Packaging solutions for small product series
Batch sizes are becoming smaller, the number of necessary batch changes is rising. The trend towards more individual products can clearly be seen in the pharmaceutical and biotech industries. But what are the actual concrete requirements being faced by companies in this context, and which packaging solutions can MULTIVAC offer to meet these?
There are three major topics, which exercise the sector greatly at the moment, and on which the packaging specialists at MULTIVAC are working intensively to find a solution: packs for sensitive products, combination packs and flexible solutions for small product series. The focus is not just on the packs themselves, but also on the technology used, the packaging machines and the entire packaging procedure. Expensive and sensitive products need to be protected to the optimum degree and not mixed up, and the shelf life of active substances must not be adversely affected. In addition to this, factors such as efficiency, process reliability and cost-effectiveness also play an important role for the manufacturing companies.
Packing sensitive products
Sensitive products, such as auto-injectors or pre-filled syringes, require a complex forming for the pack cavity, since the shape of the pack has to correspond precisely to the product shape, so that the optimum protection is provided. Depending on the type of product, this extends primarily to protection against mechanical effects and damage, as well as external influences such as temperature and UV light, but it can also however include protection against product activation. In order not to impair the shelf life of an active substance, the method of choice is often to pack the product with a reduced oxygen content, in other words under modified atmosphere. Other features: The pack should underline the high value of the product, particularly when it is a question of expensive products. It is also frequently the case, that deep forming depths are required when producing the packs due to the special shape of the products.
The requirements for the pack design and packaging procedure are very complex with combination packs. Here it is a case of packs, which have to protect several products effectively – products that are often also very sensitive. The packs frequently contain several sterile medical products as well as pharmaceuticals – and perhaps even booklets or package leaflets with important information about handling and constituents. A common example is a combination pack with a syringe, needle and filled vial. Such devices with active pharmaceutical products naturally demand a particularly high level of protection.
The pack shapes, which are used in these cases, ensure the products can not slide around during transport or activate themselves in the pack. At the same time however, handling has to be simple – when opening the pack as well as removing the products from the pack. Sometimes the pack also assumes another function – the tray can for example be used as a container for mixing active ingredients.
Flexible solutions for small product series
Packaging solutions with a high degree of flexibility are recommended when packing small series of products. When there are systems in place, which can be converted quickly and easily, even frequent batch changes can be performed efficiently and cost-effectively in a short period of time and with minimum effort. If the systems are also capable of being extended easily, they can grow with the increasing requirements of the company.
MULTIVAC has developed a comprehensive range of suitable solutions for all these requirements: flexible thermoforming packaging machines or traysealers with carrier systems, as well as compact packaging machines for automatic and semi-automatic packing, such as the R 081 thermoforming packaging machine, the T 260 traysealer and the C 300 TC chamber machine. In addition to a fully automated packaging machine for packing syringes, these three models will be shown at interpack 2017 in Düsseldorf.
Compact packaging machines for automatic and semi-automatic packing
The main area of use for the R 081 entry-level model is packaging sterile medical products in small batch sizes or for test markets. With its length of approx. three metres, it is also ideal for use in environments with limited space. The machine is characterised by its process reliability, cleanroom suitability, ease of operation and high level of flexibility. With a maximum output of 15 cycles per minute, it is able to run rigid and flexible films as well as Tyvek® and paper-based packaging materials with a total film thickness of up to 400 μm. The R 081 can be equipped with evacuation and gas flushing systems, and can therefore also be used for producing vacuum packs or packs with modified atmosphere and reduced residual oxygen content. Servo-driven lifting units provide a high level of closing force and ensure the sealing pressure is distributed evenly. This means that they guarantee a consistently high level of sealing quality and therefore increase the pack security. Thanks to MULTIVAC’s proven slide-in technology for dies, changing the forming and sealing dies is simple, fast and reproducible. The R 081 is available in different machine widths, and this enables the formats to be laid out flexibly. The T 260 traysealer, which is mobile and can therefore be utilised very flexibly, is capable of being used for producing MAP and EMAP packs as well as vacuum skin packs, which are increasingly being used in the medical products industry. With its monitored sealing pressure and precise temperature control, the compact model offers maximum process reliability.
The T 260 is designed for running a wide spectrum of trays and, due to its GMP-compliant stainless steel construction, it meets all the requirements of the medical and pharmaceutical industries with regard to cleanroom compatibility and ease of cleaning. MULTIVAC’s proven IPC control enables the entire packaging procedure to be monitored and controlled, as well as enabling scanners and printers for data communication to be integrated. Critical parameters such as sealing pressure, cooling water and temperature are monitored permanently by sensors.
The C 300 TC chamber machine is a good choice, when it comes to packing larger sterile medical products in small to medium-sized batches. Its sealing bar is temperature-controlled and continuously heated, which enables the processes to be calibrated and validated. Like all machines in the TC series, this vacuum machine is cleanroom-compatible and can be used very flexibly thanks to its mobile floor stand. The C 300 TC is easy to operate, clean and maintain. The evacuation and gas flushing processes are pressure-controlled and thus guarantee a reproducible packaging quality.
Thermoforming packaging machines
MULTIVAC’s product range is wide-ranging and comprises solutions for many different output requirements. The machines can be freely configured and equipped to the customer’s individual needs. Their design depends on the required output and also takes into account, how many other systems are being used by the packer for different special products. The chain guide on MULTIVAC’s thermoforming packaging machines brings many benefits in terms of line clearance, where it is easy for example to run the machine empty during a batch change. Production can also be restarted immediately after a change – this reduces the change time and increases machine availability.
Traysealers with tray carrier system
High-output MULTIVAC traysealers with a carrier system are available for the precise infeed of filled trays into the packaging machine. The trays can be transported into the traysealer in a multi-track and multi-row format. The packs are positioned in a defined manner within the tray carrier – a great advantage for upstream process equipment such as the loading process. The degree of automation can range from a semi-automatic process with manual loading to a fully automated line. Furthermore, the system allows for a quick format change with a multi-track traysealer line, allowing even very small batch sizes to be possible. Here only the die and tray carrier have to be changed, and the machine can also be run empty very easily during a batch change. The great advantage of this solution lies in the fact, that the traysealer and the tray carrier function independently, and both systems are therefore operated separately. This means the complexity is reduced significantly. The modular construction also enables the system to be adapted at any time to the particular requirements – right up to extending it with other system components.