Manufacturing, Drug Products

Pharmaceutical Technology spoke with Bill Randolph, vice-president, Technical Services, Janssen Supply Chain, about some of the considerations for technology transfer of a continuous, solid-dosage manufacturing process and what he sees as the outlook for continuous manufacturing.

Hovione will operate a commercial-scale continuous manufacturing facility in New Jersey as part of an agreement with Vertex Pharmaceuticals.

Parenteral packaging of the future will include more automated lines, ready-to-fill packaging formats, and supply-chain transparency.

Problems in an induction-sealing process, such as untorqued or crooked caps, can be identified and corrected in real time using dynamic thermal imaging.

Although shortages, quality, and regulatory challenges remain, improved technologies and new investments suggest that the worst may be over.

Miriam Beyer, European marketing manager, West Pharmaceutical Services, describes causes of recent parenteral drug shortages.

The challenge of achieving zero visible defects (i.e., particulates) in parenteral drugs will require a coordinated effort at all stages of the supply chain, particularly in the production and filling of primary containers.

Manufacturers of parenteral drugs face challenges to increase efficiency, control particulates, control extractables and leachables, and eliminate product/package interactions; new containers and packaging equipment offer increased options.

Current guidance for absorption of elemental impurities does not address dermal exposure, resulting in a simplistic approach to limit setting.

Vacuum-conveying conditions for powders and other free-flowing solid forms can be simulated in Volkmann's new laboratory.

Electronic pharmaceutical tablet counters meet demands for accuracy, flexibility, speed, compact size, easy cleanability, and quick changeover.

Box-Behnken modeling was used to optimize a resinate complex, to mask the taste of levocetirizine dihydrochloride and montelukast sodium in orally disintegrating tablets.

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

This article looks at data gathered from several studies of a widely marketed chlorobutyl rubber formulation used for vial stoppers and prefilled syringes.

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

Innovative equipment, analytical techniques, software, and modeling systems are improving the tableting process.

MG America's TEKNA Capsule Filler has advanced controls to reduce powder loss and maintain optimal performance.

Pre-sterilized, nested syringes and vials are seeing increased use in sterile filling.

New materials and software modeling streamline the blister-package design process.

The final article of this series will look at the last two steps of the PharmaCare seven-step process?Lubricate and Store.

Solving the problem of tablet spots or specks involves prevention and thorough investigation.

Over the last three weeks, we have been looking at each step and the benefit of adopting the process. This week, we look at Step 4, Measure.

As the second part of this series, we look at the importance of ?assessing? the punches and dies to check their condition and how this step may help avoid any problems that may occur during tablet manufacture.

Capsugel gives lead users access to intrinsically enteric capsule technology and support services.

The parenteral manufacturing industry is taking action to address particulate contamination issues.

This review highlights relevant physicochemical drug properties and formulation design considerations critical to quality and performance of the sublingual tablets.

PharmaSpray delivers a consistent, validatable amount of dry lubricant.

Temperature-controlled packaging trends include prequalified systems that simplify adoption, reusable systems that are more sustainable, and new temperature-monitoring technology.

Fette Compacting America FE75 Tablet Press is designed to produce up to 1.6 million tablets per hour.