Contamination Control in Pharmaceutical Cleanrooms

Contamination Control in Pharmaceutical Cleanrooms

Contamination control in pharmaceutical clean rooms is driven by various technologies and disciplines like engineering and science. And it is surrounded by a large body of domestic and international regulations. It requires up-to-date information on microbiological contamination in sterile manufacturing, microbiological media fills and environmental monitoring, control in aqueous-bases, non-sterile pharmaceuticals, rapid testing methods, and clean room contamination control.

To control contamination effectively, routes and sources of contamination must first be identified, then controlled.

This is a huge topic and this article focuses on identifying the sources of contamination and ways to address them.

Sources of Cleanroom Contamination

Sources of cleanroom contamination include:

  1. Areas adjacent to the cleanroom
  2. Unfiltered air supply
  3. Room air
  4. Surfaces
  5. People
  6. Machines
  7. Ancillary equipment
  8. Materials
  9. Containers, and
  10. Packaging.

After identifying a hazard, its relative importance must be assessed. Then comes assessing the necessity and method for controlling it.

Control of Contamination in Pharmaceutical Cleanrooms

Methods that can be used to control the routes and ways that contamination spread are as varied as the contamination possibilities themselves. They include:

  1. Using HEPA filters to prevent contaminants entering the cleanroom with the air supply. This does not, however, address unfiltered air passing through a damaged filter.
  2. Ensure correct air filter housing construction.
  3. Ensure that air moves from the cleanroom outward to avoid less clean air entering from an adjacent unfiltered air supply. To do this, use air locks and a cascade flow of air through the doorways.
  4. Use conventional turbulent system to dilute contamination from air transfer route, or a unidirectional ventilation system to sweep it away, or an isolator to provide a barrier.
  5. Use adhesive cleanroom mats and flooring.
  6. Remove outdoor shoes. Wear foot coverings.
  7. Clean and disinfect floors, walls, ceilings, trolley and all exposed surfaces to minimize contamination from surface dirt and micro-organisms.
  8. Ensure that personnel wears cleanroom garments that cover their mouth, hair, clothing, and skin. Cleanroom garments and gloves minimize contamination from people, and their clothing.
  9. Minimize contamination from machines and ancillary equipment with the use of a unidirectional or exhaust air system.
  10. Ensure that raw materials, containers and packaging are manufactured to comply with producing minimal amounts of contamination.
  11. Ensure that all materials are correctly wrapped to ensure that they are not contaminated during shipping and that removal of packing materials does not produce contamination.

Pharmaceutical cleanrooms are highly regulated environments that require meticulous levels of compliance with various regulations and codes. Particle levels are tested and addressed, as is the presence of microorganisms.

In the United States, advanced technologies are now combined to address air and surface contamination and control in pharmaceutical cleanrooms. This is done using environmental monitoring methods that rely on advanced monitoring systems to control and identify non-viable particle counts, the presence of microorganisms, temperature, humidity, and pressure.

To ensure that your pharmaceutical cleanroom is fully compliant with the regulations and as efficient as possible through the use of appropriate technology, get in touch with our experts at Blue Thunder Technologies today.