Engineering a Grade A Solution for End-User Pharmaceutical Testing
Read more on how Hosokawa Micron Limited designed a series of bespoke Vertical Laminar Air Flow units for end-user testing under Grade A conditions.
When an international biopharmaceutical manufacturer needed to bring a critical product testing process into Grade A compliance, they worked closely with the team at Hosokawa Micron Limited to design a custom Vertical Laminar Air Flow unit, which was engineered around the specific constraints of their site and the demands of their validation process. This collaborative approach turned a tightly constrained engineering challenge into a solution that has since been adopted as a standard design across the customer’s wider operations.
The customer is one of the world’s leading biopharmaceutical companies, with global manufacturing operations across multiple continents. The customer’s facility is a centre of excellence for sterile manufacturing, producing a range of pharmaceutical products including the terminally sterilised Ozurdex and Durysta ocular implants.
Although both products undergo terminal sterilisation, they are exposed to the cleanroom environment during several stages of manufacture, including a critical visual inspection of the implant filament. During this inspection, the product is uncovered, creating a potential contamination risk that must be carefully controlled.
Following the latest revision of EU GMP Annex 1, Section 8.4, operations where terminally sterilised products are exposed and considered to be at an unusual risk of contamination should be performed within a localised Grade A environment. To remain compliant with the updated guidance, the customer required a bespoke solution capable of providing validated Grade A conditions during the filament inspection process, while integrating seamlessly into its existing production operation.
A Made-to-Measure Solution — Why Non-Custom Wouldn’t Work
A health and safety assessment carried out at the site had identified a challenge. The testing process for finished pharmaceutical products needed to be performed under Grade A conditions (equivalent to ISO 5) to remove the risk of product contamination during testing. Without that, the validation couldn’t be achieved.
The complication was space. The room earmarked for the installation was tight, with limited access through small doorways. A standard, off-the-shelf solution wouldn’t fit — and even if one had, it wouldn’t have been engineered around the specifics of the testing process the unit needed to protect.
Put simply, if the customer can’t test the product properly, they can’t validate it, and that’s a risk to their business.
A Long Partnership and a Fast Response
The customer’s relationship with Hosokawa goes back to the 1990s, and over more than a decade they’ve worked together on multiple installations. That history was important when the enquiry was raised, because there was already a level of trust and an existing technical understanding to draw on.
The engineering process began with a site visit from Hosokawa’s representatives, who were working with the customer’s local engineering team.
From there, Hosokawa’s engineering team in the UK was brought into the conversations early. Rather than offer a single fixed proposal, they presented several technical options — each with its own design implications, cost, and operational benefits. The customer was given the information to make an informed choice, with the engineering trade-offs laid out plainly.
The Solution
The agreed solution was a series of bespoke Vertical Laminar Air Flow units, designed and manufactured at Hosokawa’s UK facility. The unit delivers very high HEPA-grade filtered air downwards across the testing process, protecting the product from contamination and creating the validated Grade A environment the customer needed.
The design was shaped around the customer’s specific site requirements — including the tight installation footprint and the constrained access — without compromising on the performance demand. Factory acceptance testing was completed at Hosokawa’s premises before the unit was shipped, with particle counting carried out to confirm the ISO 5 qualification. The system was also designed to allow independent third-party validation.
The full project, from initial enquiry to factory acceptance, ran from early 2024 to early 2025 — on time, in line with the customer’s expectations.
A Made-to-Measure Solution That Became Standard
Once the design had been validated and the unit installed, the customer recognised that the engineering Hosokawa had developed for them could be applied beyond this single site.
The bespoke design the customer ended up with has effectively become their standard for Grade A applications in constrained installation environments. Because the original validation was in place, they can replicate the design across their wider site network — which gives them economy-of-scale benefits without losing the custom engineering that made the solution work in the first place.
That’s the Hosokawa-client relationship working as it should. A custom solution designed around one site has become a repeatable design across many — without giving up what made it specific in the first place.
“Working with this customer, we developed a collaborative approach to produce a design that delivers Grade A conditions in challenging room sizes and constrained installation environments.” – Carl Emsley, Sales Manager at Hosokawa Micron Limited.
Discuss Your Process
Hosokawa has been designing and delivering bespoke pharmaceutical containment solutions for over six decades. Hosokawa’s support spans initial consultation, engineering, factory acceptance testing, installation, and long-term aftercare. Every project is built around the specific operational reality of the customer’s site.
To discuss how Hosokawa can support your next pharmaceutical containment project, contact our team.
