Whitepapers - Pharmaceutical Technology

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PharmTech Europe

Whitepapers

Devolatilization/Solvent Extraction via Twin Screw Extrusion

April 23, 2014

Devolatilization (DV) is the process by which various amounts of unreacted monomer, solvent, water, or other undesirable volatile contaminants are removed from a polymer melt. A twin-screw extruder (TSE) is a device that is commonly utilized to compound polymer formulations to facilitate specific end-product performance. Oftentimes, there are chase impurities in the polymeric system that needs to be cleansed, sometimes as a result of tighter governmental or commercial standards, or due to the deleterious effects the residuals may have on final product properties.

Trust the Originator: HPMCAS Technology

April 23, 2014

HPMCAS (Hypromellose Acetate Sucinate) has been used for enteric coating and solubility enhancement for over 30 years. The white paper shows basic data of this polymer for solubility enhancement using melt-extrusion process.

Functional Surfaces To Control Surface-Biomolecule Interaction

April 23, 2014

The toolbox material science containing several pathways for selective surface functionalization enables the development of novel biological assays and applications. These new functional materials give the chance to overcome existing limitations in biotechnology. Cell-based assays, microarrays as well as optimized protein crystallization platforms are exemplified.

eBook: Troubleshooting Tips & Best Practices for Validation/Mapping

April 23, 2014

• Sensor placement: where, how many, and for how long? • Validation Master Plan checklist • Links to 1-hour webinars: Protocols, GMP Guidance, and Regulations on Validation

Validation, Qualification, and Calibration in a Pharmaceutical Facility

April 23, 2014

This paper outlines outsourcing requirements for validation, qualification and calibration activities. These ongoing activities cover development, operation, and maintenance and require a partner with high quality standards that can manage challenging requirements.

Applications In Pharmaceutical Manufacturing

April 23, 2014

This comprehensive white paper covers how to approach critical cleaning in the pharmaceutical industry. This tool enables one to ask and answer the logical issues that arise when performing one of the most important aspects of pharmaceutical manufacturing: the clean-out.

The Importance of Possessing Good Polymer Chemistry Knowledge in Conducting Extractables/Leachables Studies

April 11, 2014

Extractables and Leachables studies are an important part of the development cycle of any new drug product. It is important that an appropriate packaging system is chosen such that the product is stable and protected from degradation. It is equally important that this packaging system does not affect the purity of the product by leaching chemicals into the product. Rigorous extractables and leachables testing can ensure the proper packaging system is chosen, and an integral part of this testing regiment includes an extensive knowledge polymer chemistry.

Trust the Originator: HPMCAS Technology

April 10, 2014

HPMCAS (Hypromellose Acetate Sucinate) has been used for enteric coating and solubility enhancement for over 30 years. The white paper shows basic data of this polymer for solubility enhancement using melt-extrusion process.

Keeping Relative Humidity Calibrated: To find the right vendor you need to ask the right questions

March 26, 2014

Many processes in pharmaceutical science require controlled humidity to produce the desired product and preserve the necessary quality control. To maintain a humidity-controlled environment, manufacturers must keep instruments calibrated. Do you really know your relative humidity calibration vendor?

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