Telstar offers a range of containment isolators from single chambers to multi-chamber systems to accommodate process equipment. Their isolators are designed to provide a locally controlled negative pressure environment to protect operators and the external environment from potent products. Telstar has expertise in designing, manufacturing, and installing customized isolator systems both with and without integrated process equipment.
Freeze Driers (Lyophilizers) by ACMAS Technologies Pvt Ltd.
BR-CONTAINMENT-BARRIER-SYSTEMS-EN-0214
1. Containment Barrier Systems
With the accelerated production of highly potent pharmaceutical drugs, the need for containment technology and
interest in Isolators is on the increase.
Telstar has the expertise to meet the rising challenges by offering an impressive range of containment Isolators, from
single chambers to multi chamber systems accommodating where necessary a wide range of process equipment.
BR-CONTAINMENT-BARRIER-SYSTEMS-EN-0214
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 Containment 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)
• FDA (Food and Drug Administration)
• MCA (Medical Control Agency)
• ISPE guidelines (The Society of Pharmaceutical and
Medical Device Professionals)
• American Glovebox Society Guidelines
• FDA 21CFR Part 11
Telstar provides a comprehensive validation service to
clients providing FAT/SAT/DQ/IQ/OQ & PQ protocols if
required.
Telstar Barrier Containment Isolation
Designed to provide operator protection from airborne
particles and Potent APIs for a wide range of process
applications, with and without integrated process
equipment including:
• Dispensing / Weighing / Sampling
• Sieving / Blending
• Charging / API Addition
• Mixing / Granulation
• Centrifuge
• Freeze Dryer Off-Load / Pack-Off
• Filter Dryer Off-Load / Pack-Off
• Milling / Micronising
• Tabletting
• Final Packing / Blister Pack
Isolators for API’s and cytotoxic compounds have been
independently verified to achieve operator protection
levels down to 0.2ng/m3 (0.0002 µg/m3)
Telstar Isolators are designed to provide a locally
controlled environment operating at negative
pressure, with the ability to control and monitor
all operating parameters. Providing protection to
the operator and the external environment from
the highly potent products.
Designed, manufactured, supplied and installed
- high quality stand alone or integrated systems
with or without process equipment, offering cost
efficient customised and standard solutions.
single chambers to multi chamber systems accommodating where necessary a wide range of process equipment.
Telstar Isolators are designed to provide a locally
controlled environment operating at negative
pressure, with the ability to control and monitor
all operating parameters. Providing protection to
the operator and the external environment from
the highly potent products.
Designed, manufactured, supplied and installed
- high quality stand alone or integrated systems
with or without process equipment, offering cost
efficient customised and standard solutions.
Multi Chamber Weighing, Dispensing
& Sampling Isolator
Product loading is a critical process in all barrier containment systems. At Telstar we are familiar with
the many specific requirements and challenges presented during Pharmaceutical API production.
Drum loading via an inflatable seal with an internal door is just one of a variety of solutions
available, providing an airtight seal to ensure the integrity of the Isolators internal negative pressure
conditions.
PLC based control systems utilising a Siemens PLC platform is offered as standard complete with
I/O according the specific equipment providing a fully automated system, supported by Ethernet
communication enabling critical parameters to be communicated to an external DCS system.
A fully compatible Touch Panel HMI provides operator interface, for control, indications, display
of Isolator conditions and alarm handling. Located in a suitable position on the Isolator service
plenum it is easy to reach and observe by operators.
The Telstar Glove Tester device enables both in situ and off line testing of gloves, if fitted to a
Telstar glove ring. This simple device works solely on air to test the glove integrity.
The system consists of a glove port test plug with inflatable seal, which is inserted into the glove
port. The seal is inflated making an air tight seal to the glove port. The glove is inflated to a test
pressure and the pressure decay of the glove is monitored over a period of time. At the end of this
test period the pressure decay is recorded and the leakage rate of the glove determined.
The Telstar Glove Tester is available as an integrated device (Isolator dedicated) and alternatively
a mobile device to serve multiple Isolators.
Telstar contained transfer system (CTS), independently tested to below 0.2 nanograms offers
ultimate safety, simplicity of operation and is easy to decontaminate.
The active port is designed to be used with a passive canister and or bag in / bag out grommet
connection. The purpose of the port is to allow contained transfer of materials to and from the
Isolator or waste out of the Isolator in a controlled manner, without breaking containment, ensuring
operator protection from the internal environment at all times.
