Quality Assurance

Quality Assurance

We operate a Quality Management System to meet the rigorous standards required for ISO 13485:2016, ISO 9001:2015, ISO 22716:2007, ISO 14001 and VMD Art.44 Dir 2001/82/EC x and are accredited to all these standards. These accreditations provide the assurance to our customers that we meet the required quality demands for the range of market sectors we supply.

All the products we produce are coded with their unique batch number and where required with an expiry date. We also apply GS1/2D bar codes to the medical device products we manufacture.

A team of dedicated quality professionals headed up by the Technical Director ensures that all products are manufactured to the highest standards, providing our clients with the first-class products and services required by today’s markets.

Inspection of incoming components and raw materials is carried out to a strict procedure providing positive confirmation that each item has met the required specification prior to being released to production. Batches of blended concentrates are subjected to a series of chemical and physical tests before being released to the filling process. Production line set up is strictly controlled prior to commencing filling and regular checks of the critical parameters are made throughout filling.

Once completed a further check is carried out on the finished product prior to release and delivery to the client.

Records of all raw materials and components used in each specific batch of product are maintained for a period of not less than 5 years. Samples of finished products are retained for a minimum period of 2 years or product shelf life after which time they are analysed to identify any trends in the life cycle of the product.
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Hydrokem


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Hydrokem Aerosols Ltd

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