Holopack Brochure

Contract manufacturing | Test filling | Process development | Validation Service
holopack | Probeabfllung
The company
Our product range

eye drops
The company
bladder rinsing solutions

disinfectant solutions
liquid and semi-solid
preparations
infusion solutions
infusion solution
concentrates
inhalation solutions
injection solutions
Dependable. Beneficial. Packed.
solutions
solvents
nose drops
An efficient packing system plays a very
Holopack stands for experience and high-
significant economic role in modern produc-
performance in packaging. We utilize the in-
emulsions
tion particularly where pharmaceutical and
novative bottelpack Blow-Fill-Seal (BFS)
ear drops
technical products are concerned. In this
technology for sterile filling of liquid and
suspensions
sector, Holopack has specialised itself in
semi-solid products. We are the market lead-
oral dose ampoules
innovative contract filling. Holopack is certi-
er in this sector, for good reason, the inventor
fied according to DIN EN ISO 9001:2000
of this cutting edge technology was none
and DIN EN ISO 13485:2003. We have been
other than Holopack founder Gerhard
a business partner to a large number of
Hansen. We are actively involved in the
well-known pharmaceutical and technical
further development of the bottelpack BFS
products companies. Our successful US
technology. We understand the significance
FDA inspections are proof or our quality
of a satisfied customer and are happy to
standard.
assist them with trial, clinical and contract

filling. We will take you all the way from
Our advantages are obvious: Optimised
process development to validation.
work processes and individual solutions

lead to lower costs and expenditures with
more flexibility and planning safety. We
provide the services that you need so that
you can concentrate completely on your
core business.
holopack | The company
Contract manufacturing
Contract man
Valuable ideas. In perfect moulds.
Success comes in many forms and we
We fill the smallest batches without any
can produce yours. With our bottelpack
influence on our high quality standards
BFS filling plants we are able to comply with
DIN EN ISO 13485:2003. All the products
your individual demands and needs when it
filled comply with cGMP requirements and
comes to designing containers.
with international guidelines. This was

confirmed by successful US FDA Inspec-
How Blow-Fill-Seal technology functions:
tions for Medical Devices and Drugs.
Parisons are extruded from plastic resin
Well over 100 long-term customers are
granulate. The parisons are blown and
aware of our competent contract filling
formed into sterile pyrogen-free containers.
services, aseptic filling or terminal sterilisa-
The containers are then quickly filled and
tion, and our secondary packing: labelling,
sealed within the same process area. This
overwrapping and cartoning. Our custom-
fully automated process fills the container in
ers confirm their confidence with their
the shortest possible time. This offers a
repeat business.
number of advantages: sterility, low weight,

robustness, compatibility to the filling product and cost efficiency.
Container sizes from 0.2 ml to 1200 ml in an
extensive design range. These includes
septums, screw tops, dropper caps and
metered dose containers. We are able to
provide a wide variety of optimised possibi
lities for use and administration. Furthermore, we dont just restrict ourselves to
the usual moulds but also develop flexible
solutions for our customers.
holopack | Contract manufacturing
Test filling
Test filling
Dont take any chances. Test it first.
Sensitive products need to be handled with
hardness, appearance, barrier characteris-
care. Each individual product in our current
tics and ability to sterilize. At Holopack
range of more than 200 products is manu-
nothing is left to chance, which is why we
factured with the utmost care and attention.
will recommend to you:
The range in products covers liquids, viscous liquids, gels and suspensions. In the
the suitability of the product for
pharmaceutical and medical products
bottelpack BFS technology in order
sector alone we are able to provide a wide
to achieve the highest degree of process
variety of administering forms: injections,
and product safety
inhalations, infusions, oral and rinsing solu-
container design
tions, eye drops, gels, topicals and ophthal-
and the secondary packing necessary
mic care products for contact lenses.
to fulfil functional and aesthetic
Through our trial test runs we confirm that
requirements.
the best container choice has been made.

