Cleanroom Disinfectant - Sterile Biocides

SteriShield Delivery System

It is essential that the disinfectants used to remove contamination do not bring contamination into the cleanroom environment.

The code of GMP requires that:

"Disinfectants used in Grade A and B areas should be sterile prior to use".

It is also important that the integrity of the disinfectant is maintained during use. Validation work in the licensedpharmacy unit of a major UK hospital identified that a standard trigger spray alcohol had been contaminated with fungal spores only eight hours after opening, so this risk must be eliminated.

There are advantages to using a trigger spray to apply disinfectants, but not all trigger sprays protect the sterility of the contents.  With a conventional trigger spray contaminated air can be sucked back into the bottle, contaminating the liquid.

In response to this need, Shield Medicare – a division of Ecolab – developed the patented SteriShield DeliverySystem in 1999. It was the first closed trigger spray system, preventing air being drawn back into the bottle.  The liquid is held inside a bag. The function of the bottle is simply to enclose and protect the liquid within the bag. The possibility of “suck back” associated with conventional trigger sprays, where airborne contamination can enter the liquid, is eliminated.  This provides all the benefits of a trigger spray while guaranteeing the integrity of the contents for three months.

Disinfectants fitted with the SteriShield Delivery System are used in many GMP facilities around the world.

 

Shield Medicare offers a unique range of broad spectrum biocides in a variety of ready-to-use or concentrate formats, including impregnated wipes (see wipes page for details on these).

For more information on the SteriShield Delivery System click here.

 

3035120 / KCR4241: Premier Klercide-CR Biocide A Spray 1L

Biocide A is a ready to use blend of quaternary ammonium and biguanide with broad spectrum activity.  It is 0.2 micron filtered, filled and double bagged in a Grade C (ISO Class 7) cleanroom.  The bottles are then gamma irradiated.  It has a 2 year shelf life.  This item comes packaged in the unique SteriShield Delivery System Spray Bottle.

MSDS

 

3035160 / KCR4251:  Premier Klercide-CR Sterile Biocide A Capped 5L

Biocide A is a ready to use blend of quaternary ammonium and biguanide with broad spectrum activity.  It is 0.2 micron filtered, filled and double bagged in a Grade C (ISO Class 7) cleanroom.  The bottles are then gamma irradiated.  It has a 2 year shelf life. 

MSDS

 

3035220 / KCR722:  Premier Klercide-CR Biocide X Unit Dose Concentrate 50mL

Biocide X is a unit dose concentrate blend of quaternary ammonium and biguanide with broad spectrum activity.  Each 50mL bottle makes up 5 litres of ready to use product.  This unit dose concentrate format reduces the risk of dilution errors.  It is 0.2 micron filtered, filled and double bagged in a Grade C (ISO Class 7) cleanroom.  The bottles are then gamma irradiated.  It has a 2 year shelf life.  This item comes in 50mL bottles.

MSDS

 

3035130 / KCR4242:  Premier Klercide-CR Biocide B Spray 1L

Biocide B is a broad spectrum disinfectant with excellent sporicidal activity.  It is a unique blend of stabilised chlorine dioxide and quaternary ammonium compound.  It is safe and pleasant to use and due to its faint odour it has high operation acceptance.  It is 0.2 micron sterile filtered and double bagged under laminar flow in a grade B (ISO Class 5) cleanroom.  1 year shelf life.  This item comes ready to use, packaged in the unique 1 Litre SteriShield Delivery System spray bottle.

MSDS

 

3035170 / KCR4253:  Premier Klercide-CR Biocide B Capped 5L

Biocide B is a broad spectrum disinfectant with excellent sporicidal activity.  It is a unique blend of stabilised chlorine dioxide and quaternary ammonium compound.  It is safe and pleasant to use and due to its faint odour it has high operation acceptance.  It is 0.2 micron sterile filtered and double bagged under laminar flow in a grade B (ISO Class 5) cleanroom.  1 year shelf life.  This item comes ready to use, packaged in 5 litre capped bottles.

MSDS

 

3035270 / KCW6243:  Premier WFI Klercide-CR Biocide C Spray 1L

Biocide C is a blend of high grade 6% hydrogen peroxide and water for injection.  It is specifically designed for areas where a low level, safe sporicide with very low  residues is required.  Endotoxin levels are guaranteed to be less than 0.25 EU/ml, making this sporicide ideal for product contact areas, isolators and RABS.  It is 0.2 micron sterile filtered in a grade B (ISO Class 5) cleanroom with a 1 year shelf life.  This item comes ready to use, packaged in the unique 1 Litre SteriShield Delivery System Spray Bottle.

MSDS

 

3035150 / KCR4244:  Premier Klercide-CR Sterile Biocide D Spray 1L

Biocide D is a sterile amphoteric surfactant.  It is 0.2 micron filtered, filled and double bagged in a Grade C (ISO Class 7) cleanroom.  The bottles are then gamma irradiated.  It has a 2 year shelf life.  This item comes ready to use, packaged in the unique 1 Litre SteriShield Delivery System Spray Bottle.

