Controlled environment rooms requirements

Clean Room and Work Station Requirements, Controlled Environment, Sec. 1-5 Federal Standard 209, Office of Technical Services, U.S. Department of Commerce, Washington, DC, Dec. 16, 1963. 

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. 

Commissioner, Federal Supply Service, General Services Admin. Clean Room and Workstation Requirements, Controlled Environment U.S. Government Printing Office Washington, 1976. 

It was designed to be the flnishing room where the flnal isolation of the API took place and any subsequent flnishing steps such as milling, flnal blending (required for all products), and packaging. Even within this controlled environment, covered containers were used whenever transfer of material was necessary. 

For additional discussions, refer to the 1999ASHRAE HVAC Handbook, Applications, and to the latest issue of Federal Standard 209 Clean Room and Work Station Requirements, Controlled Environment. ISO Standard 14 644-1 is a comparable international standard for clean... 

Environment (Chapter 13)—Control room environment refers to the prevailing ambient conditions, such as temperature, air quality, lighting, acoustics, vibration, interior design, and aesthetics, that are likely to have an effect on human performance in 24/7 operations. The example shows how measurements were taken on all six of these environmental factors at the workstations in a control room to see if they conformed to BS/EN/ISO 11064-6 (Ergonomic Design of Control Centers Environmental Requirements for Control Centers). 

A series of standards, BS EN 1822, High Efficiency Air Filters (EPA, HEPA, and ULPA), describes the factory testing of the filtration properties of air filters, while another series of standard, BS EN ISO 14644, describes the requirements in relation to clean rooms and associated controlled environments. BS EN ISO 14644-3 2005 establishes the in situ testing of air filters under installed conditions. 

As the construction and maintenance of a clean room requires a huge capital investment, it is also possible to do the processing of CP microfabrication using other means of providing a contamination controlled environment, such as laminar flow benches with HEPA filters. 

The primary stability condition for a product to be stored at ambient conditions is controlled at room temperature or 25 °C/60% RH (relative humidity) for climatic zones I and II. Additional stability conditions may be added to cover transportation excursion conditions, for example, 50 °C for 7 days and/or 70 C for 12 h. ICH condition also calls for the samples to be exposed to light of a designated intensity as part of the stability study. A stability program may also require more intense environments for climatic zones III and IV if the product is to be registered in countries located in these zones. 

The death knell for pneumatic control equipment has been predicted for at least the past 15 years. So far this has not happened, but it is still predicted. The major reason why pneumatic equipment is so popular is that the pneumatic control valve is cheap and requires little maintenance. The pneumatic system also has the advantage of posing no problems in the presence of flammable substances. (Extreme care must be exercised if electrical signals are used in such environments.) One major problem with pneumatic systems is the delay encountered in sending a pneumatic signal over 300 ft (90 m). However, this can usually be avoided by mounting the controller next to the unit instead of in the control room. This does not affect the monitoring of the process, which can still be done in a remote location. 

SACHEM Inc., located in Cleburne, Texas, is a producer of high-purity bulk chemicals for companies that have high-purity requirements in their chemical processing. As stated in Workplace Scene 1.2, one of their products is tetramethylammonium hydroxide (TMAH), which is sold to semiconductor industries. The analysis of TMAH for trace anions such as chloride, nitrate, nitrite, and carbonate is critical for SACHEM s quality control laboratory. If these ions are present on the integrated circuit boards manufactured by one of their semiconductor customers, they may cause corrosion severe enough to affect the functionality and performance of the electronic devices in which the circuit boards are used. In SACHEM s quality control laboratory, ion chromatography procedures have been developed to measure the anion concentrations in TMAH. Because the concentration levels are trace levels, a clean room environment, like that described in Workplace Scene 1.2, is used. A special procedure for carbonate analysis is required so that the absorption of carbon dioxide from the atmosphere can be minimized. 

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