Search results for "cleaning validation"

Article PDA's Technical Report for Biotech Cleaning Validation
49 for a detailed perspective on current practices and issues in biotech cleaning validation. By Anurag S. Rathore, Destin A. LeBlanc ABSTRACT Quality by Design principles such as design spac…

Article Cleaning of Dedicated Equipment: Why Validation is Needed
This article covers cleaning validation of equipment dedicated to the production of a single API; equipment used for manufacturing a class of products (e.g., penicillins) should be considered as share…

Article ISPE Releases Cleaning Validation Guide
The International Society for Pharmaceutical Engineering (ISPE) has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitione…

Article Increasing capacity through reduced cleaning and rapid change-over
CMC Biologics A/S (CMC), Denmark, a contract manufacturing organization, has a multi-product facility with several production lines. It performs both microbial fermentation and cultivation of mammal…

Article Evaluating Surface Cleanliness Using a Risk-Based Approach
…sampling and recovery testing of the sampling technique, and visual inspection performed during the cleaning validation. Each element of the justification needs to be reviewed and evaluated during th…

Article Reconciling Sensor Communication Gaps
…racy against the well-known benefits of single-use processing, including the avoidance of cleaning, cleaning validation, and calibration. For most of the history of the biomanufacture of therapeu…

Article The Lifecycle Change of Process Validation and Analytical Testing
Read More About Process Validation in this PDA Tech Report for Biocleaning Cleaning Validation.

Article Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3 Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…

Article Understanding Validation and Technical Transfer, Part 2
Understanding Validation and Technical Transfer, Part 2 A validation plan developed to support a process unrelated to bio-pharmaceutical manufacture is applied to biopharmaceutical processes and sys…

Article Bioterminology: A Guide to the Biopharmaceutical Lexicon
Bioterminology: A Guide to the Biopharmaceutical Lexicon This lexicon was generated by the editors of BioPharm International magazine. Please feel free to email your suggestions for terms that s…

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