Environmental cleanliness

ISO 9001 is not specific on what is meant by working environment . ISO 9001 only applies to product and factors that affect the product therefore working environment means the environment in which work on product is carried out. If temperature, cleanliness, humidity, electromagnetic, and other environmental factors need to be controlled to ensure conforming product then their control provides a suitable working environment. 

This requirement hides an important provision. It not only applies to inspection, measuring, and test equipment but to the measurements that are performed with that equipment. Anywhere you intend performing product verification or monitoring processes you need to ensure that the environmental conditions are suitable. By environmental conditions is meant the temperature, pressure, humidity, vibration, lighting, cleanliness, dust, acoustic noise, etc. of the area in which such measurements are carried out. To avoid having to specify the conditions each time, you need to establish the ambient conditions and write this into your procedures. If anything other than ambient conditions prevail, you may need to assess whether the measuring devices will perform adequately in these conditions. If you need to discriminate between types of equipment, the ones most suitable should be specified in the verification procedures. 

All finishes should be selected to be resilient to expected average and worst-case environmental exposure such as high/low humidity or temperature, airborne contaminants, vibration, possible aggressive liquid spillages, cleanliness/hygiene requirements, etc. 

Environmental cleanliness and hygiene 3.2.2 Entry to aseptic areas... 

Areas for the manufacture of sterile products are classified according to the required characteristics of the environment. Each manufacturing operation requires an appropriate level of microbial and particulate cleanliness four grades (Table 22.1) are specified in the Rules and Guidance for Pharmaceutical Manufacturers and Distributors (1997), defined by measures of airborne contamination (Table 22.2). Environmental quality is substantially influenced by the air supplied to the manufacturing environment. 

In a separate study, Igwe and Abia46 determined the equilibrium adsorption isotherms of Cd(II), Pb(II), and Zn(II) ions and detoxification of wastewater using unmodified and ethylenediamine tetraacetic acid (EDTA)-modified maize husks as a biosorbent. This study established that maize husks are excellent adsorbents for the removal of these metal ions, with the amount of metal ions adsorbed increasing as the initial concentrations increased. The study further established that EDTA modification of maize husks enhances the adsorption capacity of maize husks, which is attributed to the chelating ability of EDTA. Therefore, this study demonstrates that maize husks, which are generally considered as biomass waste, may be used as adsorbents for heavy metal removal from wastewater streams from various industries and would therefore find application in various parts of the world where development is closely tied to affordable cost as well as environmental cleanliness.46... 

Toxic hazards never seem as acute as other hazards in the ordnance industries, and the prevailing habits of cleanliness and orderliness go a long way toward their amelioration. The current emphasis on the maintenance of environmental standards have placed additional requirements on the control of effluent gas and liq process streams. The care now being exercised is evidenced by new analytical techniques for the detection of trace contaminants such as the presence of TNT and other aromatic nitrates in the soli and in the ground w (Ref 43), New techniques of detoxification have been developed using microwave plasma oxidation of aromatic compds, heavy metal compns and chemical warfare agents (Refs 65 81)... 

All of the environmentally-controlled areas of pharmaceutical manufacturing and its related areas should meet the requirement of air cleanliness, which is expressed as classifications specified by official standards, such as ISO (International Organization of Standardization) or FED-STD (U.S. federal standard) 209, and/or GMP. The classification has a close relationship with the air treatment procedures and construction features. 

Each manufacturer shall establish and maintain requirements for the health, cleanliness,personal practices, and clothing of personnel if contact between such personnel and product orenvironment could reasonably be expected to have an adverse effect on product quality. Themanufacturer shall ensure that maintenance and other personnel who are required to worktemporarily under special environmental conditions are appropriately trained or supervised bya trained individual. 

IES (1992), Institute of Environmental Sciences, Federal Standard 209E, Airborne particulate cleanliness classes in cleanrooms and clean zones, Mount Prospect. Available at http //www.set3.com/papers/209e.pdf (accessed October 2006). 

Many industrial processes require accurate environmental control. Examples include chemical reactions and processes that are affected by atmospheric conditions biochemical reactions quality, uniformity, and standardization of certain products factors such as rate of crystallization and size of crystals product moisture content or regain deliquescence, lumping, and caking of hygroscopic materials expansion and contraction of macliines and products physical, chemical, and biological cleanliness effects of static electricity odors and fumes conditions in storage and packaging quality of painted and lacquered finishes simulation of stratosphere or space conditions and productivity and comf ort of workers. Controlled atmospheric conditions are... 

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