The powerful refrigeration system of MCR keeps samples at temperature for as low as 4OC during a continuous run at 21380 x g.
Improving Reliability Via Diaphragm Seals on Advanced Bioethanol Production P...Ravi Jethra
Improving Reliability Via Diaphragm Seals on Advanced Bioethanol Production Processes. The presentation discusses the areas of applications involving newer diaphragm seal designs for increasing reliability
Modular operation theater by workspace solutionsAbhishek vyas
We would like to take opportunity to introduce with ADVANCE technology of MODULAR OPERATION THEATER.
WMSPL( India) tied up with a leader AKCmed (CZECH REPUBLIC)
· Design & Manufacture factory made modular operation theatres
· Complying to stringent EU medical norms
· Experience of more than 20 years
· Designed and executed more than 500 OTs in more than 25 countries
WMSPL, is an Indian arm based in Udaipur, Rajasthan with world class manufacturing facility suitable for manufacturing OTs.
· Designed and executed 150 plus modular control rooms in India and overseas
· Advanced sheet metal facility with machines from Germany, Italy and Japan
Contact us:
Abhishek vyas
abhishek@pyrotechworkspace.com
+91 90 12 14 777
MadgeTech’s Ethylene Oxide (EtO) sterilization data loggers can be used to monitor, record and validate sterilization cycles. These rugged devices are capable of withstanding temperatures up to 80 °C, and are available in a temperature or temperature and humidity model. The EtO sterilization data loggers record measurements at a user-selectable interval, providing validation for the entire cycle. The MadgeTech software makes it easy to create validation reports and prove compliance with federal regulations.
Therapure has validated aseptic fill/finish suites for cost effective formulation, filling and finishing of clinical and commercial scale products. Therapure has experience filling and finishing both therapeutic proteins and small molecules into vials, preformed IV bags and prefilled syringes.
GRIFOLS - Factores de Competitividad en el Largo PlazoILDEFONSO GONZALEZ
Los sofisticados procesos de transfusión de sangre que conocemos hoy son el resultado de un largo y complicado recorrido de muchos siglos en los que diferentes científicos buscaron superar sus problemas inherentes de compatibilidad sanguínea, coagulación, conservación y otros más. El grupo empresarial Grifols se comprometió desde su nacimiento -a inicios del siglo XX- con el desarrollo científico y tecnológico de los hemoderivados, atravesando procesos históricos llenos de dificultades que incluyen todo el período del franquismo, la Segunda Guerra Mundial y las posteriores crisis económicas hasta establecerse actualmente en una de las principales empresas internacionales de esta industria. El presente trabajo constituye un análisis sistemático de los factores que han contribuido al éxito competitivo de este holding internacional y que ahora busca ampliar sus fronteras con nuevas alternativas en el área de la salud.
Today Fedegari offers the market experience required to combine machines and processes into integrated projects that are truly innovative and capable of offering more efficient and economically competitive alternative solutions to an industry, such as the pharmaceutical one, that is always very cautious in accepting original evolutions.
Fedegari Group - Company profile - Passion that drives performances.Fedegari Group
Fedegari Autoclavi SpA is the holding company of an Italian industrial group
manufacturing customized machines, plants and the relevant components for the bio-
/pharmaceutical and food industry worldwide.
The know-how of the group lies in the field of sterile and clean processes and
encompasses different technologies and products.
For many years now, Fedegari has been considered a world-class reference manufacturer in the field of sterilization by virtue of the many innovations that it has introduced in its machines and processes. A unique feature of Fedegari is the extreme verticalization of the company, which always
rejected the idea of assembling sophisticated machines with standard components
(designed for a variety of applications) but always sought to develop and produce
components and technologies in-house, so as to acquire always deeper knowledge of
the machines and innovate them always than anybody else.
Nine sunplus systems presentation for modular operation theatreSamsonZhu
Nine Sunplus Systems, a leading manufacturer in China who provides innovative solutions and products for operation theatres, hybrid operating rooms, ICU/NICU units, surgical preparation rooms and other hospital areas. We design modular OT and manufacture medical equipments for hospitals on the basis of accumulated experience since 2005: modular wall panel systems, surgical scrub sinks, control panel, X-ray viewer, Laminar airflow, peripheral lights, pressure relief damper, return air grills, OR doors, medical trolleys, OT furniture and customized products. We integrate solution for complete integration of devices and medical image management enhances workflow efficiency and improves patient care in the OT.
Positioned as micro centrifuge, MCV and refrigerated MCR stand out with excellent feature and versatility. MCV and MCR have a capacity of up to 44 x 1.5/2.0ml and can accommodate 12 x 5ml reaction tube or 4 x 8-pcr strips per run. With hematocrit rotor, it can accommodate 24 x capillaries per run for the determination of the hematocrit value.
