Consulting Services & Capabilities

Sterilization

New process development and validation
Sterilization process optimization
Product adoption into a sterilization process
Sterility assurance investigation and problem resolution

Product and Environmental Monitoring Programs

Monitoring program setup
Controlled environment monitoring
Water system monitoring
Product bioburden program
Endotoxin monitoring program
Product ethylene oxide residue monitoring program
Radiation sterilization dose audit monitoring

Auditing

Internal sterilization/ laboratory audits and assessments
Manufacturing and Sterilization/ laboratory supplier technical audits
Regulatory audit technical support

Training and Presentations

Product sterilization basics
Sterilization process development and validation
Sterility assurance program optimization
Product testing requirements
Product evaluation for adoption
Manufacturing environmental controls

Quality, Standards and Regulatory

ISO/AAMI Standards technical support
Standards Gap assessment
Regulatory technical writing support
Procedure Development and Support