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Originally Published November 1999

SPOTLIGHT

Syringes Reinvented to Address Safety Issues

Manufacturers have developed advanced syringe systems to lower the risk of spreading infections.

by Annie Lubinsky, Managing Editor

The two-piece plunger-type disposable syringe has long been an effective device for administering parenteral medications to a patient. However, safety issues have recently caused manufacturers to take a second look at this traditional syringe system.

"Syringe technology continues to advance, fueled by the need to make syringes as safe as possible for the patient and the healthcare practitioner," says Tom Walker, manager of corporate communications at West Pharmaceutical Services (Lionville, PA). West supplies the pharmaceutical industry with elastomeric plungers, needle shields, stoppers, and syringe components, as well as design and manufacturing technologies.

"Today's advances in syringe technology are driven by two needs," Walker continues. "First is the need to develop safety syringes to minimize the occurrence of needle sticks, the accidental piercing of the skin by healthcare practitioners. Second is the need to develop single-use disposable syringes. Both of these goals are being pushed by legislative initiatives, especially in the United States."

Several states have already passed safe needle legislation to protect healthcare professionals and patients. Federal legislation is now a possibility due to the growing concern about the transmission of blood-borne diseases such as HIV and hepatitis. Many healthcare workers risk needle sticks daily.

"In the United States, an estimated 1 million needle-stick injuries are reported annually, according to a June 25, 1999, article in Investors Chronicle," says Walker.

The same concerns exist in other countries. In developing countries, Walker says, "even disposable syringes are reused because practitioners cannot afford to replace them." This practice increases chances of spreading infections and creates the challenge of developing a low-cost disposable syringe.

Manufacturers of parenteral packaging have taken on this challenge of producing new, safe, and cost-effective vials and syringes. In doing so, they have addressed the needs of the user in a particular location or situation. Most of the packages described in this article have a specific application, but all have the same goal: to promote safety. The packages accomplish this goal by ensuring correct dose delivery, preventing needle sticks or needle reuse, and maintaining a sterile environment for the drug right up until the moment it is administered.

Reconstitution Occurs Inside Sterile Syringe

One company used its pharmaceutical background as a contract manufacturer and its engineering arm to create the Vetter Lyo-Ject, a syringe in which a drug can be lyophilized and packaged with its diluent.

"This device allows the drug to be reconstituted quickly, eliminates the need for a separate diluent vial and transfer cannula, provides an easy method for administering the drug, and reduces waste. "The Vetter Lyo-Ject allows the medical professional to reconstitute and administer the drug while reducing the amount of overfill of two vials," says Jeff Turns, vice president of sales and marketing at Vetter Pharma Turm (Yardley, PA). The company is the North American affiliate of the Vetter Group (Ravensburg, Germany). "By reconstituting the drug in the syringe," Turns continues, "you can give the entire amount of drug to the patient without the normal waste left in a vial."

The Vetter Lyo-Ject dual-chamber prefilled syringe is easy to use.

The Vetter Lyo-Ject syringe works with any lyophilized drug and is activated with an easy twist-and-push motion. The pitch of the screw can be changed to reconstitute a drug quickly or slowly. "Some proteins can't be shaken because the action will break them up and render them unstable," says Turns. "So the reconstitution step can take up to a maximum of 15 seconds, depending on the drug."

Although the Vetter Lyo-Ject is cost-effective, its chief benefit is ease of use. "Ease of use equals patient compliance, which equals better therapy," says Turns.

Low-Cost Plungerless Syringe Flushes Catheters

When Barry Farris was working for a large pharmaceutical company, he learned that nurses and doctors wanted a better syringe at a lower price. So he invented the Vasceze, a disposable one-piece plungerless syringe that replaces the traditional two-piece plunger-type syringe. "The name Vasceze reflects the device's largest use, which is to flush catheters," says Farris, who describes himself as the "president and shipping clerk" at Avitro (Lake Tahoe, NV, and Pollock Pines, CA).

Before the Vasceze was invented, there were two ways to flush a catheter, both of which had drawbacks. The first way was to use prefilled syringes, which were expensive. Also, the quality control at some manufacturers' facilities was poor, says Farris. Sometimes entire lots of syringes were rejected, making it difficult to supply customers with what they needed.

The second method was to take an empty syringe, fill it from a vial, throw away the needle, then insert the syringe into the catheter. One drawback to this method is that it is not the cleanest way to flush a syringe--for example, unclean ambient air may be drawn into the syringe while it is being filled. Another drawback is that this procedure has many steps.