Spray guns and rotating spray balls for WIP are offered as an option for manual cleaning /
decontamination of the Isolator.
Available in PFA or stainless steel the wash guns are suitable for use in all Telstar Isolators handling
pharmaceutical compounds.
Triclover service entries complete with manually operated ball valves will be supplied in the wall of
the Isolator for connection of the clients WIP media and in the base of the Isolator for connection
of the clients WIP drain outlet.
Dispensing & Transfer Isolators with WIP/DIP Skid
2. Recognised Leaders in Containment Barrier Technology
Telstar rises to demands in pharmaceutical Containment Barrier Isolation equipment, providing solutions for specific challenges
presented by clients’ individual requirements.
Containment 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 Barrier Containment Isolation technology of Telstar. Attention to
detail makes all the difference when designing the right solution.
Telstars hallmark at every stage:
• Exacting attention to detail and getting to know 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.
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 and accurate
production of 2D drawing elevations.
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 government regulations
and industry standards.
At Telstar we are alert to the vast requirements of the Pharmaceutical Industry and the ever
increasing demand to provide cost efficient solutions for both small and large scale containment
projects.
Powder handling of HPAPI/API product is an area which constantly presents new challenges to
safeguard the operator during pharmaceutical drug production.
Telstar showcases simplicity at it’s finest with regards to a Standard Range of containment
Isolators.
Standard Range
The Telstar Standard Range offers a
choice of single working chambers
featuring 2/3/4 glove port access.
These standard ergonomically trialled
base designs customised with various
accessories provide cost effective
tailored solutions to optimise capital
outlay.
The addition of a transfer chamber
increases the flexibility for small
scale processes such as: weighing,
dispensing, sampling, charging, milling/
sieving, testing.
For more innovative/custom Barrier
Isolation solutions Telstar offer purpose
designed Isolators.
Telstar excels in providing complete
systems with fully integrated process
equipment and specialised internal
environment conditions to suit specific
production requirements.
Lab scale production of highly potent intermediates and
active ingredients often require an extensive range of bench
mounted process equipment to carry out procedures such as
filtration and solution preparation.
This Isolator was supplied fully integrated with lab scale
glass reactors, complete with stirrer motor, glass condenser
and cooling/heating via thermostat control and evaporator
equipped with vacuum pump.
Fully GMP compliant, the high specification of the Isolator
system eliminates the need for part of the production to
be carried out in clean room conditions and reduces time
consuming gowning up procedures.
R+D Laboratory Isolator
Successful design and manufacture of production scale
containment systems demand a complete understanding of
the actual process. Telstar has accumulated over 20 years
experience specialising in providing high level customised
systems to ISO 7 & ISO 8 classification. Running at negative
pressure to the surrounding environment/room to provide
operator protection during manual handling operations.
Electrically controlled raise / lower operator
platform, provides a comfortable ergonomic
working position throughout the process
operations.
For high containment multiple drum batch
campaigns a rear chamber is recommended
with automatic drum manipulation.
Available in electric or pneumatic versions.
Some liquefied products, which may be harmless
to the operator before the lyophilising process, may
present an issue in powder format due to it’s toxic
content. Interfacing with a containment Isolator then
becomes paramount for operator protection.
Tray storage carts are used for transfer of autoclaved
trays to the Isolator for filling/loading & removal of
used trays.
The Telstar automatic tray load/unload system
(ATLUS) facilitates the loading and unloading of
trays filled with liquefied product into the Telstar
Lyophiliser.
Custom built Formulation Isolator
interfaced with a fixed glass lined reactor
vessel located at the rear.
Access to glove ports assisted by
operator platform designed for hard
fixing to facility wall.
Fully integrated internal weigh system
and external vessel load cells allows
powder product to be weighed before
being charged into reactor.
Lyophiliser Tray Load/
Unload Isolator
Formulation Isolator
Lab scale production of highly potent intermediates and
active ingredients often require an extensive range of bench
mounted process equipment to carry out procedures such as
This Isolator was supplied fully integrated with lab scale
glass reactors, complete with stirrer motor, glass condenser
and cooling/heating via thermostat control and evaporator
Fully GMP compliant, the high specification of the Isolator
system eliminates the need for part of the production to
be carried out in clean room conditions and reduces time
operator protection during manual handling operations.
