The production, filling and packing of these products take place in cleanrooms of various classes.

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11.1 IMPORTANT INFORMATION ABOUT General Information In microbiologically controlled areas disinfectants are some of the most important consumer goods.

The comprehensive and permanently increasing product range includes the following items amongst many others: sterile and non-sterile disinfectants for surfaces hand disinfectants sterile impregnated

Detailed technical data sheets or quality documentation for the offered products are available on request. Every delivery includes batch protocols/ certificates.

the sterility of the disinfectant is guaranteed for a minimum of 3 months upon opening and is validated accordingly.

1 11.1 IMPORTANT INFORMATION ABOUT General Information In microbiologically controlled areas disinfectants are some of the most important consumer goods. In this field we work closely with a competent partner, who has longstanding experience and a broad know-how: Shield Medicare Ltd a division of Ecolab. The comprehensive and permanently increasing product range includes the following items amongst many others: sterile and non-sterile disinfectants for surfaces hand disinfectants sterile impregnated wipes and mop wipes dispenser system products for training and test requirements The production, filling and packing of these products take place in cleanrooms of various classes. Detailed technical data sheets or quality documentation for the offered products are available on request. Every delivery includes batch protocols/ certificates. The SteriShield Delivery System: a closed construction without air contact in contrast to conventional "open" spray systems where the sprayed liquid is substituted with sucked in air. the sterility of the disinfectant is guaranteed for a minimum of 3 months upon opening and is validated accordingly. Advantages of the SteriShield Delivery System: Easy to handle: the liquid can be adjusted as a jet or spray. Economical: the systems allow all liquid to be dispensed from the bottle without wastage. Safe to use: larger droplets reduce the danger of inhalation. Optimal surface coverage: the larger droplets guarantee a complete moisturisation of the surface. Environmentally friendly: the packing does not contain any propellants and therefore it can be disposed of or recycled easily and safely without any purposal restriction.

11.2 STERILE ON ALCOHOL BASIS All compounds are initially filtered to 0.2 µm and filled under cleanroom conditions. The sterilisation is made with a minimum of 25 kgy. 0.5-/ 1-/ 5-l spray systems with the established SteriShield Delivery System.

Bottles and cans are double packed (WFI-Quality triple packed) in a foil/ PE bag and can be transferred immediately without any further afforts.

2 11.2 STERILE ON ALCOHOL BASIS All compounds are initially filtered to 0.2 µm and filled under cleanroom conditions. The sterilisation is made with a minimum of 25 kgy. 0.5-/ 1-/ 5-l spray systems with the established SteriShield Delivery System. Additionally we also offer 360 ml spray cans and 5 l canister capped without spray system. Bottles and cans are double packed (WFI-Quality triple packed) in a foil/ PE bag and can be transferred immediately without any further afforts. This product series is supplemented with sterile saturated wipes and mop wipes (see chapter 11.8). dispenser systems for canisters with spray device see chapter stainless steel dispenser for 4 l canister with spray system 2 alcohol in 500 ml, 1 l bottles and 4 l canisters Premier WFI Klercide 70 / % IPA 500 ml 12 bottles KW (IPA), sterile 30 % WFI 1 litre 6 bottles KW litre 4 canisters KW litre capped 4 canisters 360 ml spray can 24 cans KW Premier WFI Klercide 70/ % IMS 500 ml 12 bottles KW (IMS), sterile 30 % WFI 1 litre 6 bottles KW litre 4 canisters KW litre capped 4 canisters 360 ml spray can 24 cans KW Premier WFI Klercide 70 / % IMS 1 litre 6 bottles KW Pharma Ethanol, sterile 30 % WFI 4 litre 4 canisters KW litre capped 4 canisters KW Premier Klercide 70/ % IPA 500 ml 12 bottles KL (IPA), sterile 30 % DI 1 litre 6 bottles KL litre 4 canisters KL litre capped 4 canisters KL Premier Klercide 70 / % IMS 500 ml 12 bottles KL (IMS), sterile 30 % DI 1 litre 6 bottles KL litre 4 canisters KL litre capped 4 canisters KL

