Search results for "cleaning"
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
By Cristina Baccarelli, Paola Bernard, Teresa Cortellino, Oscar Cruciani, Rita Pacello, Chiara Parisi, Luisa Stoppa, Isabella Marta
Cleaning of pharmaceutical equipment is essential to reduce the…
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
Cleaning Protein A Resins with 1 M NaOH
Historically, protein A resins have been less chemical resistant to high concentrations of sodium hydroxide (NaOH), the commonly used cleaning and sanitization agent in bioprocessing. In this applicat…
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
Single-use systems generally suffer from a “sensor gap” related to the need to balance measurement accuracy against the well-known benefits of single-use processing, including the avoidance of cleanin…
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
Several activities must be performed in a facility to avoid any risk of cross-contamination between Product A and Product B, in particular via a thorough cleaning-in-place of all equipment surfaces in…
Article
Understanding Validation and Technical Transfer, Part 2
Validation protocols are used for processes that employ the qualified equipment and for processes related to the equipment, such as cleaning and sterilization.
It is convenient to break down eq…
Article
Process Chromatography Selection for Downstream Processing Applications
are used for one campaign only, omitting the cleaning steps and the need for cleaning validation. There is a continuous development of new chromatography resins combining separation modes. One example…
Article
Aseptic Processing: Keeping it Safe
Clean water requirements
The demand for high-quality water for aseptic processing is of paramount importance, as water is not only an ingredient in many aseptic formulations, but is also as a clea…