Back_ButtonExhibitornews Swiss Plastics 2014

SAMAPLAST AG
Your partner from idea to market

Deutscher Text >>>

Our name has been standing for high-quality synthetic products for more than 40 years. At our headquarters in St. Margrethen, we produce synthe- tic injection molded parts, medical devices as well as implants.

In 1990, we moved into the new building at Neugrütstrasse 3 where we commis- sioned a GMP-conforming clean room in 2002. Due to the strongly increasing demand, we doubled our production area in the summer of 2007, and moved into the annex where we installed a second GMP-conforming clean room.

Samaplast AG - Firmengebäude

Our philosophy – everything from one source
Our philosophy is our strong point. We attend to you and your product from the design to the serial release. Our team assumes responsibility for the product development, the application technique as well as production engineering. We devise a product or products-specific systems from your idea. We manufacture synthetic injection molded parts and components including the necessary reworking. We are able to prepare and supply any of the products you desire in their final packaging.

Corporate video

 


References

Plastics are the future, and flexible
Synthetic material is the magic word of our time. Plastics are flexible as no other material. There is barely any limit to its malleability and coloring. Its chemical and physical properties are highly variable as well.

We make use of these properties and realize your ideas in close cooperation with our material and machine suppliers. For you we process bulk plastics, technical synthetics, high-temperature plastics and high-tech plastics with the following rein- forcements:
glass fibers, steel balls, glass balls, carbon fibers, and minerals..

Samaplast AG - Diverse Teile


Manufacturing technology
We are specialized not only in the production of synthetic parts, but as well in their further processing. The following competences are part of it: pad printing, coining, laser marking, fully automatic assembly, mechanical processing, ultrasonic wel- ding, adhesive bonding, coating and metallizing (externally) and final packaging.

More information can be found here.


Development

Innovative ideas and development competency from the outset
We provide our support in every development phase of your projects. Our engineers realize your ideas and wishes rapidly and flexibly. The result of this process is a marketfriendly and tailor-made product.

We use Rapid Prototyping and Rapid Tooling to produce within a very short time prototypes in the appropriate shape, color, and surface condition for your market analysis. State-of-the-art development tools such as CAD/CAM, injection molding simulations, and special calculation programs, as well as our engineers’ long-standing experience in the design of synthetic parts and injection molding tools, further supplement these procedures.

Samaplast AG - Entwicklung

More information can be found here.


Tool making

A guarantee for optimal quality extending over years
The precision and perfection of our injection molding tools ensure the high quality and the reproducibility of our injection molding parts. These are the prerequisites for low wear and hence a long life cycle of your tools. The production of medical devices and implants makes great demands on the injection molding tools and the tool making. Our highly motivated team, the state-of-the-art machinery, and a well- engineered production technology ensure that we meet these high quality stan- dards. Highest precision is our maxim

Our tool making department has a direct interface with our development and construction department. This enables us to transform the CAD data directly into CAM data and to use them on our milling machines for the manufacture of elec- trodes.

The latest die-sinking facilities permit us to realize an autonomous machining of the most complex shapes and contours.

Samaplast AG - Werkzeugbau

More information can be found here.


Plastic molding

Plastic molding top!
We abide by our motto of top quality holding for years in the injection molding department as well. Guarantor for this us our highly skilled and motivated team as well as our state-of-the-art injection molding machines with a locking force of 150 to 3500kN that process all thermoplastic materials apart from PVC, and are capable of producing plastic components with a unit weight going from 0.01 to 100 0g.

We would like to emphasize particularly our experience of many years in the processing of high temperature plastics such as PSU, PPS, PEI, PEEK and resorbable materials (polylactides).

We get to the root of the matter

To ensure the products’ optimal quality, we have to characterize the flow behavior of the plastics (molding batch examination) as well as prove their residual moisture content. For this, we resort to elec-tronic moisture measuring devices with IR technique and MVR testers (Melt Volume Rate), as well as the DSC analysis instrument (Differential Scanning Calorimeter).

