New Trend – Prefilled Syringe Technology

Since the inception of the Needlestick Safety and Prevention Act of 2000, a transition away from traditional sharps and fixed needle syringes, toward safety engineered devices, has occurred.  Most devices utilize a variety of methods to meet OSHA safety standards and avoid needle stick injuries and bloodborne pathogen transmission.  However, prefilled syringes still do not utilize comparable needle stick prevention technology and continues to present a huge risk to healthcare professionals.

The challenge of integrating safety needlestick prevention technology is not unfamiliar to medical device professionals yet the design difficulties encountered when considering combining a dual chamber barrel with retractable needle technology may appear initially insurmountable.

Globe Medical Tech, utilizing breakthrough technologies including award winning vacuum force needle retraction has resolved the problem.  The new dual and single chamber prefilled syringes provide much needed safety and OSHA compliance to the prefilled syringe market.

As the pharmaceutical industry continues to seek out drug delivery methods that improve safety and efficiency while reducing costs, the traditional multidose or single-dose vial format for vaccines and injectables is starting to show its age.

Developed markets are increasingly turning to packaging vaccines in prefilled, single-use syringes, with more and more companies recognising the benefits that come from this area’s innovations. Prefilled syringes have been used to delivery drug categories like vaccines, therapeutic proteins, blood stimulants, erythroproteins and more.

Reports acknowledge that the market’s continued growth will have to be driven by continuing improvements to syringe technologies and materials, making prefilled syringes better, safer and more convenient than ever before.

Fortunately, this sector is abuzz with development activity seeking to improve the technology behind prefilled syringes for the benefit of the pharmaceutical industry and the patients it serves (patients particularly stand to benefit from advances in the related field of self-injection technologies).

Here, we profile the range of benefits that modern prefilled syringes are bringing to the market, and check out some of the sharpest developments in this area.

The growth of the prefilled market

The growing popularity of this drug delivery route for injectables has been noted by UK-based business analyst Visiongain, which released a report in June 2011 predicting that global revenues from prefilled syringe technology would grow from $2.7bn in 2010 to $3.9bn in 2015.

“The advantages are great, with prefilled syringes taking over from traditional formats,” said Visiongain’s healthcare reports editor Dr Gordon Low. “Prefillable syringes constitute one of the fastest-growing markets in the drug delivery and pharmaceutical packaging industries.”

Reports of rapid growth in the prefilled syringe market have not gone unnoticed by device manufacturers. In November 2010, for example, German healthcare device manufacturer Gerresheimer began work to add a fourth production line dedicated to prefilled syringes to its plant in Bünde.

The company was prompted to make the €20m investment out of a desire to tap into the prefilled market’s double-digit annual growth rates. The plant’s prefilled syringe production line is due to join its three ready-to-fill lines in 2012.

Prefilled syringes are increasingly utilized as a method of product differentiation for drugs requiring parenteral injection.  They reduce overfill, improve dosing accuracy and patient compliance, prevent accidents and provide ease of administration by eliminating the steps required and risks associated with filling a syringe from a vial.  A 2006 market study shows that the market for prefilled syringes is expected to grow by an average of 12.8% per year reaching 3 billion units by 2013.  Our Prefilled Safety Syringe is designed with market needs in mind and strategically maximizes the added value while minimizing overall system costs.

The Globe Prefilled Safety Syringe utilizes proprietary safety vacuum force needle technology to provide the maximum safety, ease of administration, improved dosing accuracy, and facilitate patient compliance to meet the challenging needs of users to prevent needle stick injury and provide full compliance with OSHA and EU directives.

Award Winning Vacuum Operated Auto Retractable Needle Technology

The Globe Prefilled Safety Syringe is the result of 10 years of safety medical device development spearheaded by Andy Hu, President and CEO of Globe Medical Tech.  Mr. Hu has an extensive record of successfully developing drug delivery and safety medical devices and received the ISIPS (International Sharps Injury Prevention Society) Sharps Injury Prevention Honorable Mention in 2005.  The Globe Prefilled Safety Syringe marks the maturation of the past five years of syringe design and development, for which Globe has already been recognized by being awarded the prestigious Medical Design Excellence Award twice in the last three years for two injection devices (MDEA Award in 2008 for the POWR Syringe and 2010 for the Vacuum Operated Auto-Retractable Safety Syringe).

