Biplas has recently made significant investments in its cleanroom facility, as well as its design software, in-house toolroom and metrology department, enabling fully validated development, tooling and injection moulding for the medical sector.
Two years ago, South-Wales based injection moulders Biplas decided to develop a ‘nose to tail’ solution for their growing portfolio of medical sector clients. Managing Director, Richard Bedwell, recognised that the company already had all of the necessary skillsets to allow the company to develop a turnkey solution to customers looking for initial design to full production within a single facility.
Biplas has subsequently made significant investments in its cleanroom facility, in conjunction with the implementation of quality systems in line with the requirements of ISO 13485, this has enabled Biplas to offer a fully validated development, tooling and injection moulding service.
Richard Bedwell commented: “Biplas has always offered both technical injection moulding and toolmaking services to our customers, and our medical and pharmaceutical clients often approached us to help in the initial design of a new product. The one service that we couldn’t provide was on-site validation, this usually being the most significant obstacle faced when taking a new product to market.
“We now manage the complete development of a new medical product, from helping to select appropriate and compliant polymer grades through to post-production sterilisation and stringent bioburden testing. Our sterile class 5 and 7 medical injection moulding facilities allow us to produce fully traceable, approved and validated products, such as medical devices and biotech packaging.
“More recently, we have seen increased demand for products relating to the manufacture of virus test kits, in particular the packaging required to keep them sterile until the point of use. Our ability to manage the complete production and validation process means that we can offer a more efficient solution to our clients. In reality, this can mean a shorter route to market. ”
Tools are manufactured with full-certification and traceability using specialist steel grades and moving parts designed to require the minimal use of lubricants. Specialist coatings can also be applied to cavities, alleviating the need for mould release agents. Despite these special adaptations, tools are still backed by a ‘one million shot’ tool life guarantee.
Medical mould tool validation incorporates full installation, operational and part qualification, and is offered to both in-house moulding customers and clients only wishing to purchase production tooling. Tool maintenance programmes can also be provided to customers that retain their tooling on-site.
Once tooling is fully validated, Biplas can take the product into full production, its ISO 14644-1:2015 Cleanroom facility also incorporating downstream equipment and added value services such as two-colour printing and product assembly.
Once parts have been manufactured, customers can also benefit from a choice of sterilisation procedures. Bioburden testing is used to identify the best option for each particular product, technologies provided including:
- ETO – Ethylene Oxide
- E Beam – Electron Beam
- Gamma Radiation
- Steam – Autoclave
The company then uses its extensive distribution network to deliver products to customers in both the UK and overseas.
For more information, visit www.biplas.com, or call their team on 01443 237654