Manufacturing

Articles

The company is investing in expansion at four sites in the United States, United Kingdom, and Italy, which will include construction of new facilities and addition of sterile and lyophilized filling lines.

Thermo Fisher Scientific Expands Sterile Drug Product Development and Commercial Manufacturing

The IsoAir Pro-E Remote Particle Counter by Particle Measuring Systems works to streamline cleanroom monitoring while complying with global regulations.

 Remote Particle Counter

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

A holistic approach to validation and quality assurance is essential.

Prepping Fill/Finish Systems to Ensure Quality Output 

Richard Denk is Head Sales Containment at SKAN AG, www.skan.ch, Richard.Denk@skan.ch.

An optimal engineering design is crucial for aseptic operation and cleaning.

Understanding the Impact of Annex 1 on Isolator Design

Joseph Baaklini is the director of the Scientific and Laboratory Services Global Technical Support group for Pall Corporation and leads the Pall Laboratory and Food & Beverage technical division globally.

Assessing the integrity of filter membranes is critical for maintaining sterile filtration operations in laboratories.

Understanding the Critical Role of Integrity Testing in Laboratory Sterility Filtration

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 new line has the ability to aseptically fill powder, liquid, suspension, and combination forms into vials in clinical or commercial batch sizes. 

Evonik Qualifies Filling Line for Parenteral Drug Products at its Alabama Facility 

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

Lucelys Caton is a technical service scientist with Gaylord Chemical Company.

Ashley Jones is analytical chemist with Gaylord Chemical Co, LLC.

Andrew Johnson is analytical specialist with Gaylord Chemical Co, LLC.

Dimethyl sulfoxide is increasingly used in high-risk parenteral and medical device applications that must be manufactured as sterile products in their finished form. A study evaluated the effects four sterilization techniques have on the product quality of this ingredient. 

Aseptic/Sterile Processing