Products for Hospitals

Vereinigte Papierwarenfabriken GmbHMedical PackagingIndustriestrasse 6 • D-91555 FeuchtwangenFon: +49 9852 901-248 • Fax: +49 9852 901-136www.vp-group.de • [email protected]

• Medical packaging

• Indicator test systems

• Sterilisation accessories

• Hygiene accessories

Products for Hospitals

Rev. 0 - 04/2004

www.vp-group.de

See - through - pouches flat , CE mark, EN 868

with 3 indicators for STEAM, EO and FORM - sterilizationOrder-No. Article-No. Size in cm Pack (pcs.)

2495 4FKFB000534 5,5 x 20 2000 1934 4FKFB000827 5,5 x 25 2000 1933 4FKFB000829 7,5 x 15 2000 1956 4FKFB000537 7,5 x 20 2000 1935 4FKFB000538 7,5 x 25 2000 1936 4FKFB000539 7,5 x 30 2000

1921 4FKFB000540 10 x 15 2000 1937 4FKFB000541 10 x 20 2000 1938 4FKFB000542 10 x 25 2000 1939 4FKFB000544 10 x 30 2000 1922 4FKFB000545 10 x 36 1000 1944 4FKFB000546 10 x 40 1000 1923 4FKFB000547 10 x 52 1000 1901 4FKFB000548 12,5 x 25 2000 1903 4FKFB000549 12,5 x 30 2000 1206 4FKFB000550 12,5 x 40 1000 1947 4FKFB000551 12,5 x 52 1000

1940 4FKFB000552 15 x 20 1000 1961 4FKFB000553 15 x 27 1000 1941 4FKFB000554 15 x 30 1000 1942 4FKFB000555 15 x 38 1000 1948 4FKFB000556 15 x 61 1000 1924 4FKFB000557 16 x 22 1000

1957 4FKFB000558 20 x 27 1000 1943 4FKFB000559 20 x 40 1000 1926 4FKFB000560 20 x 61 1000 2496 4FKFB000561 21 x 33 1000 1904 4FKFB000562 22 x 30 1000 1907 4FKFB000563 22 x 35 1000 1207 4FKFB000564 22 x 42 1000

2498 4FKFB000566 25 x 38 1000 1945 4FKFB000567 25 x 40 1000 2499 4FKFB000569 25 x 42 1000 1946 4FKFB000570 25 x 48 500

800822 4FKFB000571 27 x 45 500

1929 4FKFB000572 30 x 42 500 1928 4FKFB000573 30 x 57 500 1905 4FKFB000574 32 x 50 500 1958 4FKFB000575 36 x 58 500 1930 4FKFB000576 38 x 50 500 1925 4FKFB000577 42 x 50 500 1927 4FKFB000578 42 x 61 500

4-40-0 E 04/2004 Rev. 0

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Order-No. Article-No. Size in cm Pack (pcs.)

1949 4FKSB000580 10 x 5 x 30 2000 1960 4FKSB000831 10 x 5 x 40 2000

1906 4FKSB000596 15 x 5 x 28 1000 1950 4FKSB000597 15 x 5 x 40 1000

1951 4FKSB000598 20 x 5 x 40 1000 1954 4FKSB000599 20 x 5 x 48 500

1953 4FKSB000604 25 x 6,5 x 48 500

1952 4FKSB000608 30 x 6,5 x 61 500

1959 4FKSB000612 41 x 6,5 x 61 500

See – through - pouches gusseted, CE mark, EN 868

with 3 indicators for STEAM, EO and FORM - sterilization

4-41-0 E 04/2004 Rev. 0

www.vp-group.de

A good alternative to heat-sealable medical packaging are self adhesive pouches from steriCLIN®. The pouches are made of 70g/m2 strong medical kraft paper with a sealed on light blue tinted compound film. The paper conforms to EN 868 Part 3 and DIN 59853 parts 2 and 6. The colours are sterilization resistant and solvent free. The STEAM and EO-indicators are printed along size, article and batch-no outside the filling area – there is no danger of migration of indicator ink onto sterile goods! Both indicators are non-toxic. steriCLIN® self adhesive pouches should be filled only up to two thirds of their overall space. Sharp or pointed items should be protected separately in order to avoid damage to the pouch. The sealed edges prevent dust sedimentation between film and paper. Instructions for closure are printed onto the flap in english and german language. The chevron seal and the thumb cut out allow easy peeling of the film. The self adhesive closure can only be opened by destroying the seal. The peel direction is shown by an arrow. Self adhesive pouches from steriCLIN fulfil the germ proofness standards of the EN 868 Part 1. steriCLIN® self adhesive pouches - Order Information:

Order-No. Article-No. Size Pack

800887 4FKFB003617 90 x 230 / 262 mm flap

10 x 100 pcs. in dispensing

carton

800886 4FKFB003614 130 x 270 / 302 mm flap


carton

800885 4FKFB003607 190 x 330 / 362 mm flap


carton

4-50-0 E 04/2004 Rev. 0

Self adhesive pouches – the timesaving solution

With STEAM and EO-indicators, EN 868 -1

www.vp-group.de

Stericlin® Blue Line – see-through non-woven packaging

The packaging specialized for heavy weight goods Stericlin® Blue Line see-through non-woven packaging is the packaging

solution for heavy and big sterile goods like metal bowls. The pouches are

manufactured from 60 g/m2 strong non-woven subsequently sealed on a

compound film. Three indicators for steam, EO- and formaldehyde-

sterilization are printed on, of course apart the filling area.

