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Production Partner

steripac specialises in the completion of the value chain of sterile products. Our customers entrust steripac with unsterile products or components which we then refine into a sterile and secure final product.

In our new production halls, our employees work in modern cleanrooms to ISO 7 and 8 standards; in workplaces to ISO 5 standard; and with high-tech machinery, facilities and equipment for cleaning, assembling and packaging. For sterilisation, we engage external partners with whom we have worked reliably for many years. Our modern logistics centre offers sufficient capacity for planning and logistics.

Only qualified processes, equipment and cleanrooms are used for the processing of customer products. Continuous monitoring of the hygiene and quality requirements ensures maximum process reliability.

Here are our production services in detail:

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Cleaning

steripac specialises in innovative cleaning methods. By reliably cleaning the products supplied to us, we create a constant, defined and therefore secure starting point for all further processing steps.

We differentiate between three types of cleaning: microbiological cleaning with germ-reducing effects; chemical cleaning to remove manufacturing additives; and particulate cleaning of general manufacturing, transportation or storage contamination.

Already more than half of the products are cleaned at steripac prior to further processing; this is becoming a rising trend. In addition, increasingly sophisticated production techniques as well as more complex products and regulations require new methods for final cleaning. We are well equipped for all of the above.

In 2014, we invested in innovative vacuum cleaner technology. We achieve optimum cleaning results, even when handling geometrically sophisticated products, needles, filigree holes or highly textured surfaces

Here are our cleaning facilities and equipment at a glance:

  • Vacuum extraction cleaning technology
  • Cleaning machines
  • Disinfectors
  • Ultrasonic cleaning
  • Reverse osmosis system
  • Vacuum drying
  • Drying cabinet
  • Drying under laminar flow

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Assembling

The outsourcing of assembly work to steripac offers a variety of advantages.

The consequent assembly provides a maximum level of cleanliness and security, especially following the cleaning processes of individual components.

Our employees adapt flexibly and quickly to new tasks in the highly equipped cleanroom workstations of grades five, seven and eight. If necessary, our engineers and mechanics can complete the workplaces with individual assembly devices.

Our employees have years of experience with different products, materials and complex assembly processes.

Intensive training is just as important as the exact documentation and the final functional and quality test.

We fit seamlessly into the value chain of our customers, enabling a wide variety of cooperation possibilities.

  • We are exclusively manufacturing partners to whom our customers deliver every part and component.
  • We are also the concept partner, co-developing components, selecting delivery methods and monitoring the procurement and disposition.
  • We take on test assemblies for developing prototypes.

We have one thing in common for every single task: we support our customers with accurate, reproducible and efficient assembly processes.

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Packaging

At steripac, we understand packaging to be an integral part of pharmaceutical and medical products; it is of central importance for producers and users.

It serves as a sterile barrier system and meets other elementary functions: the packaging ensures the operational readiness of your product for its defined shelf life. With direct printing or labelling, it satisfies information purposes, on the one hand showing the traceability of the manufacturing process, and on the other, data and facts about the product or its application.

The packaging is the first thing that your customer holds in his/her hands, and this is usually in very challenging situations. It must be easy to open, adequately removable, and have a secure and trusting feel to it. This is achieved through quality materials, appropriate design and tamper-evident closures.

To fulfil all these functions for a wide range of products, our machinery is so broad in scope that – in addition to standard packaging – we are able to manufacture, assemble and print personalised packaging solutions developed by us. The packing into individual folded boxes or sales units often represents the final packaging step.

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Sterilising

Sterilisation is the perfect finale for long-term security. It comes at the end of every production chain, with different methods that can be applied. In order to select the appropriate procedures in each case, it is crucial to know the strengths and advantages depending on the material components, product requirements and the type of packaging.

The most common sterilisation procedures for medical products are:

  • Gamma irradiation
  • Ethylene oxide sterilisation
  • Steam sterilisation
  • E-Beam
  • Plasma sterilisation

Our partner companies carry out the sterilisation work using only qualified facilities. The processes are of course validated with appropriate documentation. In addition, we have been working reliably with these companies for many years.

All processes are also tested by independent, external and accredited laboratories, and are continuously monitored. All this provides us and our customers with double the security.

steripac GmbH

Oberreichenbacher Straße 15-17 | D-75365 Calw-Altburg Germany | T + 49 7051-58 88 0 | F + 49 7051-58 88 55 | www.steripac.com | info@steripac.com | © steripac GmbH 2017

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