Heat Transfer Characteristics of Current Primary Packaging Systems for Pharmaceutical Freeze-Drying

Hibler, Susanne; Gieseler, Henning

doi:10.1002/jps.23293

Cited by 19 publications

(13 citation statements)

References 27 publications

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“…6 During the process the product temperature should be maintained below a critical value corresponding to the glass transition temperature in amorphous product. 3,7 However, the product temperature profile cannot be directly controlled and depends on the process operating parameters (i.e., shelf temperature, chamber pressure) and on the heat transfer through the container (e.g., vial). 4,7,8 Knowledge of the heat transfer characteristics of the vial and the uniformity or non uniformity of this property within vial arrangement inside a freezedryer is thus essential to be able to predict final quality of the product batch.…”

Section: Introductionmentioning

confidence: 99%

“…The design of the vial also strongly influences the heat transfer efficiency between the shelf and the product. 4,5,7,[12][13][14][15] Considering that the vials are placed directly on the shelf, the heat flow transferred to the product can be described by three parallel mechanisms: conduction from the shelf surface to the vial via points of direct contact between the vial bottom and the shelf, conduction through the vapor entrapped in the vial bottom concavity and radiation. 5,8,12 Heat transfers via contact conduction and conduction through the gas are influenced, respectively, by the dimension of the contact area between the shelf and the vial and the depth of bottom curvature in which the gas is entrapped.…”

Section: Introductionmentioning

confidence: 99%

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How Vial Geometry Variability Influences Heat Transfer and Product Temperature During Freeze-Drying

Scutellà

Passot

Bourlés

et al. 2017

Journal of Pharmaceutical Sciences

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Vial design features can play a significant role in heat transfer between the shelf and the product and, consequently, in the final quality of the freeze-dried product. Our objective was to investigate the impact of the variability of some geometrical dimensions of a set of tubing vials commonly used for pharmaceuticals production on the distribution of the vial heat transfer coefficients (K) and its potential consequence on product temperature. Sublimation tests were carried out using pure water and 8 combinations of chamber pressure (4-50 Pa) and shelf temperature (-40°C and 0°C) in 2 freeze-dryers. K values were individually determined for 100 vials located in the center of the shelf. Vial bottom curvature depth and contact area between the vial and the shelf were carefully measured for 120 vials and these data were used to calculate K distribution due to variability in vial geometry. At low pressures commonly used for sensitive products (below 10 Pa), the vial-shelf contact area appeared crucial for explaining K heterogeneity and was found to generate, in our study, a product temperature distribution of approximately 2°C during sublimation. Our approach provides quantitative guidelines for defining vial geometry tolerance specifications and product temperature safety margins.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

How Vial Geometry Variability Influences Heat Transfer and Product Temperature During Freeze-Drying

Scutellà

Passot

Bourlés

et al. 2017

Journal of Pharmaceutical Sciences

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“…Freeze‐drying is an effective and gentle approach typically used to enhance chemical stability of these drugs . The most common container used for lyophilization is the single dose vial . Prior to administration, reconstitution of the freeze‐dried cake with an additional syringe transfer is required.…”

Section: Introductionmentioning

confidence: 99%

Energy Transfer During Freeze-Drying in Dual-Chamber Cartridges

Korpus

Haase²,

Sönnichsen³

et al. 2015

Journal of Pharmaceutical Sciences

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“…As mentioned earlier, the formation of dried layers in the product will affect the mass transfer of water vapor. Therefore, the container shape or any other constriction present in the container, which may impede the transfer of water vapor out of the container, will decrease the drying rate [10,19]. .…”

Section: Container Systemmentioning

confidence: 99%

Application of freeze-drying in the development of oral drug delivery systems

Siow

Heng

Chan

2016

Expert Opinion on Drug Delivery

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With continual focus on oral drug delivery systems (ODDS), the role of freeze-drying becomes increasingly valuable. While freeze-drying is fundamentally a desiccation process, the advantageous material properties attributed to freeze-drying extend far beyond the preparation of stable pharmaceutical products. The formulation and process variables are important considerations as they affect the final freeze-dried product characteristics. It is of interest to expound on the principles and effects of freeze-drying in the hope of introducing novel products for applications in the development of ODDS. Areas covered: In this review, basic principles, general formulation and process variables associated with freeze-drying will be covered. The application of freeze-drying in 3 areas: modification of active ingredients, development of novel freeze-dried excipients and development of freeze-dried final dosage forms will be discussed. Expert opinion: As a pharmaceutical unit operation, freeze-drying has created new dimensions in the area of oral drug delivery, where the properties of the drugs, excipients and characteristics of the final solid dosage form can be modified by the freeze-drying process. With the emergence of new applications, the role of freeze-drying technology in ODDS is indeed a relevant and promising one.

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Heat Transfer Characteristics of Current Primary Packaging Systems for Pharmaceutical Freeze-Drying

Cited by 19 publications

References 27 publications

How Vial Geometry Variability Influences Heat Transfer and Product Temperature During Freeze-Drying

How Vial Geometry Variability Influences Heat Transfer and Product Temperature During Freeze-Drying

Energy Transfer During Freeze-Drying in Dual-Chamber Cartridges

Application of freeze-drying in the development of oral drug delivery systems

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