Electrically controlled raise / lower operator
platform, provides a comfortable ergonomic
working position throughout the process
operations.
For high containment multiple drum batch
campaigns a rear chamber is recommended
with automatic drum manipulation.
Available in electric or pneumatic versions.
Multi Chamber Sub-division,
Dispensing & Sampling Isolator
3. Containment Barrier Systems
With the accelerated production of highly potent pharmaceutical drugs, the need for containment technology and
interest in Isolators is on the increase.
Telstar has the expertise to meet the rising challenges by offering an impressive range of containment Isolators, from
single chambers to multi chamber systems accommodating where necessary a wide range of process equipment.
BR-CONTAINMENT-BARRIER-SYSTEMS-EN-0214
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 Containment 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)
• FDA (Food and Drug Administration)
• MCA (Medical Control Agency)
• ISPE guidelines (The Society of Pharmaceutical and
Medical Device Professionals)
• American Glovebox Society Guidelines
• FDA 21CFR Part 11
Telstar provides a comprehensive validation service to
clients providing FAT/SAT/DQ/IQ/OQ & PQ protocols if
required.
Telstar Barrier Containment Isolation
Designed to provide operator protection from airborne
particles and Potent APIs for a wide range of process
applications, with and without integrated process
equipment including:
• Dispensing / Weighing / Sampling
• Sieving / Blending
• Charging / API Addition
• Mixing / Granulation
• Centrifuge
• Freeze Dryer Off-Load / Pack-Off
• Filter Dryer Off-Load / Pack-Off
• Milling / Micronising
• Tabletting
• Final Packing / Blister Pack
Isolators for API’s and cytotoxic compounds have been
independently verified to achieve operator protection
levels down to 0.2ng/m3 (0.0002 µg/m3)
Telstar Isolators are designed to provide a locally
controlled environment operating at negative
pressure, with the ability to control and monitor
all operating parameters. Providing protection to
the operator and the external environment from
the highly potent products.
Designed, manufactured, supplied and installed
- high quality stand alone or integrated systems
with or without process equipment, offering cost
efficient customised and standard solutions.
single chambers to multi chamber systems accommodating where necessary a wide range of process equipment.
Telstar Isolators are designed to provide a locally
controlled environment operating at negative
pressure, with the ability to control and monitor
all operating parameters. Providing protection to
the operator and the external environment from
the highly potent products.
Designed, manufactured, supplied and installed
- high quality stand alone or integrated systems
with or without process equipment, offering cost
efficient customised and standard solutions.
Multi Chamber Weighing, Dispensing
& Sampling Isolator
Product loading is a critical process in all barrier containment systems. At Telstar we are familiar with
the many specific requirements and challenges presented during Pharmaceutical API production.
Drum loading via an inflatable seal with an internal door is just one of a variety of solutions
available, providing an airtight seal to ensure the integrity of the Isolators internal negative pressure
conditions.
PLC based control systems utilising a Siemens PLC platform is offered as standard complete with
I/O according the specific equipment providing a fully automated system, supported by Ethernet
communication enabling critical parameters to be communicated to an external DCS system.
A fully compatible Touch Panel HMI provides operator interface, for control, indications, display
of Isolator conditions and alarm handling. Located in a suitable position on the Isolator service
plenum it is easy to reach and observe by operators.
The Telstar Glove Tester device enables both in situ and off line testing of gloves, if fitted to a
Telstar glove ring. This simple device works solely on air to test the glove integrity.
The system consists of a glove port test plug with inflatable seal, which is inserted into the glove
port. The seal is inflated making an air tight seal to the glove port. The glove is inflated to a test
pressure and the pressure decay of the glove is monitored over a period of time. At the end of this
test period the pressure decay is recorded and the leakage rate of the glove determined.
The Telstar Glove Tester is available as an integrated device (Isolator dedicated) and alternatively
a mobile device to serve multiple Isolators.
Telstar contained transfer system (CTS), independently tested to below 0.2 nanograms offers
ultimate safety, simplicity of operation and is easy to decontaminate.
The active port is designed to be used with a passive canister and or bag in / bag out grommet
connection. The purpose of the port is to allow contained transfer of materials to and from the
Isolator or waste out of the Isolator in a controlled manner, without breaking containment, ensuring
operator protection from the internal environment at all times.
Spray guns and rotating spray balls for WIP are offered as an option for manual cleaning /
decontamination of the Isolator.
