As you know, ReAgent have been moving closer and closer towards achieving a new accreditation: the ISO 13485 Medical Devices Standard. This will not only be testament to our quality-driven mind-set, it will also improve and expand the services we can offer clients.
What is ISO 13485 Medical Devices?
The ISO 13485 Medical Devices is a standard that specifies what requirements an organisation needs to adhere to in order to manufacture, design or supply substances for any type of medical device.
At the moment, we are unable to manufacture chemicals for use in medical devices as we currently do not have this accreditation. By obtaining the ISO 13485 later in year, ReAgent will soon be able to expand our services – and supply our top grade products – to the medical field
Plans are already being put in place for ReAgent’s first project as an accredited ISO 13485 company, so what are these exactly?
What Will ISO 13485 Be Used For?
Once accredited to the ISO 13485, ReAgent will be involved in manufacturing buffer solutions for in vitro testing. This is an exciting milestone for us, and one that requires absolute care.
In Vitro Testing
Also known as test-tube experiments, in vitro testing is a study performed on microorganisms outside of their usual biological context i.e. their living body. While it is most commonly associated with IVF treatment, in vitro testing is an important part of biochemistry and is used in a variety of reactions to isolate, grow and identify cells from multicellular organisms.
These studies are important because they offer a species-specific analysis that is detailed and accurate. So that this accuracy isn’t compromised, the temperature and pH of a sample must be carefully controlled. Ideally, the pH of the sample should stay at the physiological level of the organism so that meaningful data is obtained. This where buffer solutions step in.
Buffer solutions resist change. They are aqueous and contain a weak acid or base. Their resistance to change is why they are used during in vitro testing since they are able to maintain a stable pH even when additional amounts of strong acids or bases are added.
The concentration of H+ and OH- ions in a solution increase respective to the amount of acid or alkali being added. The pH reflects the ratio between these ions and thereby indicates whether the solution is more acidic or basic.
Buffer solutions stabilise the pH by absorbing any additional H+ or OH- ions. This means that, no matter how much acid or alkali is added, the relative concentration of a solution remains stable. This is important to in vitro testing as a varying pH could interfere with the reaction or lead to untrustworthy data.
What Will ReAgent Offer?
When it comes to manufacturing and selecting a buffer solution for in vitro testing, there is a specific criteria that must be followed. This is to ensure the best results are obtained from this incredibly sensitive experiment.
One important factor is ensuring that the buffer solution has no precipitation of reactants as this could compromise the accuracy of the in vitro test results. It is also important that a buffer solution has no biological activity that would otherwise interfere with the specimen being studied.
When manufacturing buffer solutions, it is important that these as well as many other criteria are being met. ReAgent is internationally recognised for its quality products; and once we are accredited to the ISO 13485, we can confidently begin supplying top grade buffer solutions to businesses that require it for in vitro testing.
We are proud of the range of accreditations we have in our catalogue, and are excited to obtain a standard that will help to expand our services. If you would like to know more about this, or see how we can fulfil your specific business needs, get in touch today.