safety our 1st priority - medpack...

20
Safety our 1 st priority

Upload: others

Post on 09-Aug-2020

1 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Safety our 1st priority - Medpack Swissadmin.medpack-swiss.com/files/catalog/Medpack_factory_EN.pdf · The laboratory performs comprehensive studies and tests of the products according

Safety our 1st priority

Page 2: Safety our 1st priority - Medpack Swissadmin.medpack-swiss.com/files/catalog/Medpack_factory_EN.pdf · The laboratory performs comprehensive studies and tests of the products according

2

Condoms as a Business

Page 3: Safety our 1st priority - Medpack Swissadmin.medpack-swiss.com/files/catalog/Medpack_factory_EN.pdf · The laboratory performs comprehensive studies and tests of the products according

3

COMPANY INTRODUCING

MedPack Factory is large hi-tech condom factory. High-powered facilities provide output of 300 Mio. condoms per year. This lets to cover the requirements of several Regional markets, so the plant makes products for different trademarks.

Page 4: Safety our 1st priority - Medpack Swissadmin.medpack-swiss.com/files/catalog/Medpack_factory_EN.pdf · The laboratory performs comprehensive studies and tests of the products according

4

ROMANI

BUL

GREECE

ITALY

SLOVAKIA

CZECH REPUBLIC

GERMANY

AUSTRIASWITZERLAND

DENMARKLITHUANIA

MACEDONI

ALBANIA

SERBIA

CHERNOGORIA

CROATIA

BOSNIA ANDHERZEGOVINA

SLOVENIA

LATVIA

ESTONIA

BELARU

FINLANDSWEDEN

NORWAY

POLAND

HUNGARY

COMPANY INTRODUCING

partners absolutely attractive terms for cooperation:

• Instant response to market changes

• Minimum time for equpment reorientation for production of new trade mark

• Complex design of original brand

• Short production run time

• Optimal cost price owing to good location of the factory

• Batch size starts form one pallet

• Opportunity of door-to-door deliveries

• 10-days delivery term

The enterprise is owned by Swiss companyMEDPACK SWISS GROUP AG, which specialized in manufacturing and distribution of innovative and high-quality medical goods. International team of Medpack Swiss Group consists of more than 1200 employees managing in the field of R&D, sales, marketing and production.

Page 5: Safety our 1st priority - Medpack Swissadmin.medpack-swiss.com/files/catalog/Medpack_factory_EN.pdf · The laboratory performs comprehensive studies and tests of the products according

5

ROMANIA

BULGARIA

TURKEYGREECE

ITALY

SLOVAKIA

CZECH REPUBLIC

GERMANY

AUSTRIASWITZERLAND

DENMARKLITHUANIA

MACEDONIA

ALBANIA

SERBIA

CHERNOGORIA

CROATIA

BOSNIA ANDHERZEGOVINA

SLOVENIA

MOLDOVA

LATVIA

ESTONIA

UKRAINE

BELARUS

RUSSIA

FINLANDSWEDEN

NORWAY

POLAND

HUNGARY

MARKET STRATEGY

Worldwide consumption of barrier contraceptives, especially condoms, increases. In the context of epidemics of HIV infections and STDs, a customer who cares about his health, is ready to pay for quality. Only a high-quality condom will provide a guarantee of reliable protection from AIDS and other unpleasant “surprises”.

According to research data, the European market of barrier contraceptives within high and medium price segments has increased by more than 50 % between 2006 and 2010 and experts predict further growth of this market.

Our reference point is relevant market demands, we focused our efforts on implementation of the most advanced quality standards at all stages of manufacturing process, producing output of world quality level. Innovations and optimization of industrial process play crucial role. This helps us to keep the leading position in the industry.

Quality and safety are crucial points we focused on. This is reflected in the advanced quality control system, the selection of qualified personnel, high-tech equipment and advanced production technologies.

We examine customers reaction constantly and take it into account in our manufacturing process.

Page 6: Safety our 1st priority - Medpack Swissadmin.medpack-swiss.com/files/catalog/Medpack_factory_EN.pdf · The laboratory performs comprehensive studies and tests of the products according

6

QUALITY ASSURANCE

We work with high-quality latex, use advanced technologies and standards, and apply state-of-the-art equipment from top manufacturers.