The Blue Line combines all advantages of the paper-film-see-through-

packaging with the advantages of non-woven material. For example,

because of the increased softness of the non-woven material Blue Line can

be filled much easier and faster than pouches made of paper and film.

Instructions for use: Stericlin® Blue Line was designed for stand much higher strains than

normal see-through packaging. Nevertheless it is necessary to follow some

essential rules by using this packaging material.

Filling: Stericlin® Blue Line should be filled only up to three quarter of their overall space. Sharp or pointed items should be

protected separately in order to avoid damage to the package. An empty space of at least 5 cm from the seal area should

be maintained in order to avoid stress on the seal. Avoid any kind of foldings - this weakens the material!

Bowl type medical devices should be packed with the hollow side to the non-woven side of the pouch in order to ensure the

best possible steam penetration

Sealing: For Blue Line commonly available continuous sealing devices are most suitable. Small tolerances in temperature for each

sealing device have to be fixed from case to case. The sealing temperature should be in the range of 180° - 190°C.

Place inside the sterilization basket: Smaller packs should be placed in a container (e.g. sterilization basket) so that they support one another. Place the Blue

Line film to film and non-woven to non-woven. Larger packs must be laid with the non-woven on the downside. This eases

steam penetration and drying. Always take care of the sterilizers manufacturers instructions for use respectively use

validated configurations.

4-60-0 E

07/2005 Rev. 2

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After sterilization: Check the change of colour of the indicator after the sterilization process and look for any kind of damage on the package. If

the packs are still wet 30 minutes after the sterilization process they are not storable and must be newly packed.

Open: To maintain an easy opening of the pouch with a heavy load there are specially marked and shaped seals on both edges of the pouch. Lay down the pouch for the opening procedure on a table, open the sealed edges – these prevent dust sedimentation – and peel apart the film and the non woven.

Storage: Store the pouches save from dampness, soiling, vermin, mechanical strains, extreme temperatures and ultraviolet rays . Store seperate from unsterile Goods. Refer to DIN 58953 part 7 and other norms for storage conditions.

Blue Line See-through non-woven reels - length 100m

Order-No. Article-No. Width in cm Pack (Reels)

2530 4FKFS000520 20 2

2535 4FKFS000526 42 1

Blue Line See-through non-woven pouches

Order-No. Size in cm Pack (pcs.)

1975 4FKFB000591 27 x 36 500

1977 4FKFB000593 32 x 45 500

1979 4FKFB000595 40 x 52 500

1980 4FKFB000601 50 x 60 250

1981 4FKFB000602 57 x 72 250

4-60-0 E 07/2005 Rev. 2

www.vp-group.de

Flat reels - length: 200 m

Order-No. Article-No. Size in cm Pack (reels)

2465 4FKFS000632 5 6 2466 4FKFS000638 7,5 4 2467 4FKFS000639 10 3

2525 4FKFS000640 12,5 2 2468 4FKFS000641 15 2 2469 4FKFS000642 20 2 2470 4FKFS000643 25 2

2471 4FKFS000644 30 1 2472 4FKFS000645 38 1 2473 4FKFS000646 42 1

Gusseted reels - length: 100 m

Order-No. Article-No. Size in cm (width x gusset) Pack (reels)

2509 4FKSS000647 7,5 x 2,5 4 2474 4FKSS000682 10 x 5,0 3

2475 4FKSS000683 15 x 5,0 2 2476 4FKSS000763 20 x 5,0 2 2477 4FKSS000773 25 x 6,5 2

2478 4FKSS000775 30 x 6,5 1 2479 4FKSS000779 38 x 8,0 1

See – through – reels, flat and gusseted, CE mark, EN 868

with 3 indicators for STEAM, EO and FORM - sterilization

4-80-0 E 04/2004 Rev. 0

www.vp-group.de

The material strength is the most important thing when it comes to the use of medical packaging: The stronger or thicker the material the stronger the resistance is and as a result the application safety – for yourself and your patients. steriCLIN® uses solely the strongest medical quality 1073 B with special water resistant coating and a strength of 75 g/m2. The result speaks for itself: effective barrier quality and a extremly high puncture and tear resistance. Tyvek® is suitable for the H2O2-plasma-low-temperature sterilization, ETO-gas,

