MARLIN LABS was established in 1995 and developed a competency and expertise in the design, manufacture and implementation of Reverse Osmosis water purification systems for the Renal Industry in South Africa. This Manufacturing Company has a staff compliment of 40 professionals head quartered in Durban with support offices in Cape Town, Welkom, Port Elisabeth, East London, Johannesburg and Pretoria
This experience has been adapted to apply the knowledge to the general Potable drinking water opportunity in South Africa that has evolved particularly over the past two to three years due to the significant drought challenges the country is facing.
Hence PURE CARE was launched 3 years ago to develop solutions to address this challenge spearheaded by a consulting lead approach to Water and Energy Security. The team includes Consultants and engineers to analyze the Water or Energy challenge and then develop solutions to address the challenge.
We focus on our clients Water Security goals and analyse all water sources and yields in the environment, followed by water testing to understand the composition of the water, to then determine the engineered solution to address the specific findings.
This applies equally to both the Medical system design for RO systems for Renal Dialysis and for Potable Water systems, using RO when the water quality dictates, alternatively applying varies filtration methodologies to meet the water quality standard SANS 241 for Potable water.
PURE CARE is positioned to provide basic and extensive resource solutions of clean drinking water and solar energy to power solutions, relevant to all the people of Africa, in the Industrial and Medical sectors.
Together PURE CARE and MARLIN LABS understand the challenge in that there are many Africans without access to these basic water resources that are becoming threatened and scarce across the continent.
Our mission is to be the leading provider of innovative, turnkey potable water systems, purification equipment, reverse osmosis for renal service providers and energy solutions in all geographies nationally & internationally. We understand and aim to improve all levels of society where water and energy resource limitations exist to achieve a better quality of life.
- We provide Turnkey and specialized water treatment solutions from multiple water sources with renewable energy options with the objective of helping you achieve improved water and energy security and a better quality of life.
- Many of these solutions could be delivered to all types of communities, be they remote villages, urban areas, industry or agriculture.
- We offer consulting services to advise on outcomes based on the volume output customised to specific requirements, whether it is to complement supply from the utilities or to leave the grid completely or for a sustainable back up water source.
- Our water purification systems are custom designed to fit our customers’ specific needs and are robust in order to survive harsh conditions. Parts are available locally off the shelf, effecting rapid response and repair outages.
- We build Reverse Osmosis systems for every need. Our extensive experience and geographic footprint in the Renal Dialysis industry has positioned us a Partner of choice.
- To provide potable water from a specified water source as per the volume output requirement
- To provide potable water either through a mobile or static purification system in any African geography to any community or industry sector
- To provide a sustainable model through a commercial arrangement for water output
- To strive for a renewable energy supply to the potable water output generation to ensure water security in a stressed environment.
PURE CARE is a specialised operation of professionals focussing on Potable water solutions who have now partnered with MARLIN LABS Manufacturing, specialists in Reverse Osmosis for over 20 years providing leading edge solutions in water purification.The PURE CARE leadership is a group of experienced solution providers with extensive business and socio-economic experience to successfully meet many of the basic resource challenges of water and energy.
NATIONAL STANDARDS AND COMPLIANCE
Marlin Labs have invested in certifying for all the relevant Standards to meet the high demands set by the industry. These standards include:
1.Certification to a Quality Management System for the medical devices
On the 9th of December 2016, the Government Gazette (No 1515 – 40480 – point 5) stated amongst other points that:
“5. License to manufacture, import, export or act as a distributor or wholesaler of medical devices or IVD’s A manufacturer, wholesaler or distributor referred to in section 22C(1)(b) of the act must – …….. :
(c) as part of the application, provide acceptable documentary proof of –
(iii) Certification to a Quality Management System for the medical devices and IVDs as determined by the council;”
Marlin Laboratory Manufacturing have been awarded the required License by the MCC. License number 00000061MD.
Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).) Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated.
Marlin Laboratory Manufacturing have achieved certification for ISO 13485:2016, as per the following scope: Design, Development, Manufacture, Installation, servicing and Distribution of RO Devices / water treatment systems, for medical and non-medical applications.
This specifies requirements for a quality management system when an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements. The aim is to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
Marlin Laboratory Manufacturing have achieved certification for ISO 9001:2015 , as per the following scope: Design, Development, Manufacture, Installation and Distribution of RO Devices / water treatment systems, laboratory equipment for medical and non-medical applications.
We ensure that the water quality produced meets the ISO 13959 standard through testing through accredited laboratories across Southern Africa. ISO 13959:2014 specifies minimum requirements for water to be used in haemodialysis and related therapies.
We ensure that the equipment used meets the ISO 26722 standards: ISO 26722:2014 is addressed to the manufacturer and/or supplier of water treatment systems and/or devices used for the express purpose of providing water for haemodialysis or related therapies.
All water considered in our Potable Water solutions is tested by accredited laboratories to Short Sans and Full Sans standards.