Clean areas operation

Safety hazards are treated in the same manner. For example, workers who work in trenches in clean areas of the site would be covered by the OSHA Excavation and Trenching Standard, Subpart P, 29 CFR 1926. Workers who work in trenches in contaminated areas would fall under both Subpart P and HAZWOPER. Workers who do not work in trenches fall under HAZWOPER only when working in contaminated areas and would not be covered by either standard when working solely in clean areas, provided they are not exposed to safety hazards resulting from hazardous waste operations. 

Clean tunnel A tunnel providing access of operators or production components from one clean area to another. 

Filtered air may be used to purge a complete room, or it m be confined to a specific area and incorporate the principle of laminar flow, which permits operations to be carried out in a gentle current of sterile air. The direction of the airflow may be horizontal or vertical, depending upon the type of equipment being nsed, the type of operation and the material being handled. It is important that there is no obstruction between the air supply and the exposed product, since this may resnlt in the deflection of microorganisms or particulate matter fiom a non-sterile surface and canse contamination. Airflow gauges are essential to monitor that the correct flow rate is obtained in laminar flow units and in complete suites to ensure that a positive pressure fiom clean to less clean areas is always maintained. 

Lysimeter assembly and pre-installation testing should be conducted in a clean area, preferably indoors. Careful installation is necessary to ensure proper operation. The components of the lysimeters may need to be decontaminated prior to installation... 

To reduce the accidental spread of hazardous substances by workers from a contaminated area to a clean area, zones should be delineated on the site where different types of operations will occur, and the flow of personnel among the zones should be controlled. The establishment of work zones will help ensure that personnel are properly protected against the hazards present where they are working, that work activities and contamination are confined to the appropriate areas, and that personnel can be located and evacuated in an emergency. 

While the majority of critical manufacturing operations of injectable pharmaceuticals (e.g. most biopharmaceuticals) occurs in specialized clean areas, proper design and maintenance of non-critical areas (e.g. storage, labelling and packing areas) is also vital to ensure overall product safety. Strict codes of hygiene also apply to these non-critical areas. 

SOPs must be developed for label accountability with specific tolerances spelled out. Provision must be made for label security, such as locked cabinets on operating lines. Accountability sheets for other components should be provided so that reconciliation between used and finished packages can be developed. If possible, a cleaning area and shop should be set up for the cleaning of filters and parts and the disassembly and assembly of filling machines. 

The air must flow from the critical or most clean area to the surrounding area that is, the less clean area. For this purpose, rooms used for the manufacturing operation have to be laid out according to the order of the required air cleanliness. 

These features have to be well designed, installed, validated, and maintained. Critical operation has to be performed under the unidirectional airflow (laminar airflow). Air turbulence deteriorates air quality by intake of air from the surrounding less clean areas. 

Plutonium is so toxic that processing and fabrication are always done in sealed cells or glove boxes, but accidental dispersions of aerosol occur from time to time. Following combustion of Pu metal chips in a production area at Rocky Flats, Colorado, in 1964, airborne contamination was widespread. Alpha tracks from individual particles caught on membrane filters were detected on nuclear film, and the Pu content, and hence the particle size, was deduced (Fig. 5.2, curve E). The activity median diameter was 0.3 /urn (Mann Kirchner, 1967). The same method, used during normal operations in a production area at Los Alamos, gave activity median diameters in the range 0.15 to 0.65 /urn (Moss et al., 1961). However, when a spill occurred, followed by clean-up operations, the Pu particles were found to be associated with inert dust particles of mass median diameter 7 /urn. 

Better mechanical or chemical cleaning Check degreasing operation Eliminate source of contamination Cover or remove parts to clean area Speed up coating process... 

The garments used by the workers should be made of synthetic fabrics that minimize contamination risks. Operators should be trained for their work and also for the maintenance of clean conditions and hygiene. Cleaning is a key factor in the maintenance of good conditions and reduces or eliminates potential contaminants that can affect the product. Contaminants can have various sources live particles, inert particles (dusts, glass, file dust, lubricants, etc.) or cross-contamination when different processes or products share the same clean area. To avoid problems, the cleaning procedures should be written and approved, validated, and executed by trained operators. 

The options presented herein are intended to provide facilities that will effectively restrict both viable and nonviable particles from entering the clean areas, minimize contamination introduced by the facility itself, and continuously remove contaminants generated during normal operations. 

When entering agent contaminated operational areas, isolation of clean areas from those containing released agent is assured by means of this negative pressure and by the use of air locks. 

With respect to ventilation systems, we employ standard design criteria for volume flow rate, negative pressure, and face velocity requirements in contaminated and potentially contaminated areas. In contaminated plant areas, we employ a minimum of 20 air changes per hour, while in clean operating areas we use a minimum of 6 air changes per hour. All entries to the contaminated areas incorporate airlocks to prevent migration into the clean areas. 

It is used in clean up operations after all yarn has been removed from the slasher. It should never be allowed to come in contact with usable yarn. CPD-1 is brushed or sprayed on to all parts of the slasher and allowed to stand for 3-5 minutes. The equipment is then brushed again with fresh CPD-1 and this application allowed to stand for 5 minutes. The treated area is then washed with a stream of fresh water. 

Note Clean area standards, such as ISO 14644-1 provide details on how to classify air cleanliness by means of particle concentrations, whereas the GMP standards provide a grading for air cleanliness In terms of the condition (at-rest or operational), the permissible microbial concentrations, as well as other factors such as gowning requirements. GMP and clean area standards should be used In conjunction with each other to define and classify the different manufacturing environments. 

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