For patients, ZENEO® enables the simple, rapid, needle-free, intramuscular or subcutaneous self-administration of treatments in a ‘readyto- fill’ package.
ZENEO®, a compact, user-friendly device is simple to use, fast (50ms) and the dose injected is pre-set. The patient self-administers the right drug at the right dose, safely and with a minimum of discomfort.
The company’s portfolio currently contains eight products in advanced stages of development, seven of which are for urgent or life-threatening situations, such as adrenaline for anaphylactic shock, midazolam for epileptic seizures, naloxone for opioid overdose, hydrocortisone for acute adrenal insufficiency and terbutaline for severe asthma attacks.
‘Ready-to-fill’ glass containers
In 2017, Crossject launched its new production facility in Dijon, France, which is dedicated to the manufacture of siliconised, depyrogenated, sterilised pharmaceutical-quality glass tubes. The manufacturing process behind producing the ‘ready-to-fill’ tubes begins with washing of the glass tubes, before coating with a silicone emulsion, heating and depyrogenation and, finally, performing moist heat sterilisation. A huge advantage is that tubes can then be filled without further processing.
Baked-on siliconisation technology
ZENEO® uses a lubricant to enable the stoppers to move properly through the glass tube. To ensure a very high quality of lubrication with excellent performance, Crossject chose to use a pharmaceutical silicone emulsion and baked-on siliconisation technology.
It involves coating with silicone oil as an emulsion that is then baked on to the glass surface in an oven at a specific temperature for an appropriate time. In the baked-on process, part of the silicone oil is not removed with solvent and a permanent hydrophobic layer is created. Compared with oily siliconisation technology, baked-on technology reduces the measurable quantity of free silicone oil.
Reducing interaction
Consequently, chemical reactions with the solution contained in the glass tube is reduced. Another improvement is the quantity of subvisual and visual silicone oil particles in a solution that is also reduced. By reducing product-silicone interaction and particle contents, benefits include improvements of compatibility, stability and security.
Sterilisation technology
There are several modes of sterilisation that can be used for primary packaging of injectable devices, and ethylene oxide is widely used in industry. This solution presents toxicological risks highlighted for several years by the health authorities: in particular, because of the presence of residues adsorbed on the material – mainly on plastics.
Authorities wrote guidance on limitating the use of ethylene oxide in the manufacture of medicinal products and specifications on residues. To avoid this risk and in the interest of patient safety, Crossject chose to use glass tubes and to sterilise by a process of moist heat in an autoclave. During all the development of ZENEO®, Crossject pays particular attention to driving its innovations using high-quality technologies and processes.
