Multi-layer plastic bottles are an alternative to glass vials. Some polymers such as polyolefins are transparent like glass, but protect biopharmaceuticals even better because their surface cannot be attacked by alkaline liquid medicines and contain hardly any organic substances that might enrich bio-substances. On the other hand, the polymers are relatively expensive, which is why the industry has been hesitant to use them so far.
EVERY PACKAGE UNIQUE
Progress has also been made in the fight against counterfeiting. August Faller, a manufacturer of secondary pharmaceuticals packages in Germany, has developed barcodes, alphanumeric series and data matrix codes for folded boxes and labels for the serial coding of packaging materials. The specialist uses ink-jet technology to print the packages with the serial product information, thus making it possible to trace the medicines back to the manufacturer.
The demand for identification solutions can be expected to grow rapidly in the coming years. Answering the call is securPharm, the umbrella organization for five medicinal product distribution associations, which is working to establish a system based on data matrix codes to guard against counterfeited medicines by 2017. The idea is that the medicine manufacturers make each package “one of a kind” by printing it with a square data matrix code containing a unique number. They store all the awarded numbers in a shared manufacturer database. At the pharmacy, the code of each package is then scanned and checked with the database before the medicine is given to the patient. As this check takes only seconds, counterfeited products are quickly flagged. The system has already passed its practical test with 280 participating pharmacies, 24 cooperating pharmaceutical companies, more than 3.5 million marked medicinal product packages and over 30,000 authentications, explains Reinhard Hoferichter, spokesman of the securPharm executive board. “With newly coded packages of selected drugs, we achieved system accessibility 99.5% of the time.”
Machinery and plant manufacturers have adjusted well to the new requirements of the pharmaceuticals sector. New production equipment that produces and packages medicines faster and more flexibly helps manufacturers offset high costs on elaborate packages and supplementary features through production efficiencies. For the identification and tracking of medicines, Italian automation specialist Marchesini, for example, has developed a track-and-trace solution with a printing module capable of printing 400 folded boxes per minute from both sides and from the top with different security labels. A camera then checks and verifies the codes. The data are finally stored in a huge central server from where they can be retrieved at any time, thus making counterfeiting exceptionally difficult.
MORE EFFICIENT PRODUCTION
German machinery manufacturer Bausch + Ströbel is also pulling out the stops for pharmaceuticals companies. “In the production of modern biopharmaceuticals, it is becoming more and more important to achieve highly reproducible precision in the filling process with high machine efficiency and availability in sterile conditions. We are investing heavily in innovation, quality assurance and process technology so that we can continue to offer our customers the best possible solutions,” says managing director Hagen Gehringer. The company’s innovations include a fully automatic labeling machine that labels bottles at a rate of up to 21,000 per hour and permits reel changes without interrupting production.
Bausch + Ströbel and sensor specialist visiotec have also developed a process permitting the continuous control of filling processes without output being reduced by this close scrutiny. During the production of medicines, 100% in-process checks are often necessary, as it is essential to ensure that precisely the right proportion of active substance is contained in each vial, syringe or carpule. Until now, the filled vials have been removed from the process and weighed, thus reducing the rate of production throughput. Instead, with its new method, Bausch + Ströbel and visiotec use sensors that check the vials in the ongoing process and thus maintain high machinery speed.
German equipment supplier Fette Compacting also specializes in greater speed and flexibility. It claims that the rotary table press recently added to its product range achieves product changes faster than any other presses in its performance bracket. Replacing the rotor, the key component of the machine, is said to take only 15 minutes. On existing conventional presses, this process may take more than an hour. The rotor carries the filling cams that mechanically control the movement of the punches and ensure that the tablets are pressed with precision. To change the rotor, it has always been necessary until now to unscrew many individual parts. Fette has designed the component in larger segments so that it can be replaced faster.