It is designed with compact size to save space in the lab and with low noise performance that is preferred in any working area. The powerful refrigeration system of MCR keeps samples at temperature for as low as 4OC during a continuous run at 21380 x g.
Improving Reliability Via Diaphragm Seals on Advanced Bioethanol Production P...Ravi Jethra
Improving Reliability Via Diaphragm Seals on Advanced Bioethanol Production Processes. The presentation discusses the areas of applications involving newer diaphragm seal designs for increasing reliability
Modular operation theater by workspace solutionsAbhishek vyas
We would like to take opportunity to introduce with ADVANCE technology of MODULAR OPERATION THEATER.
WMSPL( India) tied up with a leader AKCmed (CZECH REPUBLIC)
· Design & Manufacture factory made modular operation theatres
· Complying to stringent EU medical norms
· Experience of more than 20 years
· Designed and executed more than 500 OTs in more than 25 countries
WMSPL, is an Indian arm based in Udaipur, Rajasthan with world class manufacturing facility suitable for manufacturing OTs.
· Designed and executed 150 plus modular control rooms in India and overseas
· Advanced sheet metal facility with machines from Germany, Italy and Japan
Contact us:
Abhishek vyas
abhishek@pyrotechworkspace.com
+91 90 12 14 777
MadgeTech’s Ethylene Oxide (EtO) sterilization data loggers can be used to monitor, record and validate sterilization cycles. These rugged devices are capable of withstanding temperatures up to 80 °C, and are available in a temperature or temperature and humidity model. The EtO sterilization data loggers record measurements at a user-selectable interval, providing validation for the entire cycle. The MadgeTech software makes it easy to create validation reports and prove compliance with federal regulations.
Therapure has validated aseptic fill/finish suites for cost effective formulation, filling and finishing of clinical and commercial scale products. Therapure has experience filling and finishing both therapeutic proteins and small molecules into vials, preformed IV bags and prefilled syringes.
GRIFOLS - Factores de Competitividad en el Largo PlazoILDEFONSO GONZALEZ
Los sofisticados procesos de transfusión de sangre que conocemos hoy son el resultado de un largo y complicado recorrido de muchos siglos en los que diferentes científicos buscaron superar sus problemas inherentes de compatibilidad sanguínea, coagulación, conservación y otros más. El grupo empresarial Grifols se comprometió desde su nacimiento -a inicios del siglo XX- con el desarrollo científico y tecnológico de los hemoderivados, atravesando procesos históricos llenos de dificultades que incluyen todo el período del franquismo, la Segunda Guerra Mundial y las posteriores crisis económicas hasta establecerse actualmente en una de las principales empresas internacionales de esta industria. El presente trabajo constituye un análisis sistemático de los factores que han contribuido al éxito competitivo de este holding internacional y que ahora busca ampliar sus fronteras con nuevas alternativas en el área de la salud.
Today Fedegari offers the market experience required to combine machines and processes into integrated projects that are truly innovative and capable of offering more efficient and economically competitive alternative solutions to an industry, such as the pharmaceutical one, that is always very cautious in accepting original evolutions.
Fedegari Group - Company profile - Passion that drives performances.Fedegari Group
Fedegari Autoclavi SpA is the holding company of an Italian industrial group
manufacturing customized machines, plants and the relevant components for the bio-
/pharmaceutical and food industry worldwide.
The know-how of the group lies in the field of sterile and clean processes and
encompasses different technologies and products.
For many years now, Fedegari has been considered a world-class reference manufacturer in the field of sterilization by virtue of the many innovations that it has introduced in its machines and processes. A unique feature of Fedegari is the extreme verticalization of the company, which always
rejected the idea of assembling sophisticated machines with standard components
(designed for a variety of applications) but always sought to develop and produce
components and technologies in-house, so as to acquire always deeper knowledge of
the machines and innovate them always than anybody else.
We are one of the fastest growing Manufacturer, service provider and Supplier firms providing added value in its offered superior quality HVAC & Clean Room Solutions. Apart from the industry proven design of our products.
Thames Side is one of the best load cell manufacturers in India. They offer high quality products and outstanding customer service. Contact to get more details.
Best Load Cell Manufacturers In India - Thames SideThames4
Thames Side is one of the best load cell manufacturers in UK. They offer high quality products and outstanding customer service. Contact to get more details.
The Austrian market leader for timing and monitoring relays.With a wide range of timing relay products and monitoring devices
Providing high-quality industrial switching devices and power electronics.
Ensures safety and energy efficiency!
We, JIS Electric is the authorized sole distributors and stockiest for Tele Haase products in the Middle East Region, and we can supply any products for any industrial applications.
Contact us for more details,
Call: 04 4277207
Email: info@jiselectric.com
Visit: www.jiselectric.com
Lotus Surgicals manufacture medical devices that are a cut above the rest. We offer complete range of Absorbable and Non-absorbable, Braided and Monofilament Sutures catering to every speciality, including cardiovascular and plastic surgery. We also offer other medical device comprising different varieties of surgical mesh, clips and appliers, surgical staplers , surgical kits etc.
