Vai al contenuto principale
Plastic components and assemblies for pharma and medical, under certified conditions
A developing area

Pharma & Medical

For over ten years Scame Mastaf has produced components in which a non-conformity is not a cosmetic defect but a functional risk. In 2026 we completed the certification portfolio that brings that capability into the pharmaceutical and medical sector: ISO 13485 in March, UNI EN ISO 15378 shortly afterwards.

This page sets out what we are able to do today, under which certifications and with what documentary evidence. It contains no promises about capabilities we do not yet have.

We review your design for manufacturability at no cost: we look at geometry, material and process and tell you what can be improved before the design is closed. If complex engineering changes or a CAD redesign are needed, we quote that work separately.

Detail of the Scara automation cell

The certifications covering this area

Every certificate is available as a PDF, signed by the certification body, stating the sites covered and the date of the next surveillance audit. This is the level of transparency that spares a Quality Manager the preliminary documentation request stage.

Standard Scope Body Issued Sites Document
ISO 13485:2021 Medical device quality management system ICIM 31/03/2026 Suisio Download PDF
ISO 15378:2018 Primary pharmaceutical packaging — GMP for moulders IIP 22/09/2026 Suisio Download PDF
ISO 9001:2015 General quality management system IIP 01/12/1997 Suisio
Bovezzo
Vertova
Download PDF
ISO 14001:2015 Environmental management system IIP 19/05/2025 Suisio
Vertova
Download PDF
ISO 45001:2018 Occupational health and safety IIP 21/02/2020
Suisio
Bovezzo
Vertova
Download PDF

What we can do

Overmoulding of metal and plastic meshes

Meshes are placed and positioned in the mould cavity before injection, with automatic in-line seal testing and dimensional repeatability across large batches. This capability was developed over ten years in household appliances and has been transferred to medical filters, HVAC, water management and instrumentation.

Multi-material moulding (6K): up to six materials or colours in a single cycle qx

Sequential or simultaneous injection of up to six polymers or colours in a single production cycle. The component leaves the machine assembly-ready and replaces three or four separate parts: fewer joints, less assembly, fewer potential points of contamination.

Automation with 100% inspection and Device History Record

Pre-assembly cells designed and built in-house at the moulding machine: insertion force monitoring on every part, 100% machine vision inspection, and ultrasonic welding on twelve dual-head units with energy control. On medical projects the cell generates the complete Device History Record, part by part.

Industry 4.0 toolroom within the Group

Standard moulds designed and built in-house in four to six weeks, with an integrated MES and 3D presetting cycle, offline tool loading, unattended night-shift production and batch-by-batch traceability. Process documentation is available within 48 hours for an ISO 13485 audit.

Food-grade GMP culture

Decades of production for the major food and beverage brands have built hygiene procedures, batch traceability and material control that are the natural prerequisite for primary pharmaceutical packaging. UNI EN ISO 15378 formalises a practice already in place.

Biocompatible polymers

We assess feasibility with biocompatible polymers case by case, together with the customer, according to the device class and the validation protocol required.

Decoration and marking on the finished component

Painting, printing and marking are carried out in-house, under the same process controls that apply to the rest of our production. The available operations are described on the Technologies page. Feasibility on devices and on primary packaging is assessed case by case with the customer, in the light of migration, cleanability and validation requirements.

We are the right supplier if

  • you need moulded components and assemblies in industrial volumes, not one-off prototypes;
  • you work on Class I and IIa devices, in vitro diagnostics, medical instrument housings or plastic primary pharmaceutical packaging;
  • you need co-design and industrialisation, not just a quotation against a finished drawing;
  • your qualification process includes supplier audits and you want the documentation ready when you arrive.

We are not the right supplier if

  • you need production in an ISO 14644 certified cleanroom: it is under assessment in our roadmap and is not available today;
  • you need production or packaging in a sterile environment;
  • you are looking for a supplier of active pharmaceutical ingredients, formulation or fill-finish services.

What you can request before an audit

We respond to documentation requests within two working days. On request, and subject to an NDA where necessary, we make available:

  • a public extract of the Quality Manual;
  • the GMP procedures applied in production;
  • sample IQ/OQ/PQ validation records and SPC plans;
  • the change control procedure;
  • the roadmap of certifications in progress;
  • the Sustainability Report and the Code of Ethics.

If you prefer to see for yourself, we can arrange a visit to the Suisio plant: three hours, in Italian or English, with the multi-colour cell running, the automation cell, the Industry 4.0 toolroom and quality control.