Temperature and Relative Humidity Monitoring In Pharmaceutical Industry
The environment inside a pharmacy and pharmaceutical storage areas must be optimal and constant to ensure the effectiveness of the medications within them. The implications of humidity for pharmaceutical are numerous as moisture causes de-sterilization, irreversible destabilization and oxidative degradation because the proteins found in many drugs are sensitive. In extreme cases, temperature fluctuations and humidity may result in harmful toxic degradation that isn’t easily detectable. Temporary climate control solutions are the best way to ensure the ideal environment for stored pharmaceuticals and maintain their safety and effectiveness for patients.
Temperature and relative humidity should be controlled, monitored and recorded, where relevant, to ensure compliance with requirements pertinent to the materials and products, and to provide a comfortable environment for the operator where necessary.
- Maximum and minimum room temperatures and relative humidity should be appropriate.
- Temperature conditions should be adjusted to suit the needs of the operators while wearing their protective clothing.
- The operating band, or tolerance, between the acceptable minimum and maximum temperatures should not be made too close.
- Cubicles, or suites, in which products requiring low humidity are processed, should have well-sealed walls and ceilings and should also be separated from adjacent areas with higher humidity by means of suitable airlocks.
- Precautions should be taken to prevent moisture migration that increases the load on the HVAC system.
- Humidity control should be achieved by removing moisture from the air, or adding moisture to the air, as relevant.
- De-humidification (moisture removal) may be achieved by means of either refrigerated dehumidifiers or chemical dehumidifiers.
- Appropriate cooling media for De-humidification such as low temperature chilled water/glycol mixture or refrigerant should be used.
- Humidifiers should be avoided if possible as they may become a source of contamination (e.g. microbiological growth). Where humidification is required, this should be achieved by appropriate means such as the injection of steam into the air stream. A product-contamination assessment should be done to determine whether pure or clean steam is required for the purposes of humidification.
- Where steam humidifiers are used, chemicals such as corrosion inhibitors or chelating agents, which could have a detrimental effect on the product, should not be added to the boiler system.
- Humidification systems should be well drained. No condensate should accumulate in air-handling systems.
- Other humidification appliances such as evaporative systems, atomizers and water mist sprays, should not be used because of the potential risk of microbial contamination.
- Duct material in the vicinity of the humidifier should not add contaminants to air that will not be filtered downstream.
- Air filters should not be installed immediately downstream of humidifiers.
- Cold surfaces should be insulated to prevent condensation within the clean area or on air-handling components.
- When specifying relative humidity, the associated temperature should also be specified.
- Chemical driers using silica gel or lithium chloride are acceptable, provided that they do not become sources of contamination.
Reference :-
Quality Assurance of Pharmaceuticals- Volume 2