Manufacturing

Articles

Beckman Coulter Life Sciences announced that its MET ONE 3400+ portable air particle counter is now available for cleanroom compliance.

Portable Air Particle Counter for Cleanrooms

The new particle counter allows users to import their standard operating procedure routine environmental monitoring maps and sampling configurations into the counter, which reduces human error and can improve data integrity.

Beckman Coulter Life Sciences Launches the MET ONE 3400+ Portable Air Particle Counter for Cleanroom Compliance

The Faciliflex Express product line can be commissioned in six months, making it ideal for cell and gene therapy companies that need to rapidly bring their therapies to patients.

AES Introduces a New Pre-Designed Cleanroom Solution

The new site will offer initial design and development, low-volume manufacturing, and scalable high-quality production of wearable drug delivery devices.

Sorrel to Open a New Manufacturing Facility

The new facility in Grand Rapids, MI, is part of the CDMO’s aggressive expansion plan.

Grand River Aseptic Manufacturing Opens Large-Scale Injectable Fill/Finish Facility

Madison Hoal is global technical consultant at Ecolab Life Sciences.

Donald Singer is senior microbiology technical consultant at Ecolab Life Sciences.

Consider how to assess risks and understand possible sources of disinfectant residues in pharmaceutical manufacturing.

Why Do Disinfectant Residues Matter?

A variety of assays should be used to detect bacterial, fungal, and viral contaminants in the human source cells used for cell therapies.

Detecting Contamination in Cell Therapies

The right approach to biological safety cabinets, and collaboration between engineers and those who will operate the equipment, is crucial to preventing cell-culture contamination.

Minimizing Contamination During Biopharma R&D

Because conventional cleaning methods can risk product loss, biopharmaceutical manufacturers are often reluctant to use PDE/ADE limits to validate cleaning processes.

Alternative Cleaning Validation Methods for Biologics

Tim Roach is senior director of plant engineering at Recro Gainesville.

Careful design, planning, and record keeping are needed for cleaning and changeover in multiproduct pharmaceutical facilities.

Cleanroom Equipment and Supplies