A proposed rationale and test methodology for establishment of acceptance criteria for vacuum integrity testing of pharmaceutical freeze dryers

Author:

Hardwick Lisa M.,Nail Steven L.,Jarman James,Hasler Kai,Hense Thomas

Publisher

Elsevier BV

Subject

Pharmaceutical Science,General Medicine,Biotechnology

Reference7 articles.

1. The vacuum integrity testing of lyophilizers;Dern;Pharmaceutical Engineering,2005

2. FDA Guidance, Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice.

3. EU Guideline, Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use – Annex 1.

4. FDA draft Guidance, SUPAC: Manufacturing Equipment Addendum.

5. FDA Guide to Inspection of Lyophilization of Parenterals (7/93).

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1. Recommended Best Practices in Freeze Dryer Equipment Performance Qualification: 2022;AAPS PharmSciTech;2023-01-26

2. Informed Manufacturing Through the Use of Big Data Analytics for Freeze Drying Process and Equipment;Principles and Practices of Lyophilization in Product Development and Manufacturing;2023

3. Characterization of Freeze Dryers;Principles and Practices of Lyophilization in Product Development and Manufacturing;2023

4. Lyophilizer Leak Rate Testing – An Industry Survey and Best Practice Recommendation;Journal of Pharmaceutical Sciences;2022-10

5. Mass spectrometry in freeze-drying: Motivations for using a bespoke PAT for laboratory and production environment;European Journal of Pharmaceutics and Biopharmaceutics;2018-06

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