A not so traditional Black Country “metalbasher” is now manufacturing five precision metal pressings for Pfizer’s revolutionary new insulin dispense system and providing a service to other international customers, too, as a World-class supplier to the medical industry. Pfizer’s device for pulmonary delivery is claimed to provide the first non-injectable form of insulin available since the discovery of the drug in the 1920’s.

As its guiding principle for 60 years, Clamason Industries Ltd of Kingswinford near Stourbridge has always been prepared to refocus and diversify towards new areas of technical innovation and market growth, correspondingly investing in its manufacturing facilities to fulfil those needs. In three years up to the end of 2007, the leading-edge medical industry will have grown from a negligible amount to some 30% of the company’s turnover, second in value only to its first-tier automotive engineering contracts.

Clamason’s five pressings – two in 5052 grade aluminium alloy and three in 301 grade stainless steel – are for Pfizer’s ground-breaking insulin delivery system via the lungs. It dispenses a dry powder, synthesized insulin called Exubera®, the first inhalable insulin set to become available on the mass market. Exubera® is inhaled before taking food and acts rapidly and effectively.

Pulmonary delivery has been in development for a number of years. It offers a potential alternative to injections, which may subject diabetes patients (including the many needle phobics) to risk and discomfort. Reducing a reliance on subcutaneous injection is more patient compatible, clearly lessening pain and the possibility of infection.

The charity Diabetes UK estimates that 2.1 million people in Britain have the condition. It is reckoned that nearly 230 million people worldwide have diabetes, and the global figure is expected to rise to 350 million by 2025. If uncontrolled, diabetes can lead to a number of complications including blindness, heart disease, stroke, kidney failure and nerve damage. Already the complications of diabetes cost the NHS approximately £5 billion a year.

The new device allows adult patients with Type 1 and Type 2 diabetes to breathe in their insulin as powder from a handy blister pack rather than inject it. The action of loading the drug primes the pump, so that no propellant is necessary.

Appliance and molecular powder formulation – including ironically the use of sugars to carry the drug – were developed by designers Nektar Therapeutics (www.nektar.com) for the www.Exubera.com insulin produced in a joint development program between the pharmaceutical giants Pfizer and Sanofi-Aventis. It is now manufactured and sold exclusively by Pfizer.

The plastic injection mouldings are made and final assembly of the Exubera® inhaler is performed by Clamason’s UK customer, Bespak plc at their custom-built facility in Milton Keynes (www.bespak.com), and US customer, the Tech Group, Inc which includes a 50,000 sq ft, contract injection moulding facility for medical products at Tempe, Arizona (www.techgroup.com).

Bespak, a fast-growing British technology company, is quoted on the London Stock Exchange and has been providing dispense solutions for the pharmaceutical, medical, health and personal care sectors for more than 40 years. As a World leader in the production of pressurised metered dose inhalers, Bespak’s appointment as principal contractor on the Exubera® inhaler project was an obvious one.

The five Clamason pressings in the Exubera® device are as follows. Manufactured in 5052 grade aluminium alloy are a mainframe assembly (with two stainless steel studs outsourced and assembled by Clamason) and a link pump handle. In 301 grade stainless steel come three further parts – a blister retainer, a customised flat washer (replacing an off-the-shelf version) and a transjector punch. The critical dimensions of all five items achieve a capability of more than 0.05mm.

The transjector punch acts within the device release unit to access the blister packed powder, allowing the unit to dispense. This component is supplied on China-sourced, moulded plastic reels by Clamason for automatic insert moulding by both customers Bespak plc and Tech Group, Inc. It is designed for regular replacement, so that a quantity of 12 are consumed for every one of the other four.

Clamason then arranges and manages the subcontract passivation and hygienic packaging of the five parts to achieve the very strict cleanliness mandatory with medical device components. A Clamason Quality Engineer is on site to oversee all the external work.

Bespak specified Clamason as its supplier for the five metal components back in 1999, so the lengthy process of development, validation and approval of the device and Exubera® drug itself by the US Food & Drug Administration (FDA) has occupied the subsequent six years.

However, whilst approval was granted by the FDA in January 2006, with availability in the US market from June 2006, in the UK the National Institute for Health and Clinical Excellence (NICE) has declined to grant Exubera® a licence, stating that the estimated extra cost over their current insulin control regime offers little advantage to the patient. This has made the drug the subject of a discussion in Parliament (raised at Prime Minister’s Questions in April 2006) and of a media campaign by Diabetes UK.

Simon O’Neill, Director of Care at Diabetes UK, said:  “Exubera is a novel development in the treatment of diabetes. We welcome the recent recommendation by NICE to make this available to certain people, such as those with needle phobia. However, we also believe that the decision to prescribe Exubera should lie with the individual patient and their diabetes specialist. We do not want to see a repeat of the situation with insulin pumps, where other countries enjoyed the benefits of new technology while the UK fell behind with restricted access.”

Frustrated and perplexed people with diabetes, able to benefit from Exubera® but unable to obtain it in Britain, are now hoping that NICE will eventually heed their pleas to make their condition easier to manage.

Clamason Industries has a series of capabilities and procedures in place to ensure that its engineering solutions meet the exacting standards demanded of medical device protocols. Accordingly, all Clamason medical components are fully process validated using Design, Installation, Operational and Production Qualification protocols (DQ / IQ / OQ / PQ). In addition, the Clamason team is trained in the use of URS (User Requirement Specifications), CAPA (Corrective and Preventative Actions) and GMP (Good Manufacturing Practice).