Formaldehyde and γ-ray-sterilization. Tyvek® is not suitable for steam-sterilization! Pouches and reels are printed with an indicator which turns from blue to pink. The indicator does not change it´s colour after the process under normal conditions. Another characteristic feature: the film peels easy and clean without linting. For see-through pouches commonly available continuous sealing devices are most suitable. Small tolerances in temperature for each sealing device have to be fixed before use from case to case. The sealing temperature should be in the range of 120° - 130°C. Attention: higher temperatures could damage your sealing machine! Tyvek® is a registered trademark of DuPont. Reels - printed, with indicator - length: 100 m

Order-No. Article-No. Size in cm Pack (reels)

2481 4FKFS003254 7,5 2 2482 4FKFS003265 10 2 2483 4FKFS003283 15 1 2484 4FKFS003548 20 1 2485 4FKFS003559 25 1 2486 4FKFS003564 30 1 2487 4FKFS003567 38 1

Pouches - printed, with indicator


1969 4FKFB003174 7,5 x 20 1000 1974 4FKFB003178 10 x 27 500 1970 4FKFB003198 15 x 30 500 1971 4FKFB003210 20 x 40 500 1973 4FKFB003235 25 x 48 500

See-through packaging made of Tyvek®, EN 868

The resistant packaging for your plasma-sterilizer

4-90-0 E 03/2004 Rev. 0

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The paper bags are suitable for the Steam, E.T.O.-gas, formaldehyde and gamma-rays – sterilization, not for plasma-sterilization! The paper is 60 g/m² medical grade paper which conforms to the EN 868-3 and DIN 58953, parts 2 and 6. The adhesives are sterilisation resistant, the colours are solvent free. There are 10 sizes available, with heat seal top or plain-top (without heatseal-coating). Non-standard sizes or special print, also additional indicators, can be supplied upon request. Method of use: Paper bags should only be filled to 3/4 of their capacity. A free space of at least 3 cm from the seal area should be maintained in order to avoid stress on the seal. After sealing the filled bags should be placed in a container (e.g. sterilisation basket), so that they support one another. Sealing: The sealing temperature should be approx. 180°C. For paper bags rotary sealing machines are most suitable. If you are using impulse-sealers, you could get problems with closure of the side-folds: Sterile removal of contents: This is only possible by using scissors. It is not possible to peel open paper bags! Avoid tearing open bags, as this can lead to the generation of undesirable particles.

Order No. Article-No. Size in mm Code Pack (pcs.)

1088 4FPBT000977 90 x 50 x 168 A 1000 1208 4FPBT000982 110 x 30 x 196 C 1000 1210 4FPBT000983 125 x 50 x 257 R 1000 2500 4FPBT000984 140 x 75 x 260 D 1000 1899 4FPBT000985 140 x 50 x 335 F 1000 2502 4FPBT000986 160 x 70 x 384 500 1900 4FPBT000987 180 x 95 x 384 H 500 2501 4FPBT000988 200 x 60 x 335 P 500 1209 4FPBT000989 250 x 100 x 384 M34 500 1089 4FPBT000990 380 x 125 x 549 T 250

Paper bags with heat seal top and STEAM indicator

CE mark, EN 868 - 4

5-10-0 E 08/2004 Rev. 1

Double glued back-seal

Thumb-cut-outHeatseal coating

Non-toxic Steam Indicator

Trademark, size and norm reference. Order-No. and batch-no. are printed on the backside.

Double folded, heatsealed and glued bottom seal

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white


1874 4FZBH111001 40 x 40 500 1875 4FZBH111002 50 x 50 500 1876 4FZBH111003 60 x 60 500 1877 4FZBH111004 75 x 75 250 1867 4FZBH111005 80 x 80 250 1878 4FZBH111006 90 x 90 250 1879 4FZBH111007 100 x 100 250 1880 4FZBH111008 120 x 120 125

green


1881 4FZBH112001 40 x 40 500 1882 4FZBH112002 50 x 50 500 1883 4FZBH112003 60 x 60 500 1884 4FZBH112004 75 x 75 250 1866 4FZBH112005 80 x 80 250 1885 4FZBH112006 90 x 90 250 1886 4FZBH112007 100 x 100 250 1887 4FZBH112008 120 x 120 125

blue


1855 4FZBH113001 50 x 50 500 1854 4FZBH113002 60 x 60 500 1856 4FZBH113003 75 x 75 250 1859 4FZBH113004 90 x 90 250 1857 4FZBH113005 100 x 100 250 1858 4FZBH113006 120 x 120 125

Wrapping paper crepe

CE mark, EN 868-2

6-10-0 E 04/2004

Rev. 0

www.vp-group.de

white


1889 4FZBH121002 60 x 60 500

1890 4FZBH121003 75 x 75 250

1891 4FZBH121005 90 x 90 250

1892 4FZBH121006 100 x 100 250

1893 4FZBH121007 120 x 120 125 green


1894 4FZBH122002 60 x 60 500

1895 4FZBH122003 75 x 75 250

1896 4FZBH122005 90 x 90 250

1897 4FZBH122006 100 x 100 250

1898 4FZBH122007 120 x 120 125

Wrapping paper crepe , sensitive, extra soft

CE mark, EN 868-2

6-11-0 E 04/2004

Rev. 0

www.vp-group.de

COMFORT is a new non-woven which has an excellent

drapeability and an over-average mechanical strength. COMFORT

is suitable for packing of medical goods like instrument trays and

textiles.

