Article: A holistic strategy to ensure CCI of sterile vials
A framework to enable a holistic approach to CCI that assures both primary packaging and process contribute to good CCI of sterile vial product.
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A framework to enable a holistic approach to CCI that assures both primary packaging and process contribute to good CCI of sterile vial product.
22 March 2021 | By Bruker Biospin Group
In this virtual roundtable, experts explore the uses of nuclear magnetic resonance (NMR) in the analysis of biologics and biosimilars and discuss how recent advances are changing the game.
Disinfectants must be qualified on the surfaces in a pharmacopeial manufacturing environment prior to use in the facility. Building a study with robust parameters and avoiding common pitfalls is critical to avoid negative responses from regulatory agencies.
European Pharmaceutical Review’s Hannah Balfour outlines the findings of market research reports exploring the challenges and drivers for the pharmaceutical packaging equipment market between 2020 and 2025.
Over 90 percent of packages at three companies met all of the Drug Supply Chain Security Act (DSCSA) labelling requirements in 2020, despite there being three years until the final deadline.
iCON has improved delivery capacity by standardising the infrastructure for a flexible and readily available drug manufacturing facility.
iCON has improved delivery capacity by standardising the infrastructure for a flexible and readily available drug manufacturing facility.
Readily deployable, fully integrated mobile testing labs for fast-track delivery of diagnostic and analytical lab capability where and when needed.
The use of flexible mobile biocontainment and test units to prevent the spread of transmissible diseases.
A stability study that provides an opportunity to extend the product shelf life, by optimising the formulation and/or product packaging.
See how compliant products, unique packaging and smart labels make EMSURE® inorganics and solvents the smartest choice for pharmaceutical analysis.
G-CON’s standard POD maximises efficiencies in production, qualification and cost and eliminates the complexity of cleanroom construction projects.
11 February 2021 | By Lighthouse Instruments
Watch our on-demand webinar where we describe a more science-based holistic approach to ensure CCI; a framework that includes robust design and qualification of the process and the implementation of appropriate process controls is required.
4 February 2021 | By Beckman Coulter Life Sciences
Learn how the Coulter Principle can precisely measure minute distributions of biological particles. This principle can be used to analyse cyanobacteria, E. coli bacteria, CHO cells, CAR T cells, yeast cells, algae cells, fat cells, plant cells and more.
Lyophilised drug product containers and administration devices consist of the primary packaging, the reconstitution solution container, and the drug administration set.