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Freeze-Drying Systems: Freeze Dryer Interface Design Requirements and Automatic Loading and Unloading Systems (ALUS™)

  • Maik Guttzeit
  • Carolin Wolf
  • Johannes Selch
  • Thomas Beutler
Protocol
Part of the Methods in Pharmacology and Toxicology book series (MIPT)

Abstract

The requirements for manufacturing pharmaceutical products are increasing constantly, especially for aseptic and/or products. In the same time there is a clear tendency towards more complex and multi-purpose equipment. In liquid container (mainly vial or syringes) lines the handling of the critical and more often expensive product must be safe and reliable. If the lines are combined with freeze dryers, the interface between the liquid handling parts (filler, container transport, capping), the interface to the freeze dryer has to be observed sensitively. This is because of the different conditions between the 2 sections. While the liquid handling parts are now in most applications covered by isolator technology or Restricted Access Barrier Systems (RABS), which facilitates decontamination cycles and laminar air flow, the freeze dryer has no directional air flow and is equipment which is usually sterilized by saturated steam. These differences have to be taken into consideration during the design and manufacturing process. Additionally there will be increased future vial handling requirements like tracking of the pharmaceutical product.

Key words

Automated loading unloading systems (ALUS) Good manufacturing practice Isolators Restricted access barrier systems (RABS) Process flow Combined systems 

References

  1. 1.
    EU GMP guidelines Annex 1. Manufacture of sterile medicinal products (2008) https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2008_11_25_gmp-an1_en.pdf
  2. 2.
    Figure SD-5.4.1.3-1 Lyophilizer Sterile Boundary in ASME BPE (2016) http://files.asme.org/Catalog/Codes/PrintBook/35606.pdf
  3. 3.
  4. 4.
    PHSS: No.2: “Environmental Contamination Control Practice (2002) https://phss.site-ym.com/store/ViewProduct.aspx?id=1990368
  5. 5.
    Rey L, May JC (eds) (2004) Freeze drying/lyophilization of pharmaceutical and biological products, 2nd edn. Marcel Dekker, New York, NYGoogle Scholar
  6. 6.
    PHSS Guidance on isolators and RABS – 15: https://phss.site-ym.com/store/ViewProduct.aspx?id=1819470

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  • Maik Guttzeit
    • 1
  • Carolin Wolf
    • 1
  • Johannes Selch
    • 1
  • Thomas Beutler
    • 1
  1. 1.GEA Lyophil GmbHHürthGermany

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