Core2Clean Systems. SPRAY MOP FOG S Y S T E M Technical Information

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1 THE SPRAY MOP FOG S Y S T E M Technical Information Copyright June 2003, U.S. and Foreign Patents Pending, September 2002, Tel: (610) Fax: (610) C2C-2002-A1 06/2003 Page 1 of 12

Core2Clean System Introduction For years, pharmaceutical and biotechnology operations have utilized a variety of inter-related methodologies to control contamination in their controlled environments.

2 Core2Clean System Introduction For years, pharmaceutical and biotechnology operations have utilized a variety of inter-related methodologies to control contamination in their controlled environments. In review of regulatory guidelines and assuring an acceptable environment to manufacture one s product, one must be able to address known contamination with a documented control and cleaning regime that has been proven effective. Within the scope of validation studies, the control system begins with confirming disinfecting agents with one s environmental isolates through either time contact kill studies (tube or surface carriers) or by AOAC Use Dilution 10 or 60 carrier testing. Deriving an environmental isolates list from environmental monitoring programs nets the ability to prove in a laboratory study the effectiveness or ineffectiveness of one s chosen chemical agents against such organisms. Once complete, we combine the knowledge from our antimicrobial effectiveness studies and our cleaning SOP s and conduct an in situ or field study. This allows us to evaluate the chemical agent together with our cleaning SOP s in a test scenario. However, once we leave the validation study scenario, we are confronted with the complex situation of implementing what we have proven as acceptable in our operations. Maintaining a system that is meaningful, manageable and defendable becomes complex in production areas as we encounter a multitude of variables. To date mops with buckets, sprayers and foggers have all been utilized in varying capacities. Introduction of these many components to the controlled environment warrants concern. With the same concern we have learned that an effective and simplistic system nets success. Addressing a simplistic and simple system requires understanding that one needs to saturate and penetrate the cell wall of an organism over a specified contact time with a chemical agent capable of destroying the cell. Thus application becomes the keystone to our success. The Core2Clean Systems were invented by to address this requirement. Sometimes one needs to spray, sometimes to mop and at times a fogger needs to be utilized. The Core2Clean Systems incorporate all three in one. The systems incorporate a trigger activated sprayer, a trigger activated sponge mop and a fogger all in one unit. The key elements of the systems are the capability to present a sufficient amount of liquid to the surface and the capability of reducing cleaning time by nearly 50%. Introduction of all the items required to clean and disinfect an area are done at once as the entire unit can be autoclaved prior to entry. With this in mind, the Core2Clean Systems provide a simple mechanism to assure cleaning and disinfection is done in an effective and efficient manner. Tel: (610) Fax: (610) C2C-2002-A1 06/2003 Page 2 of 12

3 The Core2Clean Systems were designed to address the application of cleaning and disinfecting agents to the surface in a meaningful and manageable methodology. The Core2Clean Systems have been specifically designed for by pharmaceutical, biotechnology and healthcare facilities in their controlled environments. For years, the use of a conventional bucket and a mop or pad has been used to provide application of the chemical agent to the surfaces in controlled areas. In addition to mops/pad and buckets, facilities also incorporated a sprayer and a fogger within their cleaning and disinfecting operations. The Core2Clean Systems eliminate the need for a multitude of components and incorporate them within one device. Core2Clean System Features The Core2Clean Systems are made of stainless steel. The Core2Clean Systems can be steam sterilized eliminating the concern for introduction of viable contamination to the controlled environment from the components themselves. The Core2Clean Systems is compressed air operated (ASME rated to 100 psi). This provides the ability to dispense a continuous flow of a clean solution to the surface. Continuously providing a clean solution to the surface reduces cleaning time and end user effort. The Core2Clean Systems eliminate concerns of changing dirtied cleaning solution. This eliminates the need to discard dirtied solutions and reduces the volume of cleaning agents required to address surfaces annually. The Core2Clean Systems incorporate a trigger activated dispensing mop, a sprayer and a fogger all in one unit. The Core2Clean Systems present a sufficient wetting of the surface unavailable from other mopping systems. Increasing the time period the surface remains wet is essential to assuring efficacy performance of disinfecting agents. The Core2Clean Systems can reduce cleaning time by 50% and is easily moved from area to area by a 4-wheel caster dolly that can be removed and cleaned. The Core2Clean Systems utilize quick disconnects to attach the mop, sprayer and fogger. The Core2Clean Systems are user friendly and simplify cleaning and disinfecting procedures. Tel: (610) Fax: (610) C2C-2002-A1 06/2003 Page 3 of 12 7

The Core2Clean Systems Components: Core2Clean Spray System SPRAY The Core2Clean Spray Systems are designed of 316L stainless steel and are ASME rated for up to 100 psi.

