Editorial: Christmas edition by S.Vasseur
I am very pleased to share with you our second newsletter. I hope that you will enjoy the reading and I look forward to receive your comments and feedbacks.
Some words from management by S.Nilforoushan, General Manager
Here we are once again end of the year, I would like to thank you on behalf of Medistri management team for your support which helped us to close down the year 2011 with plenty of success. We have grown at a remarkable rate during the year 2011 due to skills, experience and hard work of reliable team that provided a stable root on which we can continue rapid expansion in each department.
The next 12 months will be a heavy challenge as we are doubling the laboratory working surface to provide new analysis and custom orders, we are constructing an additional clean room where we will we be able to clean, assemble and pack mass production. New faces are joining our team in each department to identify your needs and improve our performance in serving you. The driving force behind 2012 projects is your continues support and encouraging satisfaction. We are confident in our ability to develop our business and progress as we have done during the last 5 years.
Cheers and happiness for you and your family
I wish you a merry Christmas and happy New Year,
Quality status, by Y. Gérard, Quality Insurance Manager
Our modern and international field of activities evolves quickly, from day to day. In this context, it’s more important than ever to have a common work basis. Regulation and development of standards contribute to ensure that everybody speaks the same language. Since the beginning of its activities, Medistri SA has committed to respect the strictest standards regarding Quality Management System for sterilization of your products and the analysis of your samples. This commitment results in the high amount of certificates on the « wall of fame » of our company.
During year 2011, our Quality Department has grown. We are now able to provide you with a high level quality consulting service to help you at any stages of your project. If you have a question during development of your product or during the certification process (audit), Medistri SA can offer its help to find out the best option to reach your objectives quickly with low costs.
In 2011, Medistri SA was also audited several times by Certification Bodies, customers or internally. For us, an audit is a good opportunity to meet our customers’ Quality teams and to create with them strong links and partnership. By this mean, we had also the opportunity to improve our system and daily work by applying and implementing CAPA answers.
Laboratory news, by G. Farron, Laboratory Manager
2011: state of the art of developments and new fields explorations
With new certifications for endotoxins assays, environmental monitoring and elements of germs identification, Medistri SA strengthened during 2011 its pool of accredited analysis (STS). Simultaneously, the development and the application of other chemical and biological tests, such as Ethylen oxide residues analysis by GC, customized BI’s formulation, soil tests, germ identification, special (customized) microbiological tests, first elements of biocompatibility were conducted in order to respond to an increase of new requests. Those new tests were developed by the R&D Dpt. New accreditations are targeted for next year.
With more than 1’400 orders, 22’000 tests in 2011, the results of 2010 were largely surpassed.
New colleagues specialized in scientific marketing fields, in qualification/maintenance of autoclaves and in microbiology recently started in the Laboratory Dpt in order to allow to Medsitri to consolidate and develop an attractive pool of competences and to be responsive to customer needs.
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STERILIZATION NEWS
The second sterilization chamber is now qualified and fully operational. Furthermore, we will soon send you a complete proposal for the qualification of your products for this new equipment.
Planning for the last weeks of 2011:
As usual, we will close week 52. Please contact our customer service in order to organize your last deliveries
Objective 2012 : qualify all products for chamber N°2
MANUFACTURING
A new project starts at Medistri. From several years now, we have stated that a qualified packaging was required by the customers even in the first R&D phases. For this, Medistri is working at the setting of qualified system to handle such demand. First step of the project will be the development of a clean-room ISO7.
This project will also see the development of a cleaning process for medical device manufacturing. This process will be qualified according good manufacturing procedure.
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NEWS ABOUT THE LAB
Packaging Qualification :
The standard ISO11607 has been published in 2006, all manufacturer of sterile products should now be aware that the sterility of products have to be assessed regarding the shelf-life of the product. To comply this standard, Medistri can offer you the complete service:
Shelf-life simulation including accelerated aging conditioning and transport simulation
Packaging test : pressure test, penetration test, small hole detection… For a complete validation, contact.
Projects and challenges for 2012:
Obtain GLP certification, new tests accreditations, new analysis, such as biocompatibility and specific chemical analysis; and also new services: qualification of autoclaves
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