In the Spotlight: Pharmaceutical Science & Technology Innovations

Cyclone ePedigree (Cyclone Commerce)

Electronic Pedigree System Automates Paper-Based Drug Product Tracking Cyclone Commerce's (Scottsdale, AZ, www.cyclonecommerce.com) "Cyclone ePedigree" system helps combat counterfeit drugs by tracking the authenticity and origin of a given drug as it moves through the supply chain.

According to the company, the electronic pedigree system provides information about the custodial history of a drug or drug lot; provides reporting and alerting for exception management and regulatory compliance; complies with 21 CFR Part 11 regulations for electronic records and signatures; and links between physical inventory movements and purchase orders, ship notices, and invoices.

The system also helps to minimize the cost and time that is usually required to implement such technology. "Part of our electronic pedigree system is based on existing technology. We believe most companies can leverage their existing systems for this type of compliance," says Ron Gabrisko, vice-president of Healthcare and Life Sciences at Cyclone. "Our approach minimizes the actual costs to the pharmacist and the end user."

IBC tote washer (Sani-Matic)

IBC Tote Washer Simplifies Cleaning The Sani-Matic (Madison, WI, www.sanimatic.com) intermediate bulk container (IBC) cabinet washer is designed to clean and dry the interiors and exteriors of IBC totes safely and automatically.

To ensure the machine's interior is sanitary, the system also cleans the inside of the washer cabinet. "The last thing you want to do is wash the totes and then redeposit the soil inside the washer," says Chris McNulty, Sani-Matic's pharmaceutical manager. In addition, the unit is equipped with an expanding seal to help protect operators from exposure to hazardous materials.

Rather than using a "dishwasher method" in which the bottom of the unit fills with water and detergent, the Sani-Matic washer uses a separate clean-in-place (CIP) system that can be designed for specific cleaning applications. "If you want a three-tank CIP system for different water types, for example, that can be done," McNulty explains. The cabinet washers are available in custom sizes and can be configured with dirty- and clean-side doors for installation between two rooms.

MicroSeq (Applied Biosystems)

DNA-Sequencing System Identifies Unknown Bacterial and Fungal Organisms The "MicroSeq" microbial identification system from Applied Biosystems (Foster City, CA, www.appliedbiosystems.com) uses polymerase chain reactions to make libraries of microbes' genetic sequences. Quality control specialists can use the library to identify unknown microorganisms.

"With the MicroSeq system, you can use the same procedure for both unknown bacterial and fungal identifications," says Shalini Sharma, product manager at Applied Biosystems. "It's really not something any other system out there does. The sequencing gives the system the flexibility to do that."

In addition, the system requires no prior knowledge about a microorganism to make an identification. Says Sharma, "With most phenotypic methods, you need to do some kind of characterization at the beginning. With MicroSeq, it is not needed."