K2 MedicalA leader in medical devices
K2 Medical’s vision is to be recognised as the premier South African-owned medical device company. We aim to do this by adding value to our customers through offering quality products and services, by consistently meeting our customers’ expectations and by promoting and adhering to sound ethical business practices.
We supply a range of gold-standard products from Pall Medical and Haemonetics including a full range of blood and blood component filters, intravenous filters for both clear and TPN filtration and breathing filters for both South Africa and Sub-Saharan Africa.
We also distribute wound drainage and autologous blood reinfusion products manufactured by the Netherlands Company, Van Straten Medical.
Supporting sustainable healthcare solutions
We are committed to sourcing sustainable healthcare solutions for the hospital environment and distribute environmentally friendly, disposable systems for human waste management on agreement with a UK-based company, Vernacare.
BK Medical supplies the market-leading ultrasound systems used in procedure-driven markets such as urology, surgery, and point-of-care, to clinical practitioners.
Manta Medical is a well-established business representing renowned international brands and a large range of disposable medical devices including:
- BD (Becton & Dickinson) medical products in South Africa since 1998
- Molnlycke Health Products since 2005
- We also have a long-standing relationship with Argon Medical representing their range of specialised critical care products
Mother and Baby Bags
Mother and Baby Bags supplies maternity wards in the private hospital groups with quality products specifically designed for mothers who have just given birth. These bags bring all the essential supplies a mother and baby needs, conveniently to her bedside, in a single package.
K2 Medical clean rooms
Maximising cleanliness and sterility
A clean room is a controlled environment where products, including medical devices, are manufactured. They are utilised in almost every industry where small particles and contaminants can affect the manufacturing and final integrity of products
K2 medical assembles a range of products in its own custom manufactured clean rooms, including the assembly of custom-designed transducer kits for the critical care market.
Structured and coordinated for conformity
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:
- There are 3 clean rooms located on our premises in Midrand
- Clean room 1 is 20m2 and has additional a primary packaging area (16m2) and a final packing area (13m2). There is also a Material in / out section. The room is classified as Class 7 and has a separate wash and gowning area
- In the manufacturing room there is a downdraft stainless steel manufacturing table where assembly occurs. All rooms are separated by sliding doors to preserve the air cascade integrity
- Clean room 2 (21.5m2) is a Class 7 clean room and has its own entrance
- Clean room 3 (33.84m2) is a Class 7 clean room. It has a separate entrance and a material in / out
- All pressures throughout the cleanrooms are monitored daily by means of Magnehelic pressure gauges to ensure the clean room is operating at the designed specifications
Run by qualified experts
The clean rooms are run by qualified and competent staff, who are capable of the manufacturing and assembly of all products. In the K2 Medical Clean Rooms we can assemble a range 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
- Terminal Ethylene Oxide sterilisation can also be arranged for packaged products
Internationally accreditation in process
The clean rooms are in the process of undergoing ISO 9001 as well as ISO 13485 accreditation. This includes full documentation for cleaning of the cleanroom, all manufacturing and quality processes. All manufacturing records are maintained as required by the relevant standards and qualified technicians regularly maintain the filters and HVAC.