The retractable housings are intended solely for measurement tasks in conjunction with the specified METTLER TOLEDO electrodes/sensors, namely pH and redox (ORP) combined electrodes as well as dissolved oxygen (DO) or conductivity sensors.
Similar to BR-ASEPTIC-BARRIER-SYSTEMS-EN-1113 (20)
Retractable Sensor Housings for Analytical Sensors
BR-ASEPTIC-BARRIER-SYSTEMS-EN-1113
1. Aseptic Barrier Systems
Telstar, the only international company offering a complete aseptic production process for the pharmaceutical industry
worldwide utilizing in-house technology.
Providing product protection in all process areas against external environment, operator and bacterial growth
contamination.
BR-ASEPTIC-BARRIER-SYSTEMS-EN-1113
Telstar reserves the right to improvements and specifications changes without notice.
Unit 4, Shaw Cross Business Park
Dewsbury West Yorkshire
WF12 7RF (UK)
T. + 44 (0) 1924 455 339
F. + 44 (0) 1924 452 295
www.telstar-lifesciences.com
The production site where the products are made has been assessed and given ISO 9001:2008 approval.
All equipment is manufactured to allow it to be CE marked in accordance with 98/37/EC Machinery Directive.
1504 Grundy’s Lane
Bristol PA 19007, USA
T +1 (215) 826 0770
F +1 (215) 826 0222
Headquarters
Av. Font i Sagué, 55
08227 Terrassa (Spain)
T +34 937 361 600
F +34 937 861 380
Fully Compliant
Telstar Aseptic Barrier Systems are guaranteed to comply
with relevant standards and demands set by the regulatory
bodies to ensure conformance and clients satisfaction,
including:
• ISO 14644-1 Cleanroom & Associated Controlled
Environment
• FS 209E Airborne Particulate Cleanliness
• cGMP Guidelines (current Good Manufacturing
Practices)
• ISPE guidelines (The Society of Pharmaceutical and
Medical Device Professionals)
• FDA (Food and Drug Administration
• MCA (Medical Control Agency)
• American Glovebox Society Guidelines
Telstar provides a comprehensive validation service to
clients providing FAT/SAT/DQ/IQ/OQ & PQ protocols if
required.
Telstar Aseptic Barrier Isolation Systems
Designed for sterile product and Potent API’s either with
low or high OEL requirements. Airflow systems may
be uni-directional or turbulent. Interfaced with H2O2
generators to provide validated automated surface
sterilisation internal to the Isolator.
• Autoclave Interface
• Liquid & Powder Filling (vials & trays)
• Lyophiliser Auto Load & Un-Load
• Product Transfer
• Dirty Tray transfer, Wetting & Removal
• Bulk Powder Filling (into kegs)
• Bunging / Stoppering / Crimping
• Over bagging & Heat Sealing
• Sterility Testing
Designed, manufactured and supplied - high
quality integrated systems offering:
• Increased efficiency
• Automation
• Flexibility
• Protected critical zones
• Environment free from pathogenic micro
organisms
Custom systems both large & small designed to
specific client requirements operating at positive
pressure and having controlled environmental
internal conditions.
From full filling lines to stand alone single Isolators, barrier systems are designed to provide
solutions adhering to regulatory standards and guidelines. Running at positive pressure during
normal conditions with auto change to negative in the unlikely event of system breech, when toxic
products are involved.
Full consideration and design planning is applied to the product and equipment entry and exit
from the system to ensure the aseptic conditions are maintained throughout the process.
Mobile transfer systems/carts are available with dedicated air handling capabilities. Providing a
ISO 5 aseptic environment the cart is complete with a shelf indexing arrangement for the loading/
unloading and transfer of sterile trays from the tray sterilising tunnel to the process Barrier/Isolator.
The carts feature a connection port with an inflatable seal, docking takes place under the Isolators
unidirectional flow canopy to ensure aseptic conditions. The carts also feature connections and
necessary valve arrangement to allow bio-decontamination via a hydrogen peroxide generator.
Telstar Aseptic Barrier systems are supplied with PLC control platforms supported by the latest
software and Human machine Interface. The HMI provides full integration with the process
equipment.
Purpose designed screens ensure Telstar systems are user friendly, whilst availability of password
controlled access to different user levels and customisation of operation parameters allow secure
management according to client protocols and company quality procedures.
Telstar contained transfer system (CTS), independently tested to below 5 nanograms offers ultimate
safety, simplicity of operation and is easy to decontaminate.
The active port can be used with a passive canister or bag in/ bag out grommet connection. The
purpose of the port is to allow aseptic transfer of materials to and from the Isolator or waste out
of the Isolator in a controlled manner, ensuring the integrity of the Isolators internal environment
remains intact at all times.
