microbiology and biocompatibility services

• Manufacturing Environmental Requirements and Zoning based on product risk
  
• Environmental monitoring Requirements

• Bioburden Method Development and Validation
  
• ​Sterility Testing Methods and Validation
  
• Bacterial Endotoxin Testing (BET)
  
• Bio-compatability / Biological Evaluation
  
• Ethylene Oxide Residual Product Limits to ISO 10993-7 requirements

​​​​​​​​Sterilization and Quality System Consulting LLC