ALPO Technik MT Connect Nuremberg GermanyWelcome at ALPO Technik.

We are:

  • an independent, family run business since its foundation
  • with almost 50 years of experience in polymers processing
  •  your supplier of complete solutions from product ideas up to the manufacturing of products ready for the market
  • your service provider for make-to-order productions and customized solutions

We have:

  • the certification as manufacturer of medical devices according to the Directive 93/42/EEC
  • a certified quality management system according to DIN EN ISO 13485
  • 600 sq m of certified clean rooms according to DIN EN ISO 14644

Competences

ALPO development plastic components products We put your product ideas together with you on the market. We are your development partner and take over product and process development. Following this, we are your system supplier and manufacture the new product in-house.

  • Product development taking into account functionality, effectiveness, economic efficiency, safety, aesthetics and quality
  • Drawings
  • Identification of materials
  • Prototyping
  • Tool construction and tooling for injection moulding and tube extrusion
  • Development and construction of manufacturing equipment and special purpose machines for the production in clean rooms
  • Definition and documentation of all development and production stages
  • Planning and realisation of samplings, validations and qualifications
  • Support and preparation of technical documentations including support regarding product registration for medical devices

ALPO plastic components bonding gluing fixing medical devicesWe bond your components to safe system solutions.

  • Bonding of different polymer components in certified clean rooms
  • Manual and automatic bonding with highest exactness
  • In-house development and construction of special machines and dosing units

alpo clean room injection moulding medical devicesWe manufacture your product solutions.

  • Range of different modern injection moulding machines with a closing force from 22 to 100 tons
  • Machines located in controlled areas with direct connection to clean rooms
  • 24/7 operation
  • Ideal conditions for serial and batch production
  • In-house tool shop for maintenance and repair
  • Cooperation with toolmakers in the region

ALPO tubing punching further processing assemblyWe adapt optimally your products to the intended purpose.

  • Precise positioning of holes and eyes in medical tubes
  • Individual adaption of catheters and probes
  • All production stages in certified clean rooms

ALPO extrusion multi lumen tubing We find your tube solution for you.

  • Tubes from materials for medical devices correspondent to your specifications (kink resistance, rigidity, firmness, surface finish)
  • High production hygiene through separated and monitored extruding areas with direct connection to certified clean room areas
  • In-house planning and construction of extrusion tooling for customized tubing and profiles
  • Single lumen tubing
  • Multi lumen tubing (lumens with individual forms and dimensions)
  • Micro tubing
  • Profile extruding
  • Extruding of pipes from rigid PVC
  • Thin walled tubing
  • Tubing with inlays (for example wires and stitches)
  • Materials for non-medical applications available
  • Cut to length or coiled on demand

We print the required information on your products.

  • Scaling, marking and lettering on medical tubes
  • High adhesion and scratch resistance
  • Colour with biological compatibility

ALPO plastic tubing tip and thermoformingWe bring your products in perfect shape.

  • Range of tip forming for medical tubing (central opening, cylindrical, with integral ring wall)
  • Individual combinations of different formings and tubing angles
  • Development and construction of customized thermoforming equipments and instruments
  • Construction of circular welding machines for customized solutions

ALPO sterile packaging medical devicesWe pack your products into the required packaging based on a validated process.

  • Materials and procedures based on existing standards
  • Combination of different packaging materials (medical paper and films, fleece material and films)
  • Automatic packaging in certified clean rooms: form, fill, seal
  • Different packaging sizes
  • Packaging in sterile bags and pouches
  • Individual printing on primary packaging (bar codes, QR codes and pictograms meeting the international standards)
  • Design of labelling and cardboard boxes
  • Repackaging and labelling
  • Validation of packaging procedures
  • Planning and construction of form-fill-seal tools for the in-house packaging machines in cooperation with a toolmaker

We take care for the transport and the storage of your products. Use the advantages of our services.

  • Storage capacities for finished products under controlled warehouse conditions on site
  • Dispatch on call

ALPO medical device assembly plastics metalsWe mount your products corresponding to your individual needs.

  • Assembly in certified clean rooms
  • Hygienic processes in production surroundings controlled and monitored microbiologically
  • Development and construction of customized assembly machines
  • Assembly with quality assurance
  • Assembly by regularly trained staff

ALPO extrusion micro tubing clean room plasticsWe make your products ready for sale.

  • Validated EO sterilisation process according to DIN EN ISO 11135
  • EO sterilisation by a qualified sterilisation installation at a sterilisation service provider
  • Cooperation with a supplier of beam sterilization services according to DIN EN ISO 11137
  • Traceability of complete batches
  • Individual release certificates for OEM products on demand

Products

ALPO innovations medical devices development manufacturingAn idea becomes a ready-made medical device.

  • Development and manufacture of a special stomach tube with swallow trigger effect (Easy Swallow Probe) in cooperation with the University Hospital of the Westfälische Wilhelms-Universität Münster (nomination for the Bavarian Innovation Awards 2014)
  • Development and manufacture of the worldwide first penile clamp made from plastics
  • Development and manufacture of a rectal applicator for the preparation of the trans-rectal biopsy
  • Development and manufacture of a obstetric gel applicator
  • Certified manufacturer of medical devices according to annex V of the Directive 93/42/EEC (CE mark)
  • Serial and batch products of plastic components (for example funnels and connectors) and of finished products ( for example probes, catheters and tubing systems)

ALPO technical products plastics development manufacturing productionWe find a solution for your individual needs and for continuous product development.

  • Development and production of customized solutions for your industry and your market
  • Development and production of customized solutions made from plastics
  • Further development and manufacture of existing products and new product variants
  • Adaption of products to new standards

As well established we are able to find your individual system and process solution.

CLIENTS

We develop and manufacture single use medical devices for different applications.

