Design and de-risk your aseptic process from formulation to final fill
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.
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.
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
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.
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.
Fill out the form below.
계속 읽으시려면 로그인하거나 계정을 생성하세요.
계정이 없으십니까?