Process and Scaling

Choosing the right facility size requires tailoring the design for current needs as well as anticipating the future.

The author discusses the collection and evaluation of data part of FDA’s definition of process validation.

DAVID LEAHY/GETTY IMAGESThe pharmaceutical industry has an important role to play in implementing solutions to global envi

The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted.

Quality by design, in-vitro release testing, and modern analytical methods are improving understanding and control of these complex formulations.

The FDA grants to the Rutgers-led C-SOPS research consortium will support the introduction of continuous manufacturing techniques for pharmaceuticals.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems.

Regulatory officials and industry scientists participated in a CMC Strategy Forum sponsored by CASSS in July 2015.

The new sizes follow the 2014 launch of the company’s fully disposable purifier.

An ISPE guidance document, four years in the making, brings risk-based thinking, statistics, and Lean Six Sigma to cleaning validation.

Barry Holtz, Principal, at Holtz Biopharma Consulting, and Klyo Collaborative, spoke with Pharmaceutical Technology about collaborative success strategies for biopharm companies.

The new column features Natrix’s signature macroporous hydrogel.

Presenters at IVT's Microbiology Week discussed best practices and recent guidance publications for microbial control in sterile and non-sterile pharmaceutical processes.

Talks will explore key trends and issues in the pharmaceutical space and address the “latest industry buzz.”

Optima Pharma is exhibiting a range of technologies from sterile-filling and freeze-drying solutions to isolators and restricted access barrier systems.

Hüttlin GranuLean offers a compact solution for high-quality granulation processes.

Products on display include the newest addition to the Mobius line of single-use bioreactors; Cellvento CHO cell culture media for optimized production of specific cell lines; and new high-volume AFS water purification systems.

Pharmaceutical Technology spoke to experts in the field of biopharmaceutical manufacturing to gain insights on top trends that are currently shaping the industry.

The countdown has begun for one of the biggest trade shows for the process industry.

While biotech will revolutionize our industry through new products and new reaction pathways, process analytics is the link between process automation and the laboratory sector, and water plays a key role as a valuable resource all over the world.

Pharmaceutical Technology spoke with Tim Kearns, pharmaceutical and medical devices manager at Videojet.

Medicago's new production facility will make plant-based vaccines and therapeutics.

Economic benefits, equipment availability, research results, and FDA support are driving progress in continuous processing.

The VERISEQ nucleation technology offers a commercially viable technique for cryogenically generating a uniform dispersion of microscopic ice crystals (or ice-fog).

The author reports results of evaluations and concludes that a disinfectant composed of a low-concentration suspension of silver ions is completely sporicidal with only a one-minute contact time.

Virtualization has been mainstream in information technology (IT) for decades.

At the request of FDA, US Marshals seize unapproved prescription drugs from Florida distributor.

The document serves as guidance for the pharmaceutical industry in data integrity issues and complements existing EU GMP relating to APIs and dosage forms.

The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.

Industry awaits the final revision of USP General Chapter and the impact it will have on the evaluation of sterile product package integrity.