Diagnostics Medical Devices

 SteriPack’s support for SARS-COV-2 diagnostics

 In light of peak demand for SARS-COV-2 diagnostic devices, SteriPack can provide support and offer available capacity and expertise in the following areas:

  •  for PCR tests – clean room molding of disposable custom-designed cartridges

  •  for rapid diagnostic tests – clean room molding, membrane die cutting, assembly, pouching, kitting and packing

  •  for sample collection accessories – molding, packaging and sterilization of accessories for kits

The growing number of chronic diseases along with the expanding geriatric population has led to a drive in research and development, increasing the trend in early disease detection and maturing the clinical diagnostic market. Despite the most popular devices belonging to the point of care (POC) category and the existence of pregnancy and glucose over-the-counter self-tests, the wide range of diagnostic devices including highly sophisticated DNA technology. This category includes reagents, calibrators, control materials, kits, software and related instruments.

Whilst outsourcing in the diagnostic devices market ranges from laboratory product development through to accompanied pharmaceutical R&D, SteriPack assists in the whole processes, starting from device design for manufacturing assessment and packaging development all the way to market delivery. SteriPack’s expansive regulatory and industry experience and established processes helps to ensure smooth transitions to meet challenges and needs.

Contract services summary for diagnostic industry:

  •  Contract design and development
  •  Process integration, validation and testing
  •  Supply chain management 
  •  Injection molding
  •  3D printing / additive manufacturing
  •  Die cutting
  •  Assembly
  •  US welding
  •  Packaging and kitting
  •  Sterilization management (Gamma, E-beam, EO, X-ray)

SteriPack’s contract services are designed to support Customers at every stage of product development. Both regulatory and industry experience helps to proceed smoothly through all requirements and needs.

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Typical application areas:

blood test vials, allergy tests, breath monitoring devices.

medical devices injection moulding