Clean room equipment manufacturers

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. 

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. 

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. 

Equipment and plant location can vary from an outdoor, exposed site, as in the case of an effluent treatment plant, to a clean room with controlled climate and air quality, for example, in biopharmaceuticals manufacture. 

Biopharmaceutical clean-rooms typically house process equipment requiring utilities such as pure water, electricity, vacuum, and clean compressed air. The source of these utilities is usually outside the clean room. During the design phase a utility matrix is developed, in conjunction with end users and equipment manufacturers, identifying all equipment and the utilities required. This is the basis for determining the capacity of the utility systems as well as the point-of-use location of specific utilities. 

Pharmaceutical products for clinical trials and market supply are manufactured in a multipurpose building. The building is equipped with a flexible HVAC system that allows individual clean room parameter settings for separate rooms. These parameters are set by the employees and documented in a traditional paper logbook Question... 

Despite the high performance of CMOS, its manufacturing process requires very high-cost equipment, clean room facilities, and expensive high purity single-crystal silicon wafers. Those limitations have set up the barrier to further reduce the fabrication costs and hindered the use of CMOS technology in large area electronics such as displays. 

Some medical device manufacturers are confused with the requirements for an equipment performance qualification (PQ). In general, a PQ is not required for manufacturing equipment if its performance is demonstrated during process validation (PV) where the equipment must be shown to perform under the unique conditions of every product (or range of products). A separate equipment PQ is only required when it is used in a manufacturing support role, which typically includes compressed air systems, clean rooms, and purified water systems. 

The demand for antistatic, electromagnetic shielding and related additives in the plastics industry is driven partly by sales of electrical and electronic equipment, much of which requires antistatic packaging and housings. Antistats have an important role in office equipment, reducing paper jams. Clean rooms for the manufacture of chip trays and silicon wafer cases need antistatic and other additives with low ion contamination and low volatile eontent, which implies pine substances. Medical monitoring equipment and aircraft instrumentation need to be protected from electronic interference. 

Following the announcement of the results of the UMASS-Digital Equipment Corporation study, IBM requested JHU to perform two epidemiological studies at IBM semiconductor plants. The request was for an historical cohort study and a prospective study. The objectives of the studies were to determine if. . there was an excess of adverse reproductive health effects among clean room employees, compared with employees working in other manufacturing areas or non-manufacturing environments and to determine whether any specific processes or chemicals were associated with adverse reproductive health outeomes. With this two-study approach, JHU was able to assess both current and past risks. 

Manufacturing Rooms Manufacturing rooms must be well designed in order to ensure adequate cleaning and reduction of cross-contamination. Points of dust accumulation like 90° angles areas must be avoided in the room, dust collectors or air lines must be presented restrictly at the wall surface and only the minimum equipments must be presented in a room. 

The first component of a successful clinical trial manufacturing program is the area or facility used for the production of clinical trial batches. This facility should have limited access and be segregated from other activities where the danger of cross contamination is removed and the control of materials, product, waste, and personnel flow can be achieved. Preparation of vector batches requires rooms where a controlled environment can be maintained. Here, under class 10,000 and class 100 environments, batches can be produced, purified, and vialed for use in trials. HVAC and other equipment used within the manufacturing facility requires annual calibration, initial installation, and operational qualification, and appropriate preventive maintenance programs. Written procedures for the use, cleaning, and maintenance of the facility, and the equipment must also be written and followed by appropriate personnel. 

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