Fill-Finish

Nitrogen dioxide can sterilize and depyrogenate an aseptic fill area in a blow-fill-seal process.

New advanced aseptic manufacturing technologies are available for filling liquid pharmaceuticals, including biologics.

Funding boosts life-sciences manufacturing in West Michigan.

The effect of absorbed vapor-phase hydrogen peroxide on a lyophilized product Protein Z, was studied by spiking experiments with different amounts of hydrogen peroxide.

Application of single-use technology in a parenteral facility for syringe filling.

Catalent's Advasept platform uses blow-fill-seal technology to aseptically manufacture, fill, and seal a polymeric primary container for injectable drugs.

The ionHP biodecontamination hydrogen peroxide-based sterilization technology is designed for use in aseptic enclosures.

Dalton Pharma completes its $2.5 million expansion in Toronto for sterile and aseptic filling capabilities.

Changes in the working procedures and disposable fluid flow paths resulted in a measurable decrease in product waste in a low-volume, high-value fill-finish line.

The Parenteral Drug Association has established a task force to develop a peer- and regulatory agency-reviewed Technical Report that will serve as a science-based industry reference document.

Aesica expands aseptic capabilities at its Nottingham, UK site with the acquisition of new pre-filled syringes manufacturing equipment.

After realizing benefits from the adoption of a single-use filling line for one specific product, Patheon took the leap and installed a single-use filling line in a new facility.

RABS is a flexible barrier system that maximizes product control but minimizes operator interaction when best practices are followed.

Report outlines recommended practices for control and evaluation of operations.

The benefits of single-use systems are being realized for downstream unit operations, including aseptic filling.

Aseptic connectors provide the flexibility and robustness needed for modern parenteral manufacturing operations.

Adoption of single-use systems and more flexible systems drive innovation.

PIERRE FABRE MEDICAMENT PRODUCTION has 22 years experience in isolator technology for aseptic filling of high potent freeze-dried injectable products.

The growth in biologics drugs and vaccines is leading to greater demand for prefilled syringes, which provide greater safety and convenience for healthcare workers and patients.

PharmTech speaks to Ray O'Connor from the National Institute for Bioprocessing Research and Training (NIBRT) for an overview of aseptic processing.

GSK Extends Deadline for Tender Offer to Acquire Human Genome Services; Sartorius Opens New Filter, Aseptic-Bag Production Facility in Puerto Rico; and More.

How to avoid invisible and airborne contamination.

Closed-vial technology is an alternative to traditional glass vial filling that reduces the risk of contamination for the patient, simplifies the filling process, and provides easier handling for healthcare providers.

FDA has released a final guidance describing cGMP for preparing media fills for validation of aseptic preparations for positron emission tomography drugs.

Contamination is almost always related to human error and there is a clear drive to reduce human implications in aseptic operations. This can be achieved in multiple ways.

The future, and increasingly the present, for aseptic operations is isolated robotics. Companies that wish to gain competitive advantages in their operations are stepping up and taking notice.

The authors question certain aspects of the industry's current regulatory-compliance strategy and suggest that aseptic-process control and evaluation should be revised.

We want to fill one of our oxygen-sensitive products inside an isolator system. Can we run an isolator with pure nitrogen and defined humidity?

The authors revisit their previous effort to refine the terms that describe interventions and to dispel confusion that arose after the original article was published.

The growing uptake of single-use sterile packaging in pharmaceutical production processes mirrors the broader trend towards single-use across every sector of the pharmaceutical industry.