How one Radiopharmacy’s need led to 28 years of NHS supply

There are more than 100 NHS radiopharmacies in the UK, busy preparing and dispensing radiopharmaceuticals every day for the purpose of diagnosing and treating cancers.

As early diagnosis of cancer significantly improves patient outcomes, (Cancer Research UK states “almost all women with breast cancer survive their disease for five years or more if diagnosed at the earliest stage”) it is crucial these facilities can continue their work without concerns for the quality or supply of vital consumables.

A Glasgow Radiopharmacy

The current radiopharmacy at NHS Greater Glasgow and Clyde was opened in 1990. It is an NHS manufacturing site producing small-volume injectable radiopharmaceutical patient doses used in Nuclear Medicine for the purpose of diagnostic scans and therapeutic treatments. The radiopharmacy serves on average 30,000 patients per year.

Most doses produced here use Technetium-99m, a radionuclide agent which is added to tracers that will accumulate in various parts of the body (e.g. bone, liver, kidney, thyroid), to indicate the presence of cancerous cells and other forms of disease, such as poor kidney or liver function, or inflammation.

Technetium 99m solution is eluted from a generator and this solution is used to reconstitute kits containing the required tracer. These kits are then sub-dispensed into individual patient doses in 10ml sterile nitrogen filled vials.

This West Glasgow Hospital was instrumental in helping Adelphi to develop the Anoxos vial, which has since become a staple in NHS radiopharmacies and nuclear medicine departments across the UK.

In this article we explore what the Anoxos range of vials is, how it came into being and why it remains the trusted dosing container for radiopharmaceuticals across the NHS.

The request

Almost 30 years ago the Head of Radiopharmacy at Greater Glasgow and Clyde approached Adelphi and asked if we could produce an internally sterile vial, for the purpose of holding doses of radiopharmaceuticals.

Adelphi Managing Director, Gavin Crauford Taylor remembers the project well: “Greater Glasgow and Clyde needed a sealed 10ml vial which was guaranteed internally sterile. As the Technetium products used in radiopharmacies are sensitive to oxidation, it also needed a sterile nitrogen fill to counteract the negative effects of oxygen.

“Whilst we hadn’t produced something to this specification before, we were keen to help and certain we had the right contacts to make it happen”

The Adelphi team set about finding the ideal contract manufacturing partner for the project. It needed to be a facility that was used to processing vials for injectable use, with stringent monitoring of sterility and able to commit to a strict validated process.

Once our trusted European manufacturer was in place, development could begin. Months of process testing and validation ensued, and in 1997 the Anoxos sterile nitrogen filled vial was born.

Why work with Adelphi?

We asked current Head of Radiopharmacy, Kay Pollock, what the primary goal had been when selecting a packaging partner for this project:

“It was my predecessor who was involved in developing the Anoxos vials. At the time it was important we could be certain of good, reliable service and a consistently high-quality product. For example, any changes to packaging specifications need to be risk assessed for potential effects on our products, and then stability work might need to be carried out, so consistency of specification and reliability of supply was critical. This is something we felt we could rely on Adelphi for.”

Adelphi’s Regulatory Compliance Manager, Lorna Finch explains, “Anoxos specifications are controlled and registered in our CE and UKCA Technical Documentation. These specifications have not changed for our Anoxos stock range since 1997.

“If changes ever are required, for example to comply with new regulations, these would be strictly controlled under our change control procedure and would include full revalidation.”

What makes Anoxos special?

So, what is it that makes Anoxos the perfect product for the job?

Anoxos vials are internally clean and sterile and particle free, which is vitally important for all injectable products, but especially for those given intravenously to patients who may be immunocompromised and particularly vulnerable to infection.

"The Anoxos Vial provides an inert, bacteria-free environment for our products. We have great confidence in its reliability for our sensitive radiopharmaceutical formulations." says Kay.

“Additionally, the MDR certification gives us the assurance that the vials meet the standard required. We manufacture our doses under a licence from the MHRA (The Medicines and Healthcare products Regulatory Agency) so this is essential for us”.

Many of the Technetium products used in Nuclear Medicine are susceptible to oxidation. For this reason, Anoxos vials were developed with a nitrogen fill. This inert nitrogen atmosphere aids stability by limiting oxidation, while a slight vacuum allows for successful filling of the sealed vials using a needle through the stopper.

The Anoxos vial has been a trusted storage and patient delivery device at Glasgow for 28 years and is now supplied regularly to more than 60 NHS sites across the UK.

Maintaining standards

Our sterile nitrogen filled vials were first protected by the guidelines of the Medical Device Directive (MDD) in 2006, highlighting our commitment to the highest standards of quality and safety.

The Directive has more recently been superseded by the EU Medical Device Regulations (MDR), now with more stringent requirements which are enforceable by EU law. It is a requirement that all medical device manufacturers obtain MDR certification by December 2027, or their product be removed from the market. We are proud to confirm our Anoxos range is both EU MDR and UK MDR certified (complete with the associated CE and UKCA markings), and we can continue to ensure a safe, consistent, and secure supply of sterile vials to our customers in the UK and abroad.

View and download our Medical Device Regulations certificates here

An investment in health

A note from Adelphi’s MD, Gavin Crauford Taylor

“When European law changed in relation to medical devices, it presented a number of new challenges. The new Medical Device Regulations mandated requirements far beyond those of the MDD. With MDR we are responsible for the entire life cycle of the product. Our responsibilities have expanded to include, among others: increased General Safety and Performance Requirements, clinical evaluation, and data collection relating to customer usage. To meet these challenges, we have invested in intensive staff training and additional team members.”

Asked why Adelphi chose to make the significant investment in time and resource to keep the Anoxos range on the market, Gavin says:

“Although it would undoubtedly have been easier not to, we couldn’t in good conscience allow a product which is relied upon so widely for cancer screening to be removed from the market. I see it as a moral obligation, and Anoxos is a product worth investing in!”.

The future of Anoxos

Outside of radiopharmacy, we have seen customers using Anoxos for alternative applications including for clinical trials, and for drug preparations such as mixing, dilution and reconstitution, which require a clean and sterile container.

Our customer base continues to grow outside of the UK too, and we now supply Anoxos vials to over 30 countries worldwide. We are excited to see where else Anoxos takes us in the future, and we’ll be sure to keep you updated every step of the way.

Would you like to know more about Anoxos internally sterile nitrogen filled vials? Contact our friendly team with any questions or to request a quote: sales@adelphi-hp.com

Note, Adelphi can produce bespoke Anoxos vials to customer specifications on request: Contact Us.