Manufacturing, pharmaceutical hygiene

The sole objective of all hygiene and manufacturing controls is to ensure the quality of the pharmaceuhcal product for the safety and protection of the pahent. The manufacture of non-sterile pharmaceutical products requires that certain criteria of cleanliness, personal hygiene, produchon methods and storage must be met. Many such products are for oral and topical use and the question may fairly be posed as to the point of what are now quite stringent conditions. Nevertheless, some carefully controlled hospital studies have indeed shown that both types of medicine may be associated with nosocomial (hospital-acquired) infections and this risk can be minimized by the application of GMP principles. 

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. 

In every country, the use of food additives in the food manufacturing and pharmaceuticals industries is preceded by obligatory toxicological assays, hedged with very stringent laws and strict hygienic and sanitary requirements, it is strictly monitored by authorized institutions, which should guarantee food safety. 

Personnel should be restricted from all areas of pharmaceutical manufacture to those who are necessary. Protection from contamination from personnel is by training in hygiene, enforcement of hygiene rules, and provision of protective clothing. Hair is the major source of contamination from personnel, and street clothes is the second most significant source. Hair-covers should beprovided and worn properly in all areas of sterile manufacture beards, moustaches, and other excessive facial hair should be covered. Overall sleeves should extend to the wrist and be elasticated or studded to provide a neat fit. Because dogs are still allowed to soil the streets, protective footwear or shoe covers should be provided to all personnel allowed to enter pharmaceutical manufacturing areas. 

An undetermined amount of secondary exposure of occupational origin is caused to the general public. Occupational exposure to these compounds can be expected in the following industrial activities the agriculture, rubber, and plastics industry the chemical industry manufacturing of pharmaceuticals and hygiene products for consumers metalwork and the assembly of instruments and equipment and dry-cleaning. 

Principles In the manufacture and packaging of pharmaceutical products, high standards are set for personal hygiene and the cleanliness of working rooms and equipment. 

The establishment and maintenance of a satisfactory system of quality assurance and the correct manufacture of pharmaceutical products relies upon people. For this reason there must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the manufacturer. Individual responsibilities should be dearly understood by the individuals and recorded. All personnel should be aware of the prindples of Good Manufacturing Practice that affect them and receive initial and continuing training, including hygiene instruction, relevant to their needs. 

Taking into account the commercial interest in various kinds of nanocellulose, a great deal of importance is attached to detailed description of the manufacturing process and comprehensive characterization of the structure and properties of nanocelluloses, as well as their prospective applications, especially in the area of care and cure, including hygiene, cosmetics, pharmaceutics, medicine, etc. 

The color of the semiconductor in your computer chip or the color of your implanted biomaterial or pharmaceutical tablet is of little consequence. The color of your toothpaste, face cream, beverage, or food is another matter. Consumers are used to the manufactured brands of brilliant white toothpaste with blue, red, or green stripes. Brown is not a popular color for bathroom products (see the handbook review Porous Silicon for Oral Hygiene and Cosmetics ). There are brown and even black popular foodstuffs - think of bread, peanuts, cereals, chocolate, coffee, and marmite (see handbook chapter Porous Silicon and Functional Foods ). However, these are in the minority, and once again the consumer associates specific foods with specific colors. 

Purified c. is approved for ->food applications and used in ice cream formulations as crystallization inhibitor and in pet food. The pharmaceutical industry makes use of the property of c. to be insoluble in acidic media (stomach) and soluble in alkaline environments (intestine). Other uses are for dental impressions and in toothpaste. Cross-linked c. is used as a most powerful water absorbent in hygienic applications such as diapers and tampons. The sodium and calcium salts are used as suspending and viscosity-increasing agents in pharmaceutical applications. They act also as tablet binders as well as tablet disintegrating agents. CMMC is an effective film former in the manufacture of -> tobacco sheets. 

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