Aseptic Barrier Systems0 pages

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.
Scope

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.
Mobile transfers

Fully Compliant

Telstar Aseptic Barrier Isolation Systems

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:

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.

• 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

• Autoclave Interface

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.
Control Systems

• Liquid & Powder Filling (vials & trays)

Telstar contained transfer system (CTS), independently tested to below 5 nanograms offers ultimate
safety, simplicity of operation and is easy to decontaminate.

• Lyophiliser Auto Load & Un-Load
• Product Transfer
• Dirty Tray transfer, Wetting & Removal
• Bulk Powder Filling (into kegs)
• Bunging / Stoppering / Crimping
• Over bagging & Heat Sealing

Telstar provides a comprehensive validation service to
clients providing FAT/SAT/DQ/IQ/OQ & PQ protocols if
required.

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.

Contained transfer

• Sterility Testing

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, 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.

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.

Sterility testing

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.

The production site where the products are made has been assessed and given ISO 9001:2008 approval.

Designed, manufactured and supplied - high
quality integrated systems offering:

All equipment is manufactured to allow it to be CE marked in accordance with 98/37/EC Machinery Directive.

• 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.

Unit 4, Shaw Cross Business Park
Dewsbury West Yorkshire
WF12 7RF (UK)
T. + 44 (0) 1924 455 339
F. + 44 (0) 1924 452 295

BR-ASEPTIC-BARRIER-SYSTEMS-EN-1113
Telstar reserves the right to improvements and specifications changes without notice.

www.telstar-lifesciences.com

Headquarters
Av. Font i Sagué, 55
08227 Terrassa (Spain)
T +34 937 361 600
F +34 937 861 380
1504 Grundy’s Lane
Bristol PA 19007, USA
T +1 (215) 826 0770
F +1 (215) 826 0222

Aseptic Barrier Systems