Plastic is the future
... is flexible
Kunststoff ist Zukunft
... ist flexibel
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CH-9430 St. Margrethen SG
Neugrütstrasse 3 - Switzerland
Tel. + 41 (0)71-747 27 27
Fax + 41 (0)71-747 27 10
[email protected]
www.samaplast.ch
CH-9430 St. Margrethen SG
Neugrütstrasse 3 - Switzerland
Tel. + 41 (0)71-747 27 27
Fax + 41 (0)71-747 27 10
[email protected]
www.samaplast.ch
SAMAPLAST AG
References
Implants
Our history, our claim
For more than 50 years, SAMAPLAST AG has stood for
plastic products of the highest quality. We produce plastic
injection-moulded parts, medicinal components and
implants at our plant in St. Margrethen/SG. The production
floor was doubled in size the summer of 2007 and a further GMP-conform clean room was installed.
In addition, we manufacture plastic injection-moulded
parts and components including all the necessary reworking right up to the packaging of the final product.
SAMAPLAST AG –
your partner from the idea up to market maturity.
www.samaplast.ch
Everything at one location
SAMAPLAST AG supports you from the development of
your product up to the series release in the fields of product development, application technology and production
engineering.
We produce samples and prototypes; undertake product
and tool construction and manufacture.
SG - ZH
Medicinal products
Technical parts
LIOSAPLAST & SAMAPLAST – two companies
LIOSAPLAST AG manufactures high quality functional and decorative plastic coatings as surface finishing from just
a single piece to high volumes. Coatings of the various different plastics are applied to the most diverse materials
from just a few millimetres up to 6 m long and 1.6 m in diameter.
More detailed information can be found on the website www.liosaplast.ch.
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Development Construction
Innovative ideas and competence in development
from the beginning
SAMAPLAST AG supports you throughout all the phases
of development of your projects. We produce prototypes
in corresponding shape, colour and surface character within a short space of time.
Tool making
Guarantee for optimal quality – for years to come
The precision and perfection of our injection-mould tools determine the high quality and the reproducibility of our injectionmould components. These are the prerequisites for low wear and tear and, therefore, for the long durability of your tools.
In doing so, we implement the procedure “Rapid Prototyping” and “Rapid Tooling”. This procedure is complemented by the most modern development tools such as
CAD/CAM, injection-mould simulations and special
calculation programs.
The highest precision is our tenet
Our tool-making department possesses a direct interface with our department for development/construction. As a result,
we are in a position to convert CAD-data directly into CAM-data and to use this for electrode production on our HSC-milling
machines. Using the most up-to-date countersink erosion equipment, we can achieve the autonomous processing of the
most complex shapes and contours.
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Processing
Plastic injection
Processing – we know how
For many years, SAMAPLAST AG has been a specialist in
all areas of processing: fully-automatic manufacture,
assembly mounting, pad printing and hot stamping, laser
inscription, ultrasonic welding with hot-sert embeddings,
adhesive bonding, soldering, mechanical processing, washing of pre-turned and plastic parts, packaging and labelling
and the final-packaging in the medicinal area.
Plastic injection at its best
The most modern injection-mould machines with 150 –
3500 kN clamping force can process all thermoplastic
materials such as PSU, PPS, PEI, PEEK and absorbable
materials (polylactide). In addition, we are able to produce
plastic parts with a unit weight of 0.01 – 1000 g.
We get to the root of the matter
We characterise the flow properties of plastics (moulding
compound test) and verify their residual moisture. We fall
back on the use of electronic moisture measuring devices
with IR technology and MVR testing devices (Melt Volume
Rate) as well as DSC analysis devices (Differential Scanning Calorimetry) for this purpose.
Order is important for us
SAMAPLAST AG possesses a modernly equipped high-bay warehouse (Kardex) with pull out shelves for the storage of injection-mould tools, semi-finished products and finished products. The warehouse is accessible to all five
floors of our building and fully protected from fire by a CO2 extinguisher.
Innovation in processing for optimised products.
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We make everything out of plastic, except half-baked things!
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LEAN 5S
Lean Management – more value for our
customers
At SAMAPLAST AG, Lean Management – a
highly efficiently maintained structure in our
thinking and implementation processes –
belongs to company culture.
Quality management
Dealing with risks
In order to minimise the risk to companies and
patients, we have built up a Risk Management
system according to ISO 14971.
