Enabling Safe Syringe-Based Delivery

As the 10-year mark of the passage of the Needle Stick Safety and Prevention Act (NSSPA) approaches, injuries from contaminated needles and other sharps devices remains a front-and-center concern.
 
Products include (clockwise from top) the NovaGuard Safety Needle System from West Pharma, the Safe’n’Sound fully passive safety device from Rexam Pharma for prefilled syringes compatible with luer lock syringes, and the Unitract Safety Syringe from Unilife Corp. Photography by Hugh Hamilton.
The U.S. Centers for Disease Control and Prevention estimates sharps injuries in healthcare are in excess of a half-million each year, with about half of those sustained in U.S. hospitals.
 
The U.S. Public Health Service has called for the reduction of percutaneous injuries among healthcare workers by 30% as a national objective in 2010. New legislation in Europe aims to reduce workplace accidents from sharp objects by 25% by 2012, through the adoption of coordinated measures for assessing and preventing risks and training and informing workers.
“The healthcare sector is one of the biggest employers in Europe, and needles represent a real risk to workers, both in terms of injuries and increased rates of life-threatening infections like HIV or hepatitis,” said Laszlo Andor, EU commissioner for employment, social affairs, and inclusion.
 
“This new directive will better protect workers and their families while reducing the burden of injuries on European health services,” he added.
 
Safety features fixed to or integrated with syringes have made injection processes more safety secure and user-friendly. But engineered needle-stick prevention devices need to be combined with training and improved disposal and safe workplace practices if sharps injuries are to be reduced.
 
“Since the [NSSPA] went into effect in 2002, one in five facilities investigated by OSHA [the Occupational Safety and Health Administration] have been cited for noncompliance. [In addition,] the number of needle-stick injuries has stayed constant,” says Alan Shortall, CEO of Unilife Corp. (Lewisberry, PA).
“And injuries from syringes with attached safety systems have gone up. Current systems are not working,” Shortall maintains.
 
AUTO RETRACTION
In response to the continued concern over unprotected needle exposures and the NSSPA regulations, Rexam Healthcare has developed the Safe’n’Sound, a fully passive device for prefilled syringes. The syringe automatically retracts into the system after the injection is complete without requiring user intervention.
 
In disposable syringes, the BD Integra Syringe from BD (Franklin Lakes, NJ) enables one-handed activation by the user with virtually no change in administration technique. The system’s BD PrecisionGlide Needle retracts into the barrel when the healthcare worker pushes on the plunger rod after administering the injection. Retraction can be initiated after the needle has been removed, or while it is still in the patient.
 
Unilife features syringe safety technology integrated into the barrel of the syringe. After the dose is administered, a retraction mechanism automatically engages. The healthcare worker can then control the rate of needle extraction without removing the needle from the injection site. The technology is used in Unilife’s Unifill ready-to-fill syringe, and in the 1-ml Unitract disposable plastic syringe.
 
Unilife’s integrated safety system’s functional and automatic safety features allow retraction of the needle directly from the body, reducing the risk of needle exposure compared with conventional clip-on safety devices. These require the user to remove the needle from the injection site to operate the safety mechanism thus exposing the needle. Clinicians are reported to remove the needle from the patient before activating the needle retraction, which is rapid and uncontrolled, Shortall says.
 
“[Using the Unifill and Unitract syringes], the operator is in control of the process because they control the rate of retraction as the needle retracts directly from the patient,” he says.
 
Unilife and sanofi-aventis announced an agreement last month in which sanofi-aventis will have five-year exclusive rights to negotiate the purchase of the Unifill ready-to-fill syringe in therapeutic classes including antithrombotic agents and vaccines.
 
As part of the agreement, sanofi-aventis is providing $40 million to fund the industrialization of the Unifill syringe at a new 165,000-sq-ft plant being built in York, PA. Unifill production will begin at the facility later this year, says Shortall.
 
SAFETY IN PREFILLED SYRINGES
“The 1-ml Unitract safety syringe brought sanofi-aventis to us six years ago. They asked if we could incorporate our autoretraction technology into a bio-compatible glass prefilled syringe. The syringe components could not interfere with products’ two-year shelf life, and syringes had to work on standard filling systems,” Shortall says.
 
