pharm-liquid-dose-995x60 pharm-liquid-dose-995x60

FEATURED ARTICLES

  • Ready-To-Install Laboratory Automation Systems For Efficient Laboratory Processes
    Ready-To-Install Laboratory Automation Systems For Efficient Laboratory Processes

    Analytical laboratories have to provide sound results in a short time.  Speed and reproducibility play a significant role here.  Modern automation technology saves time, increases quality and reduces costs for the transport and distribution of samples.  Ready-to-install subsystems from Festo are opening up new possibilities for efficient processes in laboratory automation.

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WHITE PAPERS & CASE STUDIES

  • Modular Facility Design: A Cost-Effective Option In The Post-Blockbuster Drug Era
    Modular Facility Design: A Cost-Effective Option In The Post-Blockbuster Drug Era

    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.

  • How The Extrusion Process Impacts The Quality of Blow/Fill/Seal Products
    How The Extrusion Process Impacts The Quality of Blow/Fill/Seal Products

    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.

  • Load Cells For A Portable Structure
    Load Cells For A Portable Structure

    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."

  • Fundamentals Of Spray-Dried Dispersion Technology
    Fundamentals Of Spray-Dried Dispersion Technology

    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.

  • Regulatory And Fill Volume Considerations For Liquid Filling Systems
    Regulatory And Fill Volume Considerations For Liquid Filling Systems

    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.

  • Transfer Of Lab Automation And Handling Concepts From Chemical To Pharmaceutical Applications
    Transfer Of Lab Automation And Handling Concepts From Chemical To Pharmaceutical Applications

    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.

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PRODUCTS & SERVICES

Low Temperature Benchtop Bath: CharpyCool Low Temperature Benchtop Bath: CharpyCool

The new CharpyCool is a mechanically refrigerated bench top bath that eliminates the need for costly consumables such as liquid nitrogen or dry ice. Compact and completely self-contained, the CharpyCool offers up to 8 liters of working fluid volume enabling up to 91 Charpy impact test specimens to be accommodated at temperatures between -80°C and +30°C. A powerful variable speed magnetic stirrer and vortex breaker provide excellent temperature uniformity and stability enabling superior results. PID control enables the CharpyCool to sustain precise temperature control to within ± 0.1°C. The CharpyCool includes a digital temperature display, and an optional Charpy Rack is available which allows multiple-specimen loading and easy access to monitor your testing.

Vacuum Leak Detection Of Pharmaceutical Freeze Dried Products Vacuum Leak Detection Of Pharmaceutical Freeze Dried Products

Regulatory guidance (Eudralex 2008) explicitly states that containers closed under vacuum should be checked for the maintenance of that vacuum.  This guidance has led to the implementation of new types of inspection systems by the industry.  Because headspace analysis can rapidly and non-destructively detect changes in the headspace conditions, it is a leading candidate to use as a vacuum leak detection method for finished freeze dried product.

Lyophilization Chamber Moisture Mapping Lyophilization Chamber Moisture Mapping

Regulatory authorities require proof that lyophilization cycles have been developed logically and demonstrate uniformity. One measure of uniformity is the consistency of residual water content throughout a batch.

Pharmaceutical Headspace Oxygen Stability Studies Pharmaceutical Headspace Oxygen Stability Studies

Many of today's biopharmaceutical formulations may potentially suffer from oxidation to some degree. Large molecule formulations are relatively more delicate and may be prone to degrade in the presence of oxygen.  Besides a loss of efficacy and reduction in shelf life, exposure of such products to oxygen can result in product discoloration, changes in dissolution rate and profile, and even toxicity or other pharmacological properties associated with negative side effects. During the development of an oxygen-sensitive product, studies are performed that investigate the formulation’s interaction with oxygen. End-of-shelf-life stability studies verify that the product indeed retains efficacy under specified headspace oxygen levels. Such studies allow for the specification of appropriate initial headspace oxygen levels in the primary packaging.

Moisture Determination Of Lyophilized Vials Moisture Determination Of Lyophilized Vials

Moisture Determination
Residual product moisture content is a critical parameter when considering the stability and shelf life of lyophilized pharmaceutical product, sterile powders, or solid dosage product. Consequently, moisture analysis is performed in product and process development, as well as in commercial manufacturing to specify and control the maximum allowable moisture content. This is traditionally performed using Karl Fischer titration or thermo-gravimetric analysis (TGA) methods, which are destructive and labor & time intensive. Replacing these slow traditional methods with a rapid non-destructive method would streamline moisture analysis efforts and help improve the quality of finished product.

In-Line 100% Container Closure Integrity Laser Based Headspace Inspection In-Line 100% Container Closure Integrity Laser Based Headspace Inspection

Container closure integrity (CCI) plays an important role in maintaining the sterility and stability of parenteral products. LIGHTHOUSE has analyzed CCI inspection data of commercial freeze-dried product vials from sterile facilities around the world. The data set of 15 million lyo vials shows an average CCI failure rate similar to that of ampoules (a few tenths of a percent - for more details, watch the Screencasts at the bottom of this page). The risk for container closure failure in the lyo process is part of the reason for new regulations and increased attention from inspectors to this topic in the past several years.

Clinical and Pharmaceutical Production Freeze Dryers Clinical and Pharmaceutical Production Freeze Dryers

The Benchmark Freeze Dryers are custom-built production lyophilizers made to meet pilot, clinical supply and production demands. Meeting your current application demands with an eye toward future demand is what we do best.

Hotpack Glassware Washers and Controlled Environments Hotpack Glassware Washers and Controlled Environments

Hotpack glassware washers are manufactured to provide extremely accurate control and years of dependable performance. Hotpack's product line of washers meet almost any glassware washer requirement.

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