Good manufacturing practices and regulations are critical areas for having good practices for the pharmaceutical industry. Much care should be taken especially when manufacturing sterile drugs and other biological products using aseptic processing. A critical area is where sterilized drugs, containers and closures may be exposed to the external conditions, therefore must be designed and manufactured to keep the product sterility.

Why is this so? Because an exposed product is vulnerable to contamination. It may also not be sterilized in its immediate container. Therefore, the quality of an environment in which aseptic operations are being conducted, should be controlled and well maintained. The air quality should be properly controlled especially, the particles its carries.

Aseptic areaThere is a need for supporting clean areas, as these serve as zones where non-sterile components, in-process materials, equipment and containers are held and transferred. The need is therefore to have clean working environments that minimize the level of particle contaminants in the final product before they are sterilized.

Another critical issue is ensuring clean area separation. Its an essential part of preventing the contamination when processing drugs. Airflow which ensures the quality of areas of higher cleanliness to those other areas that are less clean. A positive pressure of differential at least of 10-15 Pascal (Pa) must be maintained between the adjacent rooms with closed doors. Monitoring of these air pressure differentials should be monitored frequently from one shift to another. Additionally, air filtration should be carried out using HEPA filters to ensure that air inside the rooms is equal or better than that of the air in the environment into which the air is introduced.

Over and above, the design process is a critical area in the pharmaceutical industry. Aseptic processes should minimize the exposure of sterile articles to the potential hazards of contamination during the manufacturing operation. Issues that you should notice include well-designed processes in limiting the duration of exposure of sterile products, good environment control measures, process flow optimizations, good designing of equipment to prevent lower quality air entry is critical areas. Also, personnel and material flow need to be optimized to reduce and prevent activities that may introduce contaminants to the exposed product.

Well maintained, designed and operated aseptic process minimizes personnel intervention. Using good aseptic techniques at all times ensures the maintenance of product sterility. For personnel, appropriate training should be conducted before the individual be permitted to access some of the critical areas in the process. Training topics should include hygiene, safety hazards, specific written procedures, regular ongoing programs, aseptic filling technique, clean-room behavior, microbiology etc.

Lastly, it would be worth to note that some major techniques of maintaining sterility of all items and surfaces which are critical areas may include:

  • Contacting sterile materials with sterile instruments only.
  • Slow movements to avoid any disruptions to control parameters.
  • Keep your entire body out of the path of unidirectional airflow so that to protect sterile equipment, product and container closures from contamination.
  • Maintain proper gowning to control any form of human-generated contamination.