Telstar’s standard range of five Sterility Test Isolators are designed to accommodate the rising
demand within the Pharmaceutical industry and can be supplied with various industry standard
decontamination generators according to choice.
Telstar also offers its own in house plasma charged bio-decontamination system, which was
developed by Telstar for use in Isolators, providing a unique cost effective alternative. For more
information on this range please refer to Telstar’s dedicated brochure available for download from
the website.
Scope
Mobile transfers
Control Systems
Contained transfer
Sterility testing
2. As an international leader focused on Quality, Telstar partners
with clients to provide high value on a global basis through
innovation, advanced technology, absolute reliability and
expert project management.
In house expertise in design (strengthened with 3D design
skills) and manufacture of innovative/custom Barrier Isolation
equipment, which requires research and development skills
on a day to day basis.
Telstar is constantly adapting and addressing ever changing
industry needs, evolving inline with regulatory authorities and
industry standards.
Robotic Arm
Full mechanical and software integration of a robotic
arm automates the transfer of empty trays from the
entry door, places them on the ATLUS loading/
unloading frame and fills them with liquid product for
loading into the freeze dryer. The robotic arm is also
employed to retrieve the trays containing the freeze
dried product from the ATLUS frame after unloading
from the freeze dryer, placing them on the exit out
feed conveyor for automated transfer to the vacuum
transfer chamber.
Steriliser Interface
Aseptic interface with the tray sterilising
tunnel, featuring an automated pneumatic
door and inflatable seal.
Recognised Leaders in Aseptic Technology
Telstar rises to demands in pharmaceutical Aseptic and Containment Barrier Isolation equipment, providing solutions for specific
challenges presented by clients’ individual requirements.
Aseptic Barrier Isolation is an ever more important part of any pharmaceutical process. A clear understanding of the process is
paramount to its success.
Telstar Life Sciences UK Ltd, is the centre of excellence for the Aseptic and Containment Barrier Isolation technology of Telstar.
Attention to detail makes all the difference when designing the right solution.
A leading pharmaceutical company report stated almost 25% of all lost time illnesses
were caused by ergonomic related issues.
Telstar put great emphasis on the need to perform ergonomic trials, at the onset of all
projects to identify issues and prevent them becoming a problem. Models together
with trials serve to simulate the process operations involved.
Supported by continual investment in 3D software technology operated by design
personnel from an engineering background.
3D design provides a clearer visualisation of the entire project preventing clashes,
resulting in accurate production of 2D drawing elevations.
Telstars hallmark at every stage:
• Exacting attention to detail and complete
understanding of the process.
• Evaluating and understanding process
equipment operations, containment,
ergonomic issues and stringent ergonomic
trials are critical elements to success.
• Identifying critical issues and preventing
potentially costly problems before they occur.
Vacuum transfer chamber
Operators work through gloves using a
vacuum lance to aseptically transfer the
freeze dried product from trays, via a
high efficiency cyclone transfer system
mounted on a frame above the receiving
IBC.
Tray wetting chamber
Located outside the clean room, with a
‘through-wall’ connection where trays
are wetted before exit and transfer to a
tray cleaning station.
Telstar provides complete systems, integrating high quality barrier
systems with either Telstar process equipment or third party devices.
If required Telstar’s systems can be designed to fully interface with Telstar
or third party Lyophilisers, loading/unloading systems and robotic arms
to fully automate processes, for example liquid product tray filling prior
to the freeze drying process.
To facilitate dried powder product transfer and pack-off following the
freeze drying process we are able to provide highly successful solutions
implementing high efficiency cyclone vacuum devices coupled to
IBC/s, post hoist/conical blending and IBC lifting. Automated weighing,
sampling and filling systems provide end product pack-off to clients
choice of container.
Additionally Telstar barrier systems can be designed to provide aseptic
barriers between the operator and other process equipment including
vial filling lines, capping machines, washing machines, autoclaves and
sterilising tunnels.
Illustrations showcase Telstar’s global capability, which is achieved by
close collaboration between Telstar’s global centres of excellence. The
barrier systems expertise is proven by Telstar’s Life Science UK division
located at Dewsbury in the UK.
Telstar designs, supplies and installs custom barrier systems for
an extensive range of sterile drug manufacture.
Telstar’s high quality systems provide the required internal
aseptic environment for sterile powder manufacture, ensuring
achievement of full European and FDA Approvals.
Telstar’s barrier systems are innovative and flexible
accommodating all aspects of the manufacturing process.
Telstar’s vast experience and capability to develop and
manufacture these systems entirely in-house provides a cost-
effective solution and assures quality control over the whole
process.
Inclusion of CIP/SIP systems and Bio-decontamination
generators/cycles, provide the required aseptic conditions.