11.3 STERILE STERILE BIOCIDES All sterile biocides are filtered to 0,2 µm and than either

3 11.3 STERILE STERILE BIOCIDES All sterile biocides are filtered to 0,2 µm and than either gamma sterilised with a minimum of 25 kgy or according to a validated process aseptically filled. Products are available either in a 1 l spray bottle, or a 5 l canister capped or as concentrate capped (except Biocide C). Bottles and canisters are double packed in a foil/pe bag and can be transferred immediately without any further afforts. This product series is completed with sterile wipes and mop wipes (see chapter 11.8). Some biocides can be used with a fogging system (see chapter 13.7). 1 l spray system with the established SteriShield Delivery System fogging system 2 Biocide 1l bottles and 5 l canisters 3 Biocide in 50 ml and 1 l bottles

4 11.3 STERILE / STERILE BIOCIDES Premier Klercide-CR Biocide A Spray bottle Quaternary ammonium 1 litre 6 bottles KCR Canister capped compound and biguanide. 5 litre 4 canisters KCR Concentrate capped 5 litre 4 canisters KCR Premier Klercide-CR Biocide B Spray bottle Stabilised chlorine dioxide and quaternary ammonium compound. 1 litre 6 bottles KCR Canister capped/ ready to use 5 litre 4 canisters KCR Concentrate capped 5 litre 4 canisters KCR Premier-WFI Klercide-CR Biocide C Spray bottle 6 % hydrogen peroxide solution and WFI. 1 litre 6 bottles KCR Canister capped/ ready to use 5 litre 4 canisters KCR Premier Klercide-CR Biocide C Spray bottle 6 % hydrogen peroxide solution and DI. 1 litre 6 bottles KCR Canister capped/ ready to use 5 litre 4 canisters KCR Premier Klercide-CR Biocide D Spray bottle 1 litre 6 bottles KCR Amphoteric surfactant Canister capped/ ready to use 5 litre 4 canisters KCR Concentrate capped 5 litre 4 canisters KCR Premier Klercide-CR Biocide E (Chloroclens) Spray bottle Hypochlorite solution (0.5 % free chlorine) 1 litre 6 bottles KCR Canister capped 5 litre 4 canisters KCR Premier Klercide-CR Biocide S (Chloroclens) Concentrate in tablet form Sodium dichlorocyanide NaDCC (0.5 % free chlorine) 170 g tablets 12 cans KCR Premier Klercide-CR Biocide T (Inciclens) Concentrate in bag Glucoprotamin 20 ml bag 60 bags KCR Premier Klercide-CR Biocide X Quaternary ammonium Concentrate capped compound and biguanide. 50 ml bottle 50 bottles KCR Premier Klercide-CR Biocide Y Concentrate capped Amphoteric surfactant 50 ml bottle 50 bottles KCR

11.4 STERILE CLEANING AGENT FOR SURFACES Premier Klerclean-CR, sterile, neutral (non-ionic) cleaning agent Cleaning agent to remove oil or adhesive residues.

1 litre bottles with the established SteriShield Delivery System. This product series is completed with sterile wipes and mop wipes (see chapter 11.8).

5 11.4 STERILE CLEANING AGENT FOR SURFACES Premier Klerclean-CR, sterile, neutral (non-ionic) cleaning agent Cleaning agent to remove oil or adhesive residues. Preliminary filtered to 0,2 µm, filled under cleanroom conditions and double packed. The sterilisation is made with a minimum of 25 kgy. 1 litre bottles with the established SteriShield Delivery System. This product series is completed with sterile wipes and mop wipes (see chapter 11.8). Premier Klercide-CR sterile neutral detergent DI water and fat alcohol ethoxylate Spray bottle 1 litre bottle 6 bottles KCR Concentrate capped 50 ml bottle 50 bottles KCR NON-STERILE ON ALCOHOL BASIS Bottles and cans are double packed in a foil / PE bag in a cleanroom and can be transferred immediately without any further afforts. All alcohols are available as spray (4 litre canister) or capped (5 litre canister) (except Klercide 125 IMS with H 2 O 2 ). alcohol in 1 l bottle and 5 l canister KlerAlcohol 70/ % IPA 1 litre 6 bottles KL (IPA) 30 % DI 4 litre 4 canisters KL litre capped 4 canisters KL KlerAlcohol 70 / % IMS 1 litre 6 bottles KL (IMS) 30 % DI 4 litre 4 canisters KL litre capped 4 canisters KL KlerAlcohol 70 / % IMS 1 litre 6 bottles KL (IMS) 30 % DI H 2 O 2 (0.125 %)

dastex offers filtered biocides by Shield Medicare and hand disinfection products by Ecolab.

