New Aseptic Technologies Enable Enhanced Product and Process Performance
Pharmaceutical Engineering electronic supplement magazine features five articles describing new aseptic technologies or techniques employed by a variety of organizations and researchers to improve and enhance products, processes, instruments, associated technologies, and services.
The Musculoskeletal Transplant Foundation, one of the nation’s leading tissue banks and a supplier of Allograft bone and dermal tissue, uses isolators in the production of Demineralized Bone Matrix (DBX) putty, a processed and demineralized human bone product that is biocompatible and biodegradable. DBX is used to fill voids or gaps resulting from surgery or trauma that are not intrinsic to the stability of the bony structure. MTF has been raising their standards for isolators and the purpose of the project presented in the article was to be able to better understand how to select, design, and validate isolation technologies.
Guided Wave Radar (GWR) is a well-known technology that has been used for two decades to carry out a variety of measurements employing a probe (a wave guide) that carries a microwave pulse and uses “time of flight” to measure energy reflected back up the probe. The researchers have found that GWR is an acceptable, less expensive, single use and disposable alternative technology for loading cell systems that can be used to measure biotech-type liquids accurately.
Optima Pharma completed a project to isolate and freeze-dry blood plasma that included filling and sealing sterile containment systems and freeze-drying – with associated upstream and downstream processes –blood plasma. The project was characterized by batch sizes varying from small to medium, high aseptic requirements, and best product yield. Protection of the product and product safety were of high importance and an isolator technology was central to the project.
The number of particles in the air is a key parameter for defining levels of cleanliness in aseptic manufacturing. A team from the Bio-Process Systems Alliance, an industry-led corporate member trade association, has made recommendations for particle control in the manufacture and supply of single use systems. Particles or particulate matter in parenteral and drug powder therapies is a substantial concern. The research team has found that disposal, single use systems are cost-effective and mitigate quality risks from particulates.
Crystallization is a complex and critical operation in API and fine chemicals manufacturing. This article discusses the fundamentals and basic science behind the development and “scale-up” of the crystallization process and discusses the stringent requirements laid down by the FDA and other regulatory agencies. Central to the process complexity is the fact that the chemical and physical characteristics of the product are established during crystallization while the product is being filtered, washed, dried and milled to meet certain requirements. There are potential warning signs identifying a non-robust process. However, certain variables will enable successful scale-up as the goal is to better define the crystallization process.
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There is no question that managing the complexities of aseptic environments and processes is a constant challenge. If you could go to one conference to get up to speed on the best practices and the latest thinking in aseptic processing technologies, consider attending the 2015 Aseptic Processing Technology Conference on 23 – 24 February 2015 at the Hilton Baltimore in Baltimore, MD.