4 The Core2Clean Systems Components: Core2Clean Spray System SPRAY The Core2Clean Spray Systems are designed of 316L stainless steel and are ASME rated for up to 100 psi. Available in a 2 gallon model (C2C-102) and a 5 gallon model (C2C-105), these sprayers are powered by a compressed air line. The C2C-102 and C2C-105 can be autoclaved at 121 o C. Introduction of the chemical agent is done through a top port opening. The units include all listed below and a stainless steel dolly with stainless steel casters. This system provides easy movement throughout the production facility. Core2Clean Mop System MOP The Core2Clean Mop System connects into the top the C2C-102 (two gallon tank) or C2C-105 (five gallon tank) described above. The Core2Clean Mop System provides a 3-6 ft. extendable handle that incorporates a trigger that is depressed to dispense the liquid from the end of the foam mop end. Powered by a compressed air line the C2C-102 or C2C-105 tanks can be autoclaved at 121 o C. Introduction of the disinfecting agents are done through a top port opening. This system provides easy movement throughout the production facility. Core2Clean Fog System FOG The Core2Clean Fog System connects into the top of the C2C-102 (two gallon tank) or C2C-105 (five gallon tank) described above. The Core2Clean Fog System precipitates varying droplet sizes from 5-50 microns. Powered by a compressed air line the C2C- 102 or C2C-105 tanks can be autoclaved at 121 o C. Introduction of chemical disinfecting agents are done through a top port opening. This system provides easy movement throughout the production facility. Tel: (610) Fax: (610) C2C-2002-A1 06/2003 Page 4 of 12

Quick Disconnect Sprayer Attachment Quick Disconnect Mop Frame The Core2Clean Uses the Patented VertiKlean Mophead by Contec Quick

5 Components Quick Disconnect Feature: To simplify changing from one Core2Clean component to another, all components connect with a Swaglock R Quick Disconnect Fitting that allows each component easily snaps on and off. Quick Disconnect Sprayer Attachment Quick Disconnect Mop Frame The Core2Clean Uses the Patented VertiKlean Mophead by Contec Quick Disconnect Mop Frame 3 foot Extension Arm Quick Disconnect Fogger Attachment Tel: (610) Fax: (610) C2C-2002-A1 06/2003 Page 5 of 12

6 Core2Clean 102 and 105 Quick Disconnect Features Quick Disconnect Sprayer Tip Quick Disconnect Spray Hose Quick Disconnect VertiKlean Mophead Quick Disconnect 3 ft. Extention for Spray or Mop ALSO: Quick Disconnect Hoses to Compressed Air Lines, to Sprayer and Mop and to Fogger! Tel: (610) Fax: (610) C2C-2002-A1 06/2003 Page 6 of 12

7 Core2Clean Gallon System TECHNICAL SPECIFICATIONS Maximum Working Pressure: High-Pressure Regulated Tank: 100 psi Relief Valve Setting 100 psi (0.7 MPa, 7 bar) Air Inlet Size 3/8-18 npt(f) Fluid Outlet Size 3/8-18 npt (R3/8-19) compound thread Bottom Outlet Size 1/2-14 npt(f)weight 30.25lb (13.7 kg) Tank, C2C OUTLET Hose Assembly (coil) 2 Caster, swivel w/brake, hi-temp 14 Std. Pressure Wand 3 Cart Handle 15 Spray Tip (45 degree) Attachment 4 Lower Accessory Bracket 16 Mop Attachment (option) 5 Upper Accessory Bracket 17 INLET Hose Assembly (coil) 6 Keyed NC Female Quick Connect Dip tube Assembly 7 Std. NC Female Quick Connect Std Lid 8 INLET Regulator Assembly 20 0-Ring for Std Lid 9 Manual Purge Valve 21 Drain 10 INLET Pressure Gauge (2") 22 Relief Valve (100 psi) 11 OUTLET Regulator Assembly (option) degree Drain extension (option) 12 OUTLET Pressure Gauge (1") Tel: (610) Fax: (610) C2C-2002-A1 06/2003 Page 7 of 12

8 Core2Clean Gallon System Dimensions (C2C gal unit) Tel: (610) Fax: (610) C2C-2002-A1 06/2003 Page 8 of 12

9 Core2Clean Gallon System TECHNICAL SPECIFICATIONS Maximum Working Pressure: High-Pressure Regulated Tank: 100 psi Relief Valve Setting 100 psi (0.7 MPa, 7 bar) Air Inlet Size 3/8-18 npt(f) Fluid Outlet Size 3/8-18 npt (R3/8-19) compound thread Bottom Outlet Size 1/2-14 npt(f) Weight 30.25lb (13.7 kg) 1 Tank, C2C OUTLET Hose Assembly (coil) 2 Caster, swivel w/brake, hi-temp 14 Std. Pressure Wand 3 Cart Handle 15 Spray Tip (45 degree) Attachment 4 Lower Accessory Bracket 16 Mop Attachment (option) 5 Upper Accessory Bracket 17 INLET Hose Assembly (coil) 6 Keyed NC Female Quick Connect Dip tube Assembly 7 Std. NC Female Quick Connect Std Lid 8 INLET Regulator Assembly 20 0-Ring for Std Lid 9 Manual Purge Valve 21 Drain 10 INLET Pressure Gauge (2") 22 Relief Valve (100 psi) 11 OUTLET Regulator Assembly (option) degree Drain extension (option) 12 OUTLET Pressure Gauge (1") Tel: (610) Fax: (610) C2C-2002-A1 06/2003 Page 9 of 12

