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MilliporeSigma
Aseptic processing design iscussion

Design and de-risk your aseptic process from formulation to final fill

Aseptic processing design discussion
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Preparing for Annex 1? Start here.

As EU GMP Annex 1 continues to influence approaches for contamination control, sterile filtration, integrity testing, and process design, having the right solutions in place is essential. Read our whitepaper to explore practical strategies and key considerations to strengthen your contamination control strategy and prepare your aseptic process for today’s regulatory expectations.

Download the Annex 1 whitepaper

Because every dose counts.

Protect every dose with integrated aseptic processing solutions backed by 50 years of experience. From formulation through filling, our technologies and expertise can help you safeguard product quality, maintain sterility, and support compliance with evolving regulatory expectations.

 

Which part of your aseptic process are you designing today?

Every aseptic manufacturing process is different. Whether you're optimizing mixing, streamlining sterile filtration and integrity testing or implementing single-use workflows, our technical specialists are ready to help.

Scientist in front of single-use mixer.

Drug formulation

Single-use mixers, specialized bags, and fluid management solutions to minimize leaks and maintain product integrity. 
 

Explore formulation solutions
Two process engineers discussing sterile filtration solutions holding a capsule.

Sterile filtration

Industry-leading sterilizing-grade filters supported by validation services, regulatory expertise and decades of manufacturing experience.

Explore sterile filtration solutions
Two process engineers discussing discussion single-use aseptic process design.

Assemblies and systems

Integrated single-use assemblies, automated integrity testers, and customized systems designed to streamline and secure final fill operations.

Explore single-use technologies


 

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Discover our integrated aseptic processing ecosystem.

See how our integrated portfolio of sterilizing-grade filters, single-use assemblies, systems, integrity testers, regulatory documentation, validation services and technical expertise work together to support aseptic drug product manufacturing.

Download brochure

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More than products. A partner in aseptic manufacturing.

Designing an aseptic manufacturing process requires more than selecting individual products. It takes deep technical expertise, proven technologies, and a partner who understands the complexities of manufacturing sterile drug products for patients.

A regulatory expert and process development scientist discussing risk assessment.

The Emprove® Program

Comprehensive documentation to facilitate your qualification, risk assessment, and process optimization throughout your manufacturing lifecycle.

Learn more
3 MSAT discussing extractables and leachables and patient safety evaluation.

Filter and validation services

Validation services to help select, test, and validate your filters, assemblies, and single-use systems for drug manufacturing applications.

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Engineers and scientists discussing aseptic processing optimization In the M Lab™ Collaboration Center.

Process development manufacturing support

Partner with our team at the M Lab™ Collaboration Center to optimize and scale your aseptic operation.

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Preparing for Annex 1? Start here.

Our whitepaper “Navigating EU GMP Annex 1” summarizes the latest regulatory updates for process design and contamination control in final sterile filtration with single-use technologies.

Topics include:

  • How the latest updates strengthen holistic contamination control strategies
  • Requirements and practical considerations for final sterile filtration, including filter integrity testing and PUPSIT
  • Qualification of sterile connection devices and single-use assemblies for closed processing systems
  • The importance of maintaining sterility of single-use assemblies throughout the supply and how comprehensive supplier documentation can streamline implementation.

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