Medical device manufacturers have often struggled with including multiple-page instructions for use (IFU) with sterile medical packaging. Including paper materials inside sterile packaging could present contamination challenges, and leaving an IFU loose inside a shelf pack could risk misplacement. Responding to a customer challenge, Robinson Printing & Creative Media (Temecula, CA) has developed a potential solution.
The U.S. Patent Office has awarded a patent to WS Packaging Group Inc. (Green Bay, WI) for its FlexWrap extended text label, which is part of its MultiVision line of extended text labels. FlexWrap labels are suitable for a range of applications, including fully conformable squeeze tubes, glass vaccine vials, and any small-diameter structure such as barrel containers for lip balms or brushes. The label materials are completely water-resistant.
FDA has announced that it is requiring all drugs called Erythropoiesis-Stimulating Agents (ESAs) to be prescribed and used under a risk management program, known as a risk evaluation and mitigation strategy (REMS), to ensure their safe use. The ESAs that are part of the REMS are marketed under the names Epogen, Procrit, and Aranesp.
UPM Raflatac (Mills River, NC) has received ISO 14001:2004 Environmental Management System certification for its state-of-the-art labelstock factory in Dixon, IL. This certification represents a significant step toward achieving one of the company's major goals for its labelstock and Radio Frequency Identification (RFID) facilities worldwide, which is to develop Environmental Management Systems (EMS) that operate in accordance with an internationally recognized standard.
BD Diagnostics’ (Franklin Lakes, NJ) newly launched Microtube for Automated Process (MAP) improves safety, accuracy, and turnaround time of capillary blood collection and testing in patients with fragile veins. The BD Microtainer MAP tube is the first microtube to be fully compatible with most automated hematology instruments, reducing turnaround time and costs associated with sample transfer and relabeling.
Keller-Crescent Co. Inc., a Clondalkin Group Co., has acquired Lehigh Press. Located in Juncos, Puerto Rico, Lehigh Press manufactures labels, inserts, and outserts and other packaging components, mainly for the pharmaceutical and healthcare markets.
The Institute for Safe Medication Practices (ISMP) and the American Association of Eye and Ear Centers of Excellence (AAEECE) are urging the end of a voluntary package color coding system for eye and ear products. According to AAEECE, color coding of certain ophthalmic medications may relate to medication errors.
CCL Label has launched digital printing at its Hightstown, NJ, facility for printing labels, shrink sleeves, and other products for the pharmaceutical market. The converter showcased its latest digital printer--an HP Indigo ws4500--at an open house for customers late last year.
USP is proposing a revision to General Chapter <1> regarding injections labeling of ferrules and cap overseals. The revision would limit printing on ferrules and caps to only those cautionary statements related to imminent threats of life-threatening situations. The proposal will appear in the January/February 2010 Pharmacopeial Forum; a preview of the revision can be found on USP’s Web site.
Cortegra Group Inc. (Fairfield, NJ) installs a Vijuk MV Large Format Folder in its Evansville, IN, facility. This purchase is in response to FDA's requirement for larger font sizes and additional prescribing information on packaging inserts to manage the risk of medical product use and reduce medication errors.