Aseptic/Sterile Processing

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.

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.

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

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

Single-use technologies, modular systems, and robots are on the rise.

Automated robotic arms manipulate nested trays and containers inside closed aseptic filling systems.

Pfizer will invest nearly half a billion dollars to build a sterile injectable facility in Michigan.

The agency has issued a warning letter for cGMP violations at a drug manufacturing facility in Ahmedabad, India, that Baxter gained through its acquisition of Claris Injectables.

Both parties have agreed to recognize each other’s inspection of manufacturing sites for a broader range of medicines, including sterile products, APIs, biologics, and vaccines.

The author reviews current approaches to sterile containment and compares several sealed transfer and barrier techniques, including isolators, restricted access barrier systems, and split butterfly valve technology.

Automated robotic arms manipulate nested trays and containers inside closed aseptic filling systems.

Flow imaging microscopy can be used to identify particulates and their sources.

PDA reviews an industry survey of concerns and best practices regarding the EU GMP’s required PUPSIT test for filters used in sterile filtration.

Rommelag will showcase its blow-fill-seal technology that collectively offers container production, aseptic filling, and container closure.

Optima will also display the freeze dryer CS and the sterility test isolator STISO at the show.

In adding a Vanrx Pharmasystems aseptic filling isolator, FUJIFILM adds fill/finish for gene therapies and viral vaccines.

Pharmaceutical machine concepts for large and small factories of the future need to be readily available, flexible when it comes to processing variation, and modular in design.

Innovations in fill/finish equipment and in solid-dosage moisture-control packaging technologies were on display at INTERPHEX 2018.

Choosing the right contamination control platform requires considerable research into what a product needs for an effective process design.

Ready-to-use components eliminate the need for component preparation by the drug product manufacturer, enabling them to streamline their processes and focus on their core competencies, such as drug product development and manufacturing.

Understanding the advantages and suitability of different methods to measure residual moisture content in lyophilized materials--and the respective limitations--aids in selecting the most appropriate method for testing.

Environmental monitoring, which operates below the limit of detection, is little more than a rote exercise that provides limited real value. So why does it figure so prominently in current regulatory requirements for aseptic manufacturing?

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.

The technology, known as Verifi, is available with the ChargePoint’s range of valves that ensure safe and contamination-free handling of API and other formulation ingredients.