Sterile Medical Plastic Injection Moulding
Our sterile medical injection moulding facilities allow us to produce approved and validated products made with specific materials and requirements in mind. Careful manufacturing processes allow us to keep a sterile class 5 and class 7 environment for your medical devices and biotech packaging needs.
Our medical injection moulding capabilities use approved and validated materials with traceability throughout the entire manufacturing process.
At Biplas we work hard to manufacture quality medical devices for surgical procedures and biotech packaging for virus test kits.
Medical mould tool validation incorporates:
I.Q. – Installation Qualification
O.P. – Operational Qualification
P.Q. – Part Qualification
Capabilities
In conjunction with PPAP and SPC requirements we will ensure your moulded medical devices are ready for the most demanding use.
Our sterilisation know how ensures through our stringent bioburden testing we offer the most appropriate method for your medical devices.
ETO – Ethylene Oxide
E Beam – Electron Beam
Gamma Radiation
Steam – Autoclave
Sterile, certified + validated medical device and biotech packaging moulding
We with our partners supply sterilised produce fully certified and validated to your requirements. Our cleanroom allows us to ensure all products are made in a safe and clean environment, with precautions to ensure the highest quality and certification. Our facilities are equipped for medical devices injection moulding.
Medical Plastic Injection Moulding Components Manufacturer
Our top range and accredited facilities allow us to effectively manufacture healthcare components with the following capabilities:
- In-house design, prototyping, tool making and manufacturing facilities
- Cleanroom classified to ISO 14644-1:2015
- Class 5 moulding and Class 7 moulding, assembly and 2 colour printing.
- We have the capability to expand the cleanroom environment to suit demand going forward.
Medical Moulding FAQs
What is medical moulding?
“Medical moulding” refers to the specialised process of manufacturing plastic components and devices used in the medical and healthcare industry. These components can include a wide range of products, from simple items like syringe plungers to complex medical devices like catheters, connectors and implantable devices.
What are the materials that meet medical-grade standards?
Materials that meet medical-grade standards for injection moulding include; Medical-Grade Plastics, Silicone Rubber, Stainless Steel, Medical-Grade Elastomers and Biodegradable Polymers.
How do you maintain traceability and quality control in medical moulding?
We implement strict quality control processes, including traceability of materials, rigorous testing and documentation to meet regulatory requirements.
Where is medical moulding used?
Medical moulding is used to manufacture a wide range of medical and healthcare products including; surgical instruments and tools, IV and drug delivery components, catheters and tubing, diagnostic devices, implantable devices, dental products and laboratory equipment.
Can you provide cleanroom moulding for medical applications?
Yes, we provide cleanroom moulding for medical applications. We have extensive experience in cleanroom moulding and adhere to ISO 14644-1 standards to ensure cleanliness and contamination control during production. We can manufacture medical components in a controlled cleanroom environment to meet the stringent quality and hygiene requirements of the medical industry.
Contact us about sterile medical injection moulding
Our medical moulding capabilities provide you with approved, validated and sterile medical products.
Whether for the manufacture of medical devices for surgical procedures or Biotech packaging for virus test kits, we can provide you with excellent quality medical injection moulding manufacture.
