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Pharmaceutical Production Environmental Control

Producing medication is a sensitive process with often stringent requirements about air temperature and moisture levels. CFW offers the pharmaceutical industry high-quality custom control systems as well as standard units for monitoring and controlling ambient conditions.

medical tablets

Many pharmaceutical production processes are sensitive to indoor climate factors. Powder processing for medical products, for example, can be negatively affected by high humidity.

Careful measurement of humidity and temperature that is calibrated for a specific location can help to reduce concerns involving quality control, waste and shelf life. Both humidity and temperature should be managed simultaneously. Tight control tolerances can be difficult to achieve and are not always cost-effective. Although the nature of the process and the type of material will determine the appropriate environmental control system, a dry, cool climate generally results in higher processing speeds and product quality. Tablet press operations typically require an RH (relative humidity) of 20%-35%. In difficult cases, the engineer may wish to contact the manufacturer of the material or send a sample to an independent laboratory to perform a moisture equilibrium analysis. This will reveal the rates at which the powder absorbs moisture at various relative humidity levels.

Ambient moisture in pharmaceutical manufacturing is produced both by the processes being used and the materials used in manufacturing (internal moisture load) and by activities around tableting areas (external load). The external humidity load is of greater concern and generally arises from:

  • Permeation: Water vapour can leak into the conditioned space from outside. Vapour-proof insulation is needed to make sure that permeation does not place an unnecessary burden on the humidity control system.
  • Ventilation air: Incoming air from the ventilation system can account for as much as 60% of the total moisture load. Since the required airflow from ventilation affects its influence on the moisture load, this figure is determined by the need of workers for fresh air, the air required to maintain the air pressure at the desired level, and the air volume required to replace that which has been exhausted by fans, hoods and other extraction systems and equipment.
  • Door openings: The number of times that doors need to be opened can easily be underestimated, and these can have a substantial influence on the moisture load.
  • Infiltration air: Many rooms in pharmaceutical plants need to be kept at negative pressure to prevent substances from being spread to other rooms. However, this increases the amount of air which will enter the conditioned space through any openings.

For particularly sensitive applications, such as enzyme-based production processes, desiccant dehumidifiers are appropriate, whereas refrigerative cooling and dehumidification can be used for less sensitive ones. The case for desiccant dehumidification becomes especially strong where an RH of less than about 35%-40% needs to be maintained. In small enclosures, the RH can even be reduced to under 5% where necessary, if the right equipment is used.

Maintaining relative humidity at the right level has many benefits, including

  • Ensuring reproducible results
  • Reducing tablet compression friability
  • Reduced drying times
  • Improving the look of coated tablets
  • Extending shelf life
  • Controlling static electricity
  • Extending uptime by reducing machine clogging and reducing cleaning requirements

Evaporative cooling systems should not usually be used in the pharmaceutical industry, even when humidification is required, because they are more susceptible to microbial contamination. Cold surfaces may have to be insulated to prevent condensation. Pollutant control and ventilation are also crucial elements of many pharmaceutical production environments. The WHO guidelines for environmental control systems recommend that wet or dry scrubbers be used to remove fumes, preferably at the point they are generated. They also advise that pharmaceutical equipment can produce heavy dust loads, requiring at least F9 classification filters.

CFW supplies a variety of components for environment control systems, including scrubbers, dust control equipment, filters, dehumidifiers and heat pumps. In addition, we undertake turnkey environmental control projects customized for the given environment. Contact us to find out how we can support a reliable production line marked by increased uptime and consistently high quality.