The factory meets the requirements of quality management system ISO 9001:2008 and ISO 13485:2003+АС:2009, and production requirements according to European Directive 93/42/EEC Annex II Article4.

The manufacturing cycle conforming to ISO 4074:2002 is implemented at the enterprise.

All the following advantages were provided in the project design and successfully implemented at the factory:

• Clean areas

• Systems of air preparation, including microbiological preparation, for equipment ventilation and pneumatic systems

• Laboratory furnished with state-of-the-art equipment meeting ISO 4074:2002 requirements

• Archives with batches of released products

Page 7: Safety our 1st priority - Medpack Swissadmin.medpack-swiss.com/files/catalog/Medpack_factory_EN.pdf · The laboratory performs comprehensive studies and tests of the products according

7

QUALITY ASSURANCE

Page 8: Safety our 1st priority - Medpack Swissadmin.medpack-swiss.com/files/catalog/Medpack_factory_EN.pdf · The laboratory performs comprehensive studies and tests of the products according

8

PROCESSING CHAIN

Packing into sepa-rate MBP (laminate foil) packages, adding the lubricant, package marking.

4

Delivery of packing and raw materials, i.e. lubricants and un-tested items produced from high-quality natural latex.

Laboratory inspec-tion of incoming raw materials: samples for labora-tory tests are taken from each batch in accordance with ISO 2859-1.

Dry electrostatic test-ing of each condom: An operator puts selected condoms on the rod of a test-ing machine, which checks and sorts condoms as defec-tive and normal.

1 2 3

Page 9: Safety our 1st priority - Medpack Swissadmin.medpack-swiss.com/files/catalog/Medpack_factory_EN.pdf · The laboratory performs comprehensive studies and tests of the products according

9

PROCESSING CHAIN

Semi-automatic packing into boxes: the machine assem-bles boxes, a worker lays individually packed condoms into the box, the machine glues it up, a special printer applies mark-ing. Optionally the product may be packed into BOPP film.

Sampling from batches of finished products for final cer-tification inspection. In accordance with ISO 4074 samples are selected for such certification tests.

Packing into corru-gated packages, on pallets, shipping to buyers or warehousing.

Archiving of control batches until expiry of the five-year war-ranty term.

5 6 7 8

Page 10: Safety our 1st priority - Medpack Swissadmin.medpack-swiss.com/files/catalog/Medpack_factory_EN.pdf · The laboratory performs comprehensive studies and tests of the products according

10

CLEAN AREA

Raw materials are transported from a motor vehicle through a spe-cial ramp to the storage rooms with area of 800 sq.m., and further go to working area.

Raw materials are brought to the working area through a window with reverse air flow, which prevents dust from getting into the clean area.

In order to get to his workplace, a worker passes through an air heat curtain to amenity rooms furnished with personalized clothes com-partments, shower cubicles, and a water closet.

After changing his clothes, he enters a gateway where he puts on shoe covers, a shop coat and a cap, passes through a disinfec-tion barrier, treats his hands with special substances and only then reaches his workplace at the clean area.

When there are no people in the gateway room, lamps for bacteri-cidal treatment are switched on there.

Page 11: Safety our 1st priority - Medpack Swissadmin.medpack-swiss.com/files/catalog/Medpack_factory_EN.pdf · The laboratory performs comprehensive studies and tests of the products according

11

CLEAN AREA

All operations involving a worker who touches a condom directly, are performed in the so-called “clean area”. All utility lines are located outside the clean area, air within the sys-tems is filtered especially, and an excess amount of air is created to prevent dust from entering inside the area.

Raw materials and finished products move through specially fitted windows.

Page 12: Safety our 1st priority - Medpack Swissadmin.medpack-swiss.com/files/catalog/Medpack_factory_EN.pdf · The laboratory performs comprehensive studies and tests of the products according

12

LABORATORY

The laboratory performs comprehensive studies and tests of the products according to GOST 4645-81 and ISO 4074:2002. The laboratory is furnished with the state-of-the-art equipment for different tests.

Laboratory inspection of incoming raw materials: samples for laboratory tests are taken from each batch in accordance with ISO 2859-1.

Тesting of force at break, tensile strength, elongation at break.

Вursting volume and bursting pressure test.

Testing in electrolyte. Vacuum testing of the quality of the individual package.

