Thanks to our agile and versatile structure we can quickly develop and produce the device that best meets our customer’s expectations.
All Althena departments are integrated and interact with each other following the steps for the creation of a new device from scratch.
This way, the risks associated with the production process are reduced to a minimum.
We provide custom service: we work alongside the Customer to understand how they work and how we can best meet their expectations.
Quality is guaranteed by strict controls that go beyond what is required by the agreements with the Customer (IOL).
Being transparent with our customers is a priority for us. This is why we try to involve them from the earliest stages of device development, concurring on the choices and sharing the results.
Development stages of a device
1
Starting from the objectives and requests of our customer, we offer technical solutions and then select the best one together;
2
We create 3D and 2D drawings and consult both the engineering department and the mould technicians on critical issues related to the creation of moulds, moulding, production and construction of assembly machines and tools;
3
We make prototypes in 3D printing. We check usability, aesthetic appearance, overall dimensions, etc;;
4
We produce the pilot moulds. The first pieces of the devices produced by injection moulding are carefully and thoroughly tested and measured by means of 4K technology and reverse engineering, in order to verify their compliance with the initial project. Withdrawals of material are calculated, any faults are checked. The pilot moulds are generally optimised within 1-2 steps. At the same time, the tools and / or the automatic assembly systems are designed, depending on the expected production volumes;
5
Following customer acceptance, product validation tests, type tests and the drafting of technical documentation begin. The creation of the final moulds and assembly tools begins;
6
The device is put into production in both small and large batches.
The customer is involved and kept up to date on all development stages of the device.
WE ARE EQUIPPEDS TO PRODUCE BOTH SMALL AND LARGE BATCHES.
The automatic machines we manufacture for the assembly of devices comply with industry 4.0. We can thus continuously monitor production remotely, ensuring greater control. Machines, automatic systems, and tools have been designed and conceived to be flexible and suitable for the production of all Pharma Delivery Devices of any volume the pharmaceutical and medical industry requires, such as:
- disposable syringes;
- pre-fillable syringes in COP and COC;
- oral liquid dispensers;
- dropper;
- multi-dosers.
This enables us to significantly reduce production times and costs.
We also produce specific tools and automatic systems in the case of particular devices such as “aesthesiometers”.
QUALITY CONTROLS
Quality controls are the pride of Althena Medical.
They are thorough and mandatory. In fact, every device produced tells our story and says who we are and how we work.
The culture of quality is shared both with our specially trained operators and with our suppliers with whom we share the same Vision and Mission: to supply Customers with batches that meet the specifications, quickly and at the right price.
Case study
Dropper per “Oxervate”
La richiesta: progettare e realizzare un device da zero, per il farmaco “Oxervate”
Estesiometro semplice ed economico
La richiesta: progettare e realizzare un “estesiometro” semplice, di facile utilizzo ed economico
Confezionamento del Kit “Oxervate”
La richiesta: progettare, realizzare e assemblare la confezione contenente il Kit del Farmaco “Oxervate”
Siringa in COP da 1ml “Sycare”
La richiesta: progettare e realizzare una siringa pre riempibile di alta qualità, con elevate performance, affidabile nel tempo e personalizzata
Siringa in COP da 35ml “Sycare”
La richiesta: progettare e realizzare una siringa pre riempibile autoclavabile di alta qualità, con elevate performance, affidabile nel tempo e da 35 ml per liquidi viscosi
Certifications
All our production processes are planned and regulated by the “quality assurance department”.
Production workers are trained by the engineering department as well as by the quality assurance one before the start of production.
The quality system also involves our suppliers, who we audit periodically – and we are audited by our customers in return – in compliance with the highest pharmaceutical standards.
Our products are currently distributed in the USA, Europe, and China.
We are ISO 13485:2016 certified
We Internal manufacture in ISO 7 environments