COMFORT is water resistant, repellent against alcohol and meets

the requirements of the EN 868. For double packing a combination

of non-woven and crepe wrapping paper is possible - independent

from colour and size of the wrapping material. Please follow the

packing methods described in the DIN 58953 part 7 or other

relevant international norms to make a functional primary pack.

For further information on COMFORT and other products from

steriCLIN® visit our website www.vp-group.de COMFORT blue 52 g/m²

Order-no. Article-no. Size in cm Pack (pcs.)

1050 4FZBH214002 50 x 50 500 1051 4FZBH214003 60 x 60 500 1052 4FZBH214004 75 x 75 200 1053 4FZBH214006 90 x 90 200 1054 4FZBH214007 100 x 100 200 1030 4FZBH214008 100 x 140 100 1055 4FZBH214009 120 x 120 100 1046 4FZBH214010 120 x 140 100 1056 4FZBH214012 130 x 150 100 1048 4FZBH214013 140 x 140 100 1049 4FZBH214014 150 x 190 100

COMFORT green 52 g/m²

Order-no. Article-no. Size in cm Pack (pcs.)


890206 4FZBH214111 130 x 130 100

COMFORT non-woven wrapping material

CE, EN 868

6-21-0 E 01/2005 Rev. 0

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COMFORT is a new non-woven which has an excellent drapeability

and an over-average mechanical strength. COMFORT is suitable for

packing of medical goods like instrument trays and textiles.

In COMFORT Interleaved packs blue and green non-woven sheets are

alternating packed together. Packing with COMFORT Interleaved

offers a lot of benefits. The different colours of inner and outer layer

makes detection of damages of the pack easier. The time-consuming

put together of blue and green non-woven sheets from two different

packs becomes unnecessary.

COMFORT is water resistant, repellent against alcohol and meets the

requirements of the EN 868. For double packing a combination of non-woven and crepe wrapping paper is possible -

independent from colour and size of the wrapping material. Please follow the packing methods described in the DIN 58953

part 7 or other relevant international norms to make a functional primary pack.

COMFORT interleaved blue/green 52 g/m²

Order-No.. Article-No. Size in cm Pack (pcs.)

1066 4FZBH114011 75 x 75 200 1068 4FZBH114012 90 x 90 200 1069 4FZBH114013 100 x 100 200 1071 4FZBH114014 120 x 120 100 1072 4FZBH114015 120 x 140 100

COMFORT interleaved blue/green

Non-woven wrapping material - CE, EN 868

6-22-0 E 02/2005 Rev. 0

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Heavy medical goods like instrument trays are a challenge for

wrapping materials. The wrapping material must have a good

drapeability, a very high tensile strength and, of course, it must

form an efficient barrier against bacteria. PREMIUM non-woven

wrapping was developed especially for those demanding

applications in the cssd. The combination of pulp with a high

share of polyester fibres makes this non-woven extremely robust.

Therefore PREMIUM is suitable as inner packing layer and sterile

drape.

PREMIUM is water resistant, repellent against alcohol and meets

the requirements of the EN 868. For double packing a combination of non-woven and crepe wrapping paper is possible -

independent from colour and size of the wrapping material. Please follow the packing methods described in the DIN 58953

part 7 or other relevant international norms to make a functional primary pack. For further information on COMFORT and

other products from steriCLIN® visit our website www.vp-group.de PREMIUM blue 59 g/m²



PREMIUM non-woven - CE, EN 868

The wrapping material for heavy medical goods

6-23-0 E 01/2005 Rev. 0

www.vp-group.de

Condensation and wet trays are a danger which can prevent the

success of the sterilisation process. Moisture absorbent wipes fits

snugly on the bottom of the container and absorbes the condensate

inside the sterilisation container and allows a better drying.

Sharp and pointed instruments can be easily damaged if the tray or

the container is roughly handled. Placing a wipe inside the trays

reduces the danger of damaged medical instruments through rough

handling significantly.

Note: Moisture absorbent wipe has no barrier function like medical

non-woven for packing and sterilization. It is made of a special water

absorbing non woven.

