PLASTIAPE RESEARCH AND DEVELOPMENT CENTRE
The Plastiape Research and Development Centre has always been the pulsing heart of the company.
The numerous products developed have given rise to items, often patented, that have achieved success with the most celebrated international groups in the pharmaceutical and cosmetics field.
As well as providing proprietary project solutions, Plastiape can offer support service to companies intending to engineer products of their own conception, joining project development at any phase.
The Research and Development Centre deals with all activities necessary for designing, engineering and industrializing products, whether simple single-piece items or complex devices with multiple components and designed for assembly with total automation and functional control of every unit produced.
Plastiape has decided to maintain all its development and industrialization activities within the company, concentrating them in a single workgroup. Faithful to a logic focused on skill and customer service, it requires those dealing with the development of a product to be completely aware of the manner in which every project detail may affect the functionality of the moulds and production equipments. The designer must also know how to translate the qualitative requirements of the product into adequate control specifications, so that the item will be ensured stability of performance throughout its life-cycle. Only a global vision of the entire design and production cycle can provide the customer with a rapid, reliable service, reducing error margins to a minimum and combining technical project effectiveness with product manufacturing economy.
The skills acquired over the years and the habit of cooperating with multinational companies in strongly regulated areas have enabled Plastiape to offer a series of technical/regulatory services which are particularly appreciated in the area of medical devices and pharmaceutical packaging.
- Technical files for EC marking of Medical Devices
- Preparation and filling of Type III Drug Master Files (US FDA)
- Preparation and filling of Type II Drug Master Files (Health Canada)
- Risk Analysis according to ISO14971
- FMEA Design and Process
- Biocompatibility studies according to ISO10993
- Drawing up of Validation Master Plan
- Validation of moulds, production lines and clean rooms (IQ, OQ, PQ) according to European and US FDA guidelines.