At a glance
Sychem and Ortner delivered two fully validated 4-glove VHP aseptic isolators to a Midlands IV therapy specialist, from order to installed equipment in five months. The result is our client now manufactures critical products in-house, with full control over quality, lead times and stock.
Project Overview
Project Detail | Summary |
|---|---|
| Client | UK medical equipment supplier and distributor; 20+ years trading |
| Sector | IV therapy; supplying the NHS and UK pharmaceutical industry |
| Equipment | 2 x Ortner 4-glove VHP integrated isolators with XL transfer hatches |
| Delivery model | Ortner-Sychem Fast-Track; full turnkey |
| Design sign-off to build complete | 4 months |
| Order to installation | 5 months |
| Delivery to validation-ready | 1 week |
The Client
Our client is a privately owned UK medical equipment supplier and distributor, established for more than 20 years. They specialise in intravenous infusion products, including smart gravity administration sets, needle-free systems, multi-line chemotherapy closed systems and ambulatory elastomeric pumps.
As a trusted supplier to the NHS and the UK pharmaceutical industry, they operate under strict quality management systems, including ISO 9001 and ISO 13485, with patient and clinician safety at the centre of everything they do.
Their products must be developed and manufactured in a strictly aseptic environment. They needed an isolator platform with rapid gassing sterilisation, and the flexibility to handle both small batches and full production runs.
The challenge
The client needed a complete turnkey package: designed, manufactured, tested, installed and validated, all within a tight timeline set by their own end-user commitments.
Two further constraints raised the bar:
- A fixed footprint: The isolators had to fit precisely within an existing cleanroom layout, leaving no margin for dimensional error.
- Many hands on one project: The installation had to integrate smoothly with other suppliers working on the wider facility.
The solution
We proposed an Ortner-Sychem Fast-Track project, combining Ortner’s Austrian engineering with Sychem’s UK project management, installation and service teams.
At its core is Ortner’s 4-glove VHP integrated isolator, specified with XL transfer hatches to create a production-capable platform. It is a cGMP-grade system, fully aligned with EU GMP Annex 1 expectations on reducing manual interventions, and protects both product and operator.
Sychem’s in-house installation engineers positioned and commissioned the isolators within the completed cleanroom. The combined Ortner and Sychem teams then carried out cycle development and validation across a multi-cycle scope of work.
Project scope
The project ran from order to installed equipment in five months, managed locally in the UK throughout.
- Mock-up study. UK and Austrian teams worked with the client to define the isolator design and operational scope.
- Design and manufacture. Two 4-glove isolators were built and ready for factory acceptance testing within four months of design sign-off.
- Delivery and installation. Sychem’s own engineers handled on-site assembly and service connections, with the isolators ready for validation within one week of arrival.
- Cycle development and validation. Ortner and Sychem jointly developed and validated the sterilisation cycles, with consumables included in the package.
- Performance qualification. Further cycle performance development (PQ) was completed as needed.
- Handover. The client took ownership with a lifetime aftersales service and maintenance package in place.
The results
The client has removed its reliance on third parties for critical aseptic production and now controls quality from start to finish.
With an in-house isolator capability, they can fast-track customer requirements, build up local stock and offer best-in-class turnaround to their customer base. Most importantly, this shortens waiting times for the critical products that clinicians and patients depend on.
The new capability also gives them room to innovate, developing product enhancements that could improve pain relief and recovery for patients.
What made the difference
- Local project control: A UK-managed project with regular updates and hands-on support
- Joined-up delivery: close coordination with every other supplier on the wider project
- Fast-track manufacture: design approval to FAT readiness within the client’s tight schedule
- Rapid installation: Validation-ready within one week of delivery, using our own engineer
- True turnkey: Cycle development and validation included, not bolted on
- Support for life: A robust aftersales service and maintenance package from day one
- Next-day parts: Local stock of consumables and spares, ready when needed
Planning an isolator project?
Whether you need a single isolator or a full turnkey aseptic suite, Sychem and Ortner can take you from first concept to validated production, often faster than you might expect. Get in touch with our team to talk through your requirements.
