Clean Rooms

K2 Medical assembles a range of products in its ISO 13485 accredited and validated clean rooms, including the assembly of custom-designed transducer and infusion lines. K2 Medical holds a valid SAHPRA licence for the manufacturing of Medical Devices.

Our clean rooms are situated on our premises in Midrand and comprise of 2 separate validated Clean Rooms:

• ISO 7/8
• ISO 6 with a ISO 4 compliant Unidirectional Air Flow (UDAF) System

Our trained and competent staff, are capable of assembling, packing and labelling of a variety of products requiring controlled environments including:

• The assembly of orthopaedic devices
• The packaging, sealing, and labelling of medical devices according to customer specifications
• Onsite Terminal Ethylene Oxide sterilisation of packaged products

Why use our Clean Rooms?

The manner in which our clean rooms have been engineered allows them to maintain a very low concentration of airborne particulates. They are well-isolated, well-controlled from contamination, and actively cleansed. Our cleanrooms are designed to keep everything from dust, to airborne organisms, or vaporised particles, away from them, and so from whatever products are being handled inside them.

Both our cleanrooms are classified by how clean the air is, according to the particle quantity and particle size per cubic meter of air. Although several classifications exist, there has been an increasing trend to change from previous classification systems to the ISO classification system in ISO 14644-1.

The basis of cleanroom standards is the micrometer, micron (mm) in its abbreviated form. The image below compares the size of a micron with that of a human hair (70 micrometers) and a grain of beach sand (90 micrometers).

How do we maintain the air quality in our Clean Rooms?

The most effective way of maintaining the air quality in our cleanroom is to operate and maintain them correctly by:

• Minimising the amount of potential contamination that escapes from your manufacturing operations
• Strictly controlling access to the cleanroom to only trained personnel and limiting the number, as even trained operators are the most significant source of cleanroom contamination
• Regularly cleaning your facility to strictly controlled procedures
• Regular maintenance of the facility and equipment
• Regular monitoring of the air filters and air flows and frequent recertification of the cleanroom

Why would you need to use our Clean Rooms?

Maximising product yield, improving quality control and ensuring safety are common reasons to use our clean rooms.