Clean room protection

New Fibers Textile Corp. Taiwan. Development, manufacture, and marketing of a range of specialty silver and copper-coated fibers and filaments for high-performance technical and industrial textile and nonwoven fabrics in clean room, protection, filtration, geotechnical, carpet, and specialty apparel applications. Extensive technical information... 

Nonwoven wipe categories include products for babies and adults, the food service and electronics industries, medical and clean room appHcations, industrial cleaning, computer diskettes, and household products such as dusters, tea towels, shoe cleaning cloths, towelettes, and hand towels. Nonwoven fabrics are used to filter air, water, petroleum (qv), food, and beverages. Nonwovens loaded with abrasives, cleansers, or finishes can be found in a variety of products used by many industries and in many homes to scour or poHsh. Also, a majority of garments designed to protect industrial workers and consumers from hazardous environments are made from nonwoven fabrics. 

Electrical Hazards. Because carbon fibers are conductive, the airborne filaments can create serious problems shorting out electrical equipment. The best option is to locate sensitive equipment in clean rooms outside of areas where carbon fiber is being processed. If this is not possible, electrical cabinets must be effectively sealed to prevent contact with carbon fibers. A filtered air-positive purge provides additional protection for sensitive equipment. 

Bioprocess The facility necessary in a biotechnology clean room to protect the worker, the product, and the environment. 

The greatest risk of contamination of a pharmaceutical product comes from its immediate environment. Additional protection from particulate and microbial contamination is therefore essential in both the filling area of the clean room and in the aseptic unit. This can be provided by a protective work station supplied with a unidirectional flow of filtered sterile air. Such a facility is known as a laminar airflow unit in which the displacement of air is either horizontal (i.e. from back to front) or vertical (i.e. from top to bottom) with a minimum homogenous airflow rate of 0.45 ms" at the working position. Thus, airborne contamination is not added to the work space and any generated by manipulations within that area is swept away by the laminar air currents. 

The finished product is essentially sterile and if kept in a germ-free environment will be protected from spoilage. Some manufacturers handle the finished product in clean room conditions to enhance the shelf life. 

Clean rooms are environmentally controlled areas within the pharmaceutical facility in which critical manufacturing steps for injectable/sterile (bio)pharmaceuticals must be undertaken. The rooms are specifically designed to protect the product from contamination. Common potential contaminants include microorganisms and particulate matter. These contaminants can be airborne, or derived from process equipment, personnel, etc. 

A study of mercury in Lake Michigan found levels near 1.6 pM (1.6 X 10 12 M), which is two orders of magnitude below concentrations observed in many earlier studies.5 Previous investigators apparently unknowingly contaminated their samples. A study of handling techniques for the analysis of lead in rivers investigated variations in sample collection, sample containers, protection during transportation from the field to the lab, filtration techniques, chemical preservatives, and preconcentration procedures.6 Each individual step that deviated from best practice doubled the apparent concentration of lead in stream water. Clean rooms with filtered air supplies are essential in trace analysis. Even with the best precautions, the precision of trace analysis becomes poorer as the concentration of analyte decreases (Box 5-2). 

US Environmental Protection Agency, Guidance on Establishing Trace Metal Clean Rooms in Existing Facilities, EPA-821-B-96-001, [US Environmental Protection Agency, 1996d],... 

Since most chromatographic stages are found toward the end of the production process, and because very few matrices are suitable for steam sterilization, product protection must be ensured by locating the equipment within a clean room environment. Often, the temperature of the process must be controlled, typically at 4°C, and so the entire clean room may be cooled to avoid the need for local process cooling. 

Preparation equipment should be designed so it can be easily and thoroughly cleaned. Procedures for cleaning, sanitation, and storage of production equipment used in radiopharmaceutical production must be established. Special training is necessary for personnel involved in this kind of work with regard to both clean-room aspects and radiation protection aspects. 

If manual transfer is unavoidable, location of the lyophilizer relatively close to the filling line enables protected transfer to be accomplished rather easily. Remote locations may require transfer of product in carts capable of providing ISO 5 quality air. These carts will generally require battery power in order to run the necessary air blowers and control systems. Alternatively, product trays could be placed in airtight carriers this activity and the sealing of the carriers would have to be accomplished under ISO 5 conditions. Locating the lyophilizer in the fill room may restrict the ability to unload the dryer while the filling line is in use, particularly if the lyophilizer is loaded and unloaded manually, which would increase the clean room personnel load and potentially increase contamination risk. 

Standard construction techniques are used until the clean-room envelope is completed, HEPA filters with protective film in place are installed and air handlers are ready to start. The clean envelope consists of clean-room walls, ceiling, and floor. Prior to starting the air handlers, a thorough clean-up of the space within the clean envelope is accomplished as described in Appendix B, 2A-2J. Following clean-up and start-up of the clean-space air-handling system, particle counts should quickly drop to well within operational requirements. 

When general construction of the clean room is completed, steps 2A-2J of Appendix B describing coarse cleaning can be implemented. Following coarse cleaning the protective him can be removed from the HEPA filters and the airhandling system started. 

A. A major concern when working in a clean room is the generation of particles of the size that cannot be seen and spreading these particles throughout the clean room. Every possible precaution must be taken to contain these contaminants and protect the clean-room environment. Everything that is done as a standard operation must be analyzed to determine if it will adversely affect the cleanroom. If you have any concerns, ask the clean-room monitor before you damage the environment and incur unnecessary clean-up cost. 

Instrument testing should preferably be carried out in a calibration workshop. However, instruments that form part of an integrated system or control panel may be tested in the control room or instrument room after installation, using portable test gear and/or simulation equipment. All instruments that require calibration must be calibrated in both the upscale and downscale directions and, if necessary, adjusted until their accuracies are within the limits stated by the manufacturer. On completion of the tests, the instrument must be suitably cleaned and protected in accordance with the manufacturer s recommendations. 

Some ceramic membranes are used for filtering particulate matters for reasons of process requirements or protection of equipment Clean room applications constitute some major commercial usage of these membranes. 

Routes of air-borne contamination into BFS containers were investigated during a study using Sulfur hexafluoride (SFs) tracer gas. During this experiment, the tracer gas was released at a known concentration into a clean room that housed an aseptic BFS machine. Levels of the tracer gas were then measured within subsequently filled BFS units. The study concluded that the container was effectively protected by the localized air shower. Although not necessarily representative of deposition of microbial contaminants, there also was conclusive evidence of some room air within the BFS containers. The control of environmental contamination within the clean room is therefore important. 

NFPA Code 318, Standard for the Protection of Clean-rooms, National Fire Protection Association, 2000 Edition. 

Health issues arise, especially with respect to longterm exposure to low levels of these chemicals. The need for employees to work in a clean-room environment while wearing unwieldy bunny suits to reduce particulate contamination and protect against chemical exposure can also present problems with physical and mental stress, especially given the intense time pressures associated with fabs that run around the clock. 

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