Available in PFA or stainless steel the wash guns are suitable for use in all Telstar Isolators handling
pharmaceutical compounds.
Triclover service entries complete with manually operated ball valves will be supplied in the wall of
the Isolator for connection of the clients WIP media and in the base of the Isolator for connection
of the clients WIP drain outlet.
Dispensing & Transfer Isolators with WIP/DIP Skid
4. Recognised Leaders in Containment Barrier Technology
Telstar rises to demands in pharmaceutical Containment Barrier Isolation equipment, providing solutions for specific challenges
presented by clients’ individual requirements.
Containment 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 Barrier Containment Isolation technology of Telstar. Attention to
detail makes all the difference when designing the right solution.
Telstars hallmark at every stage:
• Exacting attention to detail and getting to know 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.
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 and accurate
production of 2D drawing elevations.
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 government regulations
and industry standards.
At Telstar we are alert to the vast requirements of the Pharmaceutical Industry and the ever
increasing demand to provide cost efficient solutions for both small and large scale containment
projects.
Powder handling of HPAPI/API product is an area which constantly presents new challenges to
safeguard the operator during pharmaceutical drug production.
Telstar showcases simplicity at it’s finest with regards to a Standard Range of containment
Isolators.
Standard Range
The Telstar Standard Range offers a
choice of single working chambers
featuring 2/3/4 glove port access.
These standard ergonomically trialled
base designs customised with various
accessories provide cost effective
tailored solutions to optimise capital
outlay.
The addition of a transfer chamber
increases the flexibility for small
scale processes such as: weighing,
dispensing, sampling, charging, milling/
sieving, testing.
For more innovative/custom Barrier
Isolation solutions Telstar offer purpose
designed Isolators.
Telstar excels in providing complete
systems with fully integrated process
equipment and specialised internal
environment conditions to suit specific
production requirements.
Lab scale production of highly potent intermediates and
active ingredients often require an extensive range of bench
mounted process equipment to carry out procedures such as
filtration and solution preparation.
This Isolator was supplied fully integrated with lab scale
glass reactors, complete with stirrer motor, glass condenser
and cooling/heating via thermostat control and evaporator
equipped with vacuum pump.
Fully GMP compliant, the high specification of the Isolator
system eliminates the need for part of the production to
be carried out in clean room conditions and reduces time
consuming gowning up procedures.
R+D Laboratory Isolator
Successful design and manufacture of production scale
containment systems demand a complete understanding of
the actual process. Telstar has accumulated over 20 years
experience specialising in providing high level customised
systems to ISO 7 & ISO 8 classification. Running at negative
pressure to the surrounding environment/room to provide
operator protection during manual handling operations.
Electrically controlled raise / lower operator
platform, provides a comfortable ergonomic
working position throughout the process
operations.
For high containment multiple drum batch
campaigns a rear chamber is recommended
with automatic drum manipulation.
Available in electric or pneumatic versions.
Some liquefied products, which may be harmless
to the operator before the lyophilising process, may
present an issue in powder format due to it’s toxic
content. Interfacing with a containment Isolator then
becomes paramount for operator protection.
Tray storage carts are used for transfer of autoclaved
trays to the Isolator for filling/loading & removal of
used trays.
The Telstar automatic tray load/unload system
(ATLUS) facilitates the loading and unloading of
trays filled with liquefied product into the Telstar
Lyophiliser.
Custom built Formulation Isolator
interfaced with a fixed glass lined reactor
vessel located at the rear.
Access to glove ports assisted by
operator platform designed for hard
fixing to facility wall.
Fully integrated internal weigh system
and external vessel load cells allows
powder product to be weighed before
being charged into reactor.
Lyophiliser Tray Load/
Unload Isolator
Formulation Isolator
Lab scale production of highly potent intermediates and
active ingredients often require an extensive range of bench
mounted process equipment to carry out procedures such as
This Isolator was supplied fully integrated with lab scale
glass reactors, complete with stirrer motor, glass condenser
and cooling/heating via thermostat control and evaporator
Fully GMP compliant, the high specification of the Isolator
system eliminates the need for part of the production to
be carried out in clean room conditions and reduces time
operator protection during manual handling operations.
Electrically controlled raise / lower operator
platform, provides a comfortable ergonomic
working position throughout the process
operations.
For high containment multiple drum batch
campaigns a rear chamber is recommended
with automatic drum manipulation.
