- Flexicon FMB210L used by major pharmaceutical company
- Output boosted by 300% at rates of 2400 vials an hour
- Easy process validation
A Flexicon FMB210L fully-automatic vial filling and screw capping machine from from Watson-Marlow Fluid Technology Group (WMFTG) has boosted output by 300% at a major pharmaceutical company, dedicated to reducing the impact of allergies on sufferers. The new machine has been set to work producing a sublingual immunotherapy (SLIT) product at a rate of 2400 vials an hour.
Worthing-headquartered Allergy Therapeutics, which has history tracing back to 1934, produces a wide range of aluminium-free allergy vaccines and diagnostics for customers across Europe and further afield in markets such as Canada, South Korea and Hong Kong. Sales currently stand at circa £50 million a year. The company has a special focus on allergy vaccination – also known as specific immunotherapy or desensitisation therapy – which is a treatment that deals with the underlying cause of allergies and not just the symptoms.
Meeting market demand
Central to manufacturing operations at Allergy Therapeutics is the ability to fill and cap product vials at throughput rates that match market demand. With this in mind, the company recently sought to enhance its operations in two areas.
“Firstly, we researched the market for robust components (vial and cap) to help progress the filling of our sublingual products,” explains the company’s Head of Manufacturing and Technology Rick Poland. “Secondly, we wanted to invest in an automatic filling and capping machine with faster throughput capacity.”
Having identified suitably robust 10cc vial and screw-cap components, Allergy Therapeutics set about reviewing various filling and capping machine manufacturers against a comprehensive user-requirement specification.
“We specified Flexicon for a number of reasons, but principally because the FMB210L proved to be extremely fit-for-purpose with regard to our particular application,” states Mr Poland. “Furthermore, we’ve had a number of Flexicon machines over the years, so their proven track record was a prime consideration.”
High output rates
Set up as a dedicated solution, the Flexicon FMB210L is being used to fill 10cc threaded-neck amber diluent vials with a raspberry flavouring, to which an allergen concentrate is added at a second stage before capping. Throughput rates of 2400 vials an hour are being achieved.
Allergy Therapeutics’ sublingual immunotherapy (SLIT) product is used to address the causes of allergic rhinitis (hay fever) against different allergens. It consists of a liquid that sufferers place under the tongue, and is more convenient than a traditional injected therapy in that patients can administer doses themselves at home. The raspberry flavouring is designed to increase the likelihood of sufferers using the therapy.
Automatic filling and capping
The FMB210L is a fully automatic filling and screw-capping system designed for the biopharm, diagnostic and pharmaceutical industries. It can fill volumes from less than 0.2ml to more than 250ml with ±0.5% accuracy to prevent costly overfilling. It also caps to a consistent torque that prevents leaks and over-tightening. The system is modular and easily customisable, and can work with many different liquids, containers and caps.
Only the liquid contacts a single-use fluid path, so change-over from one product to another can be completed in less than 20 minutes without the risk of cross-contamination. Flexicon offers IQ/OQ for the equipment and provides a free validation pack for the fluid path, reducing the time and resources needed.
In this case the FMB210L was equipped with an integrated Laminar Airflow System to maintain a near particle-free environment in the critical zones.
Installed at Allergy Therapeutics in October 2016, the Flexicon machine (and new vial and cap products) have since been validated, successfully passing final regulatory approval. Validation has also been achieved for processing empty vials to which a threaded cap is added. The system is now in full production.
“We worked hand-in-hand with WMFTG against a rigorous user specification, to develop a fit-for-purpose process that would withstand regulatory requirements,” says Mr Poland. “Today, we have a filling and capping machine that offers 300% more output than our previous capability. As we operate in a highly-competitive market, investments of this nature are key to our business.”
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