Parenterals and Injectables

This article discusses fully automatic inspection of glass and plastic containers and factors that affect particle detection rate. 

Stainless-steel particulates were found in one lot of 0.9% Sodium Chloride Injection, USP 1000 mL, prompting the recall to the hospital/user level.

Corning and Gerresheimer have been working together to accelerate innovations for pharmaceutical glass packaging.

A Merck, Pfizer, and Corning collaboration resulted in development of Corning Valor Glass for improved drug storage and delivery and will create US jobs.

Gerresheimer’s glass and plastic prefillable syringes will come with an innovative, integrated, passive syringe safety solution, acquired through an exclusive licence from West Pharmaceutical Services.

Lilly will provide up to $52 million in funding for research, making this Purdue’s largest strategic corporate collaboration

Poly(lactide-glycolide) has been used for drug-delivery applications because of its beneficial physicochemical properties, long safety record, and reliable commercial supply.

The need for flexibility and higher quality are driving advances in parenteral manufacturing and fill/finish equipment.

Robotic fill/finish systems reduce human intervention, improve flexibility, and allow more gentle handling of containers.

The ready-to-fill packaging solutions for vials are based on Ompi EZ-fill packaging design.

Parenteral packaging will be well-represented at INTERPHEX, especially technologies associated with fill/finish of ready-to-use vials, cartridges, and syringes.

The new commercial site, set to be located in Cambridge, Boston, MA, will serve clients on both the East and West Coast. It will also be the base for reaching new customers in the area.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates,  discusses how to ensure sterility when manufacturing small-scale parenteral batches.

SGS invested in test equipment for analyzing extractables and leachables at its New Jersey laboratory.

Vetter expanded visual inspection facilities and controlled-temperature storage at its Ravensburg Vetter West facility in Germany.

A variety of strategies have been employed to deliver proteins and peptides in improved parenteral formulations and/or via noninvasive routes.

Multiple inspection techniques facilitate the identification of particulate matter in vials as part of root-cause investigations and safety evaluations.

Primary packaging and manufacturing technologies minimize product/package interaction, protect quality, support safe travel through the supply chain, and enhance performance at point of use.

Aptar Stelmi will present PremiumCoat, an alternative coated stopper for sensitive drugs, at CPhI 2016.

Visual inspection of parenteral vials is the first step in a root cause investigation.

Improvements to aseptic manufacturing procedures are long overdue. But how feasible is it for manufacturers to modernize fill lines of legacy products?

The Parenteral Drug Association develops program to address barriers to implementation of postapproval changes.

Recipharm is investing EUR3.7 million (approximately $4.18 million) to increase lyophilization capacity at its Masate facility in Italy.

While isolators may offer advantages in high-speed commercial manufacturing lines, RABS continues to be a flexible alternative solution for small-scale production of drugs for clinical use.

Teligent is expanding its manufacturing and R&D complex in New Jersey.

Aseptic spray drying provides an alternative to lyophilization as an enabling stabilization technology for parenteral biologic formulations.

Preheating pinch valves prevents drift in the volume of liquid dispensed.

Consider the 3 Ps (product, process, and patient) when choosing a parenteral packaging material.

The syriQ Rigid Cap (SRC) and SCHOTT TopPac Rigid Cap (TRC) closure systems from Schott use an intuitive twist-off mechanism for ease of use and container closure integrity.

Expanded systems integration, serialization, and supply chain connectivity will enhance productivity and support counterfeit prevention.