Part 1, General principles: Describes the principles and basic methodologies for a formal system to access and control biocontamination.

Part 2, Evaluation and interpretation of biocontamination data: Gives guidance on basic principles and methodological requirements for all microbiological data evaluation and the estimation of biocontamination data obtained from sampling for viable particles in zones at risk, as specified by the system selected (Slote, 1987).


There are three approaches to control hazards. The first consideration for controlling biological hazards is to look at engineering controls. If a hazard cannot be eliminated through engineering processes, a second approach to controlling a hazard is administrative. If the exposure to a hazard cannot be prevented by either engineering or administrative controls, then prevention is necessary.

  • Engineering controls: These controls are the first line of defense and include built-in protection in the building, work areas, equipment, or supplies. Examples include ventilation systems and construction seals to create negative pressure rooms and biosafety hoods with specific ventilation systems (Mosey, 1981) (Table 5.5).
  • Administrative controls: These controls are steps in work procedures or work processes that minimize the risk of exposure to a hazard. This type of control does not eliminate a hazard but can significantly reduce the risk of injury. Examples include worker training, rules that require regular hand washing, etc. (Biune and Edling, 1989).
  • Personal protective equipment (PPE): When a hazard poses a threat even after engineering and administrative controls have been implemented, PPE is necessary. Some PPE include proper masks, eye protection gears, and latex gloves for biohazards. For a PPE to be effective, it must be worn correctly and must be comfortable and fitted for each person. Workers must be trained properly so that it is worn when needed (Zenz, 1988).

TABLE 5.5 Biocontamination of Air in Pharmaceutical Areas


Maximum Number of Particle Permitted per in3

Maximum Number of Viable Microorganisms per m3

0.5-5 pm

>5 pm


















  • • The role includes proactive work to eliminate biological hazards from the workplace as much as educating the workers about occupational hazards.
  • • Elimination of hazards from the work environment is always the prime choice for disease prevention.
  • • When hazards cannot be eliminated completed, they must be controlled. Workers should press management to introduce effective controls in the workplace such as engineering control, administrative control, etc.
  • • Pay attention to new workers and visitors as they are newly exposed to a workplace and can tell you if they have health problems only when they come into the workplace (Karvonen et al., 1986).
  • • Development of a risk assessment system for the rapid identification and implementation of preventive measures (Figure 5.2).
Overview of the biological risk assessment system

FIGURE 5.2 Overview of the biological risk assessment system.


Biological hazards cause health issues to humans and animals. These hazards are very dangerous and have to be taken seriously by employers and employees. There are several ways to reduce contaminants. Engineering, administrative, workplace hazardous material information, personal protective equipment, standard precautions, and ISO standards are necessary for avoiding risk to all types of biohazardous materials.


  • biocontamination
  • biological hazards
  • pharmaceuticals
  • control engineering controls
  • administrative controls
  • personal protective


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