SCHOTT solutions no. 1/2014 > Pharmaceutical Packaging

The new nest and tub system SCHOTT adaptSCHOTT iQ® can also be used together with existing nest filling systems and enables pharmaceutical companies to freeze dry, weigh or close filled vials inside the nest. Photo: SCHOTT/ A: Sell

Higher Efficiency for Pharmaceutical Companies

Innovative ready-to-use pharmaceutical vials enable pharmaceutical companies to make more flexible use of their production lines and lower the total costs of ownership.

Francis Merlie

Pharmaceutical vials are usually washed and sterilized shortly before they are filled with medications. This calls for pharmaceutical companies to use their own washing machines, clean rooms and sterilization tunnels to perform these tasks. Companies are now increasingly looking to outsource these process steps. One way to increase the efficiency of filling lines is to use ready-to-use packaging materials that are delivered pre-washed and sterilized by the packaging manufacturer. This type of packaging has since become the industry standard for prefillable syringes. And for good reason. Packaging manufacturers like SCHOTT supply sterile syringes completely packaged in a nest and tub configuration. They are ready to be filled. Besides, there is no need for the pharmaceutical company to wash and sterilize them. Yet another advantage arises during the filling process: securely fixed in the nest, the containers cannot come into contact with each other, tip over or break.
SCHOTT adaptSCHOTT iQ® consists of a tub and a nest, in which up to 100 sterile and prefillable vials can be securely fixed. Each container is held securely in place at the neck by a snap-in hook (picture bottom right). This prevents them from coming into contact and thus breaking or being scratched during the manufacturing process. Photo: SCHOTT
Transferring this successful type of packaging for syringes over to pharmaceutical vials is associated with challenges, however, as SCHOTT Product Manager Gregor Deutschle explains: ”Vials involve process steps different from syringes, including freeze drying or sealing, for example. Close cooperation between packaging experts and the manufacturers of filling lines finally brought the breakthrough in closing and flanging the pharmaceutical vials near the nest.

Due to the increasingly smaller batches in the pharmaceutical industry, flexibility and efficiency with respect to filling the various packaging products such as syringes or vials, there are new demands from the pharmaceutical industry. ”If pharmaceutical companies can fill several types of packaging such as syringes, vials and cartridges flexibly without long set-up times on their existing filling lines, this will make them more efficient and lower their costs,” Deutschle says.

SCHOTT worked closely with filling line manufacturers such as Bausch & Stroebel, Bosch, GEA and Optima for two years in order to develop an appropriate filling system for vials. The result is SCHOTT adaptSCHOTT iQ®, a ready-to-use system in which the vials can be subjected to all of the process steps and remain in the nest. It can be used with existing nest filling systems and allows pharmaceutical companies to freeze dry, weigh or close filled vials inside the nest.
Up to 100 sterile and prefillable vials can be securely fixed inside a single nest. Each bottle is securely held in place at the neck by a snap-in hook. 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 tested the vials and nests by performing 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, the well-established material, for the nests. The simulations also confirmed the stability of the nest during the freeze drying and sterilization 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 snap-in hooks 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 without breaking any of the components. SCHOTT also tested this under the simulated pressure of the filling process and determined that robots 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 depyrogenization, washing and sterilization, and also from no longer having to spend money on washing machines, sterilization tunnels and other equipment. SCHOTT plans to launch the adaptSCHOTT iQ® ready-to-use system  in the third quarter of 2014 in the most customary iso formats 2R and 4R (2 and 4 milliliters) and then gradually add other iso formats from 2 to 30 milliliters. <