FUNDAMENTALS AND TECHNOLOGY

The manufacture of sterile products is subject to special requirements to minimize the risks of microbial, particulate and pyrogen contamination.

The manufacture of sterile products should be carried out in clean areas.

Access to these areas must be through locks reserved for personnel and/or equipment and materials.

Clean areas must maintain an adequate level of cleanliness and must be equipped with air filtered through filters of appropriate efficiency (HEPA H13 or higher).

For the manufacture of sterile drugs, four grades are distinguished:

- GRADE A

Area where high-risk operations such as filling, cap trays, ampoules and open vials and aseptic connections are performed. Normally these conditions are provided by laminar flow workstations.

- GRADE B

Environment for grade A zone in the case of aseptic preparation and filling.

- GRADE C

Clean areas for less critical phases of sterile product manufacturing.

Clean rooms and clean air devices should be classified according to EN ISO 14644-1:2015. Classification should be clearly differentiated from environmental monitoring of the process in operation. The following table shows the maximum allowable airborne particulate concentration for each grade.

Clean rooms and clean air devices should be classified according to EN ISO 14644-1:2015. Classification should be clearly differentiated from environmental monitoring of the process in operation. The following table shows the maximum allowable airborne particulate concentration for each grade.

To classify zones as grade A, a minimum sample volume of 1 cubic meter (1000 liters) must be taken at each sampling point, and to classify zones as grade B, the volume is 689 liters.

Eurolab has particle counters specially designed for the pharmaceutical industry, with a suction flow rate of 50 liters per minute, which allows to classify the zones in grade A and B in a much shorter time than standard particle counters that suck at a flow rate of 2.83 l/min (it would take 17 times longer).