Better cold-chain practices
The expanding number of temperature-sensitive biologic products and increased regulatory insistence on proper handling across
the supply chain is keeping the spotlight on packaging components that protect products from temperature excursions. A flat,
USB-equipped waterproof label about the size of a sugar packet monitors temperature conditions at the pallet, carton, or item
level. Surface readings provide a more accurate time or temperature record than the ambient readings taken by conventional
time and temperature loggers. When the product reaches its destination, light-emitting diodes on the label flash if temperatures
exceeded parameters. Plugging the label's USB connection into a computer uploads the trip's time and temperature history (XpressPDF
The XpressPDF Label uploads time and temperature data directly to a personal computer through its USB port.
Prefilled syringes are gaining market share over traditional vials because they offer great dose accuracy, simplify administration,
and eliminate overfill, among other reasons (1). As a result, this packaging format, particularly autoinjector versions, often
is selected for products destined for self-injection. One off-the-shelf, disposable autoinjector shown at INTERPHEX 2011 hides
the needle before, during, and after the injection and is designed to be handled by people with limited dexterity. The initial
offering, a 1-mL long syringe with a 0.5-in. staked needle, is available in push-to-activate and press-button–push-to-activate
configurations. Both designs provide visual and audible feedback of activation and automatically retract the needle (OTS Autoinjector,
bespak injectables, filled by Catalent).
Pharma Tech Industries has installed a Stik Pak S/N 307 form–crimp–fill–seal machine from Ropak.
Single-use product-contact parts
Attendees at INTERPHEX 2011 also had a chance to explore the possibility of converting to single-use product-contact parts.
A single-use fluid path ensures purity, simplifies validation, and expedites changeover on high-throughput peristaltic filling
and capping systems (AsepticSU single-use fluid path technology, Flexicon Liquid Filling).
Pharmaceutical packagers switching to disposable product paths have a growing number of pump choices, including 6- and 50-cm3 peristaltic pumps as well as a rolling diaphragm pump (PreVAS Single-use Dosing System, Robert Bosch Packaging Technology).
The appeal of skinny stick packs includes ease of opening, ease of dispensing, and portability, plus the convenience and accuracy
of single-dose dispensing. In response to rising interest in this flexible packaging format, Pharma Tech Industries, a contract
manufacturer and packager of powder products, installed a machine that forms, crimps, fills, and seals the slender, cylindrical
packs (Stik Pak S/N 307 machine, Ropak Manufacturing).
Set up to handle 10 lanes simultaneously, the machine produces 600 stick packs/min and features in-line collation and cartoning,
as well as a color touch-screen operator interface. Servo-driven continuous motion corrects deviations. An adjustable dosing
system allows tool-less changeover of dosing-specific components.
Hallie Forcinio is Pharmaceutical Technology's Packaging Forum editor, 4708 Morningside Drive, Cleveland, OH 44109, tel. 216.351.5824, fax 216.351.5684, firstname.lastname@example.org
1 K. Abdelkader, R.M. Akers, and M.J. Akers, "Sterile Prefilled Syringes: Market Dynamics & Current Issues in Manufacturing
& Control," in Prefilled Syringes, Innovations that Meet Growing Demand (ONdrugDelivery, Newtimber, UK, 2005), p. 4.