Healthcare brochure RPC PET Power

1. HEALTH CARE
www.petpower.eu
Packaging
your brand

2. PET Power’s ISO 9001:2008* certification is the base for our
quality system. The structure in clear SOP’s and work
instructions is not only audited by our notified body, but also
almost weekly by our customers, amongst them world leading
pharmaceutical companies. Our systems and controls are
updated with the feedback of our valued clients. Our staff is
regularly updated through specific training. Clients see the proof
of continuous improvement during their audits, but foremost in
the constant quality and reliable service as PET Power has
agreed with its customers. For pharmaceutical packaging we
work according to cGMP. We are also BRC certified. This standard
for the food industry does offer benefits for the pharmaceutical
industry as well.
Quality
AssurancePET PowerPET Power
PET Power
packaging your brand
PET bottles and jars are widely used in the
health care industry. PET Power is the leading
specialist in PET packaging. The health care
industry is one of our target markets. We have
developed a wide range of moulds for producing
pharma specific bottles and jars. The
combination of moulds and an expanded range
of machines offers our customers solutions
fitting to their needs.
Product development is at the heart of our company. PET Power
continuously invests in the research of new materials, closures
and bottles/jars for the benefit of our clients.
Countries with
RPC offices
Quality Control
Finished products are tested on the production line and in our QC-lab. 100% of the
products are leak tested. Critical products can be tested on a 100% base with vision
systems on particles. The operators perform visual inspection on a regular basis
and have a clear quality responsibility. The laboratory receives during production
samples from all cavities with a fixed frequency. The parameters which are
measured are:
• Weight
• Wall distribution
• Shape and dimensions
• Filling volume
• Top load
The samples are visually inspected for colour against reference samples and
on other visible defects. For pharmaceutical customers sample frequency and
acceptance/non acceptance of defects and AQL levels can be agreed in a
QA-agreement.
Certification
Following after process and product registration checks, each pallet with finished
product is formally released by our Quality Control department. Upon request your
order is given a Certificate of Conformity (CoC) which outlines the agreed
specifications of your order.
PET Power factsheet
• Founded: 1995
• Number of employees: more than 260
• More than 55 ISBM machines
• 7 ISBM machines in the cleanroom
• 1200 m² cleanroom (class 7, ISO 14644-1)
• More than 240 preforms
• More than 1300 different blow moulds
• Storage capacity of 20.000 pallets
• Partner of the global RPC packaging group

3. PET is an abbreviation for polyethylene terephthalate,
which is a particular kind of polyester. PET is a material
that can be easily heated and formed into packaging for
many different applications. The use of PET for
packaging has many advantages that include:
- unbreakable
- clear and transparent
- lightweight
- good barrier properties (oxygen, water vapour,
odours, carbon dioxide, UV, temperature), which
can potentially be further improved by the use
of additives
- extremely accurate dimensions
- wide range of colours and shapes
PET Power uses resins suitable for producing pharma-
ceutical primary packaging. The resin is produced in
conformity with Good Manufacturing Practice. The resin
is tested and complying to:
• European Pharmacopoeia 3.1.15
• USP 661
• USP class VI
PET Power also has a Drug Master III file.
Properties LDPE HDPE PP PET PETG Glass
Density 0,92 0,96 0,91 1,36 1,27 2,23
Gas transmission O2
* 118 73 53 1,7 9 0
Gas transmission CO2
* 1063 228 154 12 41 0
Gas transmission H2
O-vapour ** 3,3 0,8 0,8 4,7 11,4 0
Hot fill temp 104 121 127 60 71 N/A
Clarity P P P E F E
Drop impact F/G F/G F E F P
Chemical resistance F/G F/G F/G E F E
Process I/E I/E I/E S E N/A
Recycle code 4 2 5 1 1 1
01
PET
The
material
The ISBM
production
process in brief
Our production process is called Injection Stretch Blow Moulding (ISBM).
Bottles and jars are made in a single stage process. First, the raw material,
PET granulate, is pressed in a machine using a screw-shaped cylinder. If
needed, colour is added at this stage. A liquid is formed in the cylinder at a
temperature of close to 300 °C. This liquid is injected in step 1 of the
process­into the so-called pre-form mould. The neck of the bottle or jar has
repeatable and excellent precision. Great precision is needed because the
combination of bottle and closure must create a perfect seal. The preform
is made in step 2 of the process, in the blow mould section, stretched and
blown into the final shape. Stretching is done by using a pin to press the
base down from above and, at the same time, we are slowly blowing the
walls of the bottle or jar against the walls of the mould. In the third step of
the production process, the products are placed on a conveyor belt and
tested for any leakage. Every bottle or jar is filled with an overpressure of
filtered air to test for the absence of holes.
1
3
2
plunger screw/barrel
top-view single stage (ISBM)
neckring
side-view step 3: ejection productside-view step 2: stretch and blow
bottum plug
neckring
blowmouldblowmould
blow air blow air
blow air blow air
neckring
plunger screw/barrel
dryer hopper preform tool
hotrunner
side-view step1: injection