1 2 3 4

Page 13: Safety our 1st priority - Medpack Swissadmin.medpack-swiss.com/files/catalog/Medpack_factory_EN.pdf · The laboratory performs comprehensive studies and tests of the products according

13

LABORATORY

Sampling from batches of finished products for final certification inspection. In accordance with ISO 4074:2002 samples are selected for such certification tests:

• Freedom from holes test• Wall thickness, condom’s length and width test• Force at break, tensile strength, elongation at break test• Bursting volume and bursting pressure test• Lubrication test• Packaging and labeling test• Visible defects test• Microbiological purity test• Force at break, tensile strength, elongation at break of oven-treated condoms test

Condom wall thick-ness, length and width measurement.

Control of quality of applied lubricants with viscosimeter.

Rubber treatment in ovens enabling to predict the storage life of finished prod-ucts.

Assessment of mi-crobiological purity of premises within the clean area, person-nel, and raw materi-als with lumitester.

5 6 7 8

Page 14: Safety our 1st priority - Medpack Swissadmin.medpack-swiss.com/files/catalog/Medpack_factory_EN.pdf · The laboratory performs comprehensive studies and tests of the products according

14

PRODUCTION

We produce condoms with variety of shapes and sizes

49 mm 52 mm 53 mm 56 mm

XXXXXL

classic baggy anatomic flaredthick head

Page 15: Safety our 1st priority - Medpack Swissadmin.medpack-swiss.com/files/catalog/Medpack_factory_EN.pdf · The laboratory performs comprehensive studies and tests of the products according

15

PRODUCTION

ribbed surface

dotted/stud-ded surface

ribbed-dotted surface

dotted-ribbed surface

smooth surface

classic baggy anatomic thick head flared

Page 16: Safety our 1st priority - Medpack Swissadmin.medpack-swiss.com/files/catalog/Medpack_factory_EN.pdf · The laboratory performs comprehensive studies and tests of the products according

16

PRODUCTION

red orange green purpleyellow blue pink

gold blacktwo-

coloredsilver brownthree-

colored

We can produce condoms of 13 colors

Page 17: Safety our 1st priority - Medpack Swissadmin.medpack-swiss.com/files/catalog/Medpack_factory_EN.pdf · The laboratory performs comprehensive studies and tests of the products according

17

PRODUCTION

1,5 ± 0,3

0,065-0,1 мм

Tensile strenght > 20 mPa

Natural latex

Equal to ISO 4074, EN 600, WHO

Mass ± 1,7 g

49 ± 7 мм

3,0

мм

3,0

мм

Ø 0,7 мм

18 ±

2≥

170

мм

Latex density 0,933 g/cm3

Working life 5 years

Elongation at break > 700%

Bursting volume 16-22 Dm3

Microbiological purity 103 KBE/g

Non-allergic dimethyl polysiloxane lubricant

Forse at break > 39 N

Bursting pressure ≥ 1,0 kPa

Ø 0,3 мм

Structural layout of a condom

Page 18: Safety our 1st priority - Medpack Swissadmin.medpack-swiss.com/files/catalog/Medpack_factory_EN.pdf · The laboratory performs comprehensive studies and tests of the products according

18

European brands place their orders at our factory because of high level of technology and technique:

• DOLPHI TM – in premium segment• JAM TM – in premium segment• LEX TM - in medium segment• Mister Ben TM - in medium segment• Your LIBIDO TM and SEXXXY TM - in low segment

CLIENTS

Page 19: Safety our 1st priority - Medpack Swissadmin.medpack-swiss.com/files/catalog/Medpack_factory_EN.pdf · The laboratory performs comprehensive studies and tests of the products according

19

CLIENTS

Page 20: Safety our 1st priority - Medpack Swissadmin.medpack-swiss.com/files/catalog/Medpack_factory_EN.pdf · The laboratory performs comprehensive studies and tests of the products according

20

MedPack Swiss GmbHTramstrasse 16,

9442 Berneck, SwitzerlandTel +41 71 747 11 95Fax +41 71 747 11 91

[email protected]

R&D / ProductionMedPack LLC Manufacturing Factory775-D Peredovaya Str., Dnipropetrovsk, Ukraine, 49082Tel +380 56 788 40 46

To know more please contact us or visit our website.

www.medpack-swiss.comMEDPACK SWISS GMBH IS A MEMBEROF MEDPACK SWISS GROUP, SWITZERLAND