Core2Clean 105 5-Gallon System Dimensions (C2C-105 5-gal unit) Tel: (610)

10 Core2Clean Gallon System Dimensions (C2C gal unit) Tel: (610) Fax: (610) C2C-2002-A1 06/2003 Page 10 of 12

11 The Core2Clean Uses the VertiKlean Mophead by Contec 100% polyester fabric. Available in 7 and 12 sizes Laser cut to completely seal edges High sorbency rate Abrasion resistance Designed for general cleaning and wipe down of walls and ceilings Ideal for use in pharmaceutical and lab clean-up The VertiKlean mophead is performance engineered by laminating Contec s Polynit wiping material (non-run polyester knit) to a clean polyester based polyurethane foam. The edges of the Polynit fabric on the mophead are sealed using a proprietary edge sealing process. The VertiKlean mophead is free of any cellulosic contaminants and is compatible with gamma, ETO, and autoclave sterilization. All lots of all sizes of the mophead conform to the following specifications: PHYSICAL PROPERTIES: Core2Clean System Mopheads Basis Weight (fabric) (g/m²) 144 to 150 Foam Type Polyester Polyurethane Basis Weight (foam) (g/m²) 405 to 415 Sorbency Extrinsic (ml/mophead) 285 Intrinsic (ml/g) 10.8 Rate in water less than 5 seconds Adhesive between layers Thermoset Polyurethane STERILE/NON-STERILE OPTIONS: The VertiKlean mophead is delivered sterile (terminally sterilized via ANSI/AAMI/ISO (Radiation Sterilization), Method 1) and individually packed. The nonsterile product can be autoclaved on site, using a recommended cycle of 30 to 60 minutes at C. VertiKlean VK-SOX Option Contec s VertiKlean Mophead is available with a Polynit VK-SOX that fits over the mophead and is used to clean floors. This adds to the strength of the mophead and is easily implemented during cleaning operations. Contec and VertiKlean are registered in the U.S. Pat. & TM off. and are the property of Contec, Inc. Tel: (610) Fax: (610) C2C-2002-A1 06/2003 Page 11 of 12

12 Basic Components: Order # C2C-102 C2C-105 C2C C2C (7 inch = A) (12 inch = B) C2C Spare Parts: Order # C2C-100-4A C2C-100-4B C2C C2C C2C C2C Mopheads: Order # C2C C2C C2C C2C C2C C2C C2C C2C C2C C2C C2C C2C Core2Clean System Ordering Description 2 gallon spray tank ready for connection to the C2C Spray Gun Accessory, Mop Accessory or Fogger Accessory. Includes: caster wheels, pressure gauge, and 15 ft autoclavable source and dispense pressure hose. (Includes C2C Spray Gun) 5 gallon spray tank ready for connection to the C2C Spray Gun Accessory, Mop Accessory or Fogger Accessory. Includes: caster wheels, pressure gauge, and 15 ft autoclavable source and dispense pressure hose. (Includes C2C Spray Gun) Spray Gun Accessory with Quick Disconnect Tip (included with the C2C-102 and C2C-105) Automatic Mop Accessory with Mophead base (7 or 12 with quick disconnect) and 3 foot extension arm (additional arms available). Fogger with Quick Disconnect (5-50 micron droplet) Description Extra 15 ft. Autoclavable Source Pressure Hose Extra 15 ft. Autoclavable Output Pressure Hose Replacement Quick Disconnect (Male & Female) Replacement Gauge psi. 10 ft. Mop Handle Extension Accessory Description 7 VertiKlean Mophead for C2C System ( Non-Sterile) 48/cs 7 VertiKlean Mophead for C2C System ( STERILE) 48/cs 12 VertiKlean Mophead for C2C System ( Non-Sterile) 32/cs 12 VertiKlean Mophead for C2C System ( STERILE) 32/cs 7 VertiKlean VK-SOX Floor Cover for C2C (Non-Sterile) 32/cs 7 VertiKlean VK-SOX Floor Cover for C2C (STERILE) 32/cs 12 VertiKlean VK-SOX Floor Cover for C2C (Non-Sterile) 120/cs 12 VertiKlean VK-SOX Floor Cover for C2C (STERILE) 120/cs 10' extension wand with fittings on both ends Optional 7' Mophead Base (Mophead Only) Optional 12' Mophead Base (Mophead Only) 3' extension wand with fittings on both ends C2C Core2Clean 12' Curtain Cleaner Delivery: 6-8 weeks. For Additional Replacement Parts: Contact VAI Technical Support at Tel: (610) Fax: (610) C2C-2002-A1 06/2003 Page 12 of 12

Core2Clean Systems THE. SPRAY MOP FOG S Y S T E M Technical Information

Core2Clean Systems THE. SPRAY MOP FOG S Y S T E M Technical Information THE SPRAY MOP FOG S Y S T E M Technical Information Plus Copyright June 2003, U.S. and Foreign Patents Pending, September 2008, Tel: (610) 644-8335 Fax: (610) 644-8336 http://www.sterile.com C2C-2002-A4