Tristel Solutions Ltd.

During the course of the following decade Tristel gradually captured significant market share in the United Kingdom hospital market. In June 2005 Tristel plc was listed on the London Stock Exchange AIM market.

By this time the Company had developed a broader vision for the use of its chlorine dioxide chemistry and had set in train its strategy to apply the chemistry to the four vectors of transmission of infection in a hospital: instruments, surfaces, water and skin.

A key milestone in the development of the Tristel group was the establishment of its manufacturing plant in Cambridgeshire in 2007.

Having established its capability as an ISO 9001:2015 and BS EN 13485:2016 manufacturer of high-level disinfectants, in 2009 Tristel acquired the intellectual property and manufacturing rights for a portfolio of disinfectants used in animal healthcare facilities worldwide. Tristel manufactured these products until March 2012 when it created its Anistel brand and has since served the animal healthcare market directly.

Following its initial public offering Tristel also embarked upon its plan to take its products into overseas markets, establishing distributors throughout Continental Europe, the Middle and the Far East. It is one of the stated aims of the Group to be a recognised force in the global infection control industry. In the pursuit of this aim, Tristel has established direct operations in New Zealand, Australia, Hong Kong, China, Russia and throughout Europe.

Tristel also manufactures and sells contamination control products under the Crystel brand to the pharmaceutical and personal care industry. For this market, the Company has established a Class 6 cleanroom to enable it to manufacture sterile-packed disinfectant products.

Chlorine dioxide is a broad-spectrum biocide with proven efficacy against a range of microbial organisms such as bacteria, viruses, protozoa, yeasts, mycobacteria and bacterial spores. Originally used in water treatment and food industries, chlorine dioxide has now been adopted as the go-to high-level disinfectant in medical, pharmaceutical, veterinary and laboratory settings.

The mechanism through which chlorine dioxide achieves its potent biocidal effect is oxidation[1]. Oxidation involves the oxidising agent sequestering electrons from the microorganism, this causes a molecular imbalance which inevitably leads to the microorganism’s death. The main advantage of using oxidising biocides over non oxidising biocides (alcohols, quaternary ammonium compounds), is the inability for microorganisms to develop resistance[2], as well as the broad range of efficacy[1].

The comparison of chlorine dioxide with other oxidisers, such as hydrogen peroxide is of interest. Whilst hydrogen peroxide and other oxidisers work through the same mechanisms as chlorine dioxide, they have been shown to be less effective against microbes[3]. This is attributed to chlorine dioxide’s unique ability to penetrate the microorganism’s 3D protein structure[3], and thus better oxidise the molecules.  Additionally, chlorine dioxide forms no hazardous by-products[4], and is less harmful to people and equipment than other common biocides such as hydrogen peroxide and chlorine[2].

Chlorine dioxide is supported through the Biocidal Product Regulation for use in product types 2, 3, 4, 5, 11 and 12 and is also approved by the United States Environmental Protection Agency.

Manufacturing

Tristel operates from a 40,000 sq ft in-house GMP manufacturing facility located in Newmarket, Cambridgeshire, where the key areas of operation include bulk production, packing and logistics.

Bulk Production

Within the bulk production area, there are seven standard production vessels made of stainless steel and polypropene, ranging in size from 500L to 2,000L. There is also a separate area containing three 2,000L vessels for processing flammable liquids.

The water treatment plant is capable of providing water to the standards required by customers and is monitored by microbial and chemical analysis.

Packing Operations

There are three packaging areas within the facility. Two areas contain semi-automated filling machines. Packaging sizes range from 50ml to 1,000ml.

The third packaging area is an 800 sq ft cleanroom, which is used to package aseptic filled and terminally sterilised products. The cleanroom has a dedicated goods in and out airlock and personnel changing area.

The cleanroom is validated to Class 6 (ISO14644) and contains two filling areas validated to Class 5 (ISO14644). Microbial contamination is monitored via an environmental monitoring program, using the standards set in GMP guidelines.

Laboratory

A fully equipped laboratory performs batch release analysis including testing of appearance, pH and specific gravity. Manual and automatic titration machines and photo spectrometers are also used for active ingredient analysis. A technical team conducts research and development of new products and variants, performs customer product evaluations, corrosion studies and provides general support for customers.

Logistics

Quantities from one box to a full lorry load are routinely dispatched using national couriers and transport companies.