Fill-Finish

Fogg Filler’s enclosures for bottle-rinsing machines have improved fume containment and doors with lift-off hinges for maintenance.

Non-destructive container closure integrity testing allows 100% inspection of all ampoules, syringes, vials, and cartridges.

The revised USP Chapter 1207 gives best practices for obtaining reliable data in container closure integrity testing.

South Africa’s Biovac Institute, which develops and produces vaccines for the country, launched a public-private partnership with Pfizer to enable local manufacturing of Prevenar 13, a vaccine against pneumonia-causing bacteria.

Problems in an induction-sealing process, such as untorqued or crooked caps, can be identified and corrected in real time using dynamic thermal imaging.

Scottish injectable-drug manufacturer Symbiosis Pharmaceutical Services plans to expand its sterile filling facility.

Ajinomoto Althea, a biopharmaceutical CDMO, is expanding its existing biological drug product manufacturing operations to include highly active materials, such as antibody-drug conjugates (ADCs), the company announced on Oct. 14, 2015. The new facility is located in close proximity to the company’s existing operations in San Diego, CA.

The challenge of achieving zero visible defects (i.e., particulates) in parenteral drugs will require a coordinated effort at all stages of the supply chain, particularly in the production and filling of primary containers.

Manufacturers of parenteral drugs face challenges to increase efficiency, control particulates, control extractables and leachables, and eliminate product/package interactions; new containers and packaging equipment offer increased options.

Vetter plans to invest approximately 300 million Euros during the course of five years to expand drug product manufacturing and logistic services in Germany; upgrades will include an improved RABS system for aseptic processing.

Novo Nordisk will build a local manufacturing plant for FlexPen prefilled insulin delivery devices in Iran.

FDA warns that compounded or repackaged drugs stored in certain syringes made by Becton-Dickinson may lose potency because of an interaction with the rubber stopper.

Creating closed processes and reducing room air classification in a biopharmaceutical facility can reduce operational costs.

Teva Parenteral Medicines initiates voluntary nationwide recall of select lots of Adrucil due to particulate matter.

Bill Hartzel, Director Strategic Execution, Advanced Delivery Technologies at Catalent Pharma Solutions, spoke with Pharmaceutical Technology about blow-fill-seal for aseptic processes.

The agency clarifies its requirements for allowable excess volume and labeled vial fill size in injectables and biologics.

Vetter completes on-site expansion activities of visual inspection and in-process control at Chicago facility.

Groninger has developed FlexPro 50, an isolator system for aseptic processing of nested syringes, cartridges, and vials. FlexPro 50 is capable of achieving outputs of up to 5000 containers per hour.

Optima Pharma is exhibiting a range of technologies from sterile-filling and freeze-drying solutions to isolators and restricted access barrier systems.

Machine manufacturer IMA is showcasing a number of technological advances for the processing and packaging of pharmaceutical products at ACHEMA 2015.

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

The use of disposables requires careful consideration and planning.

CDMO Vetter produces identifiable labeling for a top-ten pharmaceutical company.

McNeil-PPC pleads guilty in connection with adulterated infants' and children's over-the-counter liquid medications.

MedImmune will provide funds and access to monoclonal antibodies to seven postdoctoral associates for the creation of protein measurement and characterization tools.

Pre-sterilized, nested syringes and vials are seeing increased use in sterile filling.

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

GSK Australia's Boronia site will install next-generation blow-fill-seal machinery for aseptic filling.

Grand River Aseptic Manufacturing has announced that the company executed two commercial production contracts in one day.

Innovative therapeutic approaches beyond mAbs will require new methods for future facility construction.