Search results for "cleaning"
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Such procedures may include aseptic training, purchasing of suitable raw materials, raw material supply-chain management, and cleaning and sanitization, for example.
Biosafety should b…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Removing the need for cleaning and sanitization, for example, means that switching between one product and another becomes quicker and easier. One way to take advantage of this flexibility is by makin…
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Lessons Learned Accelerate Vaccine Development
In addition, disposable technologies offer the potential to eliminate equipment cleaning, process cleaning validation, and cross-contamination, plus facilitate changeovers between processes, according…
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Fluid Handling in Biopharma Facilities
Industry experts discuss challenges, trends, and innovations in fluid handling.
By Susan Haigney
Contamination prevention in biopharmaceutical manufacturing is crucial, and the proper handling…
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Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
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AstraZeneca: The use of SUS removes some of the risks that would otherwise come with the required cleaning process (e.g., cross-contamination and cleaning residues). Risks that may arise with the u…
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Modular Manufacturing Platforms for Biologics
In addition, closed modular systems are said to reduce required manufacturing area, HVAC requirements, chilled water and steam demands associated with cleaning, construction and start-up times, and po…
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Regulatory Challenges in the QbD Paradigm
Under a QbD paradigm, new manufacturing facilities will be designed for appropriate containment and segregation of operations, best practices for cleaning and disinfection, and appropriate level of en…
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Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
Furthermore, disposables minimize the risk for cross-contamination between production batches, and the need for time-consuming and costly cleaning and validation procedures is made redundant.
Si…
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Under pressure: exploring root causes of leaks in single-use mixers
It reduces downtime by eliminating cleaning steps, helps avoid risk of cross-contamination, and enables modularity in manufacturing and unit operations.
But efficiency isn’t just about what your e…
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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
… issue especially for smaller companies in the early stages of development at smaller scales, where cleaning validation is not a top priority,” he explains.
Hold-up volumes also become increasingl…