Excessive humidity is one of the environmental factors that accelerate chemical and biological reactions. Not only is a controlled environment necessary for the preparation of pharmaceutical products, as they are submitted to countless processes and are highly sensitive to temperature variations, but they are extremely susceptible to humidity. Even the slightest oscillation in the humidity percentage may compromise a whole batch of medicine.
Precise environmental control is key in keeping up with the advancements in manufacturing techniques that are driving the pharmaceutical industry forward. This can be the defining factor that gets your product to market before your competitors’. The humidity levels inside your production facilities will affect the outcome at every stage of the process – from research and development, to manufacturing, packaging and storage.
When relative humidity levels are too high, there is a risk that products will absorb the moisture in the air. Not only does this make them less effective, but in some cases it can also make the products dangerous. This is a particular problem in the production of antibiotics as it can lead to a reduction in potency.
To help ensure public safety in the production of potentially life-saving drugs, the World Health Organisation (WHO) recommends maintaining RH levels at 50 per cent to optimise quality, yield and shelf-life.
Unregulated humidity has all kinds of implications in bringing a product to market, as well as its long-term stability and effectiveness as a drug.
Faults in environmental control are one of the biggest reasons for the rejection of entire batches of products. Not only does this come at a huge cost financially, but it could also put you weeks, or even months, behind competitors in the development and roll-out of new products.
Beyond the manufacturing process, it is also crucial for temperature and humidity levels to be optimised for storage. The exact conditions should be defined by the product, but this is normally at 50 per cent RH and between 15°C and 25°C for drugs kept at room temperature.
When the difference in a few degrees can result in the loss of so much hard work and risk public safety, accurate climate control is vital.
Calorex dehumidifiers are designed for both large and small pharmaceutical, as well as scientific settings. They can operate at low temperatures and achieve precise levels of relative humidity.
These industrial desiccant dehumidifiers work by passing air through a slowly rotating silica gel rotor. The desiccant material attracts the moisture to its surface, removing it from the air stream.
A second, smaller air stream usually heated to around 120°C, is required to remove the moisture from the rotor. This wet air must then be exhausted to atmosphere using a duct. Slowly rotating the rotor through both airstreams creates a continuous dehumidification process.