MEDTECH
PRODUCTION FACILITIES
FOR MEDICAL TECHNOLOGY

Medical technology for maximum quality and safety

The demand for medical aids and protective equipment, such as respiratory masks, will increase worldwide in the coming months and years. Also due to the change in both the age structure and the population's awareness of paying more attention to their health, medical technology is becoming increasingly important as a link between the technical and medical fields.

 

The Strama Group offers innovative automation solutions in the field of medical technology - from concept development to continuous implementation with maximum demand on quality and safety. Combined with our expertise in the field of IIoT we guarantee maximum automation and flexibility. Our machines and systems meet the highest clean room and hygiene requirements.

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Services

  • We develop and manufacture automated assembly lines and test systems for you that produce medium up to large volumes in a clean
    room
  • Production of individual parts up to small and medium batch sizes on our extensive machine park
  • Assembly and commissioning of mechatronic assemblies and components
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Competencies

  • Consistent Good Engineering Practice (GEP) for order processing
  • V-Model as basis
  • Validation and qualification (DQ, IQ, OQ, PQ, FAT & SAT) based on a validation master plan
  • Implementation of valid standards (e.g. EU-GMP guide, GAMP 5, FDA 21 CFR part 11)
  • Active change management
  • Complete traceability matrix for logical traceability
  • GMP-compliant documentation
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You benefit from our intensive focusing on special expertise in

  • FMEA
  • Risk analysis
  • Quality assurance
  • Data analysis
  • Plant simulation
  • Line Data Server with MES Integration

PRODUCTION LINES WITH BASE MACHINE PLATFORM ProMoCurve

The ProMoCurve is our machine platform for all your manufacturing, assembly and testing processes.

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Inserter assembly line for insulin pumps

The fully automated rotary table assembly system for the assembly and testing of EOS Insertion Units for insulin pumps meets the requirements of a clean room GMP class D. The components are provided in trays. The inserters are fed by means of palletizing systems.

 

Highlights & Challenges

  • Clean room requirements according to GMP class D
  • Threading of the flexible sensor strip into a slotted cannula with an outer diameter of 1.2mm, including process monitoring
  • Check the locking of the spring hooks
  • Check the maximum insertion force of the sensor unit into the holder of 10N 

 

Breakdown of the assembly processes & tests

  • Provision and input of the inserters
  • Check DMC of the inserter
  • Preparation and input of the insert slides 
  • Provision and installation of the sensors
  • Check that the sensors are correctly mounted
  • Final assembly of the inserter slides into the inserter with subsequent inspection

 

No limits in process technology!

 

We have developed our technology, system and process know-how over decades and in numerous demanding projects. On this basis, we can realize even the most complex tasks and requirements - from manual and semi-automatic working systems to highly automated complete solutions with integrated testing technology.

Contact Persons

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Andreas Höcherl

Sales Manager

MedTech

 

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Martin Ebner

Chief Technology Officer (CTO)
Technology Unit