Aseptic/Sterile Processing

FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.

Careful choice of wash-water parameters and attention to water quality and basket loading are important for optimal cleaning.

Box-Behnken modeling was used to optimize a resinate complex, to mask the taste of levocetirizine dihydrochloride and montelukast sodium in orally disintegrating tablets.

Grand River Aseptic Manufacturing named one of Michigan 50 Companies to watch.

OXY-CAPT brings together properties of plastic and glass containers through the combination of oxygen absorption and cyclic olefin copolymer (COP) high barrier layers.

Symbiosis Pharmaceutical Services is now offering a new bulk lyophilization (freeze drying) service in response to increasing demand in the manufacture of bulk intermediates and APIs by lyophilization.

This article looks at data gathered from several studies of a widely marketed chlorobutyl rubber formulation used for vial stoppers and prefilled syringes.

This study evaluates the impact of controlled nucleation on the ability to optimize a lyophilization cycle for a monoclonal antibody formulation.

Traditional sterility testing methods can take 14 days or longer to complete, so a growing number of pharmaceutical manufacturers and quality control

The use of disposables requires careful consideration and planning.

Total cost of ownership, including operating costs, must be considered when deciding between flexible and traditional cleanroom systems.

Aging facilities and inadequate quality systems create drug shortages. Preventing them will require harmonized regulations, and management support for continuous improvement and innovation.

The company voluntarily recalls select lots of Adrucil due to particulate matter.

The author reports results of evaluations and concludes that a disinfectant composed of a low-concentration suspension of silver ions is completely sporicidal with only a one-minute contact time.

Ansell's HyFlex gloves made with Intercept technology yarns improve hand protection.

FDA issues a Warning Letter to Hospira S.p.A. for GMP violations at the company’s Liscate, Italy facility.

Baxter voluntarily recalls select lots of IV solutions due to possible particulate matter.

Flow indicators maximize the view into sterile processes.

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.