STRATEC Consumables GmbH is a leading supplier of microstructured consumables for medical and diagnostic applications such as blood and cell analyses. The company has just successfully commissioned a Multivac C 300 TC chamber machine for packaging difficult microfluidic products.
STRATEC Consumables GmbH has been part of STRATEC Biomedical AG since 1 July 2016. As an OEM for renowned companies from the life sciences and in-vitro diagnostics sectors, the new business unit produces microstructured plastic components for medical and diagnostic applications that enable, for example, faster and more precise identification of bacteria and therefore better diagnosis for patient treatment.
High-performance and affordable microfluidic products: ...
STRATEC Consumables' range of services covers the entire value chain from design, tool creation and prototyping to injection moulding with optical precision, biological functionalisation and automated reagent filling through to mass production, including scalable manufacturing and logistics processes. Production takes place at the ISO-13485-certified site in Anif, Salzburg.
The company is the global market leader for microstructured polymer chips. The production process draws on 30 years of experience in the production of optical storage media in order to manufacture so-called smart consumables. The polymer discs have tiny cavities into which liquids are poured. These are analysed in corresponding devices, such as those produced by the parent company STRATEC. „A single disc replaces half a million test tubes,“ explains Dario Borovic, Project Manager at STRATEC Consumables. This means, for example, that several medical tests with tiny patient samples can be analysed in the shortest possible time - an important aspect for diagnostics, but above all for the patient.
[infotext]Sony DADC BioSciences became STRATEC Consumables
With the complete acquisition of Sony DADC BioSciences GmbH, the Group, which is based in Birkenfeld in the Enzkreis district, has significantly expanded its vertical integration. The portfolio includes Holistic solutions for diagnostic and medical applications, which are developed in close cooperation with and on behalf of the partners, integrated and fully automated analysis systems, as well as system software solutions and middleware for connecting the systems to the laboratory software and intelligent consumables[/infotext].
... a real challenge
„One of the biggest challenges in the development of new diagnostic products is the Best possible balance between the performance of such a product and the costs,“ explains Dario Borovic. At the start of the new project, in which Multivac's chamber machine plays an important role, „we were really at a loss. The key question was: how do we manage to lower the pressure in a microfluidic product to 300 pascals and maintain it for at least two years without driving product prices through the roof?“
The solution was lengthy and very complex. STRATEC Consumables has outstanding capabilities and applications, including in nano- and microstructuring, in various coating technologies, in polymer science applications and in automated manufacturing. The company has numerous partnerships with universities and research institutes, including international ones. „With Multivac, we also had a competent solution provider with a comprehensive service for the highly demanding packaging process,“ adds the expert.
The task: ...
Most microfluidic products require one or more pumps to process the samples and reagents. These mechanical components increase the Production costs of the devices and require regular maintenance intervals and calibration. One possible cause of sample contamination is always the pneumatic interface. A product that manages without these components is therefore much more robust, safer and also more cost-effective. Dario Borovic: „At this point, however, the question arises: How do you get the samples and reagents into the chamber without pumps? The solution to the puzzle is to create a vacuum in the chamber.“
... very concrete
So if you manage to create a vacuum in the chamber during production and maintain it until the end application, you can actually transport the liquids into the chamber without the need for a pump. However, what sounds so simple is actually an immense challenge and a real challenge. 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 maturity. This patented solution is now being implemented in the manufacture of a number of microfluidic products,“ explains Dario Borovic.
Key factors for the successful manufacture of such products are Special joining processes for the plastic components and High-quality packaging solutions, which meet the extremely demanding requirements in terms of precise process control and process stability, the recording of process values and the archiving of relevant data. Cleanroom suitability, easy cleaning and low maintenance requirements play a not insignificant role.
The solution: ...
After extensive research, STRATEC Consumables decided in favour of the High-performance chamber machine C 300 TC from Multivac, which can be used flexibly for processing different pouch materials. The model is designed for packaging sterile medical products in small to medium-sized batches and is equipped with a permanently heated sealing bar. The suffix „TC“ stands for „thermo controlled“. The Temperature-controlled sealing bar with this machine is the guarantee for a safe packaging process and for a Reproducible sealing quality. The required sealing temperature can be defined in the machine control system. The temperature is measured and controlled by two sensors in the sealing bar, which keep it within a defined tolerance. This allows the sealing process to be monitored, controlled and both validated and calibrated.
The C 300 TC utilises an IPC control system in combination with the HMI 2.0 user interface, which is controlled via a Touch screen is intuitive to operate. The integrated recipe memory and an optionally available RFID system for automatic recognition of the bag holder increase the Process reliability in addition. It was also important to STRATEC Consumables that the process values are recorded and the data archived. The machine does this too.
... a special packaging machine
The C 300 TC also fulfils all relevant GMP, GAMP5 and ISO guidelines. Thanks to its closed stainless steel housing with smooth surfaces, it is easy to clean and is suitable for use in cleanroom class ISO 6. STRATEC Consumables packs the products in aluminium composite bags under vacuum with a final vacuum of 3 mbar. OPA/PE/aluminium composites in various thicknesses are used as packaging materials. Although the C 300 TC is currently still in the validation phase, Anif is already very satisfied with its choice. The machine fulfils the high expectations and reliably handles the packaging tasks. It is easy to operate and the packaging and, above all, sealing quality are very good. „The customer-orientated service has also absolutely convinced us,“ concludes Dario Borovic.
