Manufacturing

Articles

The GENiSYS R from AST (pictured) is a modular system that automates aseptic filling and the closing of vials, syringes, and cartridges.

Robotic Modular System for Small Batch Filling

Feliza Mirasol is the science editor for 

CDMOs address the unique challenges of liquid and lyophilized forms as well as preparing for the large capacity needed for COVID-19 vaccines.

Meeting Fill/Finish Challenges for COVID-19 Vaccines

The fill line will work to manufacture high-value APIs for drug product manufacturing to meet the needs of the COVID-19 pandemic.

LSNE Adds New Aseptic Fill Line to New Hampshire Facility

Consider a matrix of factors when choosing what type of cleanroom facility to construct.

Choosing a Cleanroom Infrastructure Technology

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

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

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 

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