6 11.5 NON-STERILE BIOCIDES For the cleaning and disinfection in non-sterile areas you have a choice of a multitude of established products. Apart from a variety of ingredients different sizes and versions ( ready to use solution and concentrates) are available. Hence you can create a bespoke disinfection procedure for your needs. dastex offers filtered biocides by Shield Medicare and hand disinfection products by Ecolab. Klercide-CR Biocide A Spray bottle Quaternary ammonium 1 litre 6 bottles KCR Canister capped/ ready to use compound and biguanide. 5 litre 4 canister KCR Concentrate capped 5 litre 4 canister KCR Klercide-CR Biocide B Spray bottle Stabilised chlorine dioxide 1 litre 6 bottles KCR and quaternary ammonium Canister capped/ ready to use compound. 5 litre 4 canister KCR Concentrate capped 5 litre 4 canister KCR Premier Klercide-CR Biocide X Concentrate capped Quaternary ammonium 50 ml 50 bottles KCR compound and biguanide. Premier Klercide-CR Biocide Y Concentrate capped Amphoteric surfactant 50 ml 50 bottles KCR Incidin PLUS 20 ml 400 bags YA YA20 Concentrate Patented agent 2 litre 3 bottles YA 3N 8016-YA3N Glucoprotamin 6 litre 1 canister YA YA6 Incidin Extra 40 ml 200 bags YE YE200 Concentrate Benzalconiumchloride, 6 litre 1 canister YE YE6 polyhexamethylen biguanide, biphenylol Incidin Liquid Spray bottle Propanol 1 litre 12 bottles YLS YLS12 Canister capped/ ready to use 5 litre 2 canister YLS YLS2

11.6 HAND DISINFECTION AND CARE Hand disinfection is an operation which is done in order to reduce the microbial count on hands.

Additional accompanying measures are also taken into account, as for example: form and duration of the application, skincare and nurture, doses, ect.

This range is completed by a lotion for the gentle cleaning and nurturing of hands. Dispenser units see chapter 11.7.

7 11.6 HAND DISINFECTION AND CARE Hand disinfection is an operation which is done in order to reduce the microbial count on hands. The aim is the avoidance of contamination, especially microbial, and the possible dispersion of germs. Additional accompanying measures are also taken into account, as for example: form and duration of the application, skincare and nurture, doses, ect. dastex offers you for hand disinfection two established products from the ECOLAB range, which are listed in RKI or DGHM. This range is completed by a lotion for the gentle cleaning and nurturing of hands. Dispenser units see chapter Spitacid 500 ml 24 bottles AS AS4 Ethanol, Propanol, Benzyl alcohol 1 litre 12 bottles AS AS12 5 litre 1 canister AS AS5 Skinman soft Benzalconiumchloride, 500 ml 24 bottles SMS SMS4 Undecylen acid, 1 litre 12 bottles SMS SMS12 Propanol 5 litre 1 canister SMS SMS5 Seraman Medical 500 ml 24 bottles SER SER4 Nurturing surfactant 1 litre 12 bottles SER SER12 5 litre 1 canister SER SER6

11.7 DISPENSER SYSTEMS FOR DISINFECTION PRODUCTS to be used with arm or elbow to avoid cross contamination made from high grade stainless

Stainless steel dispenser for 5 l suitable for wall mounting 1 unit KHFD05 24805 canister with spray system Alcohol resistant plastic