Both methods shared one major drawback: high cost. Farris knew that blow-fill-seal was the least expensive way to put a liquid into a package. He needed to invent a way to use this technology for manufacturing syringes. "In a traditional syringe, the plunger serves two purposes," Farris says. "It administers the medicine and it expels the air." Farris needed to make a syringe that would accomplish the same tasks.

"The first part was easy," he says. "I found I could make a bellows that would administer the dose. The question was how to expel the air using the bellows. That was harder."

After some thinking, Farris came up with a solution. "Allow the air to go up, where it wants to go," he says. A small reservoir at the tip of the syringe holds the air. The reservoir is removed before the medicine is administered.

With the two problems solved, Farris says, "now you have a very inexpensive syringe." The Vasceze costs less than 20 cents to make and sells for less than 40 cents. According to Farris, medical professionals use between 1 and 10 billion syringes a year, making low cost important.

Disposable Device Prevents Reuse in Developing Countries

Cost was the largest issue for the UniJect, an injection device created for use in developing countries. In many cases, prefillable syringes are too expensive for these countries. The UniJect, a prefilled single-use disposable injection device, is lightweight, easy to ship, and cannot be refilled or reused.

"In some developing countries, disposable syringes are reused, spreading blood-borne diseases such as hepatitis," explains Peter Heyman, manager of customer process development for the Pharmaceutical Systems Division of Becton Dickinson (BD; Franklin Lakes, NJ). "Also, it can be hard to get the syringes and vaccine or drug to the same location. The syringes may be diverted during shipping." The UniJect device makes it possible for medical professionals in developing countries to receive and administer medicines safely.

Avitro's Vasceze syringe is inexpensive and disposable.

The UniJect replaces the disposable syringe and vial. It consists of a needle attached to a reservoir that is made from a three-layer laminate film. To inject the drug, a seal must be broken and the reservoir squeezed. The UniJect is inexpensive, durable, and easy to use; the device provides an accurate dose and eliminates wasted medicine.

Its unique design created challenges. "There is no other product like the UniJect," says Howard Leary, vice president, applied engineering, at Luciano Packaging Technologies Inc. (Somerville, NJ). "We had to invent machines to process it."

Developed by the Program for Appropriate Technology and Health (PATH; Seattle), the UniJect design was optimized by Horizon Medical Inc. (Santa Ana, CA), which created prototype machines to manufacture the product. BD then acquired the product, turning its attention toward modifying the design of the device for low-cost, high-volume manufacturing.

Because the UniJect machines would be used "anywhere in the world," according to Leary, Luciano Packaging aimed for high quality, reliability, and ease of use. "Our objective was to make a productive, efficient machine," says Leary. "We needed to produce 120 pieces per minute but keep the machine simple and easy to maintain."

The UniJect machines are now being used worldwide. The first fully integrated, automated packaging line will be installed in Asia in early 2000 for processing of UniJects to be used by UNICEF and PATH in a program to eliminate neonatal tetanus.

Needleless System Eliminates Extra Components

The demand for safe, easy-to-use syringes led to one solution, the Bio-Set Injection from Biodome America Inc. (Princeton, NJ). Created in 1997, Bio-Set Injection offers three benefits to users: it is easy to use, it saves time by reducing the number of components needed to prepare the injection, and it promotes safety by reducing the chance of needle sticks and by keeping the drug sterile until it is ready to be injected.

"With Bio-Set Injection, you need only a prefilled diluent syringe, the drug vial, and a needle to administer," says Raymond J. Scheire, Biodome's sales and marketing director.

The Bio-Set system helps prevent needle-stick injuries.

The product is a device to reconstitute a powdered or lyophilized (freeze-dried) pharmaceutical, usually a biotech drug designed to be administered by intramuscular or subcutaneous injection. The system is designed for a variety of therapeutic injectable classes such as vaccines, hormones, and cardiovascular drugs with diluents ranging from 1 to 50 ml. Because these are expensive drugs, waste must be minimized. "When you draw the diluent from an ampule, it's hard to retract all of the contents," Scheire says. "Bio-Set Injection allows you to use more of the drug."

"Bio-Set is not a medical device; it is a packaging component," Scheire says. "Bio-Set has a Drug Master File, which a pharmaceutical company refers to when submitting a new drug application with Bio-Set."

The system is used on a standard vial (neck diameter 13 and 20 mm) and rubber stopper (lyo or standard) combination in place of a crimp. "We were required to test the Bio-Set system to show that it has the same integrity as a crimp seal. Biodome has done these tests systematically," says Scheire.

Bio-Set Infusion, a similar product, was created in 1996 to eliminate the use of a diluent vial, a syringe, a needle, and an alcohol swab when reconstituting a drug administered with an IV bag. Both Bio-Set Injection and Infusion allow pharmaceutical companies to differentiate their drugs by providing a package that increases safety.

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