+27 10 045 2500 info@k2medical.za.com
Areas of Expertise

Clean rooms

Clean Rooms

K2 medical assembles a range of products in its own custom manufactured clean rooms, including the assembly of custom-designed transducer and fluid delivery kits.

Our manufacturing facility is situated on our premises in Midrand and comprises of 3 separate Class 7 clean rooms.

We have documented the requirements for the infrastructure needed to achieve conformity to product requirements, prevent product mix-ups and to ensure correct handling of the products.

The clean rooms are run by qualified and competent staff, who are capable of the manufacturing and assembly of a variety of products requiring controlled environments including:

  • The filling of diagnostic kits and final packing and the quality control of these kits
  • The packaging and sealing of various pharmaceutical and medical devices
  • Onsite Terminal Ethylene Oxide sterilisation of packaged products

The K2 Medical Clean rooms have just undergone ISO 9001 as well as ISO 13485 accreditation. This includes full documentation for cleaning of the facility, all manufacturing and quality processes. We maintain all manufacturing records as required by the relevant standards and the facility is regularly maintained by qualified technicians.