Sniffer flange for the operating room
The project
For a medical device intended for use in sterile environments, we designed and manufactured a contamination-free technical flange. The project required the design of a PVDF-coated stainless steel mould and an integrated moulding, final check, and sterile packaging island.
Sector:
Technologies involved:
Initial requirement
The customer in the medical sector needed to produce a flange for devices in use in operating theatres and sterile environments. The entire production process had to guarantee a level of surface cleanliness to avoid any possible contamination and ensure controlled handling of the individual part.
What was the problem?
Even the slightest presence of external residues, such as grease, dust, or packaging particles, would have compromised the functionality of the component. The handling of the part, from production to packaging, posed a constant risk to sterility.
What was the client looking for?
A design and production solution capable of eliminating all contamination during all phases: moulding, handling, inspection, and packaging. The component had to be safe, visually controlled and packaged to ensure integrity until final use.
The challenge
The aim of guaranteeing an absolute level of cleanliness required unconventional solutions. The real complexity lay in producing, handling, and packaging the part without introducing external contamination, guaranteeing maximum safety.
- Total elimination of grease, dust, and residues from every stage.
- Production without lubricants, with neutral surfaces at all times.
- Automated check of critical elements such as 360 micro-holes.
- Sterile double-barrier packaging for high-sensitivity environments (sterile such as operating rooms).
The process
To ensure the total absence of contamination, every step is custom-designed: from mould manufacture to sterile packaging. The result is a closed, highly controlled supply chain designed to meet the strictest standards of the medical sector.
We analysed the critical issues involved in using the component in sterile environments and designed a production system that avoided the use of contaminants. Every geometric detail was thought out to ensure optimal cleanliness, including micro-drilling to be verified in post-production.
The mould was made of stainless steel with PVDF coating, in order to avoid the use of lubricant oils. The materials used were selected for their compatibility with sterile environments and to ensure the safety of the part in its context of use.
The mould was designed to operate without lubrication, thanks to the use of specific materials and coatings. This approach eliminated the risk of oil or grease contamination on component surfaces at source.
After being printed, the part is immediately subjected to a flow of ionised air to eliminate electrostatic charges. This is followed by a vision system check to verify the correct opening of the 360 micro-holes, before packing in a double bag, which protects the sterility of the contents until use.
The result
The project led to the development of a medical component produced under controlled conditions, free of contamination and ready for use in sterile environments. The integration of moulding, inspection and packaging made the entire process traceable, reliable, and compliant with the industry’s cleanliness requirements.
Targeted selection of production materials.
Automated and targeted controls.
Reduced risk of contamination.
Guaranteed hygiene until the use.
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