OR WAIT null SECS
January 02, 2016
Parenteral packaging of the future will include more automated lines, ready-to-fill packaging formats, and supply-chain transparency.
The revised USP Chapter 1207 gives best practices for obtaining reliable data in container closure integrity testing.
December 16, 2015
Collaboration between users and suppliers to increase understanding, clearly define user requirements, and mitigate risk is facilitating acceptance by industry and regulators.
December 02, 2015
Microorganism lethality requirements for process validation must always be balanced with the need to protect product integrity and patient safety.
All openings and potential apertures for air penetration must be considered when designing a cleanroom so that the HVAC system can maintain the desired negative or positive pressure.
November 02, 2015
Problems in an induction-sealing process, such as untorqued or crooked caps, can be identified and corrected in real time using dynamic thermal imaging.
October 02, 2015
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.
September 28, 2015
The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.
September 16, 2015
Preventing contamination requires quality systems to be in place, including routine cleaning, a robust cleaning validation program, and preventive maintenance.
September 02, 2015
Creating closed processes and reducing room air classification in a biopharmaceutical facility can reduce operational costs.