1. Introduction
The procedures, cleaning frequency and indicated maintenance are illustrative. The user must establish standardized procedures and frequencies in specific work procedures , according to the experience with the equipment and the historical incidents.
2. Cleaning and disinfection of Clean rooms
In the design of premises, it has been considered as one of the priorities that cleaning and disinfection are easily achievable.
A program of cleaning and disinfection of premises in which the following points are taken into account should be developed:
- The different areas featuring the area, such as changing rooms, SAS, workrooms … detailing, among them, the different parts that constitute them as floors, ceilings, walls, doors, windows, furniture and the order in which the cleaning should be done.
- In general, cleaning should begin in areas that require the most critical levels of cleanliness and continue on those areas where requirements are lower.
- At what point it should be carried out: before entering, during the processing, when the day finishes, when the specialty finishes, for periods of stoppage longer than usual…
- Who will do it: room staff, external staff.
- The clear and detailed elaboration of a method to follow to perform these operations simple as they seem, stating:
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- Evacuation of the resulting residues during the elaboration of both general or medical, indicating in which moment, where, how…
- Access to the tools and products to use.
- The preparation of cleaning products which shall specify who prepares it, when, where, in which container, in which concentration, with what kind of water and at what temperature…
- How it should be realized, for it will have to be detailed:
- The parties to treat and in what order (begin with the walls and continue with the horizontal elements: furniture, floors…
- The tools to use: vacuum, mop, rags…
- The way to do it: soaking, with the two cubes system, por el sistema de dos cubos, collecting remaining liquid discarding the used tools…
- Discharge of the used or surplus products and tools.
- Disinfection and storage: Who is responsible for supervision.
- Tools. Depending on the specific characteristics: Ex. Washing mops: immerse in disinfectant solution (indicating type, concentration and time)…
- Products. The solutions will only be stored in previously cleaned containers for as short as possible periods of time. Special attention to the identification of such containers.
- The different types of products used for disinfecting, products that have previously been subjected to microbiological study, and that for its application it has been taken into account to prevent the development of resistant strains.
- Advisability of establishing a plan of microbiological counts after the cleaning, to validate and verify the processes.
- Cleaning programs must be approved by the Quality Control Department.
- Once a cleaning or disinfection plan adopted, it must be modified to any change, in order to remain always updated.
3. Cleaning of Clean rooms: specific parts
A. CEILINGS
Prelacquered metal sheep panels.
In general, cleaning is done by washing with a mixture of tap water and neutral agent, followed by rinsing with tap water and dried.
In order not to degrade the surface with the cleaning products we recommend:
- Respect the dosis (about 1 to 3% and pH comprised between 5 and 9)
- Diluate in warm water (about 20 °C, always below 40 °C)
- Respect the application temperature (ideal 30 ° C, maximum 50 ° C to eliminate fats)
- Respect the application pressures (maximum 50 bar)
- Do not exceed the application time (max 30 min)
- For persistent stains, rub with a soaked sponge with the adequate cleaning product, without allowing it to change the appearance of the final result, and rinse immediately with plenty of clear water .
B. LUMINAIRES
The luminaires should be cleaned with a special cloth for clean room dampened with a compatible cleaning agent (to avoid attacking the lenses). The inside of the lenses must be cleaned similarly.
C. WALLS
The walls must be cleaned starting from the roof and working in vertical lines to the ground.
First the walls should be cleaned with a vacuum cleaner or a cloth using overlapping strokes, followed by a rag or cloth moistened with cleaning agent. Rinsing may be necessary depending on the type of cleaning agent used.
The strongest dirt must be removed with hot water and soap or with a normal detergent without abrasive or corrosive components.
The most persisten stains such as paint, adhesive, ink, pen marks and similars are generally removed with organic solvents in a well ventilated area and respecting the use precautions (ex: alcohol, acetone, trichlorethylene, based nitro solvents , gasoline / benzene). To remove sticker residue or persistent paintings, it must consulted with the product provider to find the most suitable solvents.
Condensed resin wastes (adhesives based on urea, melamine and phenol), reaction adhesives (epoxy adhesives, unsaturated polyester, polyurethane, etc…) can not be removed after hardening. Therefore, it is necessary to intervene before it hardens. After the treatment with disolvents, some halos may appear that can be removed with normal detergent ammonia based.
Los residuos de parafina y siliconas se pueden quitar previamente de manera mecánica, prestando atención a no rayar las superficies. Los demás residuos se pueden quitar con la plancha caliente interponiendo papel absorbente.
The paraffin and silicone residual can be previously removed mechanically, being careful not to scratch the surface. Other residues can be removed with a hot iron and absorbent paper.
D. DOORS, FRAMES AND COMPONENTS
First clean the top and the edges of the doors while they are ajar, using an appropriate tool or an adhesive mop, followed by a cloth. The cloth should be moistened with a cleaning agent and the surface cleared if required by the cleaning agent. Both doors and the associated surfaces should be cleaned following the procedure referred to the walls.
E. WINDOWS
The windows should be cleaned using a cloth moistened with a suitable cleaning agent. Cleaning should follow a vertical movement up and down to moisten the windows. After each move, the cloth should be folded to expose a not used area. In case of non aseptic environment, a dry cloth must be employed to dry the window up and down as described above.
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