Through the consistent focus of all activities
on our customers, potential optimizations
become immediately visible and lead to
enhanced customer satisfaction. However,
only through the involvement of all our
employees is the realisation of this philosophy possible.
Validation for the right actions
We carry out process validation according to GMP, GHTF and FDA guidelines for our processes in order to guarantee the suitability of our processes for their intended purpose and
to meet regulatory requirements.
SAMAPLAST AG guarantees the highest quality!
We aim to achieve unitary management systems with
efficient and optimised structures. Perfect organisation
according to ISO 9001 and ISO 13485 supports us in the
adherence to and optimisation of our quality requirements.
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Clean room
Clean room production is a matter of trust
Pharmaceutical Quality
SAMAPLAST AG produces medicinal components,
implants and instruments on the most modern injectionmould machines in two GMP-conform clean rooms of the
standard ISO-class 7 (in operation) according to EN ISO
14644.
In addition, SAMAPLAST AG possesses
a qualified water treatment plant which
produces the HPW (Highly Purified Water)
that is required by the ultrapure water
washing machine.
The necessary follow-up operations such as pad printing,
laser inscription, ultra-sonic welding, mechanical processing, assembly fitting, tempering, adhesion and the final
packaging can also be carried out in the clean room when
required.
We implement Hygiene-Monitoring in these processes in
which the adherence to the air and surface bacterial count
(wipe test) as well as the microbiological contamination of
the medical products (bioburden) are regularly tested.
We have them – ultrapure water
washing machine
The highest precision is our responsibility
We rely upon seamless documentation of the required
parameters and their retraceability in the production on our
state-of-the-art injection-mould machines, which are linked
together by a central computer.
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For the final cleaning of medicinal products, we use our ultrapure water washing
machine with sluice function.
This wash machine has a number of functions: it is adapted for spray cleaning in
rotating method, for rinsing and for drying
(warm air drying) of medicinal technology
parts.
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Final packaging Sterilisation
© Synthes, Inc. [2010]
Final packaging of medicinal products
Validation of final packaging
Medicinal products are to be constructed, manufactured
and packaged so that their characteristics of use and performance do not change during storage and shipping
taking the information of the manufacturer into account.
To implement the requirements of packaging validation, SAMAPLAST AG has worked out a validation
concept which serves as a guideline for the determination of the project-specific validation process and
is already planned during the development phase
together with the customer.
SAMAPLAST AG is able to package medicinal products in
the clean room and provide the proof that the final packaging meets legal requirements.
In the course of the validation of the final packaging
the documented proof is brought that the specific
requirements of the final packaged medicinal product are fulfilled throughout the entire life cycle.
Validated
final packaging
Phase 4
Durability validation 2
(real time aging)
Phase 3
Durability validation 1
(accelerated aging)
Phase 2
Stability validation
(sterilisation and transport)
Phase 1
Validation of sealing process
Functionality and
efficiency of
packaging design
Compliance
packaging material
with ISO 11607
Validated standard packaging
In order to minimise the amount of time and the costs during the development process and during project management
respectively, SAMAPLAST AG has determined standard medicinal packaging for bags and blisters of various sizes and
materials.
Standard medical packaging POUCHES
Material
Sizes
OPA-PE-Peel
45 x 95 mm to 250 x 500mm
OPA-SiOx-PE-Peel
85 x 150 mm to 200 x 380mm
OPA Aluminum PE Peel
45 x 110 mm to 250 x 500mm
Tyvek Peel tubular pouches
width 70 mm to 400mm
Qualified equipments
(DQ/FAT/IQ/OQ)
Sterilisation
To achieve the sterility of the final packaged medicinal products, SAMAPLAST AG offers to realise sterilisation according to
the norms in cooperation with its partners.
Gamma/X-ray sterilisation process
Standard
Ethylene oxide sterilisation process
Standard
Method 1, sterilisation dose: 14,2–36,3kGy
ISO 11137-2
Half-cycle method (Overkill)
ISO 11135-1
ISO 11137-2
Ethylene oxide sterilisation residuals
ISO 10993-7
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VDmax -method, sterilisation dose: 25kGy
Standard medical packaging BLISTERS
Material
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VDmax -method, sterilisation dose: 15kGy
ISO 11137-2
Sizes
l=67.5 to 179.5 mm
Blister material PETG
Sealing film medical Tyvek
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w=35 to 103 mm
h=max. 85 mm
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