The latest high-bay warehouse (Kardex) with tray selection is at our disposal for the storage of our injection molding tools as well as the semi-finished and finished products. It is made accessible through our five-storey building and is completely fire protected with a CO2 extinguishing system.

Samaplast AG - Kunststoffspritzerei

More information can be found here.


Further processing

Further processing - we have the know-how
Not only are we experts in the production of injection molding parts, but we have had the necessary know-how in all areas of processing at our command for years.

They include:
- The fully automated production
- The component assembly
- The pad printing and hot stamping
- The laser marking
- The ultrasonic welding with hot-sert embeddings
- The adhesive bonding
- The mechanical processing
- The washing of pre-turned and plastic parts
- The packaging and labeling
- The final packaging in the medical field

Our long-standing partners complete our services in screen and multi-color printing, metal coating, coating as well as providing subcontracting parts. We use methods such as laser marking, pad printing, and hot stamping for identification and labe- ling. With our laser marking system we are also able to label medical products under clean room conditions. Our laser marking system enables us to label medical devices under clean room conditions.

Samaplast AG - Weiterverarbeitung

More information can be found here.


Clean room

Clean room production is a matter of trust
In two GMP-conforming clean rooms of ISO class 7 (in operation) to EN ISO 14644, we use state-of-the-art injection molding machines to produce medical components, implants and instruments. If required, we can carry out the necessary follow-on operations such as pad printing, laser marking, ultrasonic welding, mechanical processing, component assembly, tempering, and the final packaging in the clean room as well.

Trust is good, control is better
In addition to the careful compliance with the manufacturing regulations, the guarantee of the optimal quality of our products also requires consistent hygiene measures. We use hygiene monitoring to regularly check the compliance with the air and surface bacterial count (wipe test) as well as the microbiological contamination of the medical devices (bioburden). This monitoring system provides us constantly with data about the particle concentration, the pressure difference, temperature humidity and the flow rate.

Samaplast AG - Reinraum Bild 1

We are responsible for the highest precision
To meet the highest requirements, we constantly monitor and document the precision of the parts and the production process, in order to take measures, if necessary. Our injection molding machines are therefore cross-linked by central computer. This cross linking ensures a complete documentation of the wanted parameters and their retraceability.

Unsoiled does not signified clean – the ultrapure water washing machine
We therefore see to it that your products are not only unsoiled, but really clean. For the final cleaning of your medical devices, we use our ultrapure water washing machine with material lock function from the controlled production area to the clean room.

Pharmaceutical quality
SAMAPLAST also disposes of a qualified water treatment plant that produces highly purified water according to the European Pharmacopoeia. This water is required by our ultrapure water washing machine.

Samaplast AG - Reinraum Bild 2

More information can be found here.


Final packaging / Sterilization

Final packaging of sterilizable medical devices to ISO 11607
According to the EEC Directive 93/42, medical devices have to be designed, produced, and packaged to ensure that their application attributes and per- formances do not change during transport and storage, bearing in mind the information of the producer. With the acquisition, installation, bringing into ser vice and the qualification of the packaging plant, we created the basic prerequisite for the implementation of the final packaging of medical devices at SAMAPLAST. Today, we are in a position to pack medical devices in the clean room of ISO class 7 (in operation) to ISO 14644 and to prove that the final packaging meets the legal requirements.

Standard packaging validated to ISO 11607-2
To minimize the expenditure of time and the costs in the development process or the project management, we determined different bag and blister sizes and materials for the standard medical packaging.

Packaging validation of final packaging
The aim of the packaging validation is to provide the documented evidence that we meet the specific requirements (sterility and function) of the fully packaged medical device during their entire life cycle, i.e. until the effective date of use. To meet the requirements of the packaging validation, we have worked out a validation concept based on ISO 11607. We use this standard concept as a guideline for the determination of the project-specific validation procedure. It should already be planned in the development phase together with the customer.

