Designed for high performance
Freeze-dried products mean increased demands for automatic filling and closing machinery
New forms of presentation determine the development of filling machines. Pre-filled ready-to-use syringes and freeze-dried products are right on trend. Find out how suppliers are meeting the new requirements.
Disposable syringes are not actually new, as Werner Wieland of Bausch+Ströbel admits: "We have been involved in this area for more than 25 years now." For the past five years or so, this segment has been growing in double digits. This is giving the industry fresh impetus, and the demand is mainly for higher performance. "For a long time, disposable syringe lines operated with production volumes of about 5,000 units per hour, then some years ago that jumped to 24,000 units", Wieland indicates the advance of technology. "Today, our high-performance lines can fill and close up to 60,000 disposable syringes per hour." One example is the SFM PLC-controlled syringe filling and closing machine, which was developed for industrially oriented high-performance operation, for nest processing of disposable syringes according to the Hypak SCF system. The syringe bodies are delivered in nests, sterile and prepared ready for filling. All the other steps in processing and transport are handled by the machine automatically, with a throughput of up to 60,000 units per hour.
"All the modules for the individual steps in the process have to be perfectly coordinated, both in time and in space", Wieland explains. "Each assembly has to have the smallest possible footprint, yet at the same time, there must be easy access to the machine for maintenance and cleaning." A clear, straightforward machine design is essential if a filling system is to operate as part of an automated production line. "On top of that, the demands made on the machine are increasing all round - for instance, in terms of fully automated CIP/SIP systems, in-process control (IPC) devices, isolator technology, and so on", Wieland elaborates.
Also, in the last two to three years there has been growing demand for vacuum-assisted plunger stopper insertion systems. The advantage of this closing method is that air, and thus oxygen which is detrimental to the product, between the liquid to be injected and the stopper is almost entirely eliminated.
The industry also has to cope with the increase in freeze-dried products. "As far as filling technology is concerned, that means using filling machines which transport the objects extremely gently", Wieland explains. No product must adhere to the glass wall above the fill level, as that would leave traces in the subsequent freeze drying process which are unacceptable to a pharmacist. Lyoproduction normally involves highly active ingredients which require extra safety precautions after freeze drying to avoid any hazards for the operators. "As the active ingredient is transferred in powder form and can be carried by air flows, the downstream crimping machine has to be wettable to immobilise the product, in order to neutralise the entire working area", Wieland explains. At the same time, speed is of the essence, as Wieland concludes: "To discharge the freeze drier as quickly as possible and get it ready for fresh batches, the downstream crimping section has to be able to handle rates of up to 600 vials per minute."
