UK Materials Supplier On Hand to Explain Best Practice in Formulation Change Control

On September 25-26, 2013, the only trade show dedicated to medical plastics, Mediplas, will open its doors to the public. The event, located at Birmingham’s National Exhibition Centre (NEC) in the UK, is being held for the second year in a row alongside the UK’s leading trade show in additive manufacturing—TCT.

Mediplas differentiates itself from general plastics shows, as it brings to the forefront the aspects and considerations of medical device manufacturing that do not feature in production for other industries. Furthermore, it is distinct from existing medical device shows because it specialises in plastics—a key material of choice for medical device makers.

One of the UK’s leading suppliers of polymers to medical processors is Albis UK. The company, based in Knutsford in Cheshire, will be exhibiting their wide range of biocompatible polymers from stand H12. Albis is a specialist distributor and compounder with proven technical prowess in medical grade engineering polymers. It represents many of the world’s largest polymer producers. It is able to provide sophisticated advice on materials selection to designers and manufacturers of medical devices.

A key issue facing quality control officials at medical device manufacturers is that of remaining up to date with any changes to ingredients used in formulations used to manufacture devices ahead of those changes taking place. Device makers have to manage supply chains consisting of three tiers of suppliers, sometimes more.

It’s a complicated issue. So we spoke to Ian Rogers of Albis to find out how, as one of the most important materials suppliers in the UK, the company uses its experience to help customers.

Q: Tell me more about the issue over change control in the medical device sector?

A: Change control is an important issue for medical device quality control professionals. It’s also known as formula lockdown and refers to the phenomenon whereby a supplier of a material agrees to provide a minimum period of notice before changing ingredients in a material formulation or making a material obsolete.

When an ingredient changes, a medical device manufacturer must inform regulators of those changes in order for the device to maintain its clearance in the market. A supplier who doesn’t tell its customers that it has changed one of its ingredients is at risk of making the manufacturer liable for any issues caused as a result of the change. By contrast, a supplier who agrees to give notice when changing ingredients gives its customers time to notify the regulators of the change and re-validate the modified material or make a complete change to maintain compliance in the marketplace.

Q: What variations are there between materials suppliers in terms of their approach to the issue?

A: There are variations from one manufacturer to the next when it comes to change control policy. Many of the suppliers we represent have specific policies in place when it comes to notification of change control relating to medical polymers. They provide a notice period that they plan to change one or more ingredient in one of their polymers. This period varies from supplier to supplier but will typically give a two year timeframe, and sometimes longer. The minimum requirement is that a supplier tells a manufacturer when they have changed an ingredient.

But smaller suppliers, perhaps new entrants in the medical device sector, may not fully understand the device manufacturer’s position with respect to what happens when an ingredient changes. When these companies do not inform their customers that they have changed one of their ingredients, no matter how small, this can cause a problem for a device manufacturer.

Suppliers change formulations more often than one might expect, not always with due regard to the consequences further downstream. Even if the change does not have a noticeable effect on the properties of the end material, a change means a device manufacturer must recertify the device and its component material. Changes occur for many reasons often for reasons outside the producer’s control.

Q: How does Albis help its customers?

A: Albis has in place a risk management system for all healthcare applications to help ensure from the outset that the correct product is specified for the use intended and that customers are given the appropriate recommendations from the earliest stage of their development. This process protects customers from potentially costly mistakes in material selection.

At the outset of a development request, the risk and suitability of a proposed polymer will be assessed carefully to ensure suitability for the application and this is overseen on a global basis by the Albis Healthcare Competence Team. A robust record system will track the history of the project and approvals, and will be retained electronically.

Q: That’s helpful for the readers. And what other activities do you carry out to help customers manage their regulatory exposure?

A: Albis offers to its customers a dedicated technical service with significant experience of the healthcare sector. This works most effectively when used at the start of a project development and includes assistance with impartial advice on material selection and tool design etc before expensive decisions are made.

To aid designers with initial material selection criteria we have developed the Medical Product Guide—detailing the approval status of each generic material type and the relevant sterilisation methods that can be employed in each case, of polymer materials within our portfolio.

We market and stock a wide range of accredited brands of polymers for use in healthcare applications. We both distribute direct from the producer but also can tailor make products under license to meet specific customer requirements ensuring regulatory accreditation is maintained. We manufacture at both our parent facility in Germany and our UK plant in Knutsford. We maintain good dialogue with our suppliers, looking to standardise on notification periods, and ensuring our customers are promptly informed of any potential changes.

The Albis Healthcare team is experienced and well established and respects totally the confidentiality surrounding projects and we try to develop a close working relationship with our customers to help increase chances of success.

About Albis: Albis UK was established in 1966 and operates close to the UK’s motorway network. The company is responsible for the distribution of the following ISO10993 and USP Class VI certified polymers: Bayblend PC/ABS, Makrolon PC, APEC PC-HT and Desmopan TPU from Bayer MaterialScience; Pocan PBT and Durethan PA6 from LanXess; Novadur HD ABS, Luran HD SAN , Terlux HD MABS, Xylar MBS & NAS SMMA from Styrolution; Purell PP and PE from LyondellBasell; Eastar, Durastar, Provista and Tritan copolyesters from Eastman; Ultraform Pro POM and Ultradur Pro PBT from BASF; Udel PSU, Radel PPSU, Avaspire PAEK and Ketaspire PEEK from Solvay Specialty Chemicals. It also looks after Evoprene TPE from AlphaGary, where grades conform to ISO10993-5.

Of these brands, Makrolon, Pocan, Novadur HD, Luran HD, Terlux HD, Purell, Eastar, Tritan, Durastar, Provista, Ultraform Pro and Ultradur Pro have Drug Master File (DMF) listings.