close
close
close
Optima Pharma has realized a complete vial filling line, including isolators and freeze-drying equipment that is equipped with various digital safety features and mass spectrometry. The customer, a globally active pharmaceutical company, places great value on production reliability and the use of future-oriented technology.
At the end of 2018, the global player faced the challenge of increasing production capacity. There were new products in the pipeline: Freeze-dried drugs for the treatment of hemophilia and other drugs to treat rare blood diseases were to be manufactured.
Hemophilia is an inherited disease found predominantly in men, which inhibits blood clotting and leads to lifelong disability. Solvents are also filled on the line to be administered alongside the product. It was clear from the outset that the supplier of the filling and closing line, which would include isolator and freeze-drying technology, should supply everything from one source as a typical turnkey project, thus making it a project that was predestined for Optima Pharma. In addition, the company would need to be a leader in isolator technology with the ability to deliver a complete qualification package. The company chose Optima as its partner for this first time on the basis of these factors. "Building a filling line project combined with freeze-drying equipment is complex. In addition, a new challenge for both sides was the almost full implementation of GMP qualification," says the responsible Senior Project Manager at the company, explaining the initial position.
Another added benefit of Video Monitoring: Operators have an improved overview of the system as the cameras transmit live images to the HMI.
Scanning format parts and verifying the DMC code ensures that the correct parts are fitted.
Optima Pharma has a proven and comprehensive technical and scientific process with CSPE that can shorten the time to production start-up using a range of measures such as digital engineering and many others. The customer has also benefited from this comprehensive approach: "Right from the sales phase and throughout the project, Optima Pharma's turnkey concept offered great benefits," says the Senior Project Manager. This had a positive effect on the coordination of overall design, communication, functional, electrical, mechanical and software interfaces and system control. Then there is the fact that there is one single contact person at Optima to advise on every aspect of the overall project.
As with the majority of filling line projects, in this case, Optima's supply scope also includes process functions for washing and sterilizing the vials. They are then filled and closed in the OPTIMA VFVM 7000 filling and closing machine. As a machine concept the OPTIMA VFVM is suitable for injection and infusion bottles with a dosage capacity of 0.1 ml to 500 ml. Output is up to 30,000 items an hour, depending on the product and filling quantity. This is connected to a loading and unloading unit for each of the two LYO-D freeze dryers. Each freeze dryer takes up nine square meters of floor space. An isolator was integrated above the filling machine and the two loading and unloading units. After the freeze-drying process, the vials are capped and stored. This is partially done under laminar flow. The initial purpose of the line is to fill hemophilia drugs and their corresponding solvents in vials of 2, 5 and 12 millliliters.
100% in-process controls in the filling area and a range of cameras to check correct stoppering and closure with a cap ensure optimum process reliability. One special feature is the mass spectrometers integrated into the freeze dryers, supplied by Optima Pharma. These check the atmosphere inside the equipment for unwanted foreign substances at fixed intervals, and so are able to detect even the most minute quantities of oil both during and before freeze-drying. This is also why Optima’s customer has chosen to include this process. Two additional goals can be achieved besides enhanced safety, due to the environment integrity test, explains Joerg Rosenbaum of Optima Pharma in Mornshausen, Hesse: "With the mass spectrometers, the freeze-drying process can be controlled very well. The device can also be used for process optimization to make even better use of production capacity." Mass spectrometers are also available as a stand-alone solution, and this means that they can also be used for maintenance purposes.
Now, almost two years later, we are seeing the fruits of our labor – a filling line that outperforms anything Optima Pharma and we have ever achieved.
The pharmaceutical company did not only attach importance to the use of future-oriented technologies in freeze-drying. The system's second special feature is the digital functions. Digitalization is playing an increasingly important role in changeover and line clearance. For example, product paths are replaced or emptied manually and packaging materials are removed. Finally, the system is cleaned and sterilized before the next cycle can be carried out. Marcel Biedermann, Project Engineering Manager at Optima Pharma, says: "There are massive risks here that can severely affect the production process. We are therefore currently providing operators with assistance here, and we will continue to do so in the future, via features from our IPAS (Intelligent Production Assistance System) digital product portfolio." One of these features is the Changeover Scan. This Smart Service from Optima is a tool designed to assist system operators and is available to all Optima business unit customers. The customers’ employees can use scanners to scan format parts that need to be changed and use a DMC code to verify that the right parts are being used.
Correct installation has to be confirmed on the HMI. This way, the risk of machine downtime arising because the wrong format parts have been fitted can be effectively minimized, and machine availability is increased. Crashes within machines are therefore prevented, and product losses are also kept to a minimum. Another benefit is that operators can be trained more quickly.
Another Smart Service available in the system is Video Monitoring. Cameras inside the machine continuously record live images, which the customers’ staff at their production site can view via their company network. In the event of a claim, this gives the company a means of providing proof to the authorities and eliminates the need to discard entire batches. Last but not least, the cameras improve the operators' visibility. It is also possible to use it in case of an alarm. If the machine control system detects a fault, it stores a certain sequence before and after the alarm is triggered and assigns a time stamp as well as other production data, such as the batch number. This means that alarms can be analyzed quickly and easily, faults can be remedied and product losses can be minimized. "When a production discrepancy is found in an aseptic production line, it is very time-consuming to investigate it. That' s why we need as much information as possible, as quickly as possible, to find the cause. Video Monitoring helps us with this“, says the Senior Project Manager.
Working in combination, both tools increase system availability and deliver an even higher level of production reliability. "Our goal is for our products to be released immediately thanks to quality control and assurance in real time," he says, explaining the company's decision to use Optima's Smart Services. Consequently, continuous, automated, closed-loop production processes are very important to the company.
The pharmaceutical company is very satisfied with the ongoing operational results from Optima Pharma: "Now almost two years later, we are seeing the fruits of our labor – a filling line that outperforms anything Optima Pharma and we have ever achieved," says the responsible Senior Project Manager, summing up. “The line is functioning as anticipated, and we are now eagerly awaiting delivery to us.” He particularly singles out for praise the simple, elegant design, the ease of cleaning and the filling accuracy, the high number of in-process controls, and careful product handling with minimal shear stress. "Compared to other suppliers, Optima's systems are the best we have ever tested," he says.
However, the majority of the qualification will be carried out at Optima, so the system will be staying at Optima Pharma's CSPE Center for a few more months. For the first time, installation, operation and initial pre-performance qualifications will all be carried out at Optima Pharma. The coordination of interfaces, the integrated Factory Acceptance Test (iFAT) under realistic conditions, which is part of CSPE, and the almost complete qualification significantly shorten the time to production start at the customer's site.
