Product Name
PharmaJet Stratis® 0.5mL Needle-free Injection System
Product Description
The PharmaJet Stratis 0.5mL Needle-free Injector System is a compact, spring-loaded needle-free injector system. The system consists of the following: a single-use sterile disposable needle-free Syringe, a single-use sterile disposable Filling Adapter, an Injector, and a Reset Station.
- Syringe (C501-31): Needle-free, single use, auto-disabling, disposable Syringe that delivers a fixed fluid
volume of 0.5mL. - Filling Adapter (C501-40): Single use, disposable, transparent Adapter that facilitates transfer of medicine
or vaccine from any size of primary vial packaging (single or multi-dose) into the needle-free syringe. - Injector (C501-10): The Injector is a reusable, compact and spring-actuated, consisting of an outer body with
an inner housing, and trigger. - Reset Station (C501-20): The Reset Station is used to energize the Injector spring.
Purpose
The Stratis 0.5 mL Needle-free Injection System is a designed for intramuscular and subcutaneous delivery of various vaccines and medicines.
Basic Technical Characteristics
Ease of use
Four simple steps: Reset Injector, fill Syringe, insert Syringe into Injector and administer injection. This
simplicity enables less experienced staff, or even patients to become rapidly proficient, enabling wider global
acceptance and utility.
No Needle
The PharmaJet syringe contains no needle and its auto-disable feature makes it impractical to re-use. This
eliminates two of the greatest concerns in health care: Needle stick injury to health care givers, and cross
contamination caused by re-use of needles. No needle, no sharps elimination issues.
Robust Design
Requiring no external power source, the smart design of the robust injector ensures a minimum of 20,000
injections can be achieved with each unit. This translates into one injection every five minutes, seven hours a
day every working day of the year.
Functional Description
The PharmaJet Needle-free Injection System delivers liquid medications and vaccines intramuscularly (IM) or subcutaneously (SC) by creating a very narrow, high velocity fluid stream (essentially a“fluid needle”) which penetrates the skin and delivers the medicine or vaccine into the body. Energy to propel the injectate is supplied by a hand-held spring powered Injector. When released, the spring energy is transferred to the Syringe plunger, expelling the injectate through a very small orifice in the face of the Syringe contacting the patient.
ISO Certification & Standards Compliance
- PharmaJet, Inc. has established and maintains a Quality Management System that complies with the requirements of ISO 13485:2003
- ISO 21649:2006 Needle Free Worldwide Standard compliant
- Our single use, sterile products are tested with guidance from: ISO 10993, ISO 11737, ISO 11607 and ISO11137
Functional Specification – Stratis 0.5mL Needle-free Injection System
- Injections: Minimum 20,000 injections.
- Depth of penetration: Intramuscular (IM) or subcutaneous (SC), depending on injection technique.
- Dose specification: 0.5mL with Automatic Dose Adjustment assuring a dose accuracy ±5% (ISO 21649:2006).
- Operational temperature: 41°F to 104°F (5°C to 40°C).
- Storage temperature: -41°F to 158°F (-40 °C to 70°C).
- Safety mechanism: Automatic; virtually eliminates accidental discharge.
- Sterilization method: Disposable products are sterilized using gamma radiation. Sterility is guaranteed unless packaging is opened or damaged.
- Disinfection method: The Injector and Reset Station can be wiped with 70% Isopropyl Alcohol and air-dried.
- Warranty: The Injector and Reset Station carry a warranty against defects in materials and workmanship for one year from the date of purchase.
Application Scope
Indications for use
The PharmaJet Needle-free Injection System is intended to deliver various medications and vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine to the body. Healthcare providers who routinely administer injections may use the PharmaJet Needle-free Injection System. It may be used for adults and children. It can also be used by patients authorized by their physicians to self inject, or have other individuals administer injections of prescribed medication.