4. closures
health care
12 CRC T/E Closure
18 DIN T/E Closure + Plug
12 CRC T/E Plug 18 DIN Closure + Paintbrush
18 DIN Closure + Pipet
18 DIN T/E Closure
20 SP410 Closure
28 ROPP T/E Closure
28 ROPP T/E Closure28 ROPP T/E Secured Closure
28 ROPP T/E Closure 28 ROPP T/E Closure
28 ROPP (30ml) Measuring Cup
28 ROPP (20ml) Measuring Cup
38 Hinge Closure38 SP400 Closure40 SNAP Closure
43 SP400 media Closure
45 Hinge Closure45 SP400 Closure
45 SP400 Closure
SAMPLES?
Ask for your
samples from
sample@petpower.eu
or www.petpower.eu
Packaging
your brand

5. RIBBED VERAL
Clear
veral
amber
1000 ml500 ml250 ml200 ml
30 ml 50 ml 150 ml100 ml 200 ml 250 ml 300 ml 500 ml 750 ml 1000 ml
150 ml
20 ml
find out
more
explore our
configurator
www.petpower.eu
also
available
in clear
also
available
in amber
SIROP
Clear
Clinch Vial
Clear
1000 ml500 ml300 ml250 ml200 ml150 ml125 ml100 ml75 ml60 ml
10 ml 20 ml 50 ml 100 ml 125 ml 200 ml 250 ml 500 ml 1000 ml
also
available
in amber
also
available
in amber

6. 125 ml
Therapy
HYGIA
ROUND
10 ml 15 ml 20 ml
125 ml600 ml 500 ml1100 ml 1000 ml
media
round/square
SCYLLA OVAL
CLEAR
150 ml 200 ml
also
available
in amber
10 ml 15 ml 20 ml 25 ml 30 ml 50 ml 100 ml
pilljar 40 m-snap
CLEAR
pilljar zéta
screw clear
60 ml 75 ml 100 ml 120 ml 150 ml 200 ml 250 ml 300 ml 400 ml 500 ml
60 ml 75 ml 100 ml 120 ml 150 ml 200 ml 250 ml 300 ml 400 ml 500 ml
pilljar zéta hinge
AMBER
50 ml 75 ml 100 ml 150 ml 250 ml 400 ml 500 ml
also
available
in amber
also
available
in amber
also
available
in clear

7. Cleanroom
production facility
PET Power operates an ISO Class 7 cleanroom. Controlling the amount of particles
in the room is the first purpose of the cleanroom production. The cleanroom has
overpressure inside. The air flowing into the cleanroom that creates the
overpressure is treated with HEPA-filters. Because the bottles are made out of
PET-resin which is melted at around 300C and injected at high pressure, the bottles
right after production, will be free of micro-organisms.
Ask for
free
samples
sample@petpower.eu
Traceability
Based on the information on each separate brickpack
label, we can fully trace production parameters like:
• Raw material, type and batch
• Production date
• Machine and mould
• Operator
Every brickpack has a unique number. The label also
specifies the PET Power article number, the number of
items per brickpack and the batch number. The
accompanying packing slip specifies all the pallet
numbers and the corresponding production date. On
pallet level we link the irradiation data to the irradiation
certificate. Treatment parameters can be traced back
and are stored for 10 years.
As soon as they run from the machine they are packed in a layer of
cleanroom quality PE-film inside the Class 7 cleanroom. The film is
hermetically sealed at 4 sides and creates a brickpack that forms a
barrier against microorganisms. Only in the short time between
production and packing, there is a slight possibility of contamination
by e.g. airborne microorganism. By keeping the amount of particles,
from which only a part are microorganisms, in the air low, we mitigate
the chance of microbial contamination. Apart from a low bioburden, a
stable bioburden numerical and species wise is necessary. For this
next to the amount of particles, temperature and air humidity are
monitored and kept stable. Probably the most important
factor are the employees. They are trained in working in
such a way that all sources of contamination are kept as
low as possible. Frequent re-training is of course part of
the cleanroom management. PET Power has placed its
ISBM machines in the cleanroom, so production is really
under cleanroom circumstances, not just the packaging!
Safe processing
All machines have their own laminar flow systems to
prevent any particles on products in the moving part of
the machine. The cleanroom is annually calibrated by an
external consultancy according ISO 14644. Adjacent to
the Cleanroom Class 7, there is a cleanroom Class 8.
The packed bottles run through an airlock to the Class 8
room where a second and third layer of cleanroom film
are put around the bottles. Both layers are sealed again
to form a perfect microbiological barrier. When the
packs of bottles are put in a pallet box, lined with an
extra PE-bag, they are ready for gamma irradiation, this
if the client requests so.