Humidity and temperature control is offered to maintain the
internal environmental parameters.
Integration includes ergonomically proved mechanical
interfacing supported by software controls and instrumentation
via PLC platforms and HMI operator interface.
Aseptic bulk product pack-off line
Bulk product contained in an IBC can be blended on a post hoist
or dedicated conical blender prior to pack-off.
Final product is filled, crimped and sealed into aluminium kegs.
Mock-ups and ergonomic trials
3. Aseptic Barrier Systems
Telstar, the only international company offering a complete aseptic production process for the pharmaceutical industry
worldwide utilizing in-house technology.
Providing product protection in all process areas against external environment, operator and bacterial growth
contamination.
BR-ASEPTIC-BARRIER-SYSTEMS-EN-1113
Telstar reserves the right to improvements and specifications changes without notice.
Unit 4, Shaw Cross Business Park
Dewsbury West Yorkshire
WF12 7RF (UK)
T. + 44 (0) 1924 455 339
F. + 44 (0) 1924 452 295
www.telstar-lifesciences.com
The production site where the products are made has been assessed and given ISO 9001:2008 approval.
All equipment is manufactured to allow it to be CE marked in accordance with 98/37/EC Machinery Directive.
1504 Grundy’s Lane
Bristol PA 19007, USA
T +1 (215) 826 0770
F +1 (215) 826 0222
Headquarters
Av. Font i Sagué, 55
08227 Terrassa (Spain)
T +34 937 361 600
F +34 937 861 380
Fully Compliant
Telstar Aseptic Barrier Systems are guaranteed to comply
with relevant standards and demands set by the regulatory
bodies to ensure conformance and clients satisfaction,
including:
• ISO 14644-1 Cleanroom & Associated Controlled
Environment
• FS 209E Airborne Particulate Cleanliness
• cGMP Guidelines (current Good Manufacturing
Practices)
• ISPE guidelines (The Society of Pharmaceutical and
Medical Device Professionals)
• FDA (Food and Drug Administration
• MCA (Medical Control Agency)
• American Glovebox Society Guidelines
Telstar provides a comprehensive validation service to
clients providing FAT/SAT/DQ/IQ/OQ & PQ protocols if
required.
Telstar Aseptic Barrier Isolation Systems
Designed for sterile product and Potent API’s either with
low or high OEL requirements. Airflow systems may
be uni-directional or turbulent. Interfaced with H2O2
generators to provide validated automated surface
sterilisation internal to the Isolator.
• Autoclave Interface
• Liquid & Powder Filling (vials & trays)
• Lyophiliser Auto Load & Un-Load
• Product Transfer
• Dirty Tray transfer, Wetting & Removal
• Bulk Powder Filling (into kegs)
• Bunging / Stoppering / Crimping
• Over bagging & Heat Sealing
• Sterility Testing
Designed, manufactured and supplied - high
quality integrated systems offering:
• Increased efficiency
• Automation
• Flexibility
• Protected critical zones
• Environment free from pathogenic micro
organisms
Custom systems both large & small designed to
specific client requirements operating at positive
pressure and having controlled environmental
internal conditions.
From full filling lines to stand alone single Isolators, barrier systems are designed to provide
solutions adhering to regulatory standards and guidelines. Running at positive pressure during
normal conditions with auto change to negative in the unlikely event of system breech, when toxic
products are involved.
Full consideration and design planning is applied to the product and equipment entry and exit
from the system to ensure the aseptic conditions are maintained throughout the process.
Mobile transfer systems/carts are available with dedicated air handling capabilities. Providing a
ISO 5 aseptic environment the cart is complete with a shelf indexing arrangement for the loading/
unloading and transfer of sterile trays from the tray sterilising tunnel to the process Barrier/Isolator.
The carts feature a connection port with an inflatable seal, docking takes place under the Isolators
unidirectional flow canopy to ensure aseptic conditions. The carts also feature connections and
necessary valve arrangement to allow bio-decontamination via a hydrogen peroxide generator.
Telstar Aseptic Barrier systems are supplied with PLC control platforms supported by the latest
software and Human machine Interface. The HMI provides full integration with the process
equipment.
Purpose designed screens ensure Telstar systems are user friendly, whilst availability of password
controlled access to different user levels and customisation of operation parameters allow secure
management according to client protocols and company quality procedures.
Telstar contained transfer system (CTS), independently tested to below 5 nanograms offers ultimate
safety, simplicity of operation and is easy to decontaminate.
The active port can be used with a passive canister or bag in/ bag out grommet connection. The
purpose of the port is to allow aseptic transfer of materials to and from the Isolator or waste out
of the Isolator in a controlled manner, ensuring the integrity of the Isolators internal environment
remains intact at all times.
Telstar’s standard range of five Sterility Test Isolators are designed to accommodate the rising
demand within the Pharmaceutical industry and can be supplied with various industry standard
decontamination generators according to choice.
