In the beginning, a cleanroom was just that–a large, decontaminated room where production operations could be performed in relative sterility. These original rooms were large, complex and costly to build and operate. They were used almost exclusively by the pharmaceutical and electronics industries, which needed them and could afford them.

“Cleanroom” today often refers to something much more practical–smaller, modular and often operated without intervention from personnel except for occasional maintenance and repair. Many full-sized cleanrooms still operate, especially in high-volume pharmaceutical operations. But the trend toward minimal cleanroom size is enabling many more manufacturers to use efficient clean filling systems. Some of the fastest growth is taking place in beverage and liquid food filling plants.

Reducing the containment

The main source of contamination in clean areas is people: the workers who have to enter a work area, and who are subject to the conditions within the cleanroom while at work. All else being equal, simply removing the people from a cleanroom causes contaminant levels to fall dramatically. Workers also have to be gowned and sanitized, a costly and time-consuming process. Eliminating workers from filling areas has been a major step forward in making cleanroom areas more practical in size and cost-effective to install and operate.

The removal took place by designing smaller clean containments with the filling operation inside and the workers and mechanical / actuating systems of the equipment outside. Not only did that change eliminate the need to decontaminate and gown workers; it also, in many cases, reduced the number of workers needed.

Bosch Packaging Technology has led in the development of barrier isolation technology in which the clean area is designed to surround and isolate only a filling operation, creating a Class 100 environment within a larger Class 100,000 external environment. All drives and motors are accessible for maintenance and repair from outside the containment; no personnel need enter the protected filling chamber. The Bosch MAFS[R] (Mini Aseptic Filling System) was introduced in 1992; there are now more than 170 MAFS operating in pharmaceutical facilities.

The benefits: a study conducted by Merck & Co. in 1997 indicated that adopting isolators like file MAFS could cut facility size in half, cut facility costs by up to 70%, reduce operating staff by 50% and double equipment utilization rates.

The newest Bosch Packaging Technology equipment, to be introduced formally in November at Pack Expo International, is the FLM aseptic filling system. Improved laminar airflow; easy access for operation, maintenance and cleaning; and a sleek, compact profile add up to a more secure and productive filling operation. The FLM is available in both isolator and non-isolator configurations and features built-in flexibility for 0.2 to 500 milliliter vials with output speeds of up to 600 units per minute. Automatic in-process checkweighing provides better sampling and streamlines the validation process.

In the beginning, a cleanroom was just that–a large, decontaminated room where production operations could be performed in relative sterility. These original rooms were large, complex and costly to build and operate. They were used almost exclusively by the pharmaceutical and electronics industries, which needed them and could afford them.

“Cleanroom” today often refers to something much more practical–smaller, modular and often operated without intervention from personnel except for occasional maintenance and repair. Many full-sized cleanrooms still operate, especially in high-volume pharmaceutical operations. But the trend toward minimal cleanroom size is enabling many more manufacturers to use efficient clean filling systems. Some of the fastest growth is taking place in beverage and liquid food filling plants.

The main source of contamination in clean areas is people: the workers who have to enter a work area, and who are subject to the conditions within the cleanroom while at work. All else being equal, simply removing the people from a cleanroom causes contaminant levels to fall dramatically. Workers also have to be gowned and sanitized, a costly and time-consuming process. Eliminating workers from filling areas has been a major step forward in making cleanroom areas more practical in size and cost-effective to install and operate.

The removal took place by designing smaller clean containments with the filling operation inside and the workers and mechanical / actuating systems of the equipment outside. Not only did that change eliminate the need to decontaminate and gown workers; it also, in many cases, reduced the number of workers needed.

Bosch Packaging Technology has led in the development of barrier isolation technology in which the clean area is designed to surround and isolate only a filling operation, creating a Class 100 environment within a larger Class 100,000 external environment. All drives and motors are accessible for maintenance and repair from outside the containment; no personnel need enter the protected filling chamber. The Bosch MAFS[R] (Mini Aseptic Filling System) was introduced in 1992; there are now more than 170 MAFS operating in pharmaceutical facilities.

The benefits: a study conducted by Merck & Co. in 1997 indicated that adopting isolators like file MAFS could cut facility size in half, cut facility costs by up to 70%, reduce operating staff by 50% and double equipment utilization rates.