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LYOPTIMUS
THERMODYNAMICS
  • Home
  • Our core knowledge
  • Services
    • Scientific services
    • Technological solutions
    • Tools/Equipment
    • Standards
  • References
    • Our experience
    • Publications
  • About us
  • Contact Us

Standards

The new GMP Annex 1 (European comission August 2022)

The new GMP Annex 1 (European comission August 2022)

The new GMP Annex 1 (European comission August 2022)

GMP Annex 1

The new GMP Annex 1 for sterile products. Comming into operation the 25th of August 2023, with an extension for lyophilizers loading systems until the  25 August 2024.

 

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ATEX Guidelines (European comission November 2022)

The new GMP Annex 1 (European comission August 2022)

The new GMP Annex 1 (European comission August 2022)

ATEX Guidelines

Lowering the pressure of a freeze drying cycle, against the common knowledge, can accelerate the lyophilization cycle. 

 

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Managment of hazardous medicinal products (European comission 2023)

Guidance for hazardous medicinal products.

How to relate the refrigerants GWP with the electrical consumption in a freeze dryer. An overview of the energy balances and the current refrigeration alternatives.

 

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Pressure equipment directive (European comission 2014)

How to relate the refrigerants GWP with the electrical consumption in a freeze dryer. An overview of the energy balances and the current refrigeration alternatives.

 

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