Cleanroom Equipment and Supplies

EMS is a leader in the cleanroom industry, delivering complete cleanroom monitoring and control solutions, services to customers, and ensuring quality by design from inception to process control.

As the therapeutic landscape grows more complex, so too must the analytical techniques for cleaning validation to ensure the utmost cleanliness is achieved.

In the all-too-common debate over building lab facilities versus outsourcing, the best strategy may be the middle ground: licensing.

Various advances in contamination control are being utilized to reduce the chance pollutants contaminate a drug product.

Validair Diamond Scientific has installed a new cleanroom for in-house testing, research, and training.

INCOG Biopharma has completed the construction of its cleanroom production area, marking a milestone in the completion of an overall $100 million investment in a new facility.

ten23 health is expanding its sterile drug product manufacturing site at Visp, Switzerland to enlarge cold storage and visual inspections capacity and add clean rooms.

Effective cleaning and disinfection along with contamination controls are imperative when operating and utilizing a cleanroom.

TCR² Therapeutics will add a second clean room to their manufacturing operations.

SGS’s new Antwerp, Belgium, clinical research site will house both clinical trial patients and good manufacturing practice drug manufacturing, and its Glasgow, UK, biosafety testing site now has increased testing capacity.

NewAge Industries has completed a plant expansion that added new cleanrooms to its headquarters in Southampton, Pa.

Summa Equity has acquired a majority stake in G-CON Manufacturing, a prefabricated cleanroom provider.

Help prevent contamination in a facility by zone.

Under the terms of the contract, Meissner will expand its Camarillo, Calif., manufacturing site by adding additional cleanroom manufacturing space, executing advanced inventory management systems, and adding support areas to supplement capacity.

Avantor plans to increase its single-use manufacturing footprint by 30% and double its cleanroom space in the US and Europe.

Mecart has achieved FM-4880 and FM-4882 certification of its cleanroom wall and ceiling panels from the FM Approvals certification organization.

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.

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.

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

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

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.

The industry’s aversion to risk has led to its treating closed aseptic processing systems as miniature cleanrooms, resulting in redundant and expensive practices. This article ponders this impasse, examining new technologies and applications in light of past regulatory guidance and more than 40 years of operating evidence.

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.

A guide for improving the planning and preparation of future validation work.

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

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.