All Tristel products are made in the UK, at Tristel’s 40,000 sq ft in-house GMP manufacturing facility located in Snailwell, Cambridgeshire, England.

In-house Manufacturing

Tristel operates from a 40,000 sq ft in-house manufacturing facility 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 polypropylene, 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 guidelines.

Onsite 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.

Country-Wide Logistics

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

Quality Assurance

Tristel maintains a single Quality Management System conforming to ISO 13485:2016/EN ISO 13485:2016, as the minimum standard for medical devices to ensure the maintenance of regulatory requirements, and ISO 9001:2015 for non-medical products to ensure continual improvement to achieve customer satisfaction. The principles and guidelines of GMP are implemented in the facility with reference to Rules and Guidance for Pharmaceutical Manufacturers and Distributors (‘The Orange Guide’).

To provide customers with effective products for infection and prevention control, a comprehensive service is offered, which includes formulation, design and development through to scaled-up manufacture, and the installation, service and repair of equipment used in the application of disinfection and cleaning products.

All Tristel products conform to the relevant European Directive and other requirements as applicable to the countries in which the device is intended to be offered for sale as well as to meet the requirements of the customer and patient.

Certificate of Registration MDSAP 703572
ISO 9001:2015 Certificate 553285
EC Certificate – Full Quality Assurance System CE 544967
ISO 13485:2016 Certificate 78322

Tristel Duo - Wipes for Medical Device

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