Telstar also offers its own in house plasma charged bio-decontamination system, which was
developed by Telstar for use in Isolators, providing a unique cost effective alternative. For more
information on this range please refer to Telstar’s dedicated brochure available for download from
the website.
Scope
Mobile transfers
Control Systems
Contained transfer
Sterility testing
4. As an international leader focused on Quality, Telstar partners
with clients to provide high value on a global basis through
innovation, advanced technology, absolute reliability and
expert project management.
In house expertise in design (strengthened with 3D design
skills) and manufacture of innovative/custom Barrier Isolation
equipment, which requires research and development skills
on a day to day basis.
Telstar is constantly adapting and addressing ever changing
industry needs, evolving inline with regulatory authorities and
industry standards.
Robotic Arm
Full mechanical and software integration of a robotic
arm automates the transfer of empty trays from the
entry door, places them on the ATLUS loading/
unloading frame and fills them with liquid product for
loading into the freeze dryer. The robotic arm is also
employed to retrieve the trays containing the freeze
dried product from the ATLUS frame after unloading
from the freeze dryer, placing them on the exit out
feed conveyor for automated transfer to the vacuum
transfer chamber.
Steriliser Interface
Aseptic interface with the tray sterilising
tunnel, featuring an automated pneumatic
door and inflatable seal.
Recognised Leaders in Aseptic Technology
Telstar rises to demands in pharmaceutical Aseptic and Containment Barrier Isolation equipment, providing solutions for specific
challenges presented by clients’ individual requirements.
Aseptic Barrier Isolation is an ever more important part of any pharmaceutical process. A clear understanding of the process is
paramount to its success.
Telstar Life Sciences UK Ltd, is the centre of excellence for the Aseptic and Containment Barrier Isolation technology of Telstar.
Attention to detail makes all the difference when designing the right solution.
A leading pharmaceutical company report stated almost 25% of all lost time illnesses
were caused by ergonomic related issues.
Telstar put great emphasis on the need to perform ergonomic trials, at the onset of all
projects to identify issues and prevent them becoming a problem. Models together
with trials serve to simulate the process operations involved.
Supported by continual investment in 3D software technology operated by design
personnel from an engineering background.
3D design provides a clearer visualisation of the entire project preventing clashes,
resulting in accurate production of 2D drawing elevations.
Telstars hallmark at every stage:
• Exacting attention to detail and complete
understanding of the process.
• Evaluating and understanding process
equipment operations, containment,
ergonomic issues and stringent ergonomic
trials are critical elements to success.
• Identifying critical issues and preventing
potentially costly problems before they occur.
Vacuum transfer chamber
Operators work through gloves using a
vacuum lance to aseptically transfer the
freeze dried product from trays, via a
high efficiency cyclone transfer system
mounted on a frame above the receiving
IBC.
Tray wetting chamber
Located outside the clean room, with a
‘through-wall’ connection where trays
are wetted before exit and transfer to a
tray cleaning station.
Telstar provides complete systems, integrating high quality barrier
systems with either Telstar process equipment or third party devices.
If required Telstar’s systems can be designed to fully interface with Telstar
or third party Lyophilisers, loading/unloading systems and robotic arms
to fully automate processes, for example liquid product tray filling prior
to the freeze drying process.
To facilitate dried powder product transfer and pack-off following the
freeze drying process we are able to provide highly successful solutions
implementing high efficiency cyclone vacuum devices coupled to
IBC/s, post hoist/conical blending and IBC lifting. Automated weighing,
sampling and filling systems provide end product pack-off to clients
choice of container.
Additionally Telstar barrier systems can be designed to provide aseptic
barriers between the operator and other process equipment including
vial filling lines, capping machines, washing machines, autoclaves and
sterilising tunnels.
Illustrations showcase Telstar’s global capability, which is achieved by
close collaboration between Telstar’s global centres of excellence. The
barrier systems expertise is proven by Telstar’s Life Science UK division
located at Dewsbury in the UK.
Telstar designs, supplies and installs custom barrier systems for
an extensive range of sterile drug manufacture.
Telstar’s high quality systems provide the required internal
aseptic environment for sterile powder manufacture, ensuring
achievement of full European and FDA Approvals.
Telstar’s barrier systems are innovative and flexible
accommodating all aspects of the manufacturing process.
Telstar’s vast experience and capability to develop and
manufacture these systems entirely in-house provides a cost-
effective solution and assures quality control over the whole
process.
Inclusion of CIP/SIP systems and Bio-decontamination
generators/cycles, provide the required aseptic conditions.
Humidity and temperature control is offered to maintain the
internal environmental parameters.
Integration includes ergonomically proved mechanical
interfacing supported by software controls and instrumentation
via PLC platforms and HMI operator interface.
