Biotechnology for Sterile Filtration


In biotechnology processes, the product is the process, the final outcome from dozens of operations over an extended period of time. To ensure safety and security, sterilizing-grade and bioburden reduction filters are used throughout the production process. Using the best products is vital.

There are many challenges affecting today’s biotechnology processes including overall process yield and increased regulatory scrutiny. Since processes should be designed to be scalable, flexible and transferrable, it is important to choose a filtration partner who has a wide range of membranes and devices, and provides global support.

Merck’s sterilizing and bioburden reduction products come in linearly scalable cartridge and disposable formats using industry standard polymers like PTFE, PVDF and PES, and cover surface areas from square centimeters to many square meters. And because our products and services are supported by a global team in over 40 countries, your sterile filtration products are assured.

Bioreactor

Challenges in Sterile Filtration Processes around the Bioreactor

  • Maximizing yield and process efficiency
  • Assured retention of a wide range of bacteria and mycoplasma
  • Robustness for effective sterilization with reliable integrity testing
  • Qualified bacteria and phage retention in sterile gas filtration

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Cell Harvest

Challenges in Harvest Clarification and Filtration

  • Optimizing performance of a combination of filtration steps
  • Maintaining low bioburden
  • Maximizing yield, process efficiency and economy
  • Robustness to handle process fluid changes
  • Availability of easy-to-use, flexible disposable formats for multiproduct facilities

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Intermediates

Challenges in Intermediate Filtration and Processing

  • Maintaining low bioburden and low pressure drops
  • Maximizing yield, flow rates and process economy
  • Robust processes that are scalable, sanitizable and sterilizable
  • Regulatory compliance/documentation

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Buffers

Challenges in Buffer Filtration

  • Fast, efficient, economical filtration
  • Reliable sterilization and sterility assurance
  • Compatible with wide range of process buffers and column cleaning/sanitizing solutions

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Utilities

Challenges in Utilities Filtration

  • Longevity and good economy
  • Reliable, retention assurance
  • cGMP compliance

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Sterile Bulk

Challenges in Sterile Bulk and Final Sterile Fill Operations

  • Preserving product purity
  • Maximum product yield
  • Ensuring product safety

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SVP

Challenges in SVP Filtration and Production

  • Maximizing product yield
  • Sterility assurance
  • Regulatory compliance
  • Reliable filter integrity testing before and after sterilization
  • Filling operations in an isolator

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Single-use Redundant Filtration Guide - Learn More

Single-use Redundant
Filtration guide

Learn More

無菌ろ過製品選択ガイド - 詳細はこちら

無菌ろ過製品選択ガイド

詳細はこちら