Search results for "cleaning validation" in Articles / App Notes
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
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
Assessing Manufacturing Process Robustness
In 2011, FDA’s revised process validation (PV) guidance (7) extended ICH’s concepts to the pharmaceutical product lifecycle, an approach that is now being applied to cleaning validation and other area…
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
The key advantage of single-use equipment is the elimination of cleaning and cleaning validation steps, which significantly reduces cleaning time, according to Stenklo. “With optimized consumables and…