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 fields of medical technology, pharmaceuticals and life science - 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.

ProMoMask - 100 % Made in Germany

 

We have built up a mask production for "community" masks and MNS masks type II according to DIN EN 14683 in our hometown Straubing and with this we would like to give everyone access to high quality articles "Made in Germany" - at a fair price.

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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

Processes

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JOINING

Gluing & dosing, joining & pressing, riveting & flanging, screwing, wire and laser bonding, punch riveting, caulking, clinching, laser-, ultrasonic-, resistance-, friction-, mirror and inert gas welding, inductive soldering, TIG welding / soldering, hot gas stamping

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RECASTING

upsetting, pre-rolling & tumbling, roller burnishing, twisting, plastic overmoulding, hot stamping, needle embossing, scribe embossing

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LABELING & PACKAGING

labelling, signing, marking, laser marking, pad printing, inkjet printing, foiling, packaging

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CUTTING

depaneling, machining, non-cutting processing, stripping, laser cleaning

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CHANGE SUBSTANCE PROPERTIES

Plasma activation, (de)magnetization, impregnation, continuous furnace

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OTHER

Adjustment, balancing, logistics systems, high-speed handling

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.

Tests

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SI-BASE VALUES

Length / volume, mass, time, temperature, current, light intensity

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ELECTRICITY

voltage (HV test), resistance, insulation test, impedance, winding test

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KINEMATICS

Speed, acceleration, frequency / speed, torque

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MECHANICS

Force, pressure, volume flow, (body) sound / vibrations

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OTHER

magnetism, tool monitoring, optics, puncture control, load spectrum

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SUPERORDINATE TESTS

Tripping behaviour, system performance, electrical / pneumatic contacting, efficiency, leak test, image processing

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

 

PRODUCTION SYSTEMS WITH BASIC MACHINE PLATFORM ProMoCell® TSX & FSX

The ProMoCell® is our machine platform for all your production, assembly and testing processes.

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Contact Persons

Martin Ebner

Chief Technology Officer (CTO)
Technology Unit

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Andreas Schmidbauer

International Business Development