Order information: Absorbent trayliner 50 g/m²


890232 4FZBH530201 25 x 30 1000

890223 4FZBH530202 30 x 50 500

Absorbent trayliner - no barrier packaging

Avoids wet trays and protects your instruments

6-30-0 E 07/2004 Rev. 0

www.vp-group.de

Indicator and fixing tapes can be used in a variety of ways by the cssd´s. They can be used with all packaging systems like crepe wrapping paper und non-woven materials. The indicator-ink shows by the change of color clearly if the sterile good has been inside the sterilisation process. Approximately 5 cm long pieces of tape are enough for fixing the package around the sterile good. The blue coloured strong adhesive tape provides high tack and is especially suitable for non-wovens, the beige-coloured is for crepe wrapping paper. Storage instructions are printed on the cardboard box. All tapes with and without indicator have a shelf life of 1 year after manufacture an are destined for single use only. Use only non-toxic and sterilisation-proofed pencils for writing on the tapes! Please note: Do not stick pieces of tape to metal surfaces e.g. sterilisation containers. Residues of the adhesive could be left. These contaminations are not easy to remove. Indicatortapes 19 mm x 50 m

Order-No. Article-No. Description Pack (reels) 1084 4FZBH421001 STEAM 48 1083 4FZBH421003 STEAM, strong adhesive, blue,

for non-woven 48 1086 4FZBH421002 EO 48

890102 4FZBH421005 Dry heat 48 Indicatortape 25 mm x 50 m

Order-No. Article-No. Description Pack (reels) 1093 4FZBH421004 STEAM 36

Fixing tapes without indicator

Order-No. Article-No. Description Pack (reels) 1096 4FZBH422001 19 mm x 50 m 48

1096-03 4FZBH422004 19 mm x 50 m, strong adhesive, blue, for non-woven 48

1097 4FZBH422002 25 mm x 50 m 36 890311 4FZBH422005 50 mm x 50 m 20

7-11-0 E 04/2004 Rev. 0

Indicator- and fixing tapes

For STEAM, EO and dry-heat sterilisation

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Indicatorstrips are a reasonably priced method for sterilisation-control and documentation. The indicator strips conform to DIN EN 867 respectively Class 1 (ISO 11140). Via change of color processindicators show clearly the sterilisation process has been passed. On the indicatorstrips is plenty space fields of documentation, for lot, autoclave, content, decay, OK/Fail and signature. The steamstrips are available in a self-adhesive version, too. The indicators are non-toxic. Indicatorstrips are for single-use only. Shelf life is two years from date of manufacture. Please be careful: direct contact of the indicator ink to metal surfaces may lead to malfunction. The date of manufacturing and the storage conditions are printed on the cardboard box.

Indicatorstrips – Size 150 x 30 mm

Order-No. Article-No. Description Pack (pcs.)

1079 4FZBH410001 Steam, self-adhesive 250 1092 4FZBH410002 Steam 250 1087 4FZBH410003 Formaldehyd 250 1098 4FZBH410004 EO 250

Indikatorstrips - STEAM, EO and Formaldehyd

The easy and reasonably priced method of documentation

7-12-0 E 04/2004 Rev. 0

www.vp-group.de

Containerfilter - CE, EN 868

Container filter are a reliable barrier against bacteria. The indicator allows easy identification of sterilized or non

sterilized goods. The indicator changes from pink to brown and is non-toxic. Shelf life is two years from date of

manufacturing. Filter are for single use only. Attention: Not suitable for MARTIN-container!

Containerlabel - DIN EN 867-2

Container labels can be fixed into the insert on the outside of the container. The indicator

changes from pink to black and is non-toxic. Documentation fields for sterilisation date,

expiry Date, Autoclave, Charge/Lot and Name are printed on the labels for easy

documentation. Shelf life is two years from manufacturing. Instructions for storage are

printed on the package.

7-13-0 E 08/2004 Rev. 1

Accessories for sterile containers

Container filter and label


1078 4FZBH511001 115 x 230 mm,

with sloped edges , with STEAM indicator

1000

1094 4FZBH511002 230 x 230 mm,

without indicator 500

1095 4FZBH511003 230 x 230 mm,

with sloped edges and STEAM-indicator

500

890131 4FZBH511004 230 x 230 mm,

without print, without indicator, rectangular

2000


1091 4FZBH521002 40 x 60 mm,

for Wagner-container 1000

890099 4FZBH521001 39 x 67 + 15 mm flap,

for Aesculap-container 1000

www.vp-group.de

Indicatorlabels and –points are an easy way for the documentation of sterile goods. The colour change

of the indicators clearly shows if the medical good has been in the sterilization process or not.

Instructions for storage are printed on the packaging.

Order-No. Article-No. Size in mm Description Pack (pcs.)