8. Irradiation
and Sterility
There is not such a thing as absolute sterility. After the production,
the products still can contain minor amounts of micro organisms. In
the medical industry a chance of less than 1 : 1.000.000 on a viable
micro organism is the standard to call a product sterile. This is
expressed as Sterility Assurance Level 10-6, abbreviated as SAL 10-6.
To guarantee this SAL level, the PET products are treated after the
production with gamma rays. This type of ionizing radiation will travel
with ease through a whole pallet of PET bottles, which means the
empty bottles can be gamma sterilized in their final packaging. This is
a great advantage. Gamma rays disrupt co-valent bonds in vital parts
of micro organisms. Rupture of both strands of the DNA of an
organism, caused by the radiation, will terminate its life processes.
We apply a minimum dose of 25 kilo Gray, or kGy. We have validated
the process and this dose will lead to the required SAL 10-6. The
validation method in use at PET Power is the VDmax method
described in the ISO 11137. More information can be obtained through
your contact as ultimately our clients carry responsibility for their
products. Co-valent bonds are not only present in DNA, they are the
building principle of polymers as well. Because of this polymers can
suffer from gamma radiation as well. The backbone of the PET
molecule has a special structure, which makes this polymer resistant
to gamma rays. Concisely, we say PET is gamma stable.
To be very sure no damage is done to the PET molecule, we cap the
maximum dose to 50 kGy. From extended literature study we know
that this is a very safe upper limit. Both dose limits minimum and
maximum are part of the gamma radiation validation process. This is
called dose mapping. Each treatment is certified. The customer
receives a certificate of gamma radiation, guaranteeing the minimum
and maximum dose.
Before launching your product you need to be sure your product is safe for the
consumer. PET Power can tell you about standard migration tests with standard
simulants/extract media. We also cooperate with renowned laboratories who can
test specific substances. Migration results are communicated directly to the
customer for further analysis and interpretation.
SAMPLES?
Ask for your
samples from
sample@petpower.eu
or www.petpower.eu
Laboratory services
Our customers are facing an increasing amount of rules, laws and industry
standards. PET Power supports their customers with laboratory services to
handle this. It concerns tests of your products for determining:
• Stability
• Sterility
• Compatibility

9. Head office
Key Account Manager health care
Guido Eijsermans
gei@petpower.eu
Sales Manager
Annette Kraan
ak@petpower.eu
Hermelijnweg 2
4877 AE Etten-Leur
The Netherlands
T 0031 (0)76 503 82 83
F 0031 (0)76 503 64 55
info@petpower.eu
sales force
PET Power Austria / Italy / CEE
Brunnergasse 1-9/Top 3, 2380 Perchtoldsdorf, Austria
Roland Cejka rc@petpower.eu
T 0043 (0)1869 5616, F 0043 (0)1865 5496
PET Power The Benelux
Hermelijnweg 2, 4877 AE Etten-Leur, The Netherlands
Annabel Nogueira an@petpower.eu
T 0031 (0)76 503 82 83, F 0031 (0)76 503 64 55
PET Power Germany / Switzerland
Dr.-Herbert-Kittel-Strasse 1, 87600 Kaufbeuren, Germany
Guido Eijsermans gei@petpower.eu
Marc Christian Pethke mcpethke@petpower.eu
T 0049 (0)8341 995 69-40, F 0049 (0)8341 995 69-42
PET Power France
12 rue de Villevert, 60300, Senlis, France
Alexandre Thibault at@petpower.eu
Julien Ha Eav jhe@petpower.eu
Audrey Vincent avi@petpower.eu
T 0033 (0)3445 32043, F 0033 (0)3446 02505
PET Power Handels GmbH Hungary
Brunnergasse 1-9/Top 3, 2380 Perchtoldsdorf, Austria
Kristof Steininger kst@petpower.eu
T 0043 (0)1869 5616, F 0043 (0)1865 5496
PET Power Handels GmbH Italy
Brunnergasse 1-9/Top 3, 2380 Perchtoldsdorf, Austria
Brigitta Cejka bc@petpower.eu
T 0043 (0)1869 5616, F 0043 (0)1865 5496
PET Power Nordics
Hermelijnweg 2, 4877 AE Etten-Leur, The Netherlands
René van Zandvoort rvz@petpower.eu
T 0031 (0)76 503 82 83, F 0031 (0)76 503 64 55
PET Power UK / Ireland
Hermelijnweg 2, 4877 AE Etten-Leur, The Netherlands
Bill Wickham wjw@petpower.eu
T 0044 7990 586 407
Pepijn Weijland pwl@petpower.eu
T 0031 (0)76 503 82 83, F 0031 (0)76 503 64 55