Even the simplest of pharmaceutical manufacturing process can involve range of steps before entire product is available to the consumer. These may include:
• Lab-scale development using glove boxes, small-scale process driers and coaters.
• Micronizing
• Storage of powders or liquids
• Mixing
• Product drying
• Tablet compression
• Film coating
• Packing & Storage
• Storage of finished products
Throughout these processes, the effects of ambient humidity can have detrimental effects on products which leads to great loss in product as well as loss to the reputation of the company.
AAI can provide custom-designed air dehumidification solutions for every single area of production: The main benefits of this system are that it provides considerable energy and cost savings, incorporating environmentally-friendly technology. Production capacity as well as hygiene conditions improve considerably thanks to the effects of controlled humidity. AAI dry air system is the simplest, most precise way of achieving and controlling the accurate humidity conditions required.
FBD
If air is allowed to flow through a bed of solid powdered material in upward direction with the velocity greater than the settling rate of the particles, the solid particles will blown up and become suspended in air stream. Use of hot air to fluidizing the bed will increase the drying rate of material. AAI Dehumidifier controls the moisture level.
The main benefits of this system are that it provides considerable energy and cost savings, incorporating environmentally-friendly technology. Production capacity as well as hygiene conditions improve considerably thanks to the effects of controlled humidity. The AAI dry air system is the simplest, most precise way of achieving and controlling the accurate humidity conditions required.
Contamination of pharmaceuticals with microorganisms can bring about changes in physiochemical characteristics of the products. Bacterial growth can occur due to high moisture content in the storage areas of pharmaceutical products which may lead to degradation of the product. Dehumidifier prevents the contamination of the product.
Product stability considerations comprise two areas:Drug potency and drug dissolution. When formulationsare considered, the water present in excipientsor employed in processing may preferentiallyconcentrate in amorphous regions of the drug. Depending on the drug properties, this moisture might then increase the rate of drug degradation. High moisture levels might also cause drug dissolution to be adversely affected, potentially resulting in reduced drug bioavailability. Dehumidifier controls moisture level.
Excessive moisture in blended solids may be theresult of incomplete drying, the presence of large blocks of granulated material that retain moisturein their core, or permeation through poor barrier materials during storage. These occurrences maycause significant effect on the flow properties ofsolids in processing.
Moisture is an important factor in compaction of blended powders or dried granulation to form tablets. Tensile strength is generally low at low moisture content. As the moisture level increases, the compact tensile strength also increases to a maximum level. Possible mechanisms for increasing the tensile strength are adsorbed water may alter surface structure such that there are more solid bridges, or immobile water at a particle surface may enhance interactions between particles. With the presence of relatively more surface moisture, it is possible for permeation into the particle, which may plasticize or soften the material. So, dehumidifier is highly needed to maintain the moisture level.
One specialty dosage form requiring exquisitecontrol of moisture in processing is the effervescent tablet. This dosage form offers distinct advantagesin terms of the following:
• Capacity to accommodate large dose drugwithin a typical 2,000 mg tablet.
• No requirement to swallow the dosage form.
• Buffering the acid environment of the stomachwith carbonation and induction of rapid emptying that aids drugs susceptible to acidic degradation.
• The foil packaging required for stability offers protection for drugs sensitive to light, oxygen, or moisture.
Selection of formulation components requires the presence of an organic acid and metal carbonate that release carbon dioxide when exposed to water. Because this reaction is autocatalytic (i.e., it also produces water that further speeds the reaction) there is a requirement for strict relative humidity control and processing steps during all phases of production and packaging.
MODERATE (RH VALUE 40 ~ 50%) |
LOW (RH VALUE < 40 ) |