Available in electric or pneumatic versions.
Multi Chamber Sub-division,
Dispensing & Sampling Isolator
5. Recognised Leaders in Containment Barrier Technology
Telstar rises to demands in pharmaceutical Containment Barrier Isolation equipment, providing solutions for specific challenges
presented by clients’ individual requirements.
Containment 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 Barrier Containment Isolation technology of Telstar. Attention to
detail makes all the difference when designing the right solution.
Telstars hallmark at every stage:
• Exacting attention to detail and getting to know 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.
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 and accurate
production of 2D drawing elevations.
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 government regulations
and industry standards.
At Telstar we are alert to the vast requirements of the Pharmaceutical Industry and the ever
increasing demand to provide cost efficient solutions for both small and large scale containment
projects.
Powder handling of HPAPI/API product is an area which constantly presents new challenges to
safeguard the operator during pharmaceutical drug production.
Telstar showcases simplicity at it’s finest with regards to a Standard Range of containment
Isolators.
Standard Range
The Telstar Standard Range offers a
choice of single working chambers
featuring 2/3/4 glove port access.
These standard ergonomically trialled
base designs customised with various
accessories provide cost effective
tailored solutions to optimise capital
outlay.
The addition of a transfer chamber
increases the flexibility for small
scale processes such as: weighing,
dispensing, sampling, charging, milling/
sieving, testing.
For more innovative/custom Barrier
Isolation solutions Telstar offer purpose
designed Isolators.
Telstar excels in providing complete
systems with fully integrated process
equipment and specialised internal
environment conditions to suit specific
production requirements.
Lab scale production of highly potent intermediates and
active ingredients often require an extensive range of bench
mounted process equipment to carry out procedures such as
filtration and solution preparation.
This Isolator was supplied fully integrated with lab scale
glass reactors, complete with stirrer motor, glass condenser
and cooling/heating via thermostat control and evaporator
equipped with vacuum pump.
Fully GMP compliant, the high specification of the Isolator
system eliminates the need for part of the production to
be carried out in clean room conditions and reduces time
consuming gowning up procedures.
R+D Laboratory Isolator
Successful design and manufacture of production scale
containment systems demand a complete understanding of
the actual process. Telstar has accumulated over 20 years
experience specialising in providing high level customised
systems to ISO 7 & ISO 8 classification. Running at negative
pressure to the surrounding environment/room to provide
operator protection during manual handling operations.
Electrically controlled raise / lower operator
platform, provides a comfortable ergonomic
working position throughout the process
operations.
For high containment multiple drum batch
campaigns a rear chamber is recommended
with automatic drum manipulation.
Available in electric or pneumatic versions.
Some liquefied products, which may be harmless
to the operator before the lyophilising process, may
present an issue in powder format due to it’s toxic
content. Interfacing with a containment Isolator then
becomes paramount for operator protection.
Tray storage carts are used for transfer of autoclaved
trays to the Isolator for filling/loading & removal of
used trays.
The Telstar automatic tray load/unload system
(ATLUS) facilitates the loading and unloading of
trays filled with liquefied product into the Telstar
Lyophiliser.
Custom built Formulation Isolator
interfaced with a fixed glass lined reactor
vessel located at the rear.
Access to glove ports assisted by
operator platform designed for hard
fixing to facility wall.
Fully integrated internal weigh system
and external vessel load cells allows
powder product to be weighed before
being charged into reactor.
Lyophiliser Tray Load/
Unload Isolator
Formulation Isolator
Lab scale production of highly potent intermediates and
active ingredients often require an extensive range of bench
mounted process equipment to carry out procedures such as
This Isolator was supplied fully integrated with lab scale
glass reactors, complete with stirrer motor, glass condenser
and cooling/heating via thermostat control and evaporator
Fully GMP compliant, the high specification of the Isolator
system eliminates the need for part of the production to
be carried out in clean room conditions and reduces time
operator protection during manual handling operations.
Electrically controlled raise / lower operator
platform, provides a comfortable ergonomic
working position throughout the process
operations.
For high containment multiple drum batch
campaigns a rear chamber is recommended
with automatic drum manipulation.
Available in electric or pneumatic versions.
Multi Chamber Sub-division,
Dispensing & Sampling Isolator
6. Containment Barrier Systems
With the accelerated production of highly potent pharmaceutical drugs, the need for containment technology and
interest in Isolators is on the increase.