1085 4FZBH431001 75 x 25 STEAM and

Ethylenoxydlabels, on reels

3 x 3000

1090 4FZBH431002 75 x 25 Formaldehydlabels,

on reels

3 x 3000

480010 4FZBH431003 36 x 60 STEAM-labels for PC

printers, with perforated margin, stack

4500

890080 4FZBH431004 16 x 22 FormaldehydPoints

5000

890082 4FZBH431005 Ø 12,5 Indicatorpoints for beta

and gamma-sterilization 10000

890083 4FZBH431007 Ø 15 STEAM-

Indicatorpoints

5000

Indicatorlabels and indicatorpoints

For STEAM, Formaldehyd- and Gamma-sterilization

7-14-0 E 08/2004 Rev. 1

www.vp-group.de

The Bowie & Dick tests system DIN A 4 is intended to check the steam penetration of steam sterilizers during the daily Bowie Dick Test. The test system is suitable for the use with the Bowie & Dick – test program (temperature: 134°C / time 3,5 minutes) provided from steam sterilizers with pre-evacuation steps. The test system consists of 3 components: The test sheet, the test pack and the stainless steel test frame. The Bowie & Dick test sheet DIN A 4 was the first certified by third party testing. The test sheet fulfils the performance requirements of the EN 867-3. The indicator is free of heavy metals. The initial colour is blue, the transition colour is pink. After transition the colour of the indicator remain unchanged. Your documentation is absolutely safe. The shelf live of the test sheet is 4 years from the time point of production. The test pack is made from special filter paper which is reusable for 15 times. The sheet above is printed with sterilization stable ink, the print pattern provides appropriate guidance for documentation. An additional indication of the centre of the test pack via cut edges makes placement and replacement of the test sheet very simple. The stainless steel test frame is reusable for at least unlimited times. Bowie & Dick Test System DIN A 4


1101 4FZBH312001 Bowie & Dick test sheet DIN A 4 100

1020 4FZBH313001 Test pack DIN A 4 5

1021 4FZBH720010 Stainless steel test frame 1

Bowie & Dick – Test System DIN A 4

The utmost challenge for your sterilizer

7-20-0 E 04/2004 Rev. 0

www.vp-group.de

Using the steriCLIN® single test pack you are able to perform the daily Bowie & Dick test in an effective and simple way: Place the test pack in your sterilizer, run the Bowie & Dick test program of your sterilizer, replace the test pack, check the result – that’s all. The advantages of the single test pack are absolute safe in handling and reproducible in results. The single test pack complies to the requirements of the EN 867-4: Independently tested and certified by third party. The certificate is available at our website www.vp-group.de The inserted test sheet changes colour from blue to pink during a proper sterilization. This colour change is not reversible. Due to that your documentation is absolutely safe. The indicator is free of heavy metals. The instructions for use are printed onto the test pack, both in English and German language. Space for fill in sterilizer no. and name enables the traceability of the test pack. Further information concerning date of production, shelf live, lot no. and recommended storage conditions are given on the back side of each single test pack. The steriCLIN® single test pack’s shelf live is 4 years from the time point of production. Bowie & Dick Single Test Pack


1124 4FZBH311001 Bowie & Dick Single Test Pack 20

7-21-0 E 08/2004 Rev. 1

Bowie & Dick Single Test Pack – certified to EN 867-4

Easy handling - reliable - free Of Heavy Metals

www.vp-group.de

The Bowie & Dick tests system DIN A 5 is intended to check the steam penetration performance of your steam sterilizers whilst run the daily Bowie & Dick Test. The test system is suitable for the use with the Bowie & Dick – test program (temperature: 134°C / time 3,5 minutes) provided from steam sterilizers with pre-evacuation steps. The test system consists of 3 components: The test sheet, the test pack and the stainless steel test frame. The Bowie & Dick test sheet format DIN A 5 is printed with indicator extensively in order to simplify indication of errors within the sterilization process. The indicator is free of heavy metals. The initial colour is blue, the transition colour is pink. After transition the colour of the indicator remain unchanged. Your documentation is absolutely safe. The shelf live of the test sheet is 4 years from the time point of production. The test pack is made from special filter paper which is reusable for 15 times. The sheet above is printed with sterilization stable ink, the print pattern provides appropriate guidance for documentation. An additional indication of the centre of the test pack via cut edges makes placement and replacement of the test sheet very simple. The stainless steel test frame is reusable for at least unlimited times. Bowie & Dick Test System DIN A 5


1111 4FZBH312005 Bowie & Dick test sheet DIN A 5 200

1220 4FZBH313004 Test pack DIN A 5 10

1221 4FZBH720013 Stainless steel test frame 1

7-22-0 E 04/2004 Rev. 0

Bowie & Dick – Test system DIN A 5

The utmost challenge for your sterilizer

www.vp-group.de

Batch cards size DIN A5

Order-No. Article-No. Sterilization Pack (pcs.) 1012 4FZBH441001 STEAM 600 1014 4FZBH442001 Formaldehyde 100

Batch cards size DIN A4

Order-No. Article-No. Sterilization Pack (pcs.) 1001 4FZBH441002 STEAM 100

Special labels

Order-No. Article-No. Sterilization Pack (pcs.) 1002 4FZBH433001 STEAM 1.000 1008 4FZBH433002 Formaldehyde 1.000

Patient forms

Order-No. Article-No. Pack (pcs.) 1009 4FZBH450001 500

Instructions for use:

1. Write all pack-related data on the two-part-

label, write batch related data on the

batchcard.

