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

FEATURED ARTICLES

  • Transient Overheating In Empty Autoclave Chambers
    Transient Overheating In Empty Autoclave Chambers

    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).

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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

Pharmaceutical Steam Sterilizer: FOB-TS Pharmaceutical Steam Sterilizer: FOB-TS

L in FOB-TS series combines outstanding performance with high quality materials, ease of use and reduced consumption.

Pharmaceutical Vertical Laboratory Sterilizer: FVG Pharmaceutical Vertical Laboratory Sterilizer: FVG

L in FVG series combines outstanding performance with high quality materials, ease of use and reduced consumption.

Pharmaceutical Laboratory Sterilizer: FVS Pharmaceutical Laboratory Sterilizer: FVS

L to FVS series combines outstanding performance with high quality materials, ease of use and reduced consumption.

R&D Sterilizer For University, Research Institutes, And Laboratories R&D Sterilizer For University, Research Institutes, And Laboratories

L in FVA / A1 series combines outstanding performance with high quality materials, ease of use and reduced consumption.

Carbon Dioxide Headspace Analyzer for Pharmaceutical Parenteral Manufacturing Carbon Dioxide Headspace Analyzer for Pharmaceutical Parenteral Manufacturing

LIGHTHOUSE is proud to announce a new addition to the FMS family product line, the FMS-Carbon Dioxide Headspace Analyzer. This new analyzer expands a family of instruments that enables rapid non-destructive analysis of the headspace conditions of a sealed parenteral container. Current LIGHTHOUSE headspace platforms enable the measurement of headspace oxygen, moisture, and vacuum levels.

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.

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