8 11.7 DISPENSER SYSTEMS FOR DISINFECTION PRODUCTS to be used with arm or elbow to avoid cross contamination made from high grade stainless steel or from impact and alcohol resistant plastic for safe and economical usage X Product Usage PU Art.-No. Art.-No. Stainless steel dispenser for 5 l suitable for wall mounting 1 unit KBMD canister with spray system or to place on top of workbench Stainless steel dispenser for 5 l suitable for wall mounting 1 unit KHFD canister with spray system Alcohol resistant plastic suitable for wall mounting 1 unit Dermados - S (for ml bottles) GSN 2N Alcohol resistant plastic suitable for wall mounting 1 unit Dermados - L (for 1 l bottles) GST 1N Alcohol resistant plastic suitable for wall mounting 1 unit Dermados - I (for 1 l bottles, lockable) GSN 1N

11.8 STERILE IMPREGNATED WIPES AND MOP WIPES various packing units impregnated with alcohol, biocides or neutral detergents various application areas Matching mops and mop holders see chapter 10.7.

9 11.8 STERILE IMPREGNATED WIPES AND MOP WIPES various packing units impregnated with alcohol, biocides or neutral detergents various application areas Matching mops and mop holders see chapter Klerwipe-CR Biocide A D wipe 2 mop with floor wipe Products / Ingredients Size PU Art.-No. Art.-No. Wipe, Biocide A 200 x 200 mm 20 packs x 15 wipes WPK Wipe, Biocide B 200 x 200 mm 20 packs x 15 wipes WPK Wipe, Biocide C 200 x 200 mm 20 packs x 15 wipes WPK Wipe, Biocide D 200 x 200 mm 20 packs x 15 wipes WPK Wipe, Neutral Detergents 200 x 200 mm 20 packs x 15 wipes WPK WPK2551 Mop wipe, 70/30 IPA 420 x 250 mm 10 packs x 20 wipes WPM WPM5000 Mop wipe, 70/30 IMS 420 x 250 mm 10 packs x 20 wipes WPM WPM5005 Mop wipe, Biocide A 420 x 250 mm 10 packs x 20 wipes WPM WPM5015 Mop wipe, Biocide B 420 x 250 mm 10 packs x 20 wipes WPM WPM5025 Mop wipe, Biocide C 420 x 250 mm 10 packs x 20 wipes WPM WPM5035 Mop wipe, Biocide D 420 x 250 mm 10 packs x 20 wipes WPM WPM5045 Mop wipe, Neutral detergents 420 x 250 mm 10 packs x 20 wipes WPM WPM5051

11.9 TRAINING AIDS FOR OPERATORS Training in contamination control is essential, especially when working according to manufacturing practice (GMP).

10 11.9 TRAINING AIDS FOR OPERATORS Training in contamination control is essential, especially when working according to manufacturing practice (GMP). Shield Medicare offers amongst others, products for the training of employees in various areas of contamination control. Glo-germ user training set With this product users can be shown essential aspects of contamination control. This includes amongst others the correct technique for hand washing, surface cleaning and transfer disinfection techniques. The training set delivers an immediate result and demonstrates instantly to an operator if the used technique is correct. With the training set total quality can be improved and the danger of expensive mistakes during production is reduced. Products PU Art.-No. Art.-No. Glo-germ Operator Training kit 1 unit GVK Glo-germ Cream replacement bottle of cream 1 x 0.4 l bottle GVK01LC Glo-germ powder replacement bottle of powder 6 x 50 g GVK06PD Replacement UV light bulb each GVK01LG Sterile Process Validation Broth Kit Klerkit universal-broth-transfer validation kit provides all the key elements required to carry out an aseptic process validation test. Products PU Art.-No. Art.-No. Sterile Process Validation Broth Kit 10 sets KVK It contains: 1 x 50 ml sterile bottle of Tryptone Soya Broth 1 x 100 ml sterile bag of Tryptone Soya Broth 1 x 10 ml sterile ampoule of Tryptone Soya Broth 3 x 20 ml sterile empty glass vial

PRODUCT NO.:

PRODUCT NO.: 7182-01 STARTER KIT (Germfree) For GermFree Glove Box DESCRIPTION: This convenient starter kit will allow the operator to jumpstart their cleaning with the GermFree Compounding Aseptic Isolator