Consulting Services Details

Consulting Services Details

Description

API provides a wide range of technical services to the pharmaceutical and biotechnology industries.  Our experience encompasses the following critical areas:

Cleaning and Disinfection Component Entry Systems: Review of current and future practices, advanced technology; cleaning of controlled and non-controlled areas; equipment cleaning and disinfection; disinfectant and sporicidal qualifications and validations; cleaning practices and methods of application; contamination control practices; residue removal; clean in place systems (CIP); sterilize in place systems (SIP); component entry systems; compliance assurance and training of personnel.

Environmental Monitoring, Media Fills and Air Flow Studies: Review of current and future technology; development of air, surface and personnel programs; qualification of controlled environments; validation; compliance assurance; conducting investigations; corrective actions; media fills; air flow studies and training of personnel.

Aseptic Processing: Review of current and future practices, advanced technology; review of aseptic practices; regulatory compliance; facility design; aseptic filling; terminal sterilization; and in-house training of personnel.

Patents: www.sterile.com/patents

Additional Information

  • Specialized Consulting Services in the Areas of
    • Environmental monitoring systems
    • Cleaning/disinfection systems
    • Personnel gowning systems
    • Aseptic processing systems
    • Component entry systems
    • Personnel training
    • Media fill trials
  • Features and Benefits
    • Four decades of knowledge
    • Experienced professionals who are deeply involved in the industry
    • Proven success
    • Specialized and customized to your operation
    • Reduced costs in operations are apparent
    • Return on investment is valuable
    • Innovative solutions