hygiene for the cleanroom environment....hygiene for the cleanroom environment. ... the cleaning and...

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Hygiene for the cleanroom environment.The perform® concept for maximum performance in hygiene quality.

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Sterile, alcohol-based ready-to-use solution

perform® sterile alcohol IPA

Sterile, sporicidal ready-to-use solution

perform® sterile PAA

Sterile, alcohol-based ready-to-use solution

perform® sterile alcohol EP

Sterile, alcohol-based wipes

perform® sterile wipes IPA

Clean solutions for clean rooms.

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Our major plus – competence in hygiene.

To realise our philosophy schülke‘s competences embrace GMP, ISO, EMAS certifications and awards.

GMP...We follow the European standards for “Good Manufacturing Practice for drugs (GMP) and are regularly audited by official drug authorities, which is documented by a GMP certificate.

ISO certified...Our quality management system is certified according to the international standard for Quality Management Systems ISO 9001. We also manufacture medical devices according to the international standard for Quality Management Systems ISO 13485.

Environmental consciousness...We have implemented a validated environmental management system according to the Interna-tional Standard for Environmental Management Systems ISO 14001. This management system is also validated by to the European Management and Audit Scheme (EMAS). Responsible Care...Our commitment to customer satisfaction and services was rewarded by the chemical association of North Germany. The association presented us with the Responsible Care Award – “Responsible Care” is a world wide initiative of the chemical industry to take care of environment, health and safety – during manufacture, transport and use.

For more than 125 years, our company philosophy has been centred around one concept: hygiene.

As we are a chemical and pharmaceutical company, our products and services protect people and materials from infection and contamination.

Our world is changing, distances are becoming shorter and borders are opening. Not only are people travelling freely from one country to another, micro-organisms are increasingly popping up as the stowaways of globalisation. The associated risks are frequently underestimated.Dangerous gaps develop in the hygiene chain, our aim is to close these gaps by means of our holistic approach. We offer effective products, competent advice and comprehensive services.

Two of our most important values are sustainabi-lity and responsibility. We advocate a sustainable and responsible approach to our natural re-sources, our environment and our health. The guideline for our daily activities is the codex of the German Association for Environmentally Friendly Management. Every two years we publish our environmental programme in the form of Environmental Declarations. These are regularly monitored for achievement of the targets set. These statements of our Company philosophy form the foundation of the environmental management system introduced in 1996.

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We are the right partner for you in the sphere of biotechnology, pharmaceuticals, cosmetics, medicinal product manufacture or life science. The cleaning and disinfection of cleanrooms places strict demands on the products and cleaning equipment used.

As in the manufacture of hygienically sensitive products, here too the relevant GMP guidelines and recommendations, standards and directives must be taken into account.

The production process for any individual company requires properly targeted cleaning and disinfection measures. For this reason, production hygiene in the cleanrooms and other production areas concerned requires the use of a variety of cleaning agents and disinfectants.

Cleaning and disinfection of cleanrooms

Our perform® product range will comprehensively cover your individual needs:

“We understand our customers because we produce to the same high standards - GMP“

GMP

TQM ISO 13485 ISO 9001

EMAS Environment ISO 14001

Responsible Care Award

perform® sterile

perform® advanced

perform® classic

perform® select

Cleanroom hygiene

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Product range

The availability of individual products may vary from one country to another.Details are obtainable locally.

