The transient overheat in empty autoclave chambers is a phenomenon that frequently occurs during validation studies. This article by Italian sterilization practitioner Vittorio Mascherpa investigates the main causes of it and suggests some methods to prevent it or to cope with it. The article also includes a useful table of superheating effects due to adiabatic isenthalpic expansion of saturated steam (i.e. in ideal conditions).
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. The literature suggests that a significant majority of new drug candidates are in the Biopharmaceutics Classification System (BCS) class II and IV space, which includes compounds that are dissolution rate, solubility or permeability limited to absorption, or all three. As portfolios across the industry are increasingly focused on these compounds, the need for enabling technologies continues to grow.
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.
Laboratory automation has significantly changed chemical and pharmaceutical research since the 1980s. Complex automation and handling solutions provided by Bosch have proven successful in chemical laboratories for a long time. Bosch Packaging Technology is now transferring its concept of lab automation and handling to the pharmaceutical market. Based on its packaging and pharmaceutical know-how, Bosch offers the pharmaceutical industry highly flexible, tailor-made solutions along the value chain.