MSDS

 

3035190 / KCR4257:  Pemier Klercide-CR Sterile Biocide D Capped 5L

Biocide D is a sterile amphoteric surfactant.  It is 0.2 micron filtered, filled and double bagged in a Grade C (ISO Class 7) cleanroom.  The bottles are then gamma irradiated.  It has a 2 year shelf life.  This item comes ready to use, packaged in 5 litre capped bottles.

MSDS

 

3035230 / KCR725:  Premier Klercide-CR Biocide Y Unit Dose Concentrate 50mL

Biocide Y is a unit dose concentrate of sterile amphoteric surfactant to conveniently make up 5 litres of ready-to-use product and reduce the risk of dilution errors.  It is 0.2 micron filtered, filled and double bagged in a Grade C (ISO Class 7) cleanroom.  The bottles are then gamma irradiated.  It has a 2 year shelf life.  This item comes in 50mL bottles.

MSDS

 

3033610 / KCR4245:  Premier Klercide-CR  Sterile Biocide E Spray 1L

Biocide E is an effective ready-to-use sporicide based on active chlorine.  It is a sodium hypochlorite solution providing 0.5% available chlorine.  Particularly suitable where high level sporicidal activity is required at short contact times.  It is 0.2 micron filtered, filled and double bagged in a Grade C (ISO Class 7) cleanroom before gamma irradiation.  It has a 2 year shelf life.  This item comes ready to use, packaged in the unique 1 Litre SteriShield Delivery System Spray Bottle.

MSDS

 

3033620 / KCR4259:  Premier Klercide-CR Sterile Biocide E Capped 5L

Biocide E is an effective ready-to-use sporicide based on active chlorine.  It is a sodium hypochlorite solution providing 0.5% available chlorine.  Particularly suitable where high level sporicidal activity is required at short contact times.  It is 0.2 micron filtered, filled and double bagged in a Grade C (ISO Class 7) cleanroom before gamma irradiation.  It has a 2 year shelf life.  This item comes ready to use, packaged in 5 litre capped bottles.

MSDS

 

3033630 / KCR718:  Premier Klercide-CR Sterile Biocide S Unit Dose Concentrate Tablets 170g Tub

Biocide S is a unit dose concentrate, also based on 0.5% available chlorine, supplied in tablet form for safety and ease of handling.  The concentrate consists of a pot of 17 tablets of sodium dichloroisocyanurate (NaDCC) in an effervescent base, which form a solution containing 0.5% (5000ppm) available chlorine when diluted in 10 litres of water.  Each tablet contains 5g NaDCC in a total tablet weight of 10g.  Each tub of tablets is double bagged in a Grade D (ISO Class 8) cleanroom and gamma irradiated.  It has a 2 year shelf life.

MSDS

 

DQ100-03-8Z:  Decon-Quat Sterile Concentrate

Decon-Quat is a quaternary ammonium solution for use in hospital/medical and healthcare institutions.  Effective as a broad spectrum hospital disinfectant, fungicide, deodoriser, hard surface disinfectant, food and non-food contact sanitiser (USDA D2).  Using specific dilution instructions, this product can clean and decontaminate against HIV-1 and HBV  or surfaces / objects soiled with blood / body fluids.  Filtered to 0.2 micron in a GMP Class 100 manufacturing area and subsequently gamma irradiated.  Each container is double bagged.  This product has a shelf life of 2 years.  It is a concentrate making 15 litres per bottle.  This item comes in 8oz bottles.

Technical Specification

 

 

 

DCY-03-2Z:  Decon-Cycle Low pH Sterile Concentrate

Decon-Cycle is a dilutable, low pH, phosphate free Phenolic.  Decon-Cycle’s multi-phenolic formula is designed to clean, disinfect and deodorise any washable, inanimate surface, in one easy step.  When used as directed, Decon-Cycle is strong enough to kill a broad spectrum of pathogenic bacteria, yet mild enough to have no harmful effect on the surface being disinfected.  Decon-Cycle is filtered to 0.2 micron in a GMP Class 100 manufacturing area and subsequently gamma irradiated.  Each 2oz (59mL) container is double bagged and makes 15 litres of diluted disinfectant.  It has a shelf life of 2 years.

Technical Specification

 

 

SHC-13Z-5.25:  Hypo-Chlor 5.25% Sterile RTU

Hypo-Chlor is designed for pharmaceutical and biotechnology operations that demand a sterile sodium hypochlorite solution.  Hypo-Chlor is an effective one step, ready-to-use product.  Formulation of Hypo-Chlor is accomplished with USP purified water.  It is used for areas such as walls, ceilings, floors, and surfaces.  Hypo-Chlor is  sterile filtered to 0.2 micron. Each 13oz (383mL) container is double bagged and ready to use.

Technical Specification

 

 

 

DC-03-4Z:  Decon-Clean Sterile Concentrate

Decon-Clean is designed for pharmaceutical and biotechnology operations that demand a cleaning agent to remove residues from disinfecting agents.  Decon-Clean is an effective one-step residue remover when diluted at 1:128 (118mL per 15L).  It is filtered at 0.2 micron and then subsequently terminally sterilised.  Decon-Clean is an excellent cleaner designed for all washable, non-porous environmental surfaces.  Using Decon-Clean can assure that noticeable and unnoticeable residues are removed.  Each 4oz (118mL) container is double bagged.  It is a concentrate making 15 litres per bottle. 

Technical Specification