2. Stick the main part of the label onto the pack,

the other part of the label onto the batchcard.

3. When sterile goods are used in theatre,

transfer the label from the pack into patients

form. The unique serial number on both parts

of the label allows easy, accurate tracing

backwards from the patients file to the

sterilising batch and records!

7-30-0 E 08/2004 Rev. 2

Patient-related batch traceability documentation system

The simple and perfect system to trace sterile goods!

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The steriCLIN® IN-Step is a chemical indicator

specially designed for batch- and tray-control. It is

suitable for the most commonly used programs for

steam sterilizers at 134°C for 5 minutes.

The Stericlin IN-Step allows the control and

compliance of all important sterilisation parameters

directly within or beside the medical device.

Independent from the sterilizers monitoring and control

of the process! It is important to use chemical

indicators - even in validated sterilisation processes -

in additional to parametric process monitoring because

the monitoring and control of the sterilizer takes place

in the steam supply pipe or at the chambers sides. The

IN-Step however can be placed directly or beside the

medical device and gives independent valuable

information about the process.

The Stericlin IN-Step meets the standards for class 6 indicators according to the ISO 11140-1. Class 6 is the highest

classification for chemical indicators.

Batch control with the IN-Step: You get an exact image of the sterilisation conditions at different locations in the sterilizer chamber with the IN-Step. The IN-

Step compliments the parametric process monitoring and thus your sterilization documentation.

Place two or three IN-Step at different locations in the chamber if the load is 4 STE. We recommend to use four or more

IN-Step devices if the load is more than 8 STE.

The placement of the IN-Step indicator inside the chamber covers ideally all three dimensions: the upper half of the

chamber, the lower half of the chamber and the lower third near the door.

Tray control with the IN-Step: For especially critical medical devices to be sterilized (e. g., big porous loads or extra heavy trays) you may place one or

more IN-Step within the tray for additional security. The IN-Step will be controlled by surgical team while the tray is opened

for use.

steriCLIN® IN-Step

The absolutely essential basis of your batch control

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The steriCLIN® IN-Step system – single components: The IN-Step system is made up of three components: the IN-Step indicator, the IN-Step Fixing System and DocuSafe,

which is for the orderly documentation of all important sterilisation related daily data, respectively the Protocol Sheet for

IN-Step.

The IN-Step indicator: The IN-Step´s sandwich shaped design includes printed sterilization paper sealed with special film on the front and on the

back side. The print of the indicator appears bright blue before and bright pink after sterilization. There are two indicator

prints: an inner and an outer print. Whereas the outer indicator print is easy to penetrate by steam, the inner will be

penetrated by passing a narrow channel. This design is called a PCD (Process Challenge Device) which represents a

torturous path for steam penetration.

There is space available on the IN-Step to note all important sterilization related data with an appropiate sterilization-proof

pencil. The shelf life of the IN-Step is 2 years. Information about date of production and storage conditions are to be found

on the package.

IN-Step Fixing System: The IN-Step´s Fixing System consists of sterilization-proof cardboard with two precise cuts intended to accept the

IN-Step while it is pushed within. Subsequently this unit is to be placed into between the load or into trays. The numbers

printed on the cardboard document the cycles already passed. The IN-Step Fixing System can be reused ten times and

facilitates the recovery of the IN-Step after the sterilization cycle is complete.

DocuSafe – a file for release documents / Protocol Sheet for IN-Step: DocuSafe is intended to file the daily sterilizer related documentation of all release documents (e. g. sterilizer protocol,

IN-Step protocol or the daily Bowie & Dick-test). This tool is designed as an envelope, printed on both sides, size C 4,

four times perforated and to be closed by a self adhesive closure.

For documentation you can use the Protocol Sheet for IN-Step.

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How does the IN-Step work? In order to achieve the required sterilization level, all sterilization parameters (temperature, saturated steam and penetration

time) shall be maintained throughout the sterilizer chamber. The IN-Step simulates a difficult to sterilize good. The

challenge for the sterilizer is: evacuating the air from the non-sealed areas and penetrating with saturated steam of

sufficient quality and time. Parameter deviations from appropiate levels are indicated by the IN-Step via different colour

changes. Interpretation of these different colour changes may lead to likely faults.

What kind of information does the IN-Step provide for the indication of errors within the sterilization process?

1. In case both indicator prints remain blue after sterilization process, it is shown that fairly no steam with appropiate

quality penetrates the indicator. Either no sterilization process took place or the process parameters failed to reach the

stated values.

2. In case the outer indicator print turned to pink whereas the inner does not or partly indicates not sufficient steam

penetration or air removal respectively.