Sanofi-aventis has the right to nominate additional therapeutic sub-groups to be added to the exclusivity list, while Unilife will be free to market the Unifill to other pharmaceutical companies for other drug classes.
The new facility is close to Unilife’s current FDA-registered 50,000-sq-ft plant where Unitract manufacturing commenced last year. Last month, Unilife announced a five-year agreement with Stason Pharmaceuticals in which Stason will market the Unitract safety syringes in Japan, China, and Taiwan.
 
The integration of the safety features for Unifill syringes within the barrel lowers packaging storage and transportation costs, as its compact size makes it less than half the size of prefilled syringes with clip-on safety features, Shortall says.
 
With 2½ billion prefilled syringes used per year, the prefilled syringe market has been growing at 15 to 20% per year. That rate will continue for the next 10 to 15 years, he says.
 
“Unifill and Unitract syringes offer significant opportunities for market differentiation and product life-cycle extension. There are compelling opportunities in the United States and also in Europe where the market is scrambling to comply with the new EU directive aimed at preventing needle-stick injuries,” he says.
 
“Stason Pharmaceuticals is working with us as a partner to develop market demand for the Unitract, funding the cost for regulatory approval within the designated territories. The 1-ml Unitract syringe can be included with drugs in procedural kits or supplied with vials, allowing pharmaceutical companies to gain a competitive market advantage with a premium safety medical device,” he says.
 
West (Lionville, PA) has introduced the NovaGuard Safety Needle System for guarding against needle sticks. The passive system requires no activation steps, allowing healthcare workers to administer injections without any change in technique.
 
“We have found that when there is a needle cover that requires active engagement, care givers find it more difficult to use. They will forget to engage it, or they will have speed issues and ignore it. Safety systems that rely on user intervention are inherently higher risk,” says Graham Reynolds, vice president of marketing and innovation.
 
Delivered in a plastic outer package, the system attaches to a standard luer-lock fitting on a prefilled syringe or to a disposable syringe up to 3 ml. The user attaches the syringe to the system to remove if from the case. A plastic shield surrounds the needle with only the tip exposed for orientation. When the needle is pressed to the patient’s skin, the shield activates. As the needle is withdrawn, the shield extends forward to cover the needle fully, and the shield locks in place.
 
NovaGuard’s first iteration is for subcutaneous injections. Reynolds says West is developing the system for different needle gauges and lengths for subcutaneous and intramuscular injections.
 
For supporting patients injecting medications in home-based care, West has developed the ConfiDose disposable single-use auto-injector system. The Tech Group, a West company based in Scottsdale, AZ, will manufacture and assemble the system in commercial quantities.
 
SUPPORTING QBD
“We will shortly be in a position to provide fully validated product for customers’ clinical studies after scale up to full production early this year,” Reynolds says.
ConfiDose incorporates a 1-ml-long affixed needle prefilled syringe that can be either glass of a Daikyo Crystal Zenith syringe. The user presses a button to initiate automatic insertion, injection, and retraction, when the needle is fully hidden. Audible, visual, and tactile cues make the system easy-to-use and intuitive.
 
“ConfiDose is a platform technology that could be adopted by any pharmaceutical company with an existing prefilled syringe. It is designed to be compatible with any standard 1-ml-long syringe and a wide range of drug viscosities,” Reynolds says.
 
For packaging components, West has unveiled its NovaPure components that support customers’ Quality by Design (QbD) initiatives. The initial NovaPure product offering will be four configurations of 13-mm and 20-mm serum and lyophilization stoppers manufactured at West’s Jersey Shore, PA, facility.
 
NovaPure components are manufactured with West FluroTec film. The film provides a barrier to minimize potential drug interaction with the stopper, and lubricity properties that eliminate the need for silicon oil. Components are delivered as Westar ready-to-sterilize or ready-to-use and can be specified for direct entry into barrier isolator or aseptic filling systems.
 
“Customers can achieve QbD by having control of their manufacturing process, the drug itself, and the drug’s container/closure system, and the components. Through our NovaPure services, we are helping with the closure components that lead to their finished output,” says Fran DeGrazio, vice president of marketing and strategic business development.
 
“We provide extractables profiles and specifications through our NovaPure product. We remove endotoxins and reduce bioburden. Product is VeriSure-certified to ensure consistent lot-to-lot extractible profiles, and undergoes vision inspection for visible contamination, sub-visible inspection, and inspection for some dimensional tolerances.
“These are all points of control of the product coming into our customers that help to minimize any variability in their process,” DeGrazio says.
 
