Clean room equipment

Aseptic techniques are used to avoid the possibility of infection of the animals or ceU cultures. These include the preparation of the vaccines and spleens under aseptic conditions in a class 100 clean room equipped with a laminar airfiow hood, sterilization of instruments, and treatment of work surfaces with disinfectant before and after use, washing of the investigator s hands with an antiseptic surgical scrub preparation, and wearing of sterile gloves, face mask, and eyeglasses. 

CDS of clean room walls, floors and accessible surfaces of clean room equipment is routinely undertaken between production runs. The final CDS step often entails fogging the room. This is achieved by placing some of the disinfectant in an aerosol-generating device (a fogging machine ). This generates a fine disinfectant mist, or fog, within the clean room, capable of penetrating areas difficult to reach in any other manner. 

Experiments were run in a clean room equipped with filters that would eliminate particles the size of bacteria (which are several microns in size), but could not eliminate seeds that can be hundreds of times smaller (See Section 3.2). 

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. 

Electromagnetic interference Interference created by rotating electrical equipment causing problems in areas such as microelectronics clean rooms. 

Electric storage hot water heaters and instantaneous water heaters are used for simple domestic applications and are not considered in this text. For many smaller HW and lower pressure steam generation applications (including bakery ovens and proofers, jacketed kettles, fish pots and other cooking equipment, wineries, breweries, textiles, laundries, phosphatizing processes, humidification, steam baths, clean rooms, and pharmaceuticals), electric boilers offer significant advantages over fossil-fuel boilers and are often the product of choice. 

Cleaning/Disinfecting Equipment Terminal cleaning required with phenolic, disinfect surfaces with 1 9 bleach/water solution (10 percent), linen double bagged, disinfect equipment before taking it from room, change air filter before room terminally cleaned. 

One of SACHEM s products is tetramethylammonium hydroxide (TMAH), which is sold to semiconductor industries. Suspended particles in TMAH solutions could cause severe mechanical damage to the electronic devices manufactured by their customers. The determination of the particle content in such solutions is therefore critical. It is performed with a laser-equipped particle counter, which provides 70% detection efficiency. The counting must take place in a clean room because tiny airborne particles can land in the solutions and give them a false high reading. A class 1000 environment is required in this case, which means that the count of particles in the air that are greater than or equal to 0.5 jrm in diameter must be less than 1000 per cubic foot. Typically, a customer s specification for TMAH solutions is less than 100 particles per milliliter for particles greater than or equal to 0.5 fim in diameter. 

Paul Plumb of SACHEM Inc. counts particles in the ultrapure solutions of TMAH by a laser-equipped particle counter in the clean room. Notice the hair net and special lab coat. 

Including 20 ft2 for miscellaneous items not identified in this section, 110.3 ft2 must be rented, at an annual cost of 44,100/yr. Note that this moderately sized complex is added to an existing electronic materials manufacturing facility. Hence, no direct charges are added for infrastructure, such as non-clean room and office space. The total purchase cost, 6,492,100, provides equipment modules that require small installation costs, on the order of 1% that is, 65,000. Note also that two PECVD reactors are provided to assure uninterrupted operation when the plant is in operation, around the clock, 330 day/yr. While the robot loads and unloads one of the reactors, the other reactor is in operation. 

Static dissipative grades covers, guards, access panels, machine windows and doors, static control shields, glove boxes, electronic equipment, process instrumentation, conveyor line covers, clean room windows and doors, partitions and pass through modules... 

Table 9-1 lists design features of the exposure chambers in the United States that have air-cleaning equipment. The facility at the University of Maryland Hospital, Baltimore, has a chamber with activated-charcoal and high-efficiency particle filters and controlled temperature and humidity. St. Vincent s Hospital and New York University, New York City, each have a clean-room facility. The University of Pennsylvania Hospital, Philadelphia, has a self-contained, reinforced-concrete... 

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. 

Clean rooms are designed in a manner that allows tight control of entry of all substances (e.g. equipment, personnel, in-process product, and even air Figures 3.1 and 3.2). In this way, once a clean environment is generated in the room, it can easily be maintained. 

Figure 3.2. Generalized clean room design. Entry of personnel occurs via changing rooms, where the operators first remove their outer garments and subsequently put on suitable clean room clothing (see e.g. Figure 3.3). All raw materials, portable equipment, etc. enters the clean room via a transfer lock. After being placed in the transfer lock, such items are sanitized (where possible) by, for example, being rubbed down with a disinfectant solution. They are then transferred into the clean room proper, by clean room personnel. Processed product usually exits the clean room via an exit transfer lock and personnel often exit the room via a changing room separate from the one they entered (in some cases, the same changing room is used as an entry and exit route). Note that, in practice, product may be processed in a number of different (adjacent) clean rooms...

The transfer of processing materials, or entry of personnel into clean areas, carries with it the risk of reintroduction of microorganisms and particulate matter. The principles of GMP minimizes such risks by stipulating that entry of all substances/personnel into a clean room must occur via air-lock systems (Figure 3.2). Such air-locks, with separate doors opening into the clean room and the outside environment, act as a buffer zone. All materials/process equipment entering the clean area are cleaned, sanitized, (or autoclaved if practicable) outside this area, and then passed directly into the transfer lock, from where it is transferred into the clean room by clean room personnel. 

SOPs detailing maintenance/validation procedures for specific items of equipment or facility areas, e.g. SOPs detailing CDS of clean rooms ... 

When appropriate, microbial monitoring of clean rooms and some other controlled environments should include quantitation of the microbial content of room air, compressor air that entered the critical area, surfaces, equipment, sanitization containers, floors, walls, and personnel garments (e.g., gowns and gloves). 

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