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When packaging operations for Abilify, a drug to treat schizophrenia, and Coumadin, a blood thinner, were transferred to a different plant, Bristol-Myers Squibb decided to install a new bottle containment filling line. The goal was to improve fill accuracy and protect workers from the products’ dust. New Brunswick, NJ-based Bristol-Myers Squibb researched different fillers on the market and chose the Model 815 15-wheel bottle filler from Aylward Enterprises. This story describes Bristol-Myers Squibb’s Mt. Vernon, IN, facility's employment of a restricted access barrier system to protect workers from high-potency drugs.
* BrailleMarker machine sprays small dots continually onto strips of labels, producing Braille that exceeds the requirements for a minimum 0.2-mm raised point size
* allows blind and visually impaired people to feel their way before taking their medicine
* prints digitally, avoiding films and masks
CCL Label
Providing quality healthcare while holding the line on costs continues to be a priority throughout much of the life sciences industry. Watching expenses is a critical task at Group Health as well, where the company’s Seattle facility handles mail-order prescriptions and serves as a central fill location for its 26 pharmacies located in both Washington and Idaho. Since adding a Maverick Enterprises UPM B/T (Universal Packaging Machine with Bottle and Tote infeed), Group Health has reduced its labor needs, improved efficiency within its confined 7,000 sq’ area, and readied itself to handle growing sales volume. In turn, those benefits help to hold down Group Health member costs.
A polypropylene container that includes a no dip-tube dispensing pump provides waste-free dispensing and fits within a reusable outer SAN container, helping Malibu Wellness, Inc. market its EC Mode skin-care products to salons, spas, and dermatologists. Malibu continues to take pride in staying in front of the curve when it comes to healthy skin care. So it's no surprise that the company is pioneering a reusable pack in the U.S. cosmeceutical market just when sustainable packaging has become so prominent.
When Sageant, LLC, Bozeman, MT, a health supplement and vitamin producer, wanted to re-brand and refresh its product image, the company sought the assistance of branding and design agency Maddocks & Co. In the process of designing new labels and recommending PVC shrink-sleeve label materials for the various liquid and solid Sageant products in assorted container sizes and shapes, Maddocks also enlisted the digital printing expertise of CL&D Digital to execute the shrink-sleeve label printing. The 2-mil PVC shrink-sleeve label material, manufactured by Klockner Pentaplast , is digitally printed by CL&D using a four-color process.
* Model 314 features two front and two back label dispensers integrated on one pressure-sensitive labeler
* eliminates downtime from label roll changes and achieves continuous operation with no missing labels or double-labeled products
servo-driven equipment labels up to 300 containers/min, handling round, oval, square, and rectangular containers from 1"x14" H and 5/8" to 6 7/8" in diameter
In June, new Food and Drug Administration rules for the format and content of patient package inserts in prescription drugs became effective. The new format emphasizes “highlights” of the label information, provides a table of contents, requires the information to appear in a different order, and sets forth specified graphic requirements. That goes along with a requirement put in place late last year calling for drug makers to submit labeling information in electronic format, for easier searching and cross-referencing. Says the FDA, “These revisions will make it easier for healthcare professionals to access, read, and use prescribing information, and will enhance the safe and effective use of prescription drug products.”
When Specials Clinical Manufacturing opened its facility in Northumberland, United Kingdom, it needed a validated label printing system to manage recordkeeping and print labels for clinical trial packs.
“Initially, there was no suitable system in place for printing labels, especially labels for randomized studies and projects,” says Elaine Mackie, packaging manager at Specials, a custom drug maker and provider of packaging services for clinical trials. In need of a system that would meet GMPs and 21 CFR Part 11 regulations, Specials installed PrisymID Inc.’sMedica software with ClinTrial, an add-on module for clinical trial label printing management.
Tolas Health Care Packaging
• external pocket accommodates printed inserts and materials, as well as other non-sterile items
• available in Tyvek/film constructions in lengths to 31 in; suitable for devices requiring EtO or radiation sterilization
• provide seal integrity, puncture resistance, and bacterial barrier properties
• TE-Series of self-adhesive labeling and brand protection products range from paper to films
• series includes SynthermTE, a destructible synthetic paper
• suitable for pharmaceuticals, products are available with a wide range of application-specific adhesives and liners to thwart would-be counterfeiters
• ClinBook labels include multiple pages of study information in each label for multi-language studies to enable users to prepare and ship clinical materials to various countries without having to use country-specific labels
• one-, two-, and three-part labels are available with different cover options, three-panel blinded labels requiring scratch-off laminates, and as slope-cut materials for label application to vials, syringes, ampoules, etc.
• Model 400 with multi-panel applicator applies various label configurations to cases and cartons at speeds to 15/min
• applies one leading- and side-panel corner wrap, one leading- and top-panel corner wrap, a front-panel label, a side-panel label, or two separate labels (front and side), in one pass
• may be changed over in less than a minute with no tools and no change parts
• CRSF blister labels are designed with a combination of permanent and peelable adhesive that’s applied to the back of a clinical trial blister pack
• peelable areas are perforated and designed to coincide with the products in the plister
• an independent certified lab recently certified the child-resistant and senior-friendly labels as meeting the effectiveness criteria as defined in the Federal Register, 16 CFR Part 1700
According to Section 502 of the Federal Food, Drug, and Cosmetic Act, “A drug or device shall be deemed to be misbranded—if its labeling is false or misleading in any particular.” Some examples of false labeling are incorrect, inadequate, or incomplete identification of a medical product.
Below are eight keys you can use to tailor your operation to prevent false labeling:
• Upgraded NV2 fully automatic, self-adhesive labeling system for cylindrical, flat, square, and oval containers now offers auto reject facility for bar code and overprint faults
• Improved VAL550 vial and ampule labeler includes upgraded Siemens control system and databus internal wiring system
