How does the PharmaJet system work? Put simply, liquid propelled with pressure through an extremely small orifice creates a ‘liquid needle’ jet capable of penetrating skin and depending on technique, is delivered to either the subcutaneous or muscle tissues.
Energy is provided by a robust, reliable and repeatable spring mechanism. When released, this spring mechanism advances the syringe plunger, expelling the contents at approximately 550 feet or 167 meters per second. From start to finish the injection is over with and in the body in about 1/3rd of a second.
Can the syringe be reused? No.
To maximize safety and prevent use on more than one patient, the syringe is single-use and auto-disabling.
Is the fluid dispersed in the tissues any differently than with a needle? No, on cut section there are no visible differences between delivery methods. To view Cross Sectional images, click here.
Does this injection method harm the substance being injected?
A very large body of published literature exists that demonstrates vaccines remain fully immunogenic and effective when delivered with jet injection.
Additionally, research collaborations with vaccine developers have evolved a body of evidence, derived from vaccine-class-appropriate assays such as potency assays, particle size measurements, viral infectivity assays, etc. that reinforce and substantiate the serologic evidence that transient exposure to pressures required to deliver the vaccine do not alter vaccine integrity.
How repeatable is the expelled volume?
Industry standards for Expelled Liquid Dose Accuracy (ISO 21649, sec. 5.3) set limits of +/- 5% for dose volumes greater than 200µl or 0.2 ml. PharmaJet products are designed, developed and validated to meet this industry standard.
Biological Testing of Device Materials
Biological evaluation of the PharmaJet Needle free Syringes and Filling Adapters is performed to determine the potential toxicity resulting from contact of the syringe and filling adaptor component materials with the body per Blue Book Memo G95-1, ISO-10993 Biological Evaluation of Medical Devices parts 5, 10, and 11. All biocompatibility testing is performed under GLP conditions at FDA registered and inspected facilities. To see a complete list of biocompatibility testing done to ensure safety, click here.
Does injection performance change over time?
PharmaJet develops and tests devices in a highly controlled laboratory setting. Devices are tested when new, subjected to the extreme conditions called out in ISO 21649, cycled 30,000 times, then retested to demonstrate within-specification injection performance. This testing matrix ensures repeatable and predictable function in a wide range of field situations.
Mechanical performance variables known to directly correlate to clinical performance include peak injection pressure, ending injection pressure and injection duration. When these variables are measured very accurately and rapidly over time, a pressure profile can be generated. This pressure profile acts as a “finger print” for a given technology. These variables are highly engineered, and by controlling them the injection performance is predictable and controlled.
Can viscous materials be delivered with jet injection?
To ensure consistent injection performance across a wide range of fluid viscosities, PharmaJet performs expelled dose accuracy and depth-of-penetration studies using viscosity reference standard between one and seventy centipoise. Across this range there is no detectable difference in injection performance.
Can Stratis be used in challenging immunization environments?
The Stratis system was designed to excel in demanding immunization environments such as campaigns. During extensive physical testing the technology is subjected to a range of temperature and humidity, free-fall, vibration and shock testing. Bench indices of delivery performance are evaluated both before and after testing and must remain within specified limits. The Stratis system passed all testing and test reports are available for review if required. Click here to see a list of testing requirements as specified by ISO 21649.
Clinical studies using Stratis
Since it’s market debut in 2011 PharmaJet has sponsored and completed two clinical studies using Stratis.
Rabies Vaccine Study – August/September, 2011: The Stratis device was used to deliver a standard 1.0 ml IM three-course series of rabies vaccine in a PharmaJet-sponsored immunization study in which 65 subjects were randomized 1:1:1 to receive full course vaccination (standard IM dose) with standard needle/syringe or jet injection delivery methods. Patients randomized to PharmaJet arms received 2 x 0.5 ml per vaccination due to a volume limit of 0.5 ml in PharmaJet syringes. Seroconversion for all treatment groups was 100%. GMTs for Stratis were non-inferior when compared to needle and syringe. There were no vaccine or device-related safety issues.
Seasonal Influenza Study – January 2012, 79 adults were randomized into one of two arms, needle and syringe or Stratis, and vaccinated with a single IM dose of Fluzone (Sanofi Pasteur). Blood was collected on Days 0 and 28. Pre-vaccination titers were not different between groups. Needle:Stratis GMT ratios were 0.94 (95% CI:0.60-1.49), 0.84 (0.49-1.45), and 1.0 (0.63-1.59) for types A1, A2 and B, respectively, reflecting no difference in vaccine performance between delivery methods. GMTs for Stratis types A1 and A2 achieved non-inferiority to needle/syringe controls despite the study design not being powered to do so. There was no difference in seroprotection rates between groups. There were no device-related safety issues.
Campaign use and field experience
Measles SIA, Kho Thom province, Cambodia – October/November 2011, Stratis was used in a Pilot Introduction format to deliver approximately 5,000 measles vaccines to children aged 5-9 years old in a national SIA. Objectives of the pilot introduction were: 1) To evaluate the use of a licensed needle-free injection device in the context of giving measles vaccine subcutaneously during a mass measles campaign; 2) To document the operational use of the DSJI during a measles campaign aimed at children aged 5 to 9 years of age in Cambodia; 3) to document the degree of acceptability and satisfaction among vaccinators and recipients; and 4) to assess the logistical, training, supervisory and communication needs for introduction of needle-free devices within the existing immunization system. The technology was very well received by healthcare workers and patients. To view the final report click here.
Measles SIA, Sindh Province, Pakistan – Stratis is currently being used in a Pilot Introduction to vaccinate 25,000 1-3 year old children in and around Thatta, a city of 1/4 million inhabitants about equidistant between Karachi and the Indus river. This city lies in the middle of what was the worst affected district of the floods of August 2010.