Sterilization
To achieve the sterility of the fully packaged medical devices, SAMAPLAST and its partners offer to realize the sterilization by means of gamma rays and ethylene oxide and their validation according to various standards

Samaplast AG - Endverpackung

More information can be found here.


Validation

Qualification and validation to warrant the correct action
We carry out a process validation to ensure the suitability of our processes for the planned purpose and to meet the regulatory requirements. Basic prerequisites for the realization of the validation are the implemented GxP environment, the qualified main and attendant facilities, the validated process software, as well as the calibrated instruments or measuring systems.

On the basis of the GMP, GHTF, and FDA guidelines, we have defined the phi- losophy, strategy and course of action in the qualification master plan (QMP) and in the validation one (VMP) to guarantee the compliance with these prerequisites. We use the validation model below for the implementation of the process validation of our core process: the injection molding. The basis is the realization of a risk analysis to identify the critical parameters (GxP pertinence) and the determination of the validation extent (validation plan).


Qualification

We guarantee the highest quality!
Our customers require it, at SAMAPLAST it is standard. With efficient and optimized structures we aspire toward holistic management systems. The perfect organization according to ISO 9001 and ISO 13485 assists us in the adherence and optimization of our quality demand. Certificates and positive customer evaluations are the visible signs of our comprehensive business approach with the focus on quality. This as well is practiced quality philosophy in all the departments and areas of SAMAPLAST.

Coping with risks
Fire, unprofitable investment, losses in sales, faulty medical devices, product recalls, etc., are all a high risk potential that may affect the processes, jeopardize the reputation or even threaten the existence. sWe have established a risk management to ISO 14971 to minimize the business and patient risks. In our company, the ZHA (Zurich Hazard Analysis) software takes care of the assessment of the business risks, the production process ones, as well as the personnel and environmental ones.

Samaplast AG - Qualitätswesen

More information can be found here.


Download
Brochure SAMAPLAST AG (PDF file)
More downloads can be found here.


Visit us at the Swiss Plastics 2014. We would be pleased to meet you on our booth (hall 2, booth E 2133).

Samaplast AG - LogoSAMAPLAST AG
Neugrütstrasse 3
CH-9430 St. Margrethen

Tel. +41 71 747 27 27
Fax +41 71 747 27 10

info@samaplast.ch
www.samaplast.ch

 

 

Swiss Plastics Spezial
Das Messe-Spezial für die Swiss Plastics - präsentiert von Kunststoff-Schweiz und Kunststoff-Deutschland

Kunststoff-Deutschland

Save the date!
24.01. - 26.01.2017
Messelink >>>

 

Swiss Plastics 2017

 Ausstellenews / Startseite  

 Suchen                                  

 Ausstellerliste 2017             

 Videothek 2017                  

 

 Messeinformationen

 Öffnungszeiten und Tickets

 Messethemen                      

 Messe-Präsentation          

 Anreise                                 

 Hotelzimmer reservieren    

 Tipps für Aussteller              

 Tipps für Besucher              

 Impressum / Kontakt           

 

Swiss Plastics 2014

 Ausstellernews 2014          

 Videothek 2014                 

 

Swiss Plastics 2012

 Ausstellernews 2012          

 Videothek 2012                   

 

Swiss Plastics 2010

 Ausstellernews 2010           

 

Swiss Plastics 2017

 Page d'acceuil                     

 Recherche                            

 Liste des exposants 2017

 Vidéothèque 2017

 

 Informations   

 Informations pratiques       

 Thèmes de l'exposition       

 Reservation d'hotel             

 Mentions légales / Contact 

 

Swiss Plastics 2014

 Nouvelles 2014                   

 Vidéothèque 2014             

 

Swiss Plastics 2012

 Nouvelles 2012                  

 Vidéothèque 2012             

 

Swiss Plastics 2010

 Nouvelles 2010                   

 

 

Kunststoff-Schweiz

Kunststoff-Deutschland

Fakuma Spezial

K Messe Spezial