Cleanliness for high patient safety – from clean fibers

P U B L I C AT I O N | A P RI L 2015
CLEANLINESS FOR HIGH PATIENT SAFE T Y –
FROM CLEAN FIBERS AND CLEAN BRAIDING PROCESS
TO FINISHED COMPONENTS
DY N A MIC S IN T ODAY’S ME DIC A L M A R K E T
Nowadays, braided microstructures gain more and more importance in the field of sports medicine, orthopedic applications and minimally invasive surgery. They are often part of game-changing innovations.
As companies become bigger and bigger, due to acquisitions or mergers, the challenge of a streamlined R&D
process becomes ever more complex. This trend towards global medical device companies with a complete
portfolio offers new opportunities for external, highly specialized companies like Meister & Cie AG. In the
field of braided microstructures, Meister & Cie AG offers the full service from R&D and design transfer to
finished products or components.
In order to achieve a high level of patient safety, regulatory requirements become stricter and will set higher
hurdles for CE or FDA approvals in the future. Therefore the use of fiber with a master file and a sophisticated
textile R&D partner and processor are tremendously important to guarantee a streamlined commercialization
process of braided textile structures to compete in today’s economic environment.
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DSM distinguishes
DSM distinguishes
Meister
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as a atrusted
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innovative textile structures for today's
innovative textile structures for today's
complex medical devices
complex medical devices
The strong partnership of DSM, manufacturer and supplier of Dyneema Purity® fibers, and Meister & Cie AG,
R&D partner and processor with a new production concept called ‘clean room in clean room’, is the medical
device companies’ answer to constantly increasing regulatory requirements when looking for braided textile
structures.
C L E A NL INE S S F OR HIGH PAT IE N T S A F E T Y –
F ROM C L E A N F IBE R S A ND C L E A N BR A IDING P ROC E S S
T O F INISHE D COMP ONE N T S
In Greenville (North Carolina), DSM is operating a dedicated ISO 13485 certified plant to produce its
medical-grade Dyneema Purity® fibers. The Dyneema Purity® portfolio ranges from 440, 110 and 55 dtex
for use in the design of orthopedic applications to 25 and 10 dtex for use in the design of low-profile cardiovascular applications. Dyneema Purity® is the industry’s only medical-grade ultra-high molecular weight
polyethylene (UHMWPE) fiber specifically designed and produced for use in the design of medical devices.
Dyneema Purity® fibers are supported by Material Master files. Its low profile, softness and abrasion
resistance render Dyneema Purity® fibers ideal for use in the design of devices for orthopedic soft tissue
repair, orthopedic trauma or for devices used in minimally invasive surgery.
R&D A ND QUA L I T Y M A N AGE ME N T
OF ME IS T E R & C IE AG
Meister & Cie AG is a 144-year-old Switzerland-based textile processor which has a quality management system certified to ISO 9001
and ISO 13485 standards.
Based on the Medical Device Directive (Medizinprodukterichtlinie
93/42/EWG), Meister & Cie AG employs a complete product development process, ranging from the proof of concept via different
stages (including design transfer) to an initial product batch, which
provides a strong basis for MDC customers to get their CE marking
and FDA approval.
The risk management process of Meister & Cie AG is a constant
part of the product development process and the following serial
production. It is compliant with EN ISO 14971:2012 (Anwendung
des Risikomanagements auf Medizinprodukte).
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Its long history in the production of braided textiles and a profound
understanding and ability of modifying machines to customer needs
are two main pillars of Meister’s success in the product development process, from a proof of concept to a serial production.
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In order to obtain maximal patient safety, Meister & Cie AG implemented an entirely new manufacturing concept, thereby maximizing
the braided textile components’ cleanness from wear particles and
any microbiological response. For certain applications, a post-manufacturing washing is even no longer necessary! To achieve this level
of cleanliness, the following arrangements have been made:
• T he entire procedure of braiding a textile component or a finished
implant (from opening the double blister of the clean fiber, the
winding, the braiding and the cutting-to-length process combined
with heat sealing and the packaging) takes place in a clean room
compliant with ISO 14644-1, class 8.
• Each piece of manufacturing equipment (such as winding and
braiding machines) is used exclusively for one single type of fiber,
so that any risk of cross-contamination is eliminated.
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CLEAN ROOM
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MEDICAL-GRADE
UHMWPE FIBER,
M A N U FA C T U R E D I N
D E D I C A T E D I S O 13 4 8 5
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CLEAN ROOM
ISO CLASS 8
CLEAN ROOM CELLS
ISO CLASS 7
CUTTING TO LENGTH
H E AT S E A L I N G
PA C K A G I N G
WINDING
BRAIDING
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DYNEEMA PURITY®
FIBERS ARE SUPPORTED
B Y M AT E R I A L M A S T E R F I L E S
• Since fast rotating machines, especially braiding and winding machines, create turbulences, these machines are positioned in additional clean room cells within the clean room, where the air flow can be
adjusted to obtain a laminar flow in the critical area of the clean fibers. These clean room cells are compliant with ISO 14644-1, class 7, even one class below the clean room (ISO 14644-1, class 8). Besides
the advantage of the ability to control the local air flow, the double security and redundancy are two
key points that ensure clean products of high quality. Additionally, this new production concept facilitates
maintenance work due to the fact that only parts of the production can put on hold.
• A failure mode and effects analysis (FMEA) of the entire manufacturing process helps detecting critical
aspects. In case risk priority numbers (RPNs) are above 125, one has to take actions to lower the risk.
These actions can consist in a simple additional working step in a standard operation procedure (SOP)
or they can lead to a modification/adjustment of a machine. After the implementation of such actions,
a solid validation of the modified process shows the effectiveness of the changes.
A quality management system which is certified to ISO 13485 incorporates a defined and established R&D
process and serial production as well as correct and complete documentation during every phase from
development to serial production.
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T O D A Y, D Y N E E M A P U R I T Y ®
H A S C L I N I C A L LY P R O V E N
B I O C O M PAT I B I L I T Y T H R O U G H
MILLIONS OF HUMAN
I M P L A N TAT I O N S
IN SUM M A RY
As global medtech companies are gaining in size due to mergers or acquisitions, they become slower in
reacting to new trends or innovations. This is where smaller and highly specialized companies such as
Meister & Cie AG can play an important role in the future. R&D and serial production under one roof, direct
communication, fast decision making and implementation of new trends and technologies and – last but not
least – the ability to implement and to react fast to new regulatory regulations are among the core competencies of Meister & Cie AG. All these qualities help to reduce the complexity of new projects at MDCs and
result in a more streamlined approval process, a shorter time to market and a higher level of cost efficiency.
Moreover, the new concept of clean room cells within the clean room, which was introduced by
Meister & Cie AG, offers both flawless production of clean and high-quality textile braiding in a controlled
environment and a higher level of flexibility in the operation of the infrastructure, which also leads to
higher cost efficiency.
MEISTER & CIE AG HASLE-RÜEGSAU
3415 Hasle-Rüegsau, Switzerland, phone +41 (0)34 460 55 55, [email protected], www.meister-ag.ch

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