Contents Page

Production hygiene

perform® sterile

perform® sterile alcohol EP – perform® sterile alcohol IPA – perform® sterile wipes IPA – perform® sterile PAA – perform® sterile concentrate PAA – perform® sterile concentrate OXY – perform® sterile concentrate Q2 – perform® sterile concentrate QB – perform® sterile cleaner ND

6 – 9

perform® advanced

perform® advanced alcohol EP

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perform® classic

perform® classic alcohol EP – perform® classic wipes EP – perform® classic alcohol IPA – perform® classic wipes IPA – perform® classic concentrate Q-Plus – perform® classic concentrate OXY –perform® classic concentrate GA – perform® classic concentrate QB – perform® classic concentrate PAA

10 – 13

perform® select

perform® select H2O2 – perform® select soproper – perform® select bactipal 3.5 HP

13 – 14

Cleaning equipment

perform® sterile dry wipes – perform® sterile premium dry wipes – perform® sterile mix dry wipes – perform® classic mix dry wipes –stainless steel mop and mop head – system trolley clino CR

15 – 17

Personal hygiene

Skin and handsdesmanol® pure – sensiva® wash lotion – sensiva® protective emulsion

18 – 19

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Production hygiene – perform® sterile

Use disinfectants safely. Always read label and product information before use.

With our perform® sterile range we offer you a targeted selection of sterile products with a broad spectrum of action and containing active substances compliant with biocide directives. These provide you with optimum safety and the possibility of rotating use in the cleanroom.

All products of the perform® sterile range are gamma-irradiated or aseptically filled and therefore comply with the strictest requirements for use in cleanroom areas. To facilitate introduction into cleanrooms through airlocks, all products in this range are double baged.

perform® sterile alcohol EPSterile, alcohol-based solution for surface disinfection in cleanrooms.

Our plus Container size Case• fast, effective and residue free

• gamma-irradiated and microbial filtered (0.2 µm)

• ready to use in handy, sterile 500 ml spray bottle

• color and perfume free

• effective against bacteria, fungi and enveloped viruses (BVDV/Vaccinia)

• efficacy according to European norms

500 ml bottle x 10

perform® sterile alcohol IPASterile, ready-to-use 70 % (v/v) IPA solution for surface disinfection in cleanrooms.







• optional with / without WFI

500 ml bottle x 10

500 ml bottle (with WFI) x 10

1 litre bottle x 6

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perform® sterile

perform® sterile wipes IPASterile, ready-to-use 70 % (v/v) IPA impregnated wipes for surface disinfection in cleanrooms.


• sachet of 20 x ready-to-use alcohol impregnated wipes

• sterile and gamma-irradiated




• low particle tested (Helmke Drum test method)

• 23 x 23 cm

20 pc bags x 20

perform® sterile PAASterile, ready-to-use solution based on peracetic acid for surface disinfection in cleanrooms.

Our plus Container size Case• fast, effective and sporicidal

• aseptically filled and microbial filtered (0.2 µm)



• effective against bacteria, fungi, spores and enveloped viruses

(BVDV/Vaccinia)


500 ml bottle x 10

perform® sterile concentrate PAASterile, liquid concentrate based on peracetic acid for surface disinfection in cleanrooms.

Our plus Container size Case• fast, effective and sporidical

• aseptically filled and microbial filtered (0.2 µm)

• convenient single-use bottle



(BVDV/Vaccinia)


40 ml x 20

(Bottles are individually double baged

for ease of introduction through airlock)

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perform® sterile concentrate Q2Sterile, liquid concentrate for disinfection and cleaning surfaces, based on a combination of quaternary ammonium compounds and amine derivatives.

Our plus Container size Case• disinfection and cleaning in one step

• gamma-irradiated and microbial filtered (0.2 μm)




• rinses off residue-free


5 x 60 ml x 4

(Double baged in sets of 5 bottles)

perform® sterile concentrate QBSterile, liquid concentrate based on quaternary ammonium compounds and biguanide for surface disinfection in cleanrooms.

Our plus Container size Case• fast and effective




• effective against bacteria, yeasts and enveloped viruses (BVDV/Vaccinia)


5 x 40 ml x 4


perform® sterile concentrate OXYSterile, concentrated powder based on active oxygen for surface disinfection in cleanrooms.

Our plus Container size Case• sporicidal and material-compatible

• gamma-irradiated

• convenient single-use sachets

• color free


(BVDV/Vaccinia)


5 x 40 g sachets x 10


perform® sterile

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Looking for high quality products but do not need sterile products?

