At PharmaJet, we are proud to display the framed certificate indicating we are the first and only Needle-free Injection Systems (NFIS) to achieve WHO prequalification (E008/050, E008/071), which is a requirement for United Nations agency procurement. But the certificate is also so much more than a fancy frame on the wall: WHO prequalification combined with our certificates from US FDA, European CE mark and other stringent regulatory authorities represent the quality design and processes that we’ve developed that set PharmaJet apart as a “go-to” partner in the novel pharmaceutical sector. Our NFIS are commercialized and registered on five continents. This means our pharmaceutical partners can switch to needle-free delivery with minimal risk. It also means that healthcare workers using our NFIS can have high confidence that our solutions will be reliable day after day, even in austere settings. Read on to better understand how we can guarantee consistent injection performance under challenging conditions around the globe.
- Cycle testing: All of our products are tested to comply with the latest ISO 21649 standard1 which requires a minimum of 20,000 cycles. In addition to cycle testing, Stratis® and Tropis® pass all vibration, drop, impact, accelerated aging, and environmental challenge testing.
- Syringe testing: PharmaJet Needle-free Injection Systems (NFIS) use single-use, disposable needle-free syringes which eliminate sharps waste, needle reuse, and needlestick injuries. These syringes go through intense packaging and sterilization validation, transportation testing, and environmental challenges and are tested to rigorous biocompatibility requirements. According to Stephan Jones, PharmaJet’s Director of Quality, “Product verification includes hemocom-patibility, cytotoxicity, pyrogenicity, system toxicity, genotoxicity, sensitization, and irritation testing in accordance with ISO 10993-1:2018 standards.2 Dust and water ingress protection (IP55) testing ensures our devices can be used anywhere – from the cleanest hospital facility in Europe to the dustiest roadside vaccine clinic in a rural village. Additional testing is conducted to simulate workflow so we can verify dose accuracy under a variety of conditions.”
Devices go through 100% visual and functional inspection.
- Design controls: Quality engineers know that no amount of testing can overcome poor design. A device must first be designed well to pass every test. PharmaJet has world-class design control systems that are compliant with regulations such as US FDA 21CFR part 8203, EU Medical Device Directive 93/42/EEC, and global ISO 134854 Quality Management Systems for Medical Devices.
- Global registrations: The medical device industry is shifting toward country-specific regulatory requirements. This shift requires a significantly more complex approach to the development of the quality practices and procedures that ensure device quality and compliance. With a library of quality-assured and verified data, PharmaJet nimbly responds to individual country requirements. This has enabled us to maintain registrations in the European Union (CE Mark), Brazil, Vietnam, Israel, India, Kenya, Ghana, South Korea, and Colombia. In the US, we have 510(k) device clearance for our Stratis System and a Device Master File for Tropis.
- Translating quality into performance and satisfaction: PharmaJet collaborates with local partners to plan, educate, implement and support integration of needle-free into existing vaccination and drug delivery programs. This customer focus really pays off. In 2019, we deployed several thousand devices in Pakistan to support the Global Polio Eradication Initiative. A peer-reviewed publication in The Lancet reported:
“Nearly all surveyed vaccinators and caregivers preferred the jet-injectors to needle-based methods (97.6% and 99.6%, respectively), specifically citing ease of use, positive parent response, improved child response, and the jet injectors’ more favorable appearance (lack of needle). The high coverage and strong acceptability of the jet-injectors in this setting provide support for exploring the use of this mode of delivery to administer fractional doses of inactivated polio vaccine (fIPV) in areas with community resistance to vaccination.”5
PharmaJet has created educational materials such as a Helpful Tips card, a User Guide, and a multilanguage Instructions for Use to emphasize proper technique and to help health care workers optimize the life of the device. All these resources are available through the PharmaJet website.
In our office in Golden, Colorado, we proudly hang our Quality certificates right next to the framed photos of those we are committed to serving. The certificates are proof that we do everything necessary to deliver high quality solutions. The smiles on the faces of our treasured customers are added evidence that we are achieving greater impact, improved healthcare delivery, and high levels of satisfaction.
1 ISO 21649:2006 Needle-free injectors for medical use — Requirements and test methods
2 ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
3 Code of Federal Regulations Title 21 Part 820 Quality System Regulations
4 ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
5 Daly, 2020, Needle-free injectors for mass administration of fractional dose inactivated poliovirus vaccine in Karachi, Pakistan: A survey of caregiver and vaccinator acceptability