Aseptic bulk product pack-off line
Bulk product contained in an IBC can be blended on a post hoist
or dedicated conical blender prior to pack-off.
Final product is filled, crimped and sealed into aluminium kegs.
Mock-ups and ergonomic trials
5. As an international leader focused on Quality, Telstar partners
with clients to provide high value on a global basis through
innovation, advanced technology, absolute reliability and
expert project management.
In house expertise in design (strengthened with 3D design
skills) and manufacture of innovative/custom Barrier Isolation
equipment, which requires research and development skills
on a day to day basis.
Telstar is constantly adapting and addressing ever changing
industry needs, evolving inline with regulatory authorities and
industry standards.
Robotic Arm
Full mechanical and software integration of a robotic
arm automates the transfer of empty trays from the
entry door, places them on the ATLUS loading/
unloading frame and fills them with liquid product for
loading into the freeze dryer. The robotic arm is also
employed to retrieve the trays containing the freeze
dried product from the ATLUS frame after unloading
from the freeze dryer, placing them on the exit out
feed conveyor for automated transfer to the vacuum
transfer chamber.
Steriliser Interface
Aseptic interface with the tray sterilising
tunnel, featuring an automated pneumatic
door and inflatable seal.
Recognised Leaders in Aseptic Technology
Telstar rises to demands in pharmaceutical Aseptic and Containment Barrier Isolation equipment, providing solutions for specific
challenges presented by clients’ individual requirements.
Aseptic Barrier Isolation is an ever more important part of any pharmaceutical process. A clear understanding of the process is
paramount to its success.
Telstar Life Sciences UK Ltd, is the centre of excellence for the Aseptic and Containment Barrier Isolation technology of Telstar.
Attention to detail makes all the difference when designing the right solution.
A leading pharmaceutical company report stated almost 25% of all lost time illnesses
were caused by ergonomic related issues.
Telstar put great emphasis on the need to perform ergonomic trials, at the onset of all
projects to identify issues and prevent them becoming a problem. Models together
with trials serve to simulate the process operations involved.
Supported by continual investment in 3D software technology operated by design
personnel from an engineering background.
3D design provides a clearer visualisation of the entire project preventing clashes,
resulting in accurate production of 2D drawing elevations.
Telstars hallmark at every stage:
• Exacting attention to detail and complete
understanding of the process.
• Evaluating and understanding process
equipment operations, containment,
ergonomic issues and stringent ergonomic
trials are critical elements to success.
• Identifying critical issues and preventing
potentially costly problems before they occur.
Vacuum transfer chamber
Operators work through gloves using a
vacuum lance to aseptically transfer the
freeze dried product from trays, via a
high efficiency cyclone transfer system
mounted on a frame above the receiving
IBC.
Tray wetting chamber
Located outside the clean room, with a
‘through-wall’ connection where trays
are wetted before exit and transfer to a
tray cleaning station.
Telstar provides complete systems, integrating high quality barrier
systems with either Telstar process equipment or third party devices.
If required Telstar’s systems can be designed to fully interface with Telstar
or third party Lyophilisers, loading/unloading systems and robotic arms
to fully automate processes, for example liquid product tray filling prior
to the freeze drying process.
To facilitate dried powder product transfer and pack-off following the
freeze drying process we are able to provide highly successful solutions
implementing high efficiency cyclone vacuum devices coupled to
IBC/s, post hoist/conical blending and IBC lifting. Automated weighing,
sampling and filling systems provide end product pack-off to clients
choice of container.
Additionally Telstar barrier systems can be designed to provide aseptic
barriers between the operator and other process equipment including
vial filling lines, capping machines, washing machines, autoclaves and
sterilising tunnels.
Illustrations showcase Telstar’s global capability, which is achieved by
close collaboration between Telstar’s global centres of excellence. The
barrier systems expertise is proven by Telstar’s Life Science UK division
located at Dewsbury in the UK.
Telstar designs, supplies and installs custom barrier systems for
an extensive range of sterile drug manufacture.
Telstar’s high quality systems provide the required internal
aseptic environment for sterile powder manufacture, ensuring
achievement of full European and FDA Approvals.
Telstar’s barrier systems are innovative and flexible
accommodating all aspects of the manufacturing process.
Telstar’s vast experience and capability to develop and
manufacture these systems entirely in-house provides a cost-
effective solution and assures quality control over the whole
process.
Inclusion of CIP/SIP systems and Bio-decontamination
generators/cycles, provide the required aseptic conditions.
Humidity and temperature control is offered to maintain the
internal environmental parameters.
Integration includes ergonomically proved mechanical
interfacing supported by software controls and instrumentation
via PLC platforms and HMI operator interface.
Aseptic bulk product pack-off line
Bulk product contained in an IBC can be blended on a post hoist
or dedicated conical blender prior to pack-off.