Then products of the perform® advanced range are just what you need. They comply with guidelines on biocides and are microbial filtered.

perform® advanced

perform® sterile cleaner NDSterile, ready-to-use solution based on non-ionic surfactants for surface cleaning in cleanrooms.

Our plus Container size Case• ready to use


• convenient sterile 500 ml spray bottle


• excellent cleaning performance

500 ml x 10

perform® advanced alcohol EPMicrobial filtered, alcohol-based ready-to-use solution for surface disinfection in cleanrooms.


• microbial filtered (0.2 µm)

• ready to use




1 litre bottle x 10

10 litre canister x 1

Indivdually baged spray pump for 1 litre bottles x 10

perform® sterile

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Our perform® classic range of products offers you a comprehensive selection of active substances with a broad spectrum of action and possible applications, conforming with biocide regulations.


perform® classic

perform® classic alcohol EPAlcohol-based ready-to-use solution for surface disinfection.


• ready to use




1 litre bottle x 10


200 litre barrel x 1

perform® classic wipes EPReady-to-use impregnated wipes for surface disinfection.

Our plus Container size Case• fast and effective and residue free

• generous supply of 200 (almost A4 size) jumbo cloths per container




200 wipe tub x 10

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perform® classic


perform® classic alcohol IPAReady-to-use 70 % (v/v) IPA solution for surface disinfection in cleanrooms.


• ready to use




1 litre bottle x 10


Available

Soon

perform® classic wipes IPAReady-to-use 70 % (v/v) IPA impregnated wipes for surface disinfection.

Our plus Container size Case• fast and effective and residue free

• generous supply of 200 (almost A4 size) jumbo cloths per container




200 wipe tub x 10

Available

Soon

perform® classic concentrate Q-PlusLiquid concentrate based on quaternary ammonium, aromatic alcohols, non ionic surfactants and amphoteric glycine derivative for surface cleaning and disinfection.

Our plus Container size Case• effective and cleansing

• good material compatibility




2 litre bottle x 5


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perform® classic concentrate OXYPowder concentrate based on active oxygen for surface disinfection.

Our plus Container size Case• sporicidal and material-compatible

• convenient single-use sachet

• color free


(BVDV/Vaccinia)


40 g sachet x 250

perform® classic concentrate GALiquid concentrate based on aldehydes for disinfection of surfaces and equipment.

Our plus Container size Case• foam-free and effective

• good material compatibility

• residue-free rinsing

• suitable for equipment disinfection (e.g. in CIP systems)




200 litre barrel x 1

perform® classic concentrate QBLiquid concentrate based on quaternary ammonium compounds and biguanide for surface disinfection.

Our plus Container size Case• fast and effective


• effective against bacteria, yeasts and enveloped viruses (BVDV/Vaccinia)


2 litre bottle x 5



perform® classic

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The products of our perform® select range are specially designed for selected uses like bio-decontamination of rooms or equipment using vapour technology or for use in isolators/transfer hatches.

perform® select

perform® classic concentrate PAALiquid concentrate based on peracetic acid for surface disinfection in cleanrooms.

Our plus Container size Case• fast, effective and sporidical




(BVDV/Vaccinia)


40 ml bottles x 12

perform® select H2O2High purity, ready-to-use solution based on hydrogen peroxide for bio-decontamination of rooms and equipment using Hydrogen Peroxide Vapour (HPV).

Our plus Container size Case• high level bio-decontamination (incl. spores) of rooms and equipment

• for use in machines with vapour technology

• residue free

900 ml bottle x 4



perform® classic

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perform® select

perform® select soproperReady-to-use solution based on peracetic acid for disinfection of surfaces in isolators/transfer hatches using vapour technology.

Our plus Container size Case• ready to use

• residue free


(BVDV / Vaccinia)


900 g bottle x 4

5 kg canister x 1

perform® select bactipal 3.5 HPReady-to-use solution based on peracetic acid for disinfection of surfaces in isolators/transfer hatches using spray technology.

