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
Products:
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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
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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