A packager of vials, syringes, and injection pens, Amcor Pharmaceutical Contract Packaging (Bethlehem, PA) plans to enhance its internal cold-chain management with investment this year in cold-chain track-and-trace technology. Bar coded product will be tracked automatically as it moves in and out of cold storage for building real-time pedigree records.
 
For product already bar coded by the manufacturer, the system could marry the temperature pedigree with the product pedigree. “Or we could implement a temporary bar code system to satisfy the pedigree temperature tracking,” says Daryl Madeira, director of marketing.
 
At Amcor Pharmaceutical Contract Packaging, lean one-piece-flow manufacturing and SOPs around product handling minimize exposure for temperature-controlled product within the packager’s four walls. These efficient processes recently won business from a competitor that was conducting packaging in a cold suite environment.
 
PACKAGING
COST-EFFECTIVELY
“We demonstrated that we could more reliably, cost-effectively, and efficiently produce the packaging, outside of cold storage, without compromising the product’s cold-chain requirements,” Madeira says.
For supplementing on-site validated cold storage, the packager has lined up outsourced cold storage with a local company that has allocated space specifically for pharmaceuticals.
“While we have adequate cold storage space, this provides us the opportunity to expand readily without any lead time issues should a customer’s volumes rapidly grow,” he says.
 
As unit-dose drug-delivery systems create more variety in customers’ packaging requirements, Amcor has partnered with KÖrber Medipak in adopting Dividella NeoTOP kits for paper-based secondary packaging.
“We can switch between a variety of primary package formats for parenterals with ease. And by replacing thermoformed trays, we provide a more environmentally friendly package, at a better price position,” Madeira says.
 
Amcor Pharmaceutical Contract Packaging’s culture of “Organizational Creativity” supports customers with expertise for package development and product commercialization, Madeira says. For example, as one of multiple suppliers of services to an international virtual firm launching a new product, Amcor has recently been called upon to offer all elements of packaging, from design through accelerated launch.
 
“All of our creative resources are brought together from the minute we get a request for proposal, right through to commercialization. As a team of creative individuals, we are asking, ‘How can we deliver a better, cost-effective solution more efficiently to the customer within the context of our core competencies?’ ” Madeira says.
 
Vetter (Ravensburg, Germany) is developing fill-finish capacity at a new facility in Skokie, IL, that will include three manufacturing clean rooms and state-of-the-art microbiological and chemical laboratories. An expansion of Vetter Development Service, the 24,000-sq-ft-facility will be operational by the fourth quarter 2010, says Vetter managing director Thomas Otto.
 
VETTER EXPANDS
FILL-FINISH CAPACITY
“We will initially focus on early-stage products from preclinical through phase IIb, after which we will scale up and transfer products to our facilities for phase III filling and market production,” Otto says.
“To help ensure a seamless transition to commercial manufacture, we’re replicating commercial processes at our early-stage [Skokie] site,” he adds.
 
One cleanroom room will include a filling line for semiautomated, small-scale filling of vials, syringes, and cartridges. syringes. Filling operations in a second are planned for pre-sterilized syringes. A third will feature the MHI 2020 automated vial filler from Bosch Packaging Technology (New Richmond, WI). The unit can be used for filling liquid vials from 10 to 10,000 pieces per batch and for lyophilized vials from 500 to 5000 pieces per batch, Otto says.
“Vetter is the first company to use the new Bosch system, designed specifically for clinical-stage, high-value pharmaceuticals. The Bosch filler uses all disposable drug-contact components, [which] eliminates the need for cleaning validation and thus supports time-to-market.
 
“It’s a compact machine with minimum tubing lengths, which increases API yield,” Otto says.
“And it includes a 100% check-weight system. That’s important, because if the amount of drug in a vial is inaccurate, that may affect the outcome of a clinical study, especially in small, early-stage trials,” Otto adds.
“Life sciences companies have shifted their central focus from small to large molecules. That, in turn, is shifting how primary parenteral packaging providers operate, says Otto.
 
“Handling sensitive, high-value biopharmaceuticals requires, for example, better control of fill volumes and technologies that deliver higher API (active pharmaceutical ingredient) yield. Unnecessary waste of API is unacceptable when dealing with expensive drug product.”
 
For final assembly and packaging of prefilled injection systems, Vetter rounded out a complete service offering in parenteral packaging with last year’s launch of a Vetter Secondary Packaging facility in Ravensburg. The facility features a fully automated production line that automates processes including labeling, plunger rod insertion, packing in boxes, and the transport between stations. The line allows packaging twice the number of injection systems in half the time required before, Vetter says.
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