MedTech - Strama-MPS Maschinenbau

MEDTECH
PRODUCTION FACILITIES
FOR MEDICAL TECHNOLOGY

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.

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

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

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

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