PRODUCTION FACILITIES FOR STERILE PRODUCTS

The production process includes all of the steps from the accumulation and combining of the ingredients of the formula into a product to be enclosed in the individual containers for distribution. The production process involves personnel who carry them out and the facilities in which they are performed. To prepare a quality product meeting the entire compendia requirements, standard operating procedures (SOP) are also required. Thus a successful manufacturing program for the sterile product requires well-trained personnel, appropriate production facilities and SOPs. The essential components of the production include the environmental control, traffic control, house keeping, surface disinfection, air control and personnel.

Facilities

Lack of appropriate facilities cannot provide the efficient controllable environment for production of products with desired features. The facilities for the manufacturing of sterile products should be designed for control of cleanliness appropriate for each step.

Near-perfect cleanliness must be achieved in the aseptic filling rooms. The surrounding area should provide a buffer area in which standards of cleanliness are only slightly lower than those for the aseptic rooms. The prevention of contamination must be primary objective in design of these facilities. To achieve such exceptional design and construction standards, knowledge of the purpose of the facility must be coupled with the utilization of the best construction materials and design. The ceiling walls and floors should be constructed of materials that is easy to clean and non-porous to prevent the accumulation of debris and moisture. One of the best materials for floors is a ceramic-plastic cement applied as a thick coat over existing rigid flooring to form a continuous sealed surfaces. Now synthetic floorings are available with better features.

Glass is often used in partitions to permit supervisory view of the operations, but more importantly to provide more pleasant, better lighted, less confining surroundings for the operations. Lighting fixtures should be recessed and the exposed piping or other dirt collecting surfaces should not be tolerated. The items of the equipments that are difficult or impossible to sterilize should be kept out the aseptic areas, if possible. If they are to be remained in the aseptic area, they should continuously be exposed to the disinfecting processes. Whenever possible the operating machinery parts should be enclosed in the stainless steel housing.

The ceiling, walls and floors in clean room

The round joining edges of floor and wall in the clean room

The round joining edges of floor and wall in the clean room

The mechanical servicing of electrical, gas, water, air ventilation and other utility lines into these areas requires careful planning. One of the most effective plans for this is to provide a floor above, space beneath, or a corridor along side of the production area where all services connections can be accessible and properly maintained. This prevents interruption of production and most importantly, contamination of the production area by maintenance operations and personnel.

Laminar airflow is the most frequently added to a clean room to achieve greater environmental contact in a local area, such as in a work bench enclosure or over a filling line.