The evolution of therapeutic modalities drives the adoption of single-use technologies.
Despite its understandable hesitancy, the pharma industry is facing a need for more widespread adoption of cloud-based solutions.
Given the criticality of fill/finish processes, it is clear that automation is the next technological step.
The article describes the basic principles of blow-fill-seal (BFS) technology together with the advantages it offers. Although BFS technology is an ideal process for aseptic filling of liquid pharmaceutical products there is still a risk of contaminating the product inside the filling area. This, together with regulatory requirements for the microbiological control of critical areas in pharmaceutical production, makes microbiological monitoring a necessity.
Recent technology improvements have made acrylics the preferred system for the aqueous enteric coating of tablets.
The content and quality of information supplied with drug products are among the most specifically defined areas associated with the products for sale. For patient or drug user, the information is presented in patient information leaflets (PILs) placed in the package. The readability testing of PILs is an important stage in the process of making the texts contained in the summary of product characteristics comprehensible to users, as this article discusses.
In this series of articles, bin blender performance is comprehensively reviewed using both free-flowing and cohesive mixtures. In part 1, an introduction to tools and techniques is presented, followed by an examination of parameter effects, mixing mechanisms, and the effects of cohesion on mixing.
The author describes a separation method for two active ingredients in the contraceptive pill with liquid chromatography UV detection.
Pharmaceutical Science & Technology Innovations
New technologies, along with changes in FDA oversight, may provide a critical path to make more new drugs available more quickly to patients.
Drug makers and their suppliers will need good planning and organization to meet the new bar coding requirements for drug products used in hospitals.
From data acquisition to enterprise resource planning, software systems operating at all levels of pharmaceutical manufacturing prepare for the seemingly inevitable implementation of process anlytical technology.
Pharmaceutical science and technology innovations
Bin blender performance is comprehensively reviewed using both free-flowing and cohesive mixtures.
Pharmaceutical Science & Technology News
Total organic carbon (TOC) analysis is a fast and effective analytical technique for cleaning validation. Understanding the various types of TOC technologies is essential for choosing the best solution.
This article describes the formulation of a tablet for a specific purpose, primarily using fractional or full factorial designs. The formulation work generated a matrix that was processed by two software packages based on neural networks. When the dataset was divided into smaller subsets, the agreement between the predicted and observed tablet properties of the optimized formulations was reasonable.
FDA's draft guidance on aseptic processing contains some inherent difficulties, including unrealistic expectations of sterility and microbial quantification, an absence of harmonization with international rules, and failure to support new technologies or a risk-based approach. The authors propose a science-based alternative.
In this article, the authors describe a study into the factorial effect of selected process parameters on the pharmaceutical characteristics of poly(DL-lactide-co-glycolide) microspheres containing methotrexate. A study of the microspheres' stability at refrigerated temperatures is also examined.
In spite of regulatory uncertainties, the industry continues to develop improved aseptic processing technologies.
Current microbiological methods cannot measure microbial contamination at the levels that engineers and regulators seek to establish for aseptic processing cleanrooms. New approaches for assessing data and establishing alert and action levels are advocated, and an example of one analytical tool is considered.
A new active dry powder inhaler has been developed using vibration frequencies to aerosolize powders.
FDA relies on e-chips to thwart bogus products, and drops paper pedigrees and unit-of-use packaging.
pharmaceutical science and technology news
Protecting a product from temperature abuse is gaining importance as regulators seek proof of product stability throughout the distribution process.
The author covers the fundamentals of lyophilization and provides case studies about the development of lyophilized biopharmaceutical products and the importance of biophysical characterization in formulaiton and the lyophilization process.
Electrical resistance, low temperature scanning calorimetry, and freeze-drying microscopy are three analytical methods that can be used to determine the thermal characterization of a product during processing for intended development of a lyophilization cycle.
Hydrogen peroxide has become the compound of choice for gaseous biodecontamination in the pharmaceutical industry. As some processes operate at vapour concentrations below the dew point, to avoid condensation, and others actually form dew, it is important to understand the relationship between the vapours and to have a method of establishing the dew point.
