Cleanroom Equipment and Supplies

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

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

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

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

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

The company’s new Milliflex Oasis System provides enhanced result reliability, increased productivity, and advanced traceability.

The fully integrated, pre-qualified, pre-installed aseptic filling facility can be shipped globally for drug development and the manufacturing of personalized medicines and clinical trial supplies.

The new device decreases the chances of filter leaks and room contamination while ensuring the lowest possible energy consumption.

The venture will focus on single-use and modular systems designed to develop novel biotherapeutics.

Particle Measuring Systems’ new Pharmaceutical Net Pro cleanroom monitoring software for data and collection management and automation offers flexible integration options and intelligent features such as facility mapping, alarming, reporting, and recipe-driven sampling.

A one-size-fits-all approach to monitoring practices and results is never appropriate, given the diversity of practice within the pharmaceutical industry.

This article takes a look at current practices for cleaning and sterilizing biomanufacturing equipment used in a multi-product versus single-product setting.

Kimberly-Clark Professional’s Kimtech A5 Sterile Boot Covers with Clean-Don Ties and Vinyl Edge provide reliable sterile protection for ISO Class 5 or higher cleanrooms.

The STERIS ProKlenz ONE alkaline cleaner now has a label performance claim for biofilm removal, in addition to the product’s existing label as a disinfectant and virucide.

Kimberly-Clark Professional added the Kimtech A5 Sterile Integrated Hood and Mask XL for head shapes, sizes, and hairstyles that pose a challenge to standard aseptic gowning for cleanroom operators.

The contract development and manufacturing organization expanded its analytical chemistry suite and added a new office in Boston, MA.

De Lama’s DLVHP/DE pass-box decontamination unit uses vacuum hydrogen peroxide sterilization.

Lonza’s new PyroTec Pro Robotic Solution provides a fully automated workflow for endotoxin detection.

This article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.

Why shouldn’t biopharmaceutical manufacturers be able to leverage standardized construction practices to improve time to market?

Vac-U-Max received “atmosphères explosibles” or equipment for potentially explosive atmospheres (ATEX) approval for three product ranges of compressed-air-powered vacuums.

Telstar has a dedicated process analytical technology (PAT) corner at its booth to display new developments for pharmaceutical freeze drying systems and aseptic manufacturing processes.

Cleanroom floor and wall solutions from Sika meet rigorous standards for pharmaceutical manufacturing facilities.

The Steris VHP DC-A atmospheric pass-through chamber is designed for aseptic drug manufacturing and laboratory research.

The Alfa Laval TJ40G tank cleaning machine with a four-nozzle rotary jet head cleans tanks quickly with less water.

Watson-Marlow Fluid Technology Group’s ASEPCO Weirless Radial diaphragm valves eliminate dead legs and product entrapment.

Airlocks, gowning rooms, and transition spaces have different uses and should be considered separately in cGMP pharmaceutical facility design.

Honeywell has launched a new range of gloves, Picguard Urban, which offers protection against needle stick and puncture.

A process-specific preventative maintenance program improves productivity and reliability.