3. In case the colour change turns out vice versa the inner indicator appears pink and the outer one blue indicates a very

humid process (i.e. wet process). Water coats the outer indicator print and prevents a complete colour change after the

inner indicator print has been penetrated with sufficient quantity of steam to cause the change of colour.

4. Only if all relevant parameters reach their optimum do both indicator prints turn uniform from bright blue to pink.

.

In case the colour of the IN-Step indicates some error, not only should the sterilizer be checked for correct function, but load

configuration and packaging of medical devices should too. Here as well faults may be caused.

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steriCLIN® IN-Step – order information:

Order.-No. Article-No. Description Pack (pcs.)

1140 4FZBH340001

Stericlin IN-Step batch control system,

For use in 134° for 5 minutes, with Fixing System

250

1320 4FZBH313008

Fixing System, for Stericlin IN-Step,

ten times reusable

100

1150 4FZBH341001

DocuSafe envelopes to file release documents

Size C 4, with self adhesive closure, four times perforated.

100

1151 4FZBH341002

Protocol sheet for Stericlin IN-Step,

Size A 4, four times perforated

100

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Instructions for use Arrangement: Fill in all relevant information onto the IN-Step with a sterilization-

proof pencil. Combine the IN-Step with the Fixing System (front or

backside) and mark the number of cycles the IN-Step has been

reused. Please note: The Fixing System is made from cellulose

and thus with additional cycles discoloration and deformation will

appear. It is important that the IN-Step gets fixed rigidly in the

Fixing System. The Fixing System is ten times reusable and can

be disposed of simply via waste paper basket subsequently.

Accomplishment: You may use as many IN-Step at the same time as you like,

placing each at different locations inside the sterilizer chamber or inside trays. After the sterilization cycle, the Fixing System

is rather helpful to find the IN-Step again.

After Sterilization: After running the sterilization cycle, please check the colour turn of the IN-Step comparing it with the IN-Step colour change

limit chart: In order to note the different colour shades more easily, please use a white back-ground to lay down the IN-Step

for inspection. The colour change reaction of the IN-Step is not reversible. Sufficient for documentation is to write down the

result and have the operator and supervisor sign the results.

Documentation: File to document the IN-Step results just like you would with daily tests (e.g. Bowie & Dick-testsheets).

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The container seals are available in pre-punched sheet of cardboard. One sheet contains 10 pieces of seals. The backside

is partial covered with an adhesive film. On the following draft (B) the adhesive film is hatching. Container seals give a

safety and clear indication that the container has not been opened.

A. Mode of Application – Removing the seal

1. Pull off the protective backing paper from the reverse side of the

cardboard sheet. 2. Press the seals through the pre-punched areas. 3. Now the seal is ready to use.

B. Application to the Container and Closing

1. The small strip of the seal must be pulled through the lock loop of the container (1).

2. The strip has to be lead back onto the adhesive surface. Now the

adhesive lock has to be bend over at the perforation for bringing the seals surfaces together (2).

3. Now the container seal is closed. For opening the container the seal

has to be broken (3).


48-0016-01 4FZBH530001 white colour code 2000 48-0016-02 4FZBH530002 red colour code 2000 48-0016-05 4FZBH530005 blue colour code 2000 48-0016-03 4FZBH530003 white seal with steam

indicator 2000

48-0016-04 4FZBH530004 thin seal white 2000 48-0016-07 4FZBH530007 thin seal with steam indicator 2000

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Container integrity paper seals

The easiest way to check the container´s integrity

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Indicator and fixing tapes can be used in a variety of ways Dust-cover-bags

offer the best protection for the primary and secondary packaging during

transport and storage. The bags are made of transparent Polyethylene-film.

Order-No. and size are printed on the front side, the print is plain blue. There

are documentation fields for name, signature, expiry date and notes.

A reusable self-seal closure allows fast and save closing of the bag.

Sterile packs must be cool and dry before packed into dust-cover-bags. We

recommend to dry and cool down the sterile packs for 24 hours before

packaging into the dust cover bags. Before opening the transport packaging

remove all dust from it.

steriCLIN® Dust cover bags


3030 4FZBH650001 20 x 30 + 5 1000 3034 4FZBH650005 20 x 75 + 5 500 3038 4FZBH650009 25 x 40 + 5 500 3039 4FZBH650010 25 x 120 + 5 500 3031 4FZBH650002 30 x 50 + 5 500 3032 4FZBH650003 42 x 70 + 5 500 3040 4FZBH650011 60 x 50 + 5 100 3033 4FZBH650004 60 x 75 + 5 100 3041 4FZBH650012 70 x 100 + 5 100

8-10-0 E 04/2004 Rev. 0

Dust cover bags from steriCLIN®

The best solution for transport and storage of sterile goods

Products for Hospitals

Documents

Transcript of Products for Hospitals