Schott is advancing to full-scale production of its new adaptiQ system for ready-to-use pharmaceutical vials at the company’s US facility in Lebanon, Pennsylvania, in preparation for commercial launch early in 2015.
‘Since introducing the adaptiQ concept at CPhI Worldwide, we have received strong interest from our customers,’ said Christopher Cassidy, Vice President Sales and Marketing, North America for the Pharmaceutical Systems Business Unit at Schott. ‘Based on the positive feedback from the market, we now plan to allocate even more of our US manufacturing resources to the production of this product.’
Schott’s adaptiQ vials will be available for purchase early in 2015, initially in the most popular ISO formats: 2R and 4R. The company will gradually introduce adaptiQ in all common ISO formats, from 2R to 30R. Samples are now available for evaluation.
A new generation of possibilities
Pharmaceutical vials are usually washed and sterilised immediately before they are filled with pharmaceutical drugs. This calls for pharmaceutical companies to use their own washing machines, cleanrooms and sterilisation tunnels to perform these tasks. Companies are now increasingly looking to outsource these process steps.
If pharmaceutical companies can fill several types of packaging on the same filling lines flexibly without long set-up times, this will make them more efficient and lower their costs
One way to increase the efficiency is to use ready-to-use packaging materials that are delivered pre-washed and sterilised in a nest and tub configuration by the packaging manufacturer. Yet another advantage arises during the filling process: securely fixed in the nest, the containers cannot come into contact with each other and thus scratch, tip over or break.
This type of packaging has since become the industry standard for prefillable syringes. Transferring this successful concept over to pharmaceutical vials and using the same standards therefore seems to make a lot of sense. ‘If pharmaceutical companies can fill several types of packaging on the same filling lines flexibly without long set-up times, this will make them more efficient and lower their costs,’ says Schott Product Manager Gregor Deutschle.
This transfer, however, is also associated with challenges, Deutschle says: ‘Vials involve process steps different from syringes, including freeze-drying and closure with a crimp seal or press-fit closure, for example.’
Intense co-operation between packaging experts and the manufacturers of filling lines finally brought the breakthrough: Schott worked with companies such as Bausch & Stroebel, Bosch Packaging Technology, GEA, Groninger and Optima for more than two years to develop an appropriate filling system for vials. The result is Schott adaptiQ, a ready-to-use system in which the vials can be subjected to all of the process steps and remain in the nest for most of them.
Intense co-operation between packaging experts and the manufacturers of filling lines finally brought the breakthrough
With adaptiQ, up to 100 sterile and prefillable vials can be securely fixed inside a single nest. Each vial is securely held in place at the neck by three clips. The vials thus survive the manufacturing process on the filling line without coming into contact with one another. This prevents scratches and breakage and consequently lowers the reject rate, a crucial aspect for pharmaceutical companies.
Schott performed extensive FEM (finite element method) simulations to ensure exact and efficient filling in nest filling systems. The results of these tests convinced Schott to use polypropylene, a well-established material, for the nests. The simulations also confirmed the stability of the nest during the freeze-drying and sterilisation processes.
The nest’s ability to bear the weight of all the vials when filled with fluids was also tested. Special emphasis was placed on the clips for securing the vials inside the nest. These clips had to be capable of withstanding bending pressures and then returning to their initial position again, all while securing the vials and supporting them vertically. Schott also tested this under the simulated pressure of the filling process and determined that existing handling systems are easily able to place the vials into the nests.
‘Pharmaceutical companies can lower their operating costs by using adaptiQ,’ Deutschle adds. Savings result from outsourcing to Schott process steps such as depyrogenisation, washing and sterilisation, and also from no longer having to spend money on washing machines, sterilisation tunnels and other equipment.
Nested freeze-drying: 10% faster
To prove the advantages of the new adaptiQ system, Schott has conducted a case study on freeze-drying of nested ready-to-use-vials together with GEA Lyophil, a company that specialises in freeze-dryers for R&D purposes and small production batches, industrial size freeze-dryers, and complete freeze-dryer systems. Tests with a 3% mannitol solution have shown that the process of freeze-drying can be accelerated by applying the adaptiQ nest and tub concept.
The lower packaging density and the product design allow for a 10% faster drying cycle
The main study result: the lower packaging density and the product design allow for a 10% faster drying cycle. This fact, combined with further product features such as simplified and stable loading or unloading, higher loading or unloading speed, and pre-treatment steps that eliminate washing and sterilising processes, means that adaptiQ facilitates lyophilisation and meets the demands of pharmaceutical companies.
adaptiQ is a registered trademark of Schott Pharmaceutical Packaging.
