Dec 16, 2015
Equipment and Processing Report
Collaboration between users and suppliers to increase understanding, clearly define user requirements, and mitigate risk is facilitating acceptance by industry and regulators.
Dec 02, 2015
Pharmaceutical Technology
All openings and potential breaches for air penetration must be considered when designing a cleanroom so that the HVAC system can maintain the desired negative or positive pressure.
Dec 02, 2015
Pharmaceutical Technology
Microorganism lethality requirements for process validation must always be balanced with the need to protect product integrity and patient safety.
Sep 28, 2015
By Pharmaceutical Technology Editors
The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.
Sep 16, 2015
Equipment and Processing Report
Preventing contamination requires quality systems to be in place, including routine cleaning, a robust cleaning validation program, and preventive maintenance.
Sep 02, 2015
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Meissner’s FlexGro single-use biocontainer assemblies feature the TepoFlex polyethylene (PE) multi-layer film and are delivered presterilized for immediate use.
Sep 02, 2015
Pharmaceutical Technology
Appropriate cleaning procedures are crucial for any cGMP aseptic or sterile pharmaceutical manufacturing process, including vial filling; operators share best practices for cleaning.
Sep 02, 2015
Pharmaceutical Technology
Creating closed processes and reducing room air classification in a biopharmaceutical facility can reduce operational costs.
Aug 19, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
Mylan received an FDA warning letter citing violations at its Agila Specialty Formulation Facility, Sterile Products Division, and Onco Therapies Limited sites in India.
Aug 01, 2015
Pharmaceutical Technology
Within the past few years, key players have left the sterile manufacturing business. Can new technology and investment revitalize this critical market?
