Success Story: European Pharmaceutical Manufacturer

Background

Pharmaceutical manufacturer with a headquarter located in the USA. One of the biggest on the list of worldwide manufacturers for insulin. Their largest insulin plants are in France and Italy to which we sell several products.  In addition, we also supply to other European plants located in Ireland (API production) and Spain (Solid form drug production). They were the first end-user auditing our NL Operations in 2016 and 2017.

History

They built their manufacturing plant in France in 1967. This factory was dedicated to chemical products production until 1971. Then, they started to produce pharmaceutical products until 1991. During this period, they also produced cosmetic and animal health products. In 1995, they produced the first injectable Insulin pens and in 1996, they concentrated this manufacturing operation to 100% injectable drugs production. This plant is now one of the largest manufacturing sites worldwide which produces 200 million units per year. The main production is the Insulin, but they also produce drugs for cancer treatments and other diseases.

Our story started at the end of the 80’s when the customer started to produce pharmaceutical drugs in a controlled environment. The first Texwipe cleanroom wipers qualified here were made of Polyester/Cellulose materials (TX609/TX612).

Then, in line with their strategic development to the injectable sterile drugs, their cleaning requirements became more critical. We upgraded this plant to a 100% polyester wiper used in their sterile suites (TX2412). In the 2000’s, we then developed a custom product for a very specific application. This product was a pre-wetted wiper using a Biocide solution specified by the customer to disinfect the wheels of their trolleys going to the production area.

Later, continuing to follow their own technological manufacturing development, we created a new sterile pre-wetted wiper, which they used for cleaning the inside of Isolators in which they fill the insulin into the syringes. This new product uses our Vectra sealed border wiper and a 70/30 IPA solution. It’s a standard product now for all their Isolator cleaning operations.

The next stage for us has been to extend our business and the TX3285 wiper at the other Insulin production site they built up in Italy in 2008. The Italian site is opening new production line which should bring us extra volume in the future.

Originally, the TX3285 wiper was made in USA only. Since 2017, and while we built up our new Texwipe manufacturing site in Europe, where a filling line has been installed, we started to produce this product in the Netherlands. Both French and Italian factories now use the TX3285. The new country of production for this product did result in audits of the NL operation by this customer, which they qualified and approved on a global scope. The last and still on-going innovation project is a product for their Isolators – to offer a full and “ready to use” solution to transfer all wipers they need for cleaning in a transfer bag, which can be easily connected to the port of these isolators (DPTE transfer bag system).

In addition to all these developments for the sterile plants, we worked in parallel at the other European sites (Ireland and Spain) where we also qualified Texwipe products at these non-sterile operations.

The opportunities in Ireland began to change their industrial wipers to a cleanroom Polyester/Cellulose wiper. TX609 and TX612 wipers were qualified and used for general cleaning application.  The initial supply was for their labs buildings but has since now extended through the production areas specifically.

We have also converted some of their adhesive mat requirements to Texwipe and clipper mops for some specific mopping usage. In the last year, we have also begun to rationalise them to TX612 as the main wiper and look at new product lines such as IPA 70/30 pre-wetted wipers once the BPR pre-wetted wipers are completed. The site is continually investing and changing from the core API manufacture to small molecule commercialisation and Biotechnology commercialisation looking at diabetes and cancer medicines.

In Spain, they produce solid forms drugs (oral and tablets). Because of the lower critical environment requirement, we concentrated on the non-woven wiper material, qualified and started our business with the Polyester/Cellulose wipers, which they have used for several years.