Whatever product is being filled it is always
Our flexibility in test and trial fillings allows
in good hands at Holopack.
us best to incorporate all of our customers

wishes.
Monolayer and Multilayer

We offer you
Our containers made from polyethylene
(PE), polypropylene (PP), Polyethylentereph-
test fillings for feasibility studies
thalat (PET) monolayer and multilayer with
filling of stability batches
barrier layer (for example EVOH) are avail-
filling of clinical trials
able in an unlimited number of plastic
combinations and moulds. This means your
We assist you with document preparation
designs have a great flexibility in colour,
for product application.
holopack | Test filling
Process development
Process deve
You provide the ideas. We develop the processes.
A company that sets high standards also
We can provide you with:
has to meet high demands. Meaning, that

you require a full service provider. This is
process development
why we do not just advise our customers
production from pilot batches to full
during production, but together with them
production runs
develop the best possible solutions. We
filtration tests for sterile filtration
take individual wishes into account starting
scale-up tests
in the initial development stages.
microbiological tests: internal or in

conjunction with external microbiological
From 20 to 5000 litres we are capable to

manufacture a product in our compounding
laboratories
comprehensive chemical tests in own
area. This also includes semi-solid forms,
laboratory in accordance with
gels and suspensions.
international guidelines
development and optimisation of
Our experts advise you extensively on what
container designs
you need to know for production with BFS

technology. Our range of comprehensive
The production process development is
quality controls and trial methods ensures
inseparable with the development of a
that nothing is ever left to chance.
trusting relationship between our customer

and holopack.
holopack | Process development
Validation Service
Validation Ser
More competence through greater experience.
Thats for sure.
Know-how is our greatest capital, and we
Our experts are active in many areas world-
are happy to share this with you. Our teams
wide. Holopacks Validation Service assists
of specialists are competent in different
you with design, planning, qualification and
areas such as BFS technology, clean rooms,
validation of your facilities and processes.
media, compounding area and many more.

From our years of practical experience we
Our services enable you to fulfil all neces-
have the know-how to develop individual
sary cGMP standards. We put you in a
solutions for your specific requirements.
position where you can react flexibly to new
Our experience in the areas of plant tech-
installations, extensions and changes to
nology, qualification and validation of sterile
your systems. This will save time, costs and
and aseptic filling or FDA handling is put
resources.
into practice so that you can profit from it.

We are able to implement cGMP standards
Today, our customers are already profiting
for Europe, Asia and the USA, and can
from our validation services.
advise you in all relevant cGMP matters.
10 holopack | Probeabfllung
holopack | Validation Service
11
HOLOPACK Verpackungstechnik GmbH
Werk 1, Bahnhofstrae, D-74429 Sulzbach-Laufen

Tel. +49.7976.98 800, Fax +49.7976.10 14
Werk 2, Bahnhofstrae, D-73453 Abtsgmnd-Untergrningen

Tel. +49.7975.9600, Fax +49.7975.52 96
[email protected], www.holopack.de
Verwaltung: Tel. +49.7976.800, Fax +49.7976.80 100
12 holopack | Probeabfllung

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Contract manufacturing | Test filling | Process development | Validation Service

Our product range

bladder rinsing solutions

Dependable. Beneficial. Packed.

An efficient packing system plays a very

Holopack stands for experience and high-

significant economic role in modern produc-

performance in packaging. We utilize the in-

tion particularly where pharmaceutical and

novative bottelpack Blow-Fill-Seal (BFS)

technical products are concerned. In this

technology for sterile filling of liquid and

sector, Holopack has specialised itself in

semi-solid products. We are the market lead-

oral dose ampoules

innovative contract filling. Holopack is certi-

er in this sector, for good reason, the inventor

fied according to DIN EN ISO 9001:2000

of this cutting edge technology was none

and DIN EN ISO 13485:2003. We have been

other than Holopack founder Gerhard

a business partner to a large number of

Hansen. We are actively involved in the

well-known pharmaceutical and technical

further development of the bottelpack BFS

products companies. Our successful US

technology. We understand the significance

FDA inspections are proof or our quality

of a satisfied customer and are happy to

assist them with trial, clinical and contract

Our advantages are obvious: Optimised

process development to validation.

work processes and individual solutions

holopack | The company

We fill the smallest batches without any

can produce yours. With our bottelpack

influence on our high quality standards

BFS filling plants we are able to comply with

DIN EN ISO 13485:2003. All the products

your individual demands and needs when it

filled comply with cGMP requirements and

comes to designing containers.

with international guidelines. This was

How Blow-Fill-Seal technology functions:

tions for Medical Devices and Drugs.

Parisons are extruded from plastic resin

Well over 100 long-term customers are

granulate. The parisons are blown and

aware of our competent contract filling

formed into sterile pyrogen-free containers.

services, aseptic filling or terminal sterilisa-

The containers are then quickly filled and

tion, and our secondary packing: labelling,

sealed within the same process area. This

overwrapping and cartoning. Our custom-

fully automated process fills the container in

ers confirm their confidence with their

the shortest possible time. This offers a

number of advantages: sterility, low weight,

holopack | Contract manufacturing