Success Story: French Pharmaceutical Manufacturer
Pharma Group, which is composed of manufacturing sites for multiple pharmaceutical drugs, for vaccines, biotech products and generics all over Europe.
More than 15 years ago this company used an industrial type of wiper made from polyester/cellulose. The only Texwipe products they were using were our swabs for their cleaning validation process. We targeted this account as one of the key pharmaceutical companies in the French market. Our first steps were to convince, educate and motivate them to move away from:
- an industrial class wiper to a real cleanroom wiper
- a polyester/cellulose material to a 100% polyester wiper
- a non-sterile wiper to a sterilized, validated and documented wiper
Our actions focussed on the vaccine plants; these are advanced and critical manufacturing facilities, where injectable vaccines are being produced in sterile suits.
Visits and meetings were scheduled with multiple departments varying from Production, Quality, Lab and Procurement to the Sterility Assurance, to explain the benefits of using Texwipe products, whilst also pointing out the risks involved with their current materials and processes.
We started to determine the best solutions for the pain-points. We defined a product specification document which could be used a reference for their SOP, reviewed by Product Managers from Texwipe.
The two following two main areas were selected for the product specifications to meet the customer’s SOPs: sterile areas and non-sterile areas. For each area, we identified and defined the following products to be used according to their main applications:
- Sterile work-surface wipers and sterile floor cleaning wipers
- Non-sterile work surface wipers and non-sterile floor cleaning wipers
The following products were selected:
- TX3215S (12” x 12” sterile sealed border, 2-ply polyester wipers) for the sterile work surface product
- TX612 (12” x 12” polyester/cellulose wiper) for the non-sterile work surface product
- TX1091 (23.5”x 10” lightweight polyester wiper) and TX630 (23.5” x 10” polyester/cellulose wiper) for non-sterile floor products
Due to the different operating procedures between the two main sites, we developed two new, custom products which were the sterile version of the TX1091:
- TX3422: 3 wipers/bag
- TX3424: 10 wipers/bag
All the above products have been used by the manufacturer for several years, until we worked with them optimising their product portfolio. The first result was to stop using TX3422 and have both sites use only the TX3424. Following this simplification, other additional sites started to duplicate the product offering.
The latest step was to upgrade the TX3215S. This involved updating and re-writing all product specifications. The customer approved the changes and we developed the TX3221S, our next generation wiper produced on Vertex. In order to be more economical, we reduced the size from a 12” x 12” to an 11” x 11” sized wiper.
Originally Vertex products were made in USA only, rendering the supply-chain and quality assurance (site-audits) vulnerable, wherefore Vertex IV was installed at ITWCC EMEA. After a successful site audit in December 2017, we obtained the approval from this customer to supply Vertex products made in EMEA, which gave us a competitive advantage towards our competitors.