11/01/2012Aseptic Freeze Dryer Load/Unload & Pack-Off Line

Serving the world's leading pharmaceutical and biotechnical corporations, Telstar excels in the design, production and installation of bespoke containment and aseptic systems.

We focus on highest quality innovation matched with respectful partnership, delivering the best possible value and advantage for our clients throughout the world.

The impressive rise in pharmaceutical capability worldwide demands extensive containment and barrier expertise. As an international leader, Telstar is the ideal partner for those who look for advanced innovation, absolute reliability and expert project management.

With more than 35 years of experience in tailoring cost-effective solutions for any containment or aseptic application, we consistently meet and exceed the most stringent global standards including ATEX, FDA, cGMP regulations and ISPE guidelines.

In addition to high quality containment technology, ergonomic excellence is of paramount importance in every Telstar project.

Given the complexity of API technology, we believe that every tiny detail of the process and the system that supports it must be carefully examined before manufacturing begins.

It is vital that operators can manage the entire system with comfort and ease.

Our commitment to ergonomic precision is well-founded: a leading pharmaceutical company reported recently that between 25 and 35 per cent of all recordable staff injuries were caused by ergonomic problems.

From our base in the UK, Telstar ACE plays a leading role in raising standards by basing all system design on thorough ergonomic trials. Working from bespoke, 3D CAD designs, full-sized models are built and exhaustively trialled in complete process simulations.

Issues such as positioning of glove ports, shelves and hangers, access to services, ease of cleaning and carrying out bio-decontamination procedures, are all tested in situ by those who will use the finished systems.

Even the smallest detail, such as the positioning of a foot switch, has been ergonomically tested and confirmed through Telstar's proven trials, so that every step can be accomplished with maximum comfort and efficiency.

Our clients find these exacting trials extremely valuable, giving reassurance and confidence that their systems will be perfectly tailored to their needs and ready to begin production promptly once installation and validation is complete.

The recent installation of an integrated automatic system for antibiotic production in China showcases Telstar's global capability.

This particular pharmaceutical containment project is the largest ever fulfilled in China by a single company.

The client, one of China's foremost pharmaceutical corporations, required the integration of dosing, freeze-drying, unloading and end-packing of bulk sterile antibiotics. The project comprised three identical systems, allowing the client to maximise their production flexibility.

Telstar has managed the entire project, from technology design and trialling to installation and training.

Implementing such a complex project is achieved by close collaboration between Telstar's global centres of excellence - freeze-drying in Shanghai, sterilisation in Granollers, Spain, containment at Dewsbury in the UK and loading systems in Terassa, Spain.

Our meticulous attention to detail throughout every project carries significant benefits for our clients. For example, the new triple line system in China not only contains and protects vulnerable Active Pharmaceutical Ingredient (API), it also ensures the safety of operators, with emphasis in mind of making the entire process efficient, comfortable and easy to manage.

Let's take a brief look at this advanced new system...

Small Parts in contact with product are cleaned and sterilised in an autoclave then transferred in alfa beta canisters to the Freeze Dryer Isolator. Parts are placed into the transfer canister inside a RAB unit, which is interfaced with the outfeed of the autoclave.

The isolator provides all the space and flexibility needed for easy assembly of filling line components and peristaltic pump parts. Any waste is removed via the transfer port.

Product trays for bulk freeze drying are sterilised in a Dry Heat Steriliser Tunnel. Trays are then transferred to the Freeze Dryer in an aseptic manner, within specially designed Transfer Carts. A RAB Unit interfaced with the outfeed of the Dry Heat Steriliser Tunnel, allowing transfer of the trays from the Tunnel to the Transfer Carts aseptically.

The Freeze Dryer Isolator and transfer Carts are bio-decontaminated prior to use, using automated gaseous decontamination systems.

Once the freeze drying is complete, the solid product is transferred by vacuum to an intermediate bulk container (IBC). The Vacuum Transfer Line and IBC is sterilised prior to transfer using an automated CIP/SIP system.

The five modules within the final pack off line are all prepared using meticulous cleaning techniques, both manual and automatic.

The main product filling chute split butterfly valve and rotary valve undergo sterilisation using a CIP/SIP system mounted on a frame

The aseptic core Modules 2, 3, & 4 are bio-decontaminated using VHP

Freeze Dried product previously transferred to an IBC via vacuum is homogenised on a post hoist before being docked via spilt butterfly valve above the Filling module.

The Pack Off Line modules are then ready for filling and packing the freeze dried product into canisters. Samples are also taken and weighed for quality checks.

Once again, the importance of exceptional ergonomic design is critical. Lighting, placement of storage shelves, manipulation of the canisters, stoppers and crimps are just some of the issues that have a critical impact on operator efficiency. By matching our client's precise needs we ease operations and speed production.

After filling the canisters are mechanically crimped in Module 4, before leaving the aseptic core for over bagging in Module 5, where each canister is sealed inside a plastic liner.

As an internationally respected organisation, we measure Telstar's success by our clients' satisfaction with our work. We're delighted to report that like many before them, this major Chinese client is reaping the many benefits of working with us.

This groundbreaking project demonstrates that Telstar is perfectly positioned to service the growing global need for high quality, integrated containment solutions, from concept to final fulfilment.

Telstar's global capability is at your service, and whatever the scale of your project, you need deal only with a single point of contact, saving you time, effort and costs.  Streamlined project management and quality assurance across our Group ensure the greatest efficiency and cost-effectiveness for you.

If you'd like to learn more about how Telstar can help your organisation, please call us on +44(0) 1924 455 339.

Wherever you are in the world and whatever your containment or barrier application, we look forward to working with you.