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Consulting and Contract Services

Single Use Devices

 Typically single use devices need to be cleaned, packaged, and sterilized prior to shipment. We have experience in integrating these processes into the manufacturing process and validating them to ensure they are effective. 

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In-Process Expertise

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Objective – Remove any soil and/or manufacturing residues to prepare device for entering the cleanroom and further processing steps (packaging, sterilization).

How do you know your device is clean before it enters your cleanroom?

  • Measure bioburden (e.g. every quarter measure bioburden)
  • Help establish in-line testing e.g. bacterial endoxin testing 

 

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Objective – Protect the device from environmental contaminants and damage caused during shipping, handling, and storage  throughout it’s shelf life.

Package Testing

  • Seal Test
    • Visual inspection
    • Dye Penetration Test
    • Peel Test

Shipping Testing

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Accelerated And Real Time aging 

We can write the protocols, establish acceptance criteria, help compile report. We can set up tests internally or identify outsource.

[/et_pb_tab][et_pb_tab title=”Terminal Sterilization” _builder_version=”3.17.6″]

Objective: Sterilize the device in it’s packaging prior to shipment. 

Select sterilization method

  • Steam 
  • Radiation 
  • Gamma 
  • EtO S

 

 

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Biocompatibility

Ensure your biocompatibility plan is in compliance with ISO 10993-1 : 2018

Perform a risk assessment to determine if biocompatibility testing is necessary 

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Reprocessing Solutions

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