In the Spotlight August 2008

Editors' Picks of Pharmaceutical Science & Technology Innovations

Plant managers must design manufacturing processes that function efficiently and ensure patient safety. Line operations should run smoothly and avoid wasting expensive materials. In addition, processes should not provide opportunities for contamination or unintended reactions that could affect a medicine's appearance or activity. These considerations apply to all aspects of production, including the packaging process. Two of this month's products provide packaging solutions that guard against contaminants that could compromise product quality. The third product is a storage option for bulk ingredients that supports efficient manufacturing by maximizing product discharge and improving flow into process equipment.

Syringe system is silicone-free

West (Lionville, PA) has introduced the Daikyo "Crystal Zenith RU" prefillable syringe system. The system's nozzle cap and piston are covered with "Flurotec" film, which adds lubricity to the piston and gives barrier properties to the nozzle cap. The combination of the Flurotec coating and the Crystal Zenith material enables smooth piston motion without the need for silicone lubrication.

Crystal Zenith RU syringe system(West)

The syringe system is presterilized and requires no component preparation for filling in customers' equipment. The Flurotec film and sterilized Crystal Zenith material ensure that drug-contact surfaces are inert and clean. The system contains few extractables.

The 1-mL luer-lock syringe system accepts various needle gauges. The syringe barrel incorporates a nozzle cap that seals the luer fitting until the needle is added. The system is suitable for packaging and administering biopharmaceuticals. The absence of silicone prevents the system from causing protein aggregation or particle formation in biopharmaceutical drugs.

Capping machines are designed for isolators

The "VRK" series overseal capping machines from Bosch Packaging Technology (Crailsheim, Germany) are designed for use in isolators. The machines' sealing and mechanical-drive systems enable unidirectional air flow and help sweep particles away from the capping operation.

The units in the VRK series are available with outputs as high as 600 vials/min to match current vial-filling line speeds.

VRK series overseal capping machine(Bosch Packaging Technology)

In addition, the VRK units use pneumatic force to compress stoppers and caps. Sensors verify that seals are properly and consistently crimped regardless of vial-height variations.

Flexible silos optimize space

Spiroflow Systems (Charlotte, NC) has introduced its "Spirostore" customizable flexible silos for the safe and efficient storage of intermediates, raw materials, and excipients. The silos are made of a durable polyester fabric supported on a steel frame. The flexible polyester walls facilitate near-total discharge of the material and improve flow characteristics. Clients choose from various fabric options to meet the requirements of their products. Materials include air-tight, coated, and uncoated fabrics, and a breathable fabric that prevents condensation.

Spirostore customizable flexible silos(Spiroflow Systems)

Each silo stores as much as 7000 ft³ of dry bulk material and supports weights as great as 90,000 lbs. The containers' square design optimizes the use of space. Customers can specify outlet parameters such as diameter, cone angle, and discharge aids, and the units are compatible with common conveyor types. The silos are suitable for short-term and pilot-plant storage applications.

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.