Consulting Services Details
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.