Cleaning procedures factors

Logistics and cleaning procedures are important factors in successful sampler inter comparison. It is not desirable or possible to endorse or to condemn... 

In an ideal situation, the equipment used to manufacture tablet dosage forms would be selected based on such factors as formulation, safety requirements, handling/production efficiencies, and commercial demands. In reality, the equipment used is usually what is already available at the development facility or production plant. In either case, the equipment should be qualified (installation and operation) before being used. Cleaning procedures should also be available... 

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. 

Documented evidence to establish that cleaning procedures are removing residues to predetermined levels of acceptability, taking into consideration factors such as batch size, dosing, toxicology and equipment size. 

There are several factors which influence the rate of reaction in a given system. Some depend on system characteristics which cannot be controlled during the cleaning operation operational-procedure factors are controllable. The first category includes sodium quantity, sodium surface-to-volume ratio, and presence of undrainable sodium pockets. 

The operating time and batch size maybe controlled by economics or other factors. For instance, it is not uncommon for the entire batch including startup and shutdown to be done in one eight-hour shift. If the same apparatus is used for several different chemicals, the batch sizes may vary. Also the time to change over from one chemical to another maybe quite long, since a rigorous cleaning procedure may be required. 

The cleaning procedure selected, which includes removal of the cleaning agent, will depend on several factors ... 

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