Production

Production

Anadolu Tıp teknolojileri A.Ş. uses PHOTO-POLYMERIZATION technology in production of implant medical device.

This technology is based on polymerization of polymeric raw-material by using light in highly light-permeable special quartz moulds.

The most significant two elements of this technology are raw-material and polymerisation processes.

Polymerisation Technology

• Medical implant is manufactured without any mechanical effect

• It is not necessary to have any other processes to provide surface smoothness(such as polishing, lustring etc.).

• Consumption of raw-material is lower comparison to other technologies.

• Manufacturing period of medical implant is lower than the other technologies.

Polymerisation Technology Advantages

Raw-Material Tehcnology

• Water content is less than % 1 which means it is hydrophobic.

• It has cross-link structure and is not solved in any solvent. Its structure does not defect in any situation after production.

• It has high refractive index( 1.51 )

• It maintains its polymeric material features even in the temperatures below room temperatures by its low Tg value.

Advantages of Raw-Material

Advantages of production process

Medical Device Area

This is the area where all production steps of medical implant devices are carried out by photo-polymerization technique. All processes and finished product controls before the sterilization is completed in this area. Prototype product development phases for new product studies are also carried out in the unit which exists in this area.

Production area is installed as ISO Class 4 (Class 10000); Raw-material and parameters of process, suitable illumination, preasure, humidity and heat parameters are kept under contol by PLC Control.

All production steps of contact lenses which is produced with lathe cut technique are carried out in this area. The devices which makes the high technology, high fidelity and highly sensetive production posible exist in this laboratory. Considering the costumer satisfaction, Productions are done in at least three working days and delivered to the patients.

With the ability to manufacture custom made products by special softwares as desired, the laboratory provides high quality mass-production by its educated personnel. Production area has the compliance with ISO Class (Class 100000) standarts.

In this laboratory which is formed to support production units, all kinds of optical surfaces can be treated in compliance with ISO 10110 standarts by the help of high technology devices. In addition, processes made through surface control devices are tested with high fidelity and non-approved materials are processed again for re-treatment.

Optical Surface treating lab aims to provide the quality to other costumers at the same time by providing service out of the company. Laboratory of optical surface treating works in accordance with the standarts of ISO Class 5 (Class100000)

Laboratory of micro-biology is designed as ISO Class 2 (Class 100) Working area and equipped with suitable devices for biological and chemical tests. Sterilisation test by ISO 11737-2, bacterial endotoxin test by USP 26 <85>, Ethylene oxyde remnant test by ISO 10993-7 and Bioburden test which is applied before sterilisation is made with appliance with ISO 11737-1 standarts under the completely validated - LAF cabinets.

In laboratory samples are taken periodically form the working area, devices and working personnel to follow the conditions of working areas. There exists two steam sterilizator in the micro-biology laboratory in which all tests can be performed.

Class 100.00 Clean room class conditions are maintained by heat vacuum air conditions. All these sterilisation processes are done by competent and experienced personel with Sterility Assurance Level( SAL ) according to TS EN 556-1 standarts.

Hydrophobic products are sterilised in ethylene oxyde sterilizer, which is validated according to ISO 11135-1 standart. Contact lens products are sterilised in steam sterilizer, which is validated according to ISO 17665-1 standart.

All products having the approval from micro-biology and quality control labs are packaged and set ready for shipmnet. Barcodes and serial numbers of all products are registered during the packaging which provides traceability for all products.

Packaging unit exists in the cleanroom which maintains ISO Class 5 (Class 100000) standarts.