Telstar has the expertise to meet the rising challenges by offering an impressive range of containment Isolators, from
single chambers to multi chamber systems accommodating where necessary a wide range of process equipment.
BR-CONTAINMENT-BARRIER-SYSTEMS-EN-0214
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 Containment 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)
• FDA (Food and Drug Administration)
• MCA (Medical Control Agency)
• ISPE guidelines (The Society of Pharmaceutical and
Medical Device Professionals)
• American Glovebox Society Guidelines
• FDA 21CFR Part 11
Telstar provides a comprehensive validation service to
clients providing FAT/SAT/DQ/IQ/OQ & PQ protocols if
required.
Telstar Barrier Containment Isolation
Designed to provide operator protection from airborne
particles and Potent APIs for a wide range of process
applications, with and without integrated process
equipment including:
• Dispensing / Weighing / Sampling
• Sieving / Blending
• Charging / API Addition
• Mixing / Granulation
• Centrifuge
• Freeze Dryer Off-Load / Pack-Off
• Filter Dryer Off-Load / Pack-Off
• Milling / Micronising
• Tabletting
• Final Packing / Blister Pack
Isolators for API’s and cytotoxic compounds have been
independently verified to achieve operator protection
levels down to 0.2ng/m3 (0.0002 µg/m3)
Telstar Isolators are designed to provide a locally
controlled environment operating at negative
pressure, with the ability to control and monitor
all operating parameters. Providing protection to
the operator and the external environment from
the highly potent products.
Designed, manufactured, supplied and installed
- high quality stand alone or integrated systems
with or without process equipment, offering cost
efficient customised and standard solutions.
single chambers to multi chamber systems accommodating where necessary a wide range of process equipment.
Telstar Isolators are designed to provide a locally
controlled environment operating at negative
pressure, with the ability to control and monitor
all operating parameters. Providing protection to
the operator and the external environment from
the highly potent products.
Designed, manufactured, supplied and installed
- high quality stand alone or integrated systems
with or without process equipment, offering cost
efficient customised and standard solutions.
Multi Chamber Weighing, Dispensing
& Sampling Isolator
Product loading is a critical process in all barrier containment systems. At Telstar we are familiar with
the many specific requirements and challenges presented during Pharmaceutical API production.
Drum loading via an inflatable seal with an internal door is just one of a variety of solutions
available, providing an airtight seal to ensure the integrity of the Isolators internal negative pressure
conditions.
PLC based control systems utilising a Siemens PLC platform is offered as standard complete with
I/O according the specific equipment providing a fully automated system, supported by Ethernet
communication enabling critical parameters to be communicated to an external DCS system.
A fully compatible Touch Panel HMI provides operator interface, for control, indications, display
of Isolator conditions and alarm handling. Located in a suitable position on the Isolator service
plenum it is easy to reach and observe by operators.
The Telstar Glove Tester device enables both in situ and off line testing of gloves, if fitted to a
Telstar glove ring. This simple device works solely on air to test the glove integrity.
The system consists of a glove port test plug with inflatable seal, which is inserted into the glove
port. The seal is inflated making an air tight seal to the glove port. The glove is inflated to a test
pressure and the pressure decay of the glove is monitored over a period of time. At the end of this
test period the pressure decay is recorded and the leakage rate of the glove determined.
The Telstar Glove Tester is available as an integrated device (Isolator dedicated) and alternatively
a mobile device to serve multiple Isolators.
Telstar contained transfer system (CTS), independently tested to below 0.2 nanograms offers
ultimate safety, simplicity of operation and is easy to decontaminate.
The active port is designed to be used with a passive canister and or bag in / bag out grommet
connection. The purpose of the port is to allow contained transfer of materials to and from the
Isolator or waste out of the Isolator in a controlled manner, without breaking containment, ensuring
operator protection from the internal environment at all times.
Spray guns and rotating spray balls for WIP are offered as an option for manual cleaning /
decontamination of the Isolator.
Available in PFA or stainless steel the wash guns are suitable for use in all Telstar Isolators handling
pharmaceutical compounds.
Triclover service entries complete with manually operated ball valves will be supplied in the wall of
the Isolator for connection of the clients WIP media and in the base of the Isolator for connection
of the clients WIP drain outlet.
Dispensing & Transfer Isolators with WIP/DIP Skid