Development and manufacturing of polymer-based medical devices – from extrusion and injection molding through to the sterile-packaged product
ALPO Medizintechnik GmbH
Auerbach i.d.OPf. (Headquarters / Production)New on Amplifa
About ALPO Medizintechnik
ALPO Medizintechnik GmbH manufactures polymer-based medical devices in Auerbach i.d.OPf. across the entire value chain: from product development and plastic injection molding (clamping forces 22–100 t) and the extrusion of mono, multi and micro tubes through to assembly, sterile packaging and sterilization, including CE marking. Manufacturing is partly carried out in certified cleanrooms of ISO class 7 (500 sqm) and ISO class 8 (100 sqm) in accordance with DIN EN ISO 14644. Additional processes include thermoforming, punching/stamping, bonding (1K/2K and UV) and surface printing. Customers come from human and dental medicine, veterinary medicine, as well as pharma and biotechnology. Founded in 1970 by Alfred Pongratz, the company has been part of a group of Bavarian medical device and pharmaceutical companies since 2019.
- Site
- Auerbach i.d.OPf.
- Processes
- Plastic injection molding, Tube extrusion (mono and multilumen), Micro tube extrusion (outer diameter < 1 mm), Extrusion of profiles and tubing, Co-extrusion with inserted materials (e.g. wire or thread), Thermoforming of plastic parts / tube tips (open, closed, bead, cylindrical), Punching of openings in plastic tubes (probes, catheters), Bonding and joining of components (1K/2K adhesives incl. pretreatment, UV processes; manual
- Materials
- Rigid PVC, Medical-grade plastics (polymer basis), Medical-grade plastics
- Certificates
- DIN EN ISO 14644 (cleanroom ISO 7/8), GMP Grade C/D
- Founded
- 1970
- Industries
- Human medicine, Dental medicine, Veterinary medicine, Pharma & Biotechnology (ATMPs)
- 01
Development (2D/3D drawings, prototypes, 3D printing)
- 02
Toolmaking or toolmaking planning
- 03
Injection molding (22–100 t)
- 04
Extrusion (mono/multilumen, micro tubes, profiles, tubing)
- 05
Finishing (thermoforming, punching, bonding, printing)
- 06
Assembly/confectioning in cleanroom
- 07
Sterile packaging (FFS, through-flow sealing)
- 08
Sterilization (EtO, radiation)
- 09
Storage, order picking, shipping
Materials and Processes
Rigid PVC
Material for extruded tubing and profiles.
Medical-grade plastics
Polymer basis for tubes, injection-molded parts and medical devices, selected for kink resistance, stiffness, strength and surface.
Sites
Auerbach i.d.OPf.
DEHeadquarters and production (injection molding, extrusion, cleanroom manufacturing, packaging)
- Lot size
- Small series, medium series, batch production
- Materials
- Medical-grade plastics, rigid PVC
- Injection molding machines 22–100 t clamping force
- FFS packaging machines
- Through-flow sealing machines
- High-performance SLA 3D printers
- Cleanroom ISO 7 (500 sqm) and ISO 8 (100 sqm)
Components and Products
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Plastic injection moldingPlastics | – | – | – | Small series | Plastics |
| Tube extrusion (mono and multilumen)Plastics | – | – | – | – | medical-grade plastics |
| Micro tube extrusion (outer diameter < 1 mm)Plastics | – | – | – | – | medical-grade plastics |
| Extrusion of profiles and tubingPlastics | – | – | – | – | rigid PVC, other rigid plastics |
| Co-extrusion with inserted materials (e.g. wire or thread)Plastics | – | – | – | – | – |
| Thermoforming of plastic parts / tube tips (open, closed, bead, cylindrical)Plastics | – | – | – | – | Plastics |
| Punching of openings in plastic tubes (probes, catheters)Plastics | – | – | – | – | Plastics |
| Bonding and joining of components (1K/2K adhesives incl. pretreatment, UV processes; manualJoining | – | – | – | – | – |
| Printing of surfaces (scales, lettering, markings)Surface | – | – | – | – | – |
| Assembly/confectioning of medical devices in cleanroomsAssembly | – | – | – | – | – |
| Sterile packaging (FFS packaging: thermoforming, filling, sealing; sterile pouches onAssembly | – | – | – | – | – |
| EtO sterilization (validated process at a certified service provider) and radiation sterilizationHeat treatment | – | – | – | – | – |
| Product development, 2D/3D drawings, material selection, prototypes incl. 3D printing,Engineering | – | – | – | – | – |
| Preparation of technical documentation, clinical evaluations, test reports,Testing | – | – | – | – | – |
4 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Injection molding machines (clamping force 22 t to 100 t) | – | – | – | – | Auerbach i.d.OPf. |
| FFS packaging machines | – | – | – | – | Auerbach i.d.OPf. (cleanroom) |
| Through-flow sealing machines | – | – | – | – | Auerbach i.d.OPf. |
| High-performance SLA 3D printers | – | – | – | – | Auerbach i.d.OPf. |
Additional services
Quality and Cleanroom
Manufacturing takes place in certified cleanrooms in accordance with DIN EN ISO 14644 (ISO 7/GMP C and ISO 8/GMP D) with electronic, microbiological and particle monitoring as well as monitoring by an external accredited testing laboratory. Image and signal processing systems support quality assurance; first-article inspections, validations and qualifications are documented.
| Evidence | Auerbach i.d.OPf. |
|---|---|
| DIN EN ISO 14644 (cleanroom ISO 7/8) | |
| GMP Grade C/D |
History
- 1970
Company founded by Alfred Pongratz (nickname ALPO) in Auerbach i.d.OPf.
- 2000
Expansion and extension of the site at that time.
- 2005
Foundation of ALPO Technik Medical Products GmbH & Co. KG.
- 2008
Opening of the second site in the Lohe Süd industrial park in Auerbach i.d.OPf.
- 2012
Start of the modernization of the second site.
- 2013
Completion of the modernization and merger of the two facilities in the Lohe Süd industrial park.
- 2019
Integration of ALPO into a group of Bavarian medical device and pharmaceutical companies.
- 2021
Renaming to ALPO Medizintechnik GmbH.