From Sony DADC BioSciences comes STRATEC Consumables
The new business division has since been renamed as STRATEC Consumables GmbH. As an OEM for well-known companies in the bioscience and In-vitro-diagnostic sectors, the company develops and produces microstructured plastic components for medical and diagnostic applications, and these enable for example bacteria to be identified more quickly and accurately, allowing a better diagnosis for treating patients ton be achieved. The range of services covers the whole added value chain of design, tool manufacturing and prototyping, right up to injection moulding with optical precision, biological functionalisation, automated reagent filling and mass production, including scalable manufacturing and logistics processes. Production is carried out at the company site in Anif, Salzburg, which is certified to ISO 13485.
STRATEC Consumables GmbH is the market leader throughout the world for microstructured polymer chips. Thirty years of experience in the production of optical storage media flow into the manufacturing of so-called smart consumables. The polymer discs have very small recesses, into which liquids are filled. These are analysed in the types of devices, which are manufactured by the STRATEC parent company. “A single disc replaces half a million test tubes,” explains Dario Borovic, Project Manager at STRATEC Consumables. This means for example, several medical tests with tiny amounts of a patient’s sample can be analysed in a very short period of time – an important aspect not just for diagnostics but also for the patient.
High-performance but also affordable microfluidic products – a real challenge
“One of the greatest challenges in the development of new diagnostic products is to achieve the best possible balance between the performance of such a product and its cost,” says Dario Borovic. “We were really puzzled at the start of the new project, in which MULTIVAC’s chamber machine was to play such an important role. The crucial question was: How do we manage to reduce the pressure in a microfluidic product to 300 pascal and hold it there for at least two years, without driving the product price into the stratosphere?”
The solution was protracted and very complex. Fortunately STRATEC Consumables has outstanding capability and capacity in many areas, including nanostructuring and microstructuring, coating technology, polymer science applications and automated manufacturing. It has a large number of partnerships, many of them international, with universities and research institutes. “And in MULTIVAC we had a service provider to hand, which has the expertise and comprehensive service for such a highly challenging packaging procedure,” adds the expert from STRATEC Consumables.
The definition of the task – in concrete terms
Most microfluidic products need one or more pumps in order to process the samples and reagents. These mechanical components increase the production costs of the devices and require regular servicing intervals and calibration. The pneumatic interface is also a possible cause of sample contamination. A product, which can do without these components, is therefore significantly more robust, reliable and cost-effective. Dario Borovic: “At this point we asked the question: How do we get the samples and reagents into the chamber without pumps? Solution to the puzzle: We create a negative pressure in the chamber.”
But even if one manages to create a negative pressure in the chamber during production and to hold this until the end of the application, it still means the liquids must also be successfully transported into the chamber without any pump operation. What sounds so simple was in fact an immense challenge and required intensive research work. “It was only after several years of hard development work, that an international group of experts succeeded in turning this idea into reality and bringing it to market. This patented solution is now used in the manufacture of some microfluidic products,” confirms Dario Borovic.
The crucial factors for successfully manufacturing such products are special bonding processes for the plastic components, as well as very high-quality packaging solutions, which can fulfil the extremely sophisticated requirements as regards accurate process control and stability, recording the process readings and archiving the relevant data. Cleanroom compatibility, ease of cleaning and low servicing requirements also play a very significant role.
The packaging machine must meet the highest requirements
Following intensive Internet research, STRATEC Consumables GmbH decided on the high-performance C 300 TC chamber machine from MULTIVAC, which can be used very flexibly for a wide range of pouch materials. The model is designed for packing sterile medical products in small to medium-sized batches, and it is equipped with a permanently heated sealing bar. The suffix “TC” stands for “thermo-controlled”. The temperature-controlled sealing bar on this machine is a guarantor of a reliable packaging procedure and reproducible seal quality. The required sealing temperature can be defined in the machine control. The temperature is measured and controlled by two sensors in the sealing bar, which keep it within a defined tolerance. This enables the sealing process to be monitored and controlled as well as being calibrated and validated. The C 300 TC uses the IPC control in conjunction with a HMI 2.0 user interface, which can be operated intuitively via a touchscreen. The integrated recipe memory and optionally available RFID system for automatic recognition of the pouch holder also increase the machine’s process reliability. It was also important to STRATEC Consumables, that the process readings could be recorded and the data archived – this can also be done by the machine.
In addition to this, the C 300 TC meets all the relevant GMP, GAMP5 and ISO requirements. Thanks to its enclosed stainless-steel housing with smooth surfaces, it is easy to clean and suitable for use in cleanrooms to ISO 6 standard.
The products at STRATEC Consumables are packed under vacuum in composite aluminium-film pouches with a final vacuum of 3 mbar. The pouch materials used are OPA/PE/Aluminium composites in various gauges. Although the C 300 TC is currently still in the validation phase, everyone at Anif is already very satisfied with the selection of machine. The machine meets the high expectations and reliably performs the packaging tasks. Operation is simple and the quality of pack and seal seam very good. “The customer-focused service from MULTIVAC has also impressed us greatly,” adds Dario Borovic in his closing remark.