Tristel operates from a 40,000 sq ft facility in-house GMP manufacturing facility located in Newmarket, Cambridgeshire, where the key areas of operation include bulk production, packing and logistics.
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.
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.
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.
Quantities from one box to a full lorry load are routinely dispatched using national couriers and transport companies.