Our plus Container size Case• high puritiy

• ready to use

• residue free


(BVDV / Vaccinia)


900 g bottle x 4

5 kg canister x 1

25 kg canister x 1

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Cleaning Equipment

Cleanroom-compatible materials, autoclavable equipment and optimum ergonomics – just some of the requirements for the cleaning equipment to be used in cleanrooms.

Here we offer you a mutually compatible selection of cleanroom cloths, mop heads and system trolleys.

perform® sterile dry wipesSterile, cleanroom-compatible dry wipes. 100 % polyester.

Our plus Container size Case• low-particle gamma irradiated wipes

• 100 % polyester

• suitable for cleanrooms A/B

• tested compatibility for products in the perform® range

• double baged in convenient softpacks of 10

• 30 x 30 cm

10 pc bags x 10

perform® sterile premium dry wipesSterile, cleanroom-compatible dry wipes. 100 % polyester.


• 100 % polyester



• triple baged in packs of 10 x 10

• 30 x 30 cm

10 x 10 pc bags x 10

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Cleaning Equipment

Basic and continuing hygiene education in production

All employees are responsible for hygienic production con- ditions. Training in the field of hygiene is therefore indispen-sable for personnel as part of basic and continuing education.

We offer you in-depth training on a wide variety of topics through our sales force team.

And to make sure that the surfaces really do become germ-free, it is decisive to use not only the right products but also the correct form of application. We show you how to use our products properly and thereby achieve your desired cleaning and disinfection goals.

perform® sterile mix dry wipesSterile, cleanroom-compatible dry wipes. 55 % cellulose, 45 % polyester.


• 55 % cellulose, 45 % polyester



• triple baged in packs of 5 x 20

• 30 x 30 cm

5 x 20 pc bags x 10

perform® classic mix dry wipesCleanroom-compatible dry wipes. 55 % cellulose, 45 % polyester

Our plus Container size Case• low-particle wipes

• 55 % cellulose, 45 % polyester

• suitable for cleanrooms C/D


• 30 x 30 cm

150 pc bags x 10

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Cleaning Equipment

DosageCal

As well as using our dosing devices, you can also easily calcu-late your ready-to-use solutions online and offline with our DosageCal.

At www.dosage-calculator-schuelke.com you can conveniently determine the amounts of concentrate you need for your floors by computer, tablet or smartphone.

And the best part: you can use the calculator anytime and anywhere – even when you have no internet reception! www.dosage-calculator-schuelke.com

stainless steel mop and microfibre mop headCleanroom-compatible mop head.

Our plus More information• autoclavable

• cleanroom compatible special microfibre-based yarn

• ensures safe disinfection by uniform wetting

• can be washed and reused

• ergonomic

For more information please speak to your

local representative.

system trolley clino CRCleaning system trolley.

Our plus More information• autoclavable

• stainless steel

• model adjustable for specific applications

• GMP-compliant

• certified by Frauenhofer IPA, Stuttgart

For more information please speak to your

local representative.

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Personal hygiene

In addition to production hygiene, personal hygiene in particular plays an important role.

The main focus of attention is skin, hand cleansing and disinfection.

Use disinfectants safely.Always read label and product information before use.

desmanol® pureReady-to-use alcoholic rub for hygienic and surgical hand disinfection.

Our plus Container size Case• broad spectrum of efficacy (incl. viruses)

• with bonus of skin protection and care through an innovative formulation

(Dexpanthenol + Ethylhexylglycerin)

• color and fragrance free, therefore kind to the skin

• dermatologically approved

100 ml bottle x 30

500 ml bottle x 20

1 litre bottle x 10


sensiva® wash lotionSkin-friendly color- and perfume-free wash lotion.

