The transient overheat in empty autoclave chambers is a phenomenon that frequently occurs during validation studies. This article investigates the main causes and methods to prevent it or to cope with it.
The pharmaceutical industry has undergone a sea of change in recent years as manufacturers have adapted to the end of the era of large-volume production of mass-market blockbuster drugs. With firms now focusing in on subpopulations of patients, there is a need for lean, adaptable facilities that can switch quickly between multiple products in multiple formats. Modular facilities can meet this need. While not a panacea, for the right project characteristics, ‘Modularity in Design’ can deliver significant and quantifiable long-term value.
A collaborative study involving Cardinal Health, Inc. and Air Dispersions Ltd. has been carried out to further the understanding of the extrusion process and its impact upon the quality of Blow/Fill/Seal product.
We know that a weighing system must be rigid to get good results. We should also know that a three point system is inherently more stable than a four point system as three points define a plane. We know that we can convert a four wheel portable vessel to a three point system by using a double frame design “sandwich concept."
A common problem statement in the pharmaceutical industry is low oral bioavailability of drug candidates with poor aqueous solubility.
While diagnostic, biotech, and pharmaceutical are distinct industries, they do share similar characteristics as it pertains to the filling & closing solution that is suitable. These products usually have a high economic value per volume and involve small, accurate fill volumes into containers that can be difficult to handle. In addition to the filling, closing, and labeling of these types of containers, there can be more complex requirements that relate to the regulatory environment. These requirements can lead to a system that needs validated control over all elements of the packaging process.