Manufacturing

Partner at Jacobs Wyper Architects, 1232 Chancellor St., Philadelphia, PA, 19107, tel: 215.985.0400, www.jacobswyper.com.

Articles

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.

Preventing Room Pressurization Failures

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

Using Dynamic Thermal Imaging to Correct Sealing Problems

Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

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.

Parenteral Packaging Advances

The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.

USP Previews New Compounding Standards

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Preventing contamination requires quality systems to be in place, including routine cleaning, a robust cleaning validation program, and preventive maintenance.

An Ounce of Prevention: Cleaning and Preventive Measures Deter Contamination Events

Creating closed processes and reducing room air classification in a biopharmaceutical facility can reduce operational costs.

Generating Savings from Room Declassification

Operator attention to detail and adherence to procedures are crucial for proper cleaning.

Cleaning a Vial Filling Line

Meissner’s FlexGro single-use biocontainer assemblies feature the TepoFlex polyethylene (PE) multi-layer film and are delivered presterilized for immediate use.

Biocontainer Assemblies Provide Repeatable Performance

Mylan received a warning letter citing violations at its Agila Specialty Formulation Facility, Sterile Products Division, and Onco Therapies Limited sites in India.

Mylan Receives FDA Warning Letter for Manufacturing Sites in India

Agnes Shanley is senior editor of Pharmaceutical Technology.

Within the past few years, key players have left the sterile manufacturing business. Can new technology and investment revitalize this critical market?

Aseptic/Sterile Processing