ReAgent Moves towards ISO 13485 for In Vitro Testing

When it comes to manufacturing formulations for medical devices, quality cannot be compromised. This is an area where ReAgent Chemicals Ltd shines. We have supplied top grade products to a range of industries, from a blue chip automotive company to the world’s first supersonic car.

In order to expand our services whilst maintaining this level of unrivalled quality, we have taken the necessary steps to gain our ISO 13485 accreditation. This will allow us to start supplying products used in medical devices, specifically for in vitro testing.

International Standards Organisation (ISO)

In case you don’t know, ISO is an international organisation that gives world-class specifications for products, services and systems. This ensures quality, safety and efficiency.

As one of the first businesses in the UK to be accredited to the BS5750, the forefather of the ISO 9001 Quality Standard, ReAgent have always placed quality as paramount among our company ideals. Our ongoing commitment to improve and be the best we can be is reflected in the various accreditations we currently hold:

  • Investors in People (IIP): In 2006, ReAgent were recognised as an IIP company. This shows that we meet the national standard for good practice in training, and are committed to help employees develop business and personal goals.
  • ISO 9001:2008 Quality Standard: Our accreditation to the ISO 9001 demonstrates our unwavering dedication to produce high quality products, to satisfy our customer’s requirements and to constantly improve by enacting rigorous quality checks. We are currently in the process of transitioning into the new ISO 9001:2015 standard, which places a higher emphasis on the relationships between staff and management.
  • ISO 14001:2004 Environmental Standard: Obtained in 2010, we are extremely proud to be accredited to the Environmental Standard. ReAgent are committed to protect the integrity of the environment to reduce our impact as much as possible. Our efforts to do this are reflected in the Environmental Standard that we hold, and we are constantly reviewing our procedures to ensure that we run as efficiently as possible.
  • ISO 45001: Occupational Health & Safety: To combat the increasing number of work-related accidents and diseases, ISO is developing a new standard that ReAgent are in the process of achieving. The ISO 45001 will provide a framework to businesses that improves employee safety; and, as a recognised IIP, we are eager to get on board.

When it comes to chemical manufacturing, safety and quality are non-negotiable. That’s why providing quality services is at the forefront of ReAgent. To ensure that we are always keeping ahead of the game, we are constantly reviewing our services and setting ourselves goals. We also welcome customer audits and feedback on our facility.

As part of our goal to always progress, ReAgent are in the process of obtaining accreditation to the ISO 13485 Medical Devices Standard. This will not only be further testament to our quality driven mind-set, it will also help to expand our services and what we can offer to clients.

What is the ISO 13485?

The ISO 13485 Medical Devices is a standard that specifies the requirements for a Quality Management System used by an organisation that manufactures, designs or supplies substances for any form of medical device.

Manufacturing chemicals used for medical devices is a service we previously could not offer due to not having this accreditation. By obtaining the ISO 13485 later this year, ReAgent will be able to supply its top grade products, as well as offer over 40 years of industry experience, to clients in the medical field.

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. In vivo, on the other hand, takes place inside the living organism.

In vitro, literally translated to in glass, is an important element of biochemistry. It is most familiarly associated with IVF treatment, but is also used in a variety of biochemical 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. To ensure 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

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.

Buffering agents stabilise a solution 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 as the pH will not change. This is important to in vitro testing as a varying pH could interfere with the reaction or lead to untrustworthy data.

Criteria of Buffer Solutions for In Vitro Testing

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 such criterion is ensuring that the buffer solution has no precipitation of reactants. This refers to the creation of a solid from a solution, and could compromise the accuracy of the in vitro test results. It is also important that a buffer solution has a non-biological nature, meaning that it 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.

ReAgent is a family-run business and leading chemical manufacturer. Industry experts since 1977, we are proud of the catalogue of accreditations we have been awarded with over the years and are excited to look ahead into what future opportunities will come our way.

ReAgent have worked with a wide range of companies worldwide. If you would like to see how we can help your business today, get in touch to speak with an expert member of our staff; or check out our online chemical shop to see what we can offer you.

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