Aseptic/Sterile Processing

Cleanability is crucial when choosing components for GMP manufacturing areas.

It is vital that companies involved in the manufacturing and handling of cytotoxic drugs ensure that staff are given the highest possible levels of protection.

The company voluntarily recalls product due to FDA observations of potential sterility problems.

The agency cites Apotex’s Bangalore facility with quality system failures.

Rommelag's all-electric aseptic blow-fill-seal packaging system encapsulates the filling point and can be installed in a cleanroom.

The acquisition of Aptuit's Glasgow, UK and Indiana, US facilities will add sterile injectable formulation development and expand AMRI's analytical services capabilities.

Representatives of contract service organizations that specialize in parenteral drug development and manufacturing describe the evolving trends.

Unique Pharmaceuticals has issued a voluntary recall of sterile compounded preparations, but aired concerns about FDA?s recall demand.

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

In legacy facilities and as buildings age, ensuring cGMP compliance can become complex. A review of a facility's gowning operations can bring insight into the current state of cGMP compliance. The author presents characteristics to look for and questions to ask.

Gowning practices embody cGMPs and can be a tool to evaluate cGMP compliance.

Players across the biologics value chain are attracted by the advantages of continuous biopharmaceutical manufacturing.

What challenges do biopharmaceutical manufacturers face when deciding to move from a fed batch process to a continuous process?

Challenges encountered when implementing a continuous monitoring system are reviewed.

sterilization approach-cycles controlled by differential pressure-is described.

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.

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

The AdvantaPass wall pass-through system from AdvantaPure permits aseptic transfer of fluids between suites.

Industry experts discuss the application, challenges, and benefits of a quality-by-design approach to sterile manufacturing.

Pfizer, Eli Lilly, and several other pharmaceutical companies are participating in the development of automated sampling technology and associated software that improve process control and reduce development times in biopharmaceutical manufacturing.

Measuring headspace gas composition and pressure allows sterile product manufacturers to simultaneously monitor important quality parameters rapidly and nondestructively.

Restricted access barrier systems (RABS) maximize product control but minimize operator interaction in aseptic manufacturing.

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.