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miscellaneous
gowning room
Low Endotoxin
ISO Class 5
GRADE A
Product Contact Surfaces
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Iso Class 5
Grade b
ISO Class 7/8
GRADE C/D
V.A.L.
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Manual cleaning and disinfection of Grade A environments brings its own challenges. The confined nature of the Grade A zone means even greater care needs to be given to ensuring all surfaces are disinfected. Consideration should be given to low residue products which are easy to transfer into the Grade A environment.
cleaning Biosafety Cabinets
cleaning Restricted Access Barrier SYSTEM
cleaning Isolators
cleaning Unidirectional Air Flow Hoods
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PROSAT® Sterile™ Polynit Heatseal Wipes
Sterile HydroPure
EasyReach Cleaning Tool and Pad
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Daily decontamination is necessary to eliminate contaminants in a biosafety cabinet. The use of specially designed tools can significantly improve the efficacy of the cleaning and disinfection process without compromising the containment.
Cleaning a Biosafety Cabinet
Grade A: Biosafety Cabinets
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Daily decontamination is necessary for isolator systems. The use of specially designed tools can significantly improve the efficacy of the cleaning and disinfection process of a closed Grade A environment. Items that are double or triple bagged aid transfer into the isolator.
Cleaning an Isolator
Grade A: Isolators
Daily decontamination is necessary for UDAFs. Cleaning can be carried out in the “open” state but disinfection or must be carried out in the “closed” state. The use of specially designed tools can significantly improve the efficacy of the cleaning and disinfection process.
Cleaning a UDAF Hood
Grade A: Unidirectional Air Flow Hoods
There are various types of RABS which are usually subject to automated cleaning and disinfection. Manual cleaning and disinfection, when required, needs products which are compatible with the disinfecting agents already used and leave little to no residue.
Cleaning a RABS
Grade A: Restricted Access Barrier System
Grade A
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Grade B
Grade B rooms are the direct support zone for the critical processing, Grade A zone. These larger areas still have strict microbial and particle limits which need to be met. Disinfectants and detergents used in Grade B rooms need to be sterile prior to use. Low particulate wipes and mops are also needed in Grade B rooms as materials liable to generate fibres should not be permitted in clean areas.
Cleaning Windows
Cleaning the Ceiling
Cleaning the wall
Cleaning the floor
Cleaning the table and equipment
Cleaning Pass-Through
Grade B: Windows
Windows can be a challenging surface to decontaminate as any disinfection residues are easily visible. Either use disinfectants with no or low residues or introduce a “wipe-to-dry” or residue removal stage.
VertiKlean® MAX Sterile Sealed Edge Mop
PROSAT® Polynit Heatseal Wipes
Sterile ProChlor
Compact Bucket System
When it's time to clean a Grade B room, the ceiling is cleaned first since it's the cleanest point in the room. It's important to use overlapping strokes, starting in the corner of the room farthest from the exit door while moving to the other side of the room.
Grade B: Ceilings
Sterile Prochlor
The walls are to be cleaned after the ceiling. There are several methods that can be used, such as: vertical overlapping strokes, horizontal overlapping strokes, or a hybrid of the two.
Cleaning the Wall
Grade B: Walls
The floor is the last surface to be cleaned inside of the room. Start in the corner furthest from the exit door. Using the S-curve or Place and Pull method with overlapping strokes, work your way to the exit door, so as not to step on a clean area.
Cleaning the Floor
Grade B: Floors
Anticon® Sterile MicroQuilt™ Wipe
Tables and equipment should be cleaned and disinfected before walls and floors. Tables and benches should be wiped from back to front with parallel overlapping strokes. All the equipment on surfaces should be disinfected before the surface itself.
Cleaning the Table and Equipment
Grade B: Table and Equipment
EasyReach Cleaning Tool
Cleaning a pass-through is similar to a room, where the ceiling is first, then the walls and doors and lastly the floors. When wiping, it's important to use overlapping strokes.
Grade B: Pass-Throughs
Grade C/D
Grade C/D cleanrooms are used for carrying out the less critical stages in the manufacture of aseptically filled products, the background environment for isolator systems or for the filling of terminally sterilised products. Defined levels of particles and viable contamination must still be maintained using validated SOP’s.
Cleaning the equipment
Cleaning Irregular Surfaces
ProChlor
VertiKlean® MAX Sealed Edge Mop
When it's time to clean a Grade C/D room, the ceiling is cleaned first since it's the cleanest point in the room. It's important to use overlapping strokes, starting in the corner of the room farthest from the exit door while moving to the other side of the room.
Grade C/D: Ceilings
Grade C/D: Walls
Grade C/D: Floors
Anticon MicroQuilt Wipes
PROSAT® Meltblown Polypropylene Wipes
Equipment has various uses. It’s important to keep these areas cleaned and disinfected to prevent cross-contamination paying close attention to irregular surfaces.
Cleaning the Equipment
Grade C/D: Equipment
Endotoxins are a big concern for pharmaceutical and medical device manufacturing. Once endotoxins are present, it's difficult to remove them. It is therefore important to control the level of endotoxins in all materials used in the production of drug products and medical devices, including products used to clean the environments.
Sterile Polynit Heatseal LE Wipes
PROSAT® Sterile™ Polynit Heatseal LE Wipes
Contec has a family of low endotoxin certified products including presaturated wipes with WFI, dry knitted wipes, dry nonwoven wipes, a hydrogen peroxide cleaner, and 70% IPA/ WFI.
Certified low endotoxin products
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Gowning Room
The Gowning room is the first step to entering a cleanroom environment. It’s imperative that it is cleaned and disinfected on a regular basis according to a facility’s SOP’s. Gowning rooms can be small or large depending on the facility. It’s important to pick tools that work best in the space and do not cause unnecessary strain for the user..
Cleaning Benches and Supply Racks
Double Polypropylene Bucket System
CyQuanol™ Disinfectant
VertiKlean® MAX™ Sterile Sealed Edge Mop
Gowning Room: Ceilings
Gowning Room: Walls
Non-Sterile CyQuanol™ Disinfectant
The floor is the last surface to be cleaned inside of the room. Start in the corner furthest from the exit door. Using the S-curve or Place and Pull method with overlapping strokes, work your way to the exit door so a not to step on a clean area.
Gowning Room: Floors
Polynit Heatseal Wipes
Benches in a gowning area can be made of several different materials. It's important to choose the cleaning products that are safe to use on those materials to prevent corrosion and pitting.
Gowning Room: Benches and Supply Racks
SATWIPES®
It's important to clean all irregular surfaces before cleaning and disinfecting the room. These surfaces can be vents, lights door knobs, light switches and supply racks.
Gowning Room: Irregular Surfaces
Miscellaneous
There are often areas in a Cleanroom that are overlooked and need special cleaning protocols as they are different or difficult to clean. These areas still need to be cleaned regularly according to the facility’s SOPs. Select the area for details for products to use and how to clean them efficiently.
Cleaning Softwall Curtains
Cleaning Sinks
Unclassified Hallways
Contec 70% Alcohol
DualClean Softwall Strip Cleaner
Softwall curtains are difficult to clean due to their flexibility. It's imperative to clean both sides of the curtain, starting at the top of the strip down to the bottom of the strip.
Miscellaneous: Softwall Curtains
NeutraKlean
QuickTask Mop
All areas of a cleanroom need to be cleaned and disinfected even if they are not considered a sterile area, such as: hallways, ceilings, walls, floors and other surfaces. These surfaces must be disinfected on a regular basis.
Cleaning Unclassified Hallways
Miscellaneous: Unclassified Hallways
