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GMP pharmaceutical manufacturing, gmp guidelines, pharmaceutical production, fda

GMP pharmaceutical manufacturing, compliant and productive

Hit quality, compliance and productivity targets with leading edge sensor technology

GMP pharmaceutical manufacturing transition from small scale process development can be challenging. Higher levels of automation and control, new instrumentation and technologies bring additional complexity. GMP compliance, industry standards and guidelines, all need to be addressed to ensure quality specifications are met. Our pharmaceutical manufacturing portfolio enables real-time monitoring and control of quality and process parameters while reaching productivity targets.

How we can help

Endress+Hauser offers a complete portfolio of scalable solutions for pharmaceutical manufacturing excellence. Our instrumentation and sensor devices enable accurate monitoring of critical process conditions, safeguarding compliance and guaranteeing batch release.

  • Bioreactor and foam level measurement and control

  • Protein separation in chromatography skids

  • Analytical measurement in both laboratory and manufacturing

  • Field instruments for easy calibration

  • Entire instrumentation designed according to the ASME BPE standard

Applications

Controlled fermentation

Involving living cells, fermentation is a very complex, sensitive and cost intensive bioprocess. Aseptic conditions must be strictly ensured throughout the biopharmaceutical manufacturing process. Consistent measurement is vital when meeting these requirements.

Controlled fermentation
Competenţa noastră în domeniu

Designed for long-term stability and accuracy, our instrumentation portfolio enables complete control of bio-reactor conditions:

Efficient chromatography

Accurate measurement of conductivity and pH parameters is vital when leveraging chromatography. Moreover, detecting the target proteins to be separated from the complex mixture of the fermentation broth can be a complex challenge.

Efficient chromatography
Competenţa noastră în domeniu

Our monitoring solutions enable essential chromatography conditions to be maintained to support the separation process. We also offer UV process photometer sensors to facilitate the detection of target proteins:

Stable pH measurement

In a bioreactor pH is a critical control parameter. Each cell line has its optimum pH range for efficient cell growth and protein expression. From laboratory to large scale manufacturing, consistent and reliable data is required.

Stable pH measurement
Competenţa noastră în domeniu

The Endress+Hauser portfolio ensures stable inline pH measurement during fermentation for maximum reliability over all scales and allows an innovative calibration philosophy in the laboratory:

  • Leverage Memosens cutting-edge sensor technology

  • Deploy the same digital technologies in sensors and instrumentation from laboratory to large scale manufacturing

Learn how to standardize your instrumentation

bioprocess overview ©Endress+Hauser

Bioprocess overview

fermentation process ©Endress+Hauser

Fermentation process

chromatography process ©Endress+Hauser

Chromatography process

virus filtration process ©Endress+Hauser

Virus filtration process

concentration process ©Endress+Hauser

Concentration process

Meet our expert

"I am really happy to work for the biopharmaceutical industry at Endress+Hauser and to bring real value to your projects."

Klaus Köhler

Global Industry Manager, Endress+Hauser (Deutschland) AG+Co. KG

Avantaje

Streamline your projects for the biopharmaceutical manufacturing process together with our employees, like Klaus Köhler. They provide both a complete range in instrumentation and profound industry expertise to find the best solution for your needs.

  • 80 %

    reduction of instrument type diversity

  • 2 months

    faster time to market

  • 0

    changes of instruments, thanks to right-first-time specification

  • Produse simple

  • Ușor de ales, instalat și administrat

Excelenţă tehnică

Simplitate

  • Produse clasice

  • Fiabile, robuste și ușor de întreținut

Excelenţă tehnică

Simplitate

  • Produse superioare

  • Extrem de funcțional și convenabil

Excelenţă tehnică

Simplitate

  • Produse de specialitate

  • Conceput pentru aplicatii solicitante

Excelenţă tehnică

Simplitate

Variabil

Colecții FLEX Excelenţă tehnică Simplitate
  • F
  • L
  • E
  • X

Colecție Fundamental

Îndepliniți-vă nevoile esențiale de măsurare

Excelenţă tehnică
Simplitate
  • F
  • L
  • E
  • X

Selecţie Lean

Gestionați-vă cu ușurință procesele de bază

Excelenţă tehnică
Simplitate
  • F
  • L
  • E
  • X

Colecție Extended

Optimizați-vă procesele cu tehnologii inovatoare

Excelenţă tehnică
Simplitate
  • F
  • L
  • E
  • X

Colecție Xpert

Stăpâniţi cele mai dificile aplicaţii

Excelenţă tehnică
Simplitate

Variabil

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