Final product is filled, crimped and sealed into aluminium kegs.
Mock-ups and ergonomic trials
6. Aseptic Barrier Systems
Telstar, the only international company offering a complete aseptic production process for the pharmaceutical industry
worldwide utilizing in-house technology.
Providing product protection in all process areas against external environment, operator and bacterial growth
contamination.
BR-ASEPTIC-BARRIER-SYSTEMS-EN-1113
Telstar reserves the right to improvements and specifications changes without notice.
Unit 4, Shaw Cross Business Park
Dewsbury West Yorkshire
WF12 7RF (UK)
T. + 44 (0) 1924 455 339
F. + 44 (0) 1924 452 295
www.telstar-lifesciences.com
The production site where the products are made has been assessed and given ISO 9001:2008 approval.
All equipment is manufactured to allow it to be CE marked in accordance with 98/37/EC Machinery Directive.
1504 Grundy’s Lane
Bristol PA 19007, USA
T +1 (215) 826 0770
F +1 (215) 826 0222
Headquarters
Av. Font i Sagué, 55
08227 Terrassa (Spain)
T +34 937 361 600
F +34 937 861 380
Fully Compliant
Telstar Aseptic Barrier Systems are guaranteed to comply
with relevant standards and demands set by the regulatory
bodies to ensure conformance and clients satisfaction,
including:
• ISO 14644-1 Cleanroom & Associated Controlled
Environment
• FS 209E Airborne Particulate Cleanliness
• cGMP Guidelines (current Good Manufacturing
Practices)
• ISPE guidelines (The Society of Pharmaceutical and
Medical Device Professionals)
• FDA (Food and Drug Administration
• MCA (Medical Control Agency)
• American Glovebox Society Guidelines
Telstar provides a comprehensive validation service to
clients providing FAT/SAT/DQ/IQ/OQ & PQ protocols if
required.
Telstar Aseptic Barrier Isolation Systems
Designed for sterile product and Potent API’s either with
low or high OEL requirements. Airflow systems may
be uni-directional or turbulent. Interfaced with H2O2
generators to provide validated automated surface
sterilisation internal to the Isolator.
• Autoclave Interface
• Liquid & Powder Filling (vials & trays)
• Lyophiliser Auto Load & Un-Load
• Product Transfer
• Dirty Tray transfer, Wetting & Removal
• Bulk Powder Filling (into kegs)
• Bunging / Stoppering / Crimping
• Over bagging & Heat Sealing
• Sterility Testing
Designed, manufactured and supplied - high
quality integrated systems offering:
• Increased efficiency
• Automation
• Flexibility
• Protected critical zones
• Environment free from pathogenic micro
organisms
Custom systems both large & small designed to
specific client requirements operating at positive
pressure and having controlled environmental
internal conditions.
From full filling lines to stand alone single Isolators, barrier systems are designed to provide
solutions adhering to regulatory standards and guidelines. Running at positive pressure during
normal conditions with auto change to negative in the unlikely event of system breech, when toxic
products are involved.
Full consideration and design planning is applied to the product and equipment entry and exit
from the system to ensure the aseptic conditions are maintained throughout the process.
Mobile transfer systems/carts are available with dedicated air handling capabilities. Providing a
ISO 5 aseptic environment the cart is complete with a shelf indexing arrangement for the loading/
unloading and transfer of sterile trays from the tray sterilising tunnel to the process Barrier/Isolator.
The carts feature a connection port with an inflatable seal, docking takes place under the Isolators
unidirectional flow canopy to ensure aseptic conditions. The carts also feature connections and
necessary valve arrangement to allow bio-decontamination via a hydrogen peroxide generator.
Telstar Aseptic Barrier systems are supplied with PLC control platforms supported by the latest
software and Human machine Interface. The HMI provides full integration with the process
equipment.
Purpose designed screens ensure Telstar systems are user friendly, whilst availability of password
controlled access to different user levels and customisation of operation parameters allow secure
management according to client protocols and company quality procedures.
Telstar contained transfer system (CTS), independently tested to below 5 nanograms offers ultimate
safety, simplicity of operation and is easy to decontaminate.
The active port can be used with a passive canister or bag in/ bag out grommet connection. The
purpose of the port is to allow aseptic transfer of materials to and from the Isolator or waste out
of the Isolator in a controlled manner, ensuring the integrity of the Isolators internal environment
remains intact at all times.
Telstar’s standard range of five Sterility Test Isolators are designed to accommodate the rising
demand within the Pharmaceutical industry and can be supplied with various industry standard
decontamination generators according to choice.
Telstar also offers its own in house plasma charged bio-decontamination system, which was
developed by Telstar for use in Isolators, providing a unique cost effective alternative. For more
information on this range please refer to Telstar’s dedicated brochure available for download from
the website.
Scope
Mobile transfers
Control Systems
Contained transfer
Sterility testing