In the Spotlight October 2008

Pharmaceutical manufacturers are increasingly interested in biologically derived drug products. Many biopharmaceuticals are administered as injections, and sterility is of paramount importance for parenteral delivery. This month's featured products are appropriate for biopharmaceutical production processes that require sterility. The first is a filter that removes bacterial contaminants and can be used in biopharmaceutical fill–finish applications. The second is an automated, aseptic filling system for injectables that can accommodate a disposable fluid path. This month's third product is a series of platinum-cured stoppers that withstand gamma irradiation and various chemicals, thus facilitating sterilization.

Filling system accepts various vial sizes

The "FPC50" system from Watson-Marlow Flexicon (Wilmington, MA) automatically and aseptically fills, plugs, and caps injectable-drug vials for clinical-trial and small-batch applications. The compact, universal-format unit never needs extra format parts, according to Peter Lambert, the company's filling-division manager.

FPC50 filling and plugging system (Watson-Marlow Flexicon)

The system includes a walking-beam mechanism that easily adjusts to 2–100-mL vial diameters. It keeps vials stable and ensures that they do not tip over while they are being conveyed or indexed. The unit also incorporates universal stopper- and cap-sorting bowls that sort 13- and 20-mm closures.

Lambert adds that the FPC50 unit features Watson-Marlow's peristaltic dispensing pump. The peristaltic pump allows the use of disposable fluid paths, which simplify the cleaning validation of injectable filling.

The FPC50 system is designed to enable tool-free format changeovers.

Filter withstands gamma-sterilization

Meissner Filtration Products (Camarillo, CA) recently introduced its 0.2-µm-rated, 50-mm "Steridyne 50" vent filter for biopharmaceutical applications. The filter is made of polyvinylidene fluoride, which can be gamma-irradiated or autoclaved for sterile applications.

Steridyne 50 filter (Meissner Filtration Products)

The Steridyne 50 unit can be easily incorporated into single-use biocontainer assemblies as a sterile vent filter. The product is also designed for in line filtration of air or gases and as a sterile barrier in receiving vessels, culture vessels, bioreactors, fermentation tanks, transfer vessels, carboys, and other small containers.

Stoppers meet regulatory standards

AdvantaPure (Southampton, PA) has introduced platinum-cured silicone closures and stoppers for containers used in pharmaceutical and biopharmaceutical processing. The closures are free of animal-derived ingredients and meet US Pharmacopeia Class VI and US Food and Drug Administration standards.

Platinum-cured silicone closures (AdvantaPure)

The platinum-cured silicone units offer higher purity and longer life expectancy than components made from other materials, according to the company. Unlike rubber products, the closures withstand temperatures from –100 to 400 °F and resist cracking and various chemicals. In addition, users can sterilize the components by autoclave or gamma radiation. The products are appropriate for reuse and single-use applications.

The biologically safe products are designed to ensure aseptic fluid transfer, sealing, filling, and sampling.

New Product Announcements may be sent to New Products Editor, Pharmaceutical Technology, 485 Route One South, Building F, First Floor, Iselin, NJ 08830, fax 732.596.0005, ptpress@advanstar.com