Tablet Coating, Compression and Packaging

Tablet Coating, Compression and Packaging

Pharmaceutical applications in the pharmaceutical industry are shaped according to Good Manufacturing Practices (GMP) or Food and Drug Administration (FDA) standards. Most products in pharmaceutical manufacturing consist of different raw materials with high hygroscopic capacity, combined with the correct formulation. Raw material mixtures achieve the best flowability at a certain humidity level. High humidity causes the raw materials to stick together and clump, resulting in tablets that are soft and brittle. Extremely low humidity increases dust and static electricity, disrupting the homogeneity of the mixture and preventing the tablets from binding properly. Each pharmaceutical preparation's powder components may react differently to humidity. Optimal control levels can be obtained from raw material suppliers or determined through sample analyses in laboratories. In a systematic climate design where the moisture absorption tendency of components under different temperature and humidity conditions is analyzed, target absolute humidity and relative humidity are determined, and all climate control calculations for dehumidification are based on this framework.

Proper design and optimal humidity levels support the desired hardness and durability of tablets. For integrating dehumidifiers in pharmaceutical production, a complete analysis of humidity loads in the production process must be conducted. Based on internal and external humidity load determinations, the main source of humidity in the system is identified, and dehumidifiers are selected accordingly. In many tablet production rooms, the amount of humidity entering the system internally is negligible compared to the circulation rates. The design of tablet production ventilation systems is fundamentally based on positive or negative pressure. Pharmaceutical production is sensitive to particle contamination in addition to humidity and temperature. Fresh air is a source of both humidity and particles for the system. To maintain the desired room pressure, the fresh air required by personnel and the exhaust air needed by process machines must be included in the system air. Positive pressure involves including fresh air from outside, which constitutes a significant part of the total humidity load. When designing a new system, the capacity of the dehumidifier must consider the amount of fresh air required from outside. Given the external conditions, the absolute humidity level of fresh air varies with climate, affecting the seasonal productivity of adsorption type dehumidifiers. Therefore, the amount of fresh air introduced into the circulation must be controlled to maintain system stability. In cases of high circulation rates and low fresh air amounts, pre-cooling the air to a stable temperature before the dehumidifier can significantly save on operating costs and increase dehumidifier productivity. In some pharmaceutical applications, designing production under negative pressure results in drawing air from surrounding areas into the controlled humidity area. In such cases, the additional humidity load from neighboring areas due to negative pressure must be included in the calculations. Areas with low vapor pressure are particularly affected by pressure differences from neighboring areas. The design of a system with positive or negative pressure and the amount of fresh air in the ventilation cycle represent the impact of fixed loads. Variable loads include changes in the number of personnel, the number and duration of door openings, the air volumes drawn by variable-speed fans of process machines, and their impact on the cycle number. When conducting engineering calculations for dehumidifiers, the effect of all fixed and variable loads on the cycle number must be determined. Air from dehumidifiers typically has a higher dry bulb temperature, as latent heat removed from the air becomes sensible heat. Therefore, it is common to add a low-capacity cooling coil after the dehumidifier.

In addition to designing new tablet press rooms, dehumidifiers can be integrated into existing tablet production and press rooms. This application, which requires the modulation of various parameters, is more complex than new designs. In facilities with multiple climate-controlled areas, the conditioning of one or more rooms with dehumidifiers is proportional to the cycle number and the volume of circulated air. It must be confirmed that making the air sent into the room humidity-controlled by the dehumidifier will not cause problems for other work areas returning to the main climate control unit.

We as NKT – Humidity Control Technologies, our expert engineering team provides the best industrial dehumidifier solutions for tablet production and press rooms in pharmaceutical manufacturing. We offer energy-efficient, high-performance solutions.

For more information, please contact us using the form below.

Contact Form

First and Last Name
Phone Number
Company Name
Your Email Address
Message
I have read and accept the GDPR Information Notice.