Certified Quality

• Fully FDA cGMP compliant, ISO 9002 Certified (NSAI), ISO 13488 Certified, CE Mark (MDD 93/42/EEC)
• Registered with the FDA as both a medical device and pharmaceutical manufacturer.
• 2003 - 2004 Successfully Completed FDA inspection and Notified Body Audits.

Manufacturing Infrastructure

• 5,000 sq. ft. of class 10,000 Clean Room assembly areas.
• Class 100 sterile solution filling suite.
• Enterprise Resource Planning software, controlled inventory and production.
• Experienced regulatory personnel with both medical device and pharmaceutical background.
• Located in an Economic Development Zone for reduced costs.

Autoclave Sterilization Capabilities

• Sterilization Validation Services.
• SAL 10-6
• Air Over Pressure.
• Flexible Packaging Sterilization.
• Two Autoclave for Moist Heat (Steam)

Sterilization Onsite.

• >320 cu ft. Total Capacity.
• Microbiology Facility Onsite.
• 100% EtO Sterilizer Contracted.
• Gamma Sterilization Contracted.

Analytical Capabilities

• Full chemical assay lab with HPLC capability onsite.
  
• Validated Liquid and Gel Particle Counter Onsite.

Experience
Cytosol Ophthalmics personnel have been manufacturing liquid pharmaceuticals and
assembling medical devices for more the 15 years in our Lenoir, NC facility.