Aseptic Processing, Inc.

GMP operations occasionally require external consulting expertise to develop or confirm compliant solutions.

Trusted Expertise

Trusted Expertise

API® consulting and training division specializes in contamination control, cleaning and disinfection, disinfectant validation, component entry, environmental monitoring, aseptic processing, gowning, media fills, CIP/COP, and personnel training.

Specialized Consulting

Contamination Control Systems
Four decades of industry insight
Environmental monitoring systems
Assuring guidance for compliant solutions.
Cleaning/disinfection systems
Seasoned professionals delivering proven results.
Personnel gowning systems
Customized solutions
Aseptic processing systems
Enhanced efficiency and reduced operational costs.
Component entry systems
Strong return on investment
Personnel training
Innovation that drives lasting impact.
Media fill trials
CIP/COP

Our Solutions

GMP teams excel in manufacturing and testing but often face heavy regulatory burdens. API has supported pharmaceutical, biotech, compounding, and medical device firms for over 40 years.

Our Experience

Our Experience

Our expertise includes but is not limited to faculty members at PDA TRI since its inception, routine CBER/CDER/EMEA/MHRA training since 2001, Faculty USP 797 training, assistance to FDA in writing sections of the Aseptic Processing Guide, countless book chapters, industry papers, industry presentations and consulting projects for nearly 40 years.

Connect with VAI to design a contamination control program built for your process.

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