Cross contamination, prevention

Controlled environment requirements Preventative maintenance Emergency repairs Validated classified areas Structural changes Cross contamination prevention General housekeeping and sanitation Cleaning agents and pest control Critical utilities... 

Cross-contamination prevention segregation by space or time cleaning and personnel precautions. 

Verification of cross-contamination prevention by performing air sampling and machine swabs. 

Shared equipment Design to avoid or minimize use of (e.g. auxiliary process- common equipment for incompatible ing scrubbers ). Pos- materials sihility of incompatible, Implement proper cleaning procedure materials coming between incompatible uses to prevent together. cross contamination Prescrub or treat process streams before transfer to common equipment API RP 750 CCPS G-11 CCPS G-22 Kletz 1991 Lees 1996 NFPA-91... 

Minimize contamination via fewer cross-connections and fewer hose stations. Minimize the number of hoses required in loading/un-loading facilities. Cross-contamination, sometimes even from catalytic amounts of material, can result in undesired hazardous reactions. To prevent contamination due to rainwater and spills, consider storing a material that can react vigorously with water under a roof. 

Segregation is another important requirement and not only for nonconforming product as specified in clause 4.13. Segregation is vital in many industries where products can only be positively identified by their containers. It is also important to prevent possible mixing or exposure to adverse conditions or cross-contamination. Examples where segregation makes sense are ... 

Figures 10-7, 10-7A, 10-7B, and 10-7C illustrate the general arrangements of most manufacturers, although several variations of plate flow pattern designs are available to accomplish specific heat transfer fluids temperature exchanges. Also, the gasket sealing varies, and some styles are seal welded (usually laser) to prevent cross-contamination. Note that Figure 10-7C has no interplate gaskets and is totally accessible on both sides, yet easy to clean.

Once the sample has been processed in such a way as to maintain residue stability, to prevent cross-contamination, and to ensure homogeneity, strategies to extract the drug from the tissue and to isolate the drug residue from potential interferences must be evaluated. The following sections will review these two concepts separately. 

Sample handling and shipment 3.3.1 Prevention of cross-contamination... 

The section on components deals with all materials that may be used in the manufacture, processing, and packaging of drug products, plus materials used for maintenance of the building and equipment. They must be stored and handled in a safe, sanitary, and orderly manner. These precautions are needed to prevent mix-ups and cross-contamination of drugs and drug products. All items should be held until they have been sampled and tested according to the company s specifications and not released until the tests have been completed. In this section it is required that ... 

Delineation of these three zones should be based on sampling and monitoring results and on an evaluation of the potential routes and amount of contaminant dispersion in the event of a release. Movement of personnel and equipment among these zones should be minimized and restricted to specific access control points to prevent cross-contamination from contaminated areas to clean areas. A decision for evaluating health and safety aspects of decontamination methods is presented in Figure 16.22.105... 

Decontamination procedures must provide an organized process by which levels of contamination are reduced. The decontamination process should consist of a series of procedures performed in a specific sequence. Each procedure should be performed at a separate station in order to prevent cross-contamination. The sequence of stations is called the decontamination line. 

Stations should be separated physically to prevent cross-contamination and should be arranged in order of decreasing contamination, preferably in a straight line. Separate flow patterns and stations should be provided to isolate workers from different contamination zones containing incompatible wastes. Entry and exit points should be conspicuously marked, and the entry to the CRZ from the exclusion zone should be separate from the entry to the exclusion zone from the CRZ. Dressing stations for entry to the CRZ should be separate from redressing areas for exit from the CRZ. Personnel who wish to enter clean areas of the decontamination facility, such as locker rooms, should be completely decontaminated. 

The conditions for a complete separation of a binary mixture can be defined in terms of the Yj model parameters, which are directly related with the TMB (SMB) operating variables (fluid and solid velocities in the four sections of the TMB unit). From the constraints presented, those related to sections II and III play the crucial role on the separation performance of the TMB. It is in these central zones that the separation between the two species takes place. The role of the adjacent sections (I and IV) is to prevent cross-contamination and to allow the improvement of the continuous operation of the system by regenerating the solid and liquid phases. Taking into account these considerations, a region of complete separation in a Ym-Yn plane can be defined. Considering that the constraints concerning sections I and IV are fulfilled, the YnrYn plot is 311 important tool in the choice of best operating conditions. 

Handle all contaminated and potentially contaminated equipment and linen in a manner that will prevent cross contamination. 

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