OCR

PRODUCTS

  • Consider the benefits of an integrated operations and project management approach across all phases and regions.

  • When AST came to the table on the design for our new fill-finish isolator, one of the first areas AST engineers wanted to address was the usability and accessibility of the isolator and corresponding operations. With our customers’ point of view in mind, we wanted to address specific points of friction routinely encountered by operators and closely examine whether those friction points were necessary.

    Does an isolator need to be ergonomically unfriendly to clean?

    Should simple mechanisms like isolator doors be challenging to engage? (As much as one can appreciate exercise, no one wants to do “arm day” in cleanroom coveralls).

    Does routine maintenance have to be time-consuming and laborious?

    Many of these factors are accepted as par for the course in aseptic fill-finish manufacturing. Our question was, why?

  • Our model combines the depth and experience level of our people with effective tools and processes already in place that are designed to ensure your critical eTMF documents and content are secure, organized, readily accessible, and always in complete compliance with all relevant regulations.

  • Are you anticipating rapid growth, getting ready for an equity event, or coming off a legacy system? NetSuite ERP’s all-in-one cloud business management solution helps future-proof your organization, eliminate redundancies and data silos, and automate manual processes, so you’re always ready for your next business milestone.

  • For more than 20 years, Eurofins PSS Insourcing Solutions® has partnered with biotech and pharmaceutical companies to successfully validate and open new or remodeled facilities, meeting regulatory requirements. With a proven track record across numerous facility projects, our flexible, client-focused model ensures seamless integration with internal teams and third-party vendors, delivering high satisfaction and long-term partnerships.

WHITE PAPERS AND CASE STUDIES

NEWS