Aseptic/Sterile Processing

Quality cannot be verified through testing, especially at the limit of detection, and no test method can confirm the absence of a microbe or particle.

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

The highly customized nature of cell and gene therapy production means that manufacturing innovations for one therapy may not be easily transferable to others.

Closed systems for aseptic fill and finish were featured at INTERPHEX 2019.

The company is recalling one lot of Ketorolac Tromethamine Injection, USP, 60mg/2mL because of a lack of sterility assurance.

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

Closed systems for aseptic fill and finish were featured at INTERPHEX 2019.

At INTERPHEX 2019, CEO Richard Johnson highlighted the importance of PDA’s new Asian business unit and outlined the organization’s plans. Data integrity guidance for manufacturing and quality systems will be published by the end of the year, as efforts move into big data and artificial intelligence.

In a keynote session at INTERPHEX 2019, experts will review and debate the issues and present potential solutions for contamination issues in aseptic manufacturing.

At INTERPHEX 2019, MG2/MG America stages a packaging/processing summit; exhibitors offer packaging equipment innovations for parenteral products.

The Pharma Services business of Thermo Fisher Scientific will invest $150 Million at three facilities.

Understanding the API, delivery mechanism, and excipient functionality is essential to solving drug solubility challenges.

The US District Court for the Western District of Pennsylvania entered into a consent decree of permanent injunction against Ranier’s Rx Laboratory Inc., a compounding facility.

The company will open its first European manufacturing facility in Castlebar, Ireland.

The Flexicon FPC60 peristaltic fill/finish system from Watson-Marlow Fluid Technology Group can use a variety of modules that allow users to create their own customized filling solution to suit small-batch applications.

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.

Robotic isolators and single-use technologies are gaining ground, according to aseptic processing consultant Jim Agalloco.

ChargePont Technology has revealed that it is now able to expand its smart monitoring technology into North America thanks to being granted HazLoc (Hazardous Area) certification.

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.

Microbial identity data can be critical for determining contamination sources.

Collaborative robots work beside laboratory employees to improve efficiency in pharmaceutical research and quality control labs.

The agency is developing a new way to assess, record, and report data from surveillance and preapproval inspections of sterile drugs.

Collaborative robots work beside laboratory employees to improve efficiency in pharmaceutical research and quality control labs.

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

FDA sent a warning letter to Lernapharm (Loris) Inc. detailing the company’s lack of procedures to prevent microbiological contamination.

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.

Watson-Marlow Fluid Technology Group added a new actuator suitable for applications where reduced weight is a concern.

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.