Globe has utilized this award winning technology to design the safety prefilled syringe for dual and single chamber as well as custom designs for glass or plastic syringe barrels.  This patented technology will be implemented into Globe’s pipeline devices including safety IV catheters and other needle stick prevention devices.

The Globe Prefilled Safety Syringe, with patented safety auto-retractable needle technology, integrates the latest technology for full OSHA safety compliance.   Globe’s double chamber design allows lyophilized powder and liquid solution to mix when ready for injection and the single chamber design (and/or customized design) is also available.  Globe utilizes medical grade USP biocompatible materials that meet FDA criteria.  Our manufacturing process includes the assembly and filling-finish machinery for an integrated turnkey solution.

Our Prefilled Safety Syringe is different.  By design our vacuum retraction technology is wholly unique to the syringe market and meets all OSHA and EU safety compliance standards.  Passive safety, combined with intuitive function, ensures that not only the needs of patients are met, but the needs of stakeholders at all levels are addressed. This includes:

It is designed to be economically mass producible as there are no mechanisms (springs or metal components).  Also, all components in contact with pharmaceuticals are constructed of USP and EP compliant materials.  Together with cost competitive system design we are able to minimize total process costs by integrating production with fill-finish lines.

Integrated Needle Stick Prevention with patented vacuum needle auto-retraction technology at the end of injection (without any necessary activation procedure) provides full compliance with OSHA and EU Bloodborne Pathogen directives.   Passive needle auto-retraction is the key to safety as any prefilled syringe which has a form of needle cover (shield, cap, or lid) to cover the needle is not considered a complete safety syringe as the caregiver can be injured during placement of the cover over the exposed needle, contaminated with blood.  The Globe Prefilled Safety Syringe does not have a separate need of activation (twisting or capping to engage the safety).  Our activation is automatic after the injection.  The needle is retracted into the syringe body after the injection with a gentle push on the plunger.

Single unit dose syringes are prefilled with medication and prevent human error (selection of wrong medication, wrong dosage injection), the ready to inject condition and with no necessity of manually covering the exposed sharp needle (as it gets retracted at the end of the injection) significantly reduces the contamination risk.

Single and dual chamber versions, as well as material and lubricant selections maximize pharmaceutical compatibility and extend product shelf life.  The dual-chamber version has the ability to maintain the individual pharmaceutical components in completely separate chambers, whereby extending the shelf life of some drugs by separating the lyophilized powder from the diluents/dispersant.  Custom materials can also be utilized to meet specific reactivity requirements of sensitive pharmaceuticals.  Our syringe is made with FDA compliant USP and EP medical grade plastics which are especially compatible with a wide range of pharmaceutical drugs, as the syringe components offer excellent bio-compatibility, least leachability and are very inert thus extending the shelf life of the prefilled drug.

Globe Medical Tech, Inc. specializes in drug delivery and safety device design, development and manufacturing.  For the past 20 years, our award winning team has accumulated the most valuable integration experience for medical devices.  Globe provides the medical industry with innovative low-cost, high-quality medical products.  Globe has established itself as one of the most cost-effective operations in the medical device industry by effectively integrating patent development, research, and engineering design capabilities with a fully FDA compliant clean-room manufacturing presence in China.

We offer our customers integrated turnkey solutions, including patent development, product design, regulatory approval, prototyping, injection molding, final product manufacturing, and marketing.  Our customers – medical devices inventors with an innovation or established device companies are searching for a partner that can provide cost-effective engineering and manufacturing services.  Recently, we have completed the design and launch of our innovative, Auto-Retractable Safety Scalpel with Permanent Lock, designed to replace generations of outdated and unsafe devices.  Globe’s experiences, capabilities and strengths provide the exact solutions that our customers are looking for.

Globe Medical Tech will provide customized design and biocompatible medical grade materials to most drug delivery systems with a safety needle design solution.