OUR CLEANROOMS

We understand that it’s vital for you to always ensure the sterility and integrity of your medical devices and critical care products. It’s vital to the patients who need your medical devices and it’s a vital for your business’ success.

At our headquarters in Lane Cove, Sydney, Australia, we have made significant investments in infrastructure, including four on-site cutting-edge cleanrooms, with adjoining packaging facilities. Our ISO Class 7 and Class 8 cleanrooms, adhere to the strict standards required by ISO 14644:1-4, guaranteeing clean and controlled environments that meet the most stringent requirements for all your packaging needs.

They are fitted with the highest quality machines, equipment, and technologies, including a European Thermoforming machine and Rapid Small Run Tray forming System, the only one of its kind in the Asia-Pacific region.

State-of-the-art Equipment

Take a virtual tour and to see our Cleanrooms in action

Our state-of-the-art Cleanrooms for manufacturing medical device packaging can help you with:

  • Creating your custom designed and made medical device and sterile barrier packaging solutions
  • Adjusting off the shelf packaging solutions to accommodate your specific medical device product needs
  • Realising rapid prototyping solutions enabling us to design and manufacture packaging products right here in Australia, eliminating the need for sourcing from Europe or Asia

Our Cleanroom Specifications

  • Validated tray forming process within an ISO class 7 cleanroom Controlled environment in compliance with ISO 14644
  • ISO Class 7 and Class 8 cleanroom facilities
  • Facility layout in compliance with CGMP PE 009-13
  • Our 200m2 ISO Class 7 Cleanroom is fitted with a specialised thermoforming machine to manufacture clean sterile barrier packaging
  • Our 100m2 cleanroom includes a controlled packaging room for primary packaging of medical devices
  • Latest Building Management Systems ensure accurate temperature and humidity monitoring and control during Australia’s seasonal changes

Our Commitment to Quality

Sabre Medical adheres to the ISO 14644:1-4 Cleanroom standards. Our cleanrooms are temperature and humidity controlled, with HEPA filtration to meet stringent requirements for ISO Class 7 and 8 Cleanrooms.
Cleaning of the facilities are undertaken by our production team, and we adopt a policy of alternating biocides from the Micronclean CleanGuard range. Our cleanrooms are all subject to Quarterly microbiological monitoring & monthly environmental cleaning.

Our Cleanroom and Warehouse Production team

From Assembling, cleaning, and packaging devices, to making the perfect customised trays, or simply cutting and packing pouches to suit our customer needs, our production team is here to help.
Our Production and Warehouse team has a diverse spread of qualifications in different Engineering and Science disciplines bringing a wealth of experience from Pharmaceutical, Medical and food industries. Our team’s mix of qualifications, experience, and dedication to adhering to strict quality standards is crucial in maintaining a productive and efficient production process.
To ensure that only the highest standards are maintained, our production team are all trained in accordance with ISO 14698-1.

Find out more about our customised medical device packaging design and manufacturing services.

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