Fine Organics is a custom manufacturer of intermediates and APIs, to meet your requirements from 10s kg to 100 tonnes.

We work mainly on the basis of tech transfers, and our key skill is the optimisation and scale-up of customers’ tech packages.

We also develop new processes from scratch when a viable synthetic route may not have been identified.

As a privately-owned, single-site company based exclusively in the UK, and with a low staff turnover, Fine Organics is an especially safe location for our customers’ Intellectual Property.

All our business is conducted under secrecy agreement.

During the development phase of a pharmaceutical, timelines are especially challenging, with approvals for clinical trials and allocation of funds often received at short notice.

Fine Organics has six labs which are fully equipped to carry out process development work, together with safety studies.

All standard equipment is available, backed up by specialist items (Mettler LabMax reactors, distillation units, autoclaves, multi-unit reactors) and this is supported by small-scale production equipment (100 - 450 litre vessels) to carry out the initial scale-up.

The Development department has its own analytical equipment (HPLC, GC etc) to monitor lab runs and support new method development.

Although the prime focus of the Development group is to optimise customers’ processes, we also investigate alternative processing routes and changes of reagents or solvents, as requested by our customers.

The aim is to ensure that the process ultimately operated on the plant is safe, robust, and economical.

We are proud of our track record in process scale-up, and can in most cases omit a “piloting” exercise if project timelines require a rapid progression from the lab to full-scale manufacture.

Cost pressure increases during the lifetime of a pharmaceutical. Once the business is established, Fine Organics will commit resources in order to reduce the cost of manufacture, through our Continuous Improvement programme.

Structured data collection and evaluation techniques, such as value stream mapping and Overall Equipment Effectiveness (OEE), are routinely employed at Fine Organics to eliminate process wastes in materials, labour and time.

Over 30 years, Fine Organics has built up a portfolio of commercial-scale chemical synthesis skills and assets which combined with a broad operating permit under IPPC regulations, enable a fast and efficient response to our customers’ needs.

50 reactors in 4 production buildings have individual capacities from 100 litres to 20m3 and are typically operate from -30 °C to +150 °C. (Certain vessels can operate outside this range.)

Our reactors are mainly Hastelloy or glass-lined steel to allow operations over a wide pH range.

Specialised equipment includes continuous processing capabilities in photochemistry, vapour phase reductions and ozonolysis.

Solids are isolated and dried in centrifuges and cone, paddle and filter dryers. These are in Hastelloy, glass-lined steel, polymer-lined steel and stainless steel. Distillation & fractionation capacity is provided by glass-lined, glass and Hastelloy batch stills, and by wiped film evaporators.

It is our policy that all products sold are tailored to meet the customer’s specific quality requirements.

We maintain, improve and operate a prescribed Quality Management System which satisfies the requirements of pharmaceutical current Good Manufacturing Practices (cGMP).

The site has been US FDA inspected, and our systems and assets are frequently audited by our customers. Our QC labs operate 24/7, and employ techniques covering all routine industry analytical requirements.

Regardless of commercial pressures, nothing should compromise the quality of the products we deliver, or the safety and integrity of our plant.

For this reason, all process optimisations are covered by our site Change Management procedure, and no process changes are implemented without going through this system.

Change Control agreements are often included as part of wider Quality Agreements signed with our customers.