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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 | Probeabfllung

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 | Probeabfllung

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

holopack | Probeabfllung

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 | Probeabfllung

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

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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

mail@holopack.de, www.holopack.de

Verwaltung: Tel. +49.7976.800, Fax +49.7976.80 100

12 holopack | Probeabfllung