  • Development and manufacture of components and assembly groups for single use devices made from plastics
  • Development and manufacture of finished products (with CE mark) for single use
  • Development and manufacture of customized solutions
  • Applications in gastroenterology, gynaecology, ophthalmology, pulmology, urology and anaesthesia

ALPO manufacture toys components plasticsWe produce your required product solution.

  • Development and manufacture of small-scale series for scale modelling
  • Development and manufacture for special parts of the toy industry

ALPO medical devices animals veterinary plastics single useWe develop and manufacture your devices for veterinary medicine applications.

  • Development and manufacture of different disposables made from plastics
  • Development and manufacture of custom-made solutions for the veterinary medicine
  • Applications: cats, dogs, horses and cows

ALPO tube tubing beverage plastics componentsWe create your product for the required application.

  • Development and manufacture of plastic components for the beverage industry
  • Development and manufacture of plastic products for the food industries

ALPO pharmaceutical industry supplier plastic components quality clean roomWe develop and manufacture your single use devices made from plastics.

  • Development and manufacture of application systems
  • Assembly and packing of treatment units

ALPO technical components electronics made from plasticsAt ALPO, you get your customized solution made from plastics.

  • Development and manufacture of plastic components for technical home applications
  • Development and manufacture of plastic components and packaging for electronic control systems
  • Manufacture of technical housings and covers

Quality

ALPO quality clean room multi lumen tubingQuality determines our activities.

  • Manufacturing processes according to DIN EN ISO 13485
  • Quality assurance system following the requirements of annex V of the Directive 93/42/EEC
  • Certificates available on request

“Quality is the absolute condition for us to be competitive and successful in the market. … Product safety, product comfort, product compatibility and user friendliness are fundamental elements of our product quality policy. We strive for steady, constantly high, reliable quality in manufacturing.”

(Extract of the quality policy at ALPO Technik Medical Products)

ALPO quality clean room assembly injection moulding plastic components medical devicesWe implement quality requirements with the help of the appropriate documents.

  • Technical documentations for medical devices
  • Clinical evaluations for medical devices in-house
  • Reports on measurements and testings
  • Realisation and reports on samplings, validations and qualifications
  • Support for the registration of medical device
  • Documentations complying with the international standards
  • Development and construction of monitoring systems for in-house manufacturing
  • Quality assurance via picture processing and signal processing systems

Clean Room

ALPO clean room veterinary medicine assembly devices single use plasticsWe have a lot of experience in working with and in certified clean rooms.

  • Production in clean rooms according to DIN EN ISO 14644
  • Clean room area of 400 sq m of ISO class 8 / EC GMP Guideline Grade D
  • Clean room area of 200 sq m of ISO class 7 / EC GMP Guideline Grade C
  • Certificate available on request

ALPO clean room injection moulding medical technology pharmaceutical industryWe emphasize und cleanness and hygiene. Your requirements regarding the production environment are important to us.

  • Independent, external microbiological monitoring by an accredited testing laboratory for microbiological analytics
  • Internal electronic and microbiological monitoring
  • Regular staff training on hygienic topics

Company

1970Foundation of the company by ALfred POngratz (nick name ALPO) close to Auerbach i.d.OPf., Bavaria, Germany
2000Modernisation and expansion of the company headquarters close to Auerbach i.d.OPf., Bavaria, Germany
2008Opening of the second manufacturing location in Auerbach i.d.OPf., Bavaria, Germany
2012-2013Modernisation and extension of the second manufacturing location in Auerbach i.d.OPf., Bavaria, Germany
2013Integration of both industrial premises in the modernised (former second) production site as new headquarters in Auerbach i.d.OPf., Bavaria, Germany

ALPO clean room quality injection moulding tube extrusion mounting assembly plastic devices

ALPO clean room injection moulding medical devices

As ALPO Technik Medical Products we unite the competence of polymer processing from numerous industries and medical technology. Besides, we base our knowledge on more than 40 year experience in polymer processing.

Deepening the dialogue with our customers and suppliers, we establish long-term and fair business relations. By intensifying knowledge exchange with users, we identify new market requirements. Thus, we are able to transform product ideas quickly into innovative solutions focusing on the individual needs of our customers.

By the steady advancement of our processes and by the extension of our services we have the ability to position ourselves in new markets of the medical technology and other branches successfully as a supplier of customized solutions. Therefore, we protect our financial independence as a family run medium-scale enterprise.

As a responsible partner of the medical technology we contribute to the quality of life and to the restoration of the health of patients in an essential manner by reliable and high quality products. The safety of patients, users and products play the central role for us. We regard fast idea conversion, benefits to patients, cost consciousness and efficiency increase in the healthcare system as fundamental pillars of our activities.

ALPO clean room quality injection moulding components single use devices medical technologyResponsibility and respect

We are aware of our responsibility in-house and towards third parties if it is about the quality level as well as the safety of products and processes. We respect the demands of our clients and the position of our suppliers.

Communication and transparency

We communicate among each other in an open and direct way, but also with our suppliers and customers, because we focus on a fruitful long-term partnership.

Curiosity and ambition

We are motivated to transfer product ideas into individual solutions. Our curiosity and our ambition make it possible. We promote new ways of thinking and the qualification of our employees by continuous training. We realize common challenges as common achievements.

Motivation and flexibility

We are motivated, committed and respond to special customer needs and wishes in a flexible manner.

Reliability and flexibility

We aim at the  satisfaction of our costumers by reliable products, adherence to delivery dates and schedules as well as by excellent services. We are characterized by professionalism and credibility. Optimal customer services are essential to us.

ALPO clean room quality plastic components extrusion injection moulding assembly packaging sterilisationWe are in permanent contact with representatives from science, politics and economics.