Our plus Container size Case• soap-free wash lotion on basis of skin-compatible surfactants

• gentle on skin • mild cleaning

• color, perfume and lanolin free

• dermatologically tested

500 ml bottle x 20

1 litre bottle x 10

sensiva® protective emulsionColor- and perfume-free lotion for normal skin.

Our plus Container size Case• soft skin care • moisturizing • fast absorbing • easy to spread

• does not reduce the action of hand disinfection (desderman® pure

and desmanol® pure)


• dermatologically tested

150 ml bottle x 30

500 ml bottle x 20

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Effective solutions for hands and skin.

In cleanrooms and pharmaceutical production, no instrument is as important with respect to hygiene as the human hand. Those who are in constant contact with equipment require optimal, antiseptic protection with simultaneous comprehensive care for the skin.

The right protection for your most valuable instruments.

The hand is the most versatile tool in the worldand the most important for human beings.Despite all modern technology, the human hand is in constant use in cleanrooms and other production areas and in permanent contact with equipment.

Hand hygiene is therefore the most important preventative measure. Hand hygiene routines demand products that are specially formulated to care for and protect stressed skin whilst conserving natural moisture.

1 2 3

Run right palm over the back of the left hand – and vice versa.

Rub palm to palm, additionally rub the wrists.

Rub palm to palm with interlaced spread fingers.

4 5 6

Rub the backs of theinterlocked fingers onthe opposing palms.

Rub the closed fingertips of the right hand on the left palm using a circular motion – and viceversa.

Rub the right thumb in the closed palm of the left hand using a circular motion – and vice versa.

Hygienic hand disinfection

Standard rubbing technique for hygienic hand disinfection in accordance with EN 1500.

Make sure that the hands remain moist during the entire contact time. If necessary, apply more hand disinfectant.

For hygienic hand disinfection, apply the hand disinfectant onto cupped dry palms and rub in up to the wrists for 30 seconds following the steps listed above. Please pay special attention to fingertips and thumbs.

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Schülke & Mayr GmbH22840 Norderstedt | GermanyPhone | Fax +49 - 40 521 00 - 0 | -318www.schuelke.com

schülke worldwide:

... plus our international distributors

A company of the Air Liquide Group

AustriaSchülke & Mayr Ges.m.b.H.1070 ViennaPhone +43-1-523 25 01 0Fax +43-1-523 25 01 60

NetherlandsSchülke & Mayr Benelux B.V.2031 CC HaarlemPhone +31-23-535 26 34Fax +31-23-536 79 70

United KingdomSchülke & Mayr UK Ltd.Sheffield S9 1ATPhone +44-114-254 35 00Fax +44-114-254 35 01

ChinaShanghai Representative Office Shanghai 200041Phone +86-21-62 17 29 95Fax +86-21-62 17 29 97

PolandSchulke Polska Sp. z o.o.01-793 WarsawPhone +48-22-568 22 02-03Fax +48-22-568 22 04

FranceSchülke France SARL92800 Puteaux, Paris La DéfensePhone +33-1- 42 91 42 42Fax +33-1- 42 91 42 88

RussiaMoscow Representative Office123001, MoscowPhone +74-99-270-58-75Fax +79-62-902-77-15

SingaporeSchülke & Mayr (Asia) Pte. Ltd.Singapore 159410Phone +65-62-57 23 88Fax +65-62-57 93 88

IndiaSchulke India Pvt. Ltd. New Delhi 110044 Phone +91-11-40 55 02 00Fax +91-11-40 55 02 01

ItalySchülke & Mayr Italia S.r.l.20148 MilanPhone +39-02-40 26 590Fax +39-02-40 26 609

SwitzerlandSchülke & Mayr AG8003 ZurichPhone +41-44-466 55 44Fax +41-44-466 55 33

MalaysiaSchülke & Mayr (Asia) Sdn Bhd. 47301 Petaling Jaya, SelangorPhone +60-3-78 85 80 20Fax +60-3-78 85 80 21

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hygiene for the cleanroom environment....hygiene for the cleanroom environment. ... the cleaning and...

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