MDS has improved the quality of its welds for the pharmaceutical market

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MDS is a manufacturer of Ethylene Oxide and Steam sterilizers.
Their related equipment and accessories for medical devices manufacturers and sterilization services providers.

The pharmaceutical market is governed by
the requirements of european directives

 

sterimed3The pharmaceutical industry is subject to many standards. For example, to quote a few: NF EN ISO 13485 related to quality management system for medical devices; ISO 15378 for primary packaging materials for medicines; or ISO 9001: 2000 standard for good manufacturing practices (GMP).

In this context, companies which operate in this market must adapt all their processes and components to comply with all applicable standards!

MDS does a lot of international work and is thus directly required to comply with these standards (in particular for EtO: ISO 11135 and steam: ISO 17665).  MDS has no available prototype, each client order corresponds to a specific project. Australia, for example, is subject to IECX standards (ATEX equivalence in France), which requires adapted solutions in risk environments (explosive, flammable, confined, ...) MDS must therefore manufacture and provide solutions in compliance with the requirements imposed by the European Directives, but also by adapting to non-EU countries and their respective regulations.

Orbital welding is an ideal solution
for the pharmaceutical industry

 

MDSIn manual welding, surface condition inside the pipe does not allow for compliance with standards. 
Indeed, manual welding can leave retention zones that can lead to accumulation of matter conducive to bacteria proliferation.
The resultant products will not be neutral or sterilized; two essential criteria in the pharmaceutical market.

In order to comply with good manufacturing practices (GMP) in the pharmaceutical market, MDS has taken the definitive step of turning to orbital welding solutions.

The company contacted AXXAIR to respond to this challenge. It equipped itself with a cutting machine, a SATF 65ND welding machine and a SASL-160T power source.


"Thanks to orbital welding we have increased our level of quality and profitability"

Positive results were not long in coming for MDS.

# 1 Pharmaceutical standards are respected

Thanks to the quality of the welds produced by AXXAIR machines, standards imposed by the European Directives for the pharmaceutical industries can be complied with. Stérimed can confirm the quality of its components in the pharmaceutical and medical market.

# 2 Optimised working time

The ease of use and performance of AXXAIR Orbital Welding Machines allow for  welds to be completed in reduced time, without neglecting quality.

Previously MDS worked on large projects that took a lot of time. The basic configuration of the workshop allowed for about 5 projects per year. The time savings offered by the AXXAIR solutions enabled part of the workshop to move towards developing their second activity: fine boiler making with high added value.

"Thanks to orbital welding we have increased our level of quality and our profitability.  We spend less time on each project and we can devote ourselves to the development of our second subcontracting activity.”

#3 Irreproachable quality

The projects carried out with the AXXAIR orbital welding machines have made it possible to produce very high quality welds which differ from those performed by manual welding. For the pharmaceutical market, but also for all other Stérimed customers, the welds carried out are of irreproachable quality.

This is something not to be ignored; indeed it is a key factor which differentiated us from the competition.

"From proposal to purchase, we were well advised. Our employees received personalized training in using the machines. We even brought specific parts with us, to make sure that the AXXAIR machines could weld them. AXXAIR of course found the solution! We are absolutely satisfied with AXXAIR products and the professional and cordial relationship we have with them. “

Ludovic Gonet - Co-founder and President - MDS

 

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Ludovic Gonet

President, MDS

About MDS

MDS offers a long experience in the field of industrial sterilization processes and proposes state-of-the-art, safe solutions either for single piece of equipment as well as turn-key plant.

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