Humidity Control For Pharmaceutical Industries

Dec 28, 2020Blogs

Pharmaceutical Industries are mainly involved in developing, producing and marketing of all kinds of medicines for diagnosis, treatment or prevention of disease. Most pharmaceuticalingredients such as Active Pharma Ingredients (API), filling powders, capsules, tablets arehygroscopic in nature

Good Manufacturing Practices (GMP) for pharmaceutical industry also advocate that all equipment, persons, process and environment which may have a direct impact on the quality and safety of the product must be maintained within specified limits

It is essential to ensure optimal humidity is maintained in all aspects of pharma production, storage, testing, mixing& packaging in the process of manufacturing  

Applications  

RESEARCH & DEVELOPMENT LABORATORIES

Clean Rooms and R&D Labs require high sterility to protect the sensitive equipment. High moisture content in the air affects the chemical integrity of the substances used and will give inaccurate results. Chemical reactions can also be affected due to excess moisture content. In addition to this, controlled humidity helps in fighting against dampness and stale odour.

FILLING & PACKAGE OF PHARMACEUTICALS

During the packaging process of substances like tablets, capsules and such hygroscopic products the moisture content plays a prominent role. 

In packaging and filling of dry powders, the powder might stick to the conveyor if lumps are formed because of excess humidity. This will cause downtime and inappropriate filling.

Some main sources of moisture can be:

  1. Headspace(the air within the package at the time of production)
  2. Moisture ingress into the packet 
  3. The initial water content of the product 

This can cause in reduction of shelf life of products and also compromise in potency and efficiency of the products.

STORAGE OF PHARMACEUTICALS

Storage area needs to have controlled humidity. High moisture content in the air damages the storage boxes which will ultimately lead to the damage of products inside it. Packing of moisture with the product is likely to happen when using Aluminium as it is moisture sensitive. 

Humid conditions tend to promote microbial growth and condensation indoors. To keep the products intact for a longer period of time and reduce the number of damaged products it is important to have a dehumidification technology. Dehumidifiers can be used to minimise the adverse effects of moisture as they help in maintaining optimal humidity levels.

MANUFACTURING PROCESS

Humidity control becomes important in various areas of processing to ensure that the products obtained are of the highest quality 

  1. Precise humidity control is required in tablet coating to make sure that the coating does not dry too fast or too soon. High moisture results in tablets having an uneven and rough coating
  2. During the processing of powdered substances if moisture content is high – then lumps are formed. This process is called Agglomeration., and it makes it difficult to grind them since they stick on process equipment
  3. Table compression also requires that the powdered substances remain dry. This is to make sure that caking and lumping is avoided and the process is executed smoothly.
  4. High moisture content can also result in Production issues or batch rejections of Active Pharmaceutical Ingredients, since even a small amount of unwanted changes water can cause changes in intended reactivity and specificity of medication 

Industrial Dehumidifiers keep the air around these areas dry and help in increasing productivity and reduce downtime. Optimal humidity conditions also make certain that products have a significant shelf life and that the quality is not compromised.

TESTING

In pharmaceutical industry, testing of the products is a very important step. There are several testing labs such as the LCMS (Liquid Chromatography with tandem mass spectrometry), GCMS (Gas Chromatography Mass Spectrometry), XRD (X-Ray Diffraction), and HPLC (High performance liquid chromatography) etc.

All these labs use high performance equipments which are very sensitive to moisture. High moisture is a threat to such equipments as condensation can take place and damage them. Equipments such as X ray Diffractometer, mass spectrometer, HPLC equipment etc need to be utilized in humidity controlled environment for maximum efficiency and to avoid errors.

High humidity can also cause deterioration in quality of the sample. To keep the air clean, mould and mildew free and the room free from musty odour a dehumidifier can be installed. It will serve the purpose of maintaining required RH levels and will reduce downtime and errors.

MANUFACTURING AND DRYING

In pharmaceutical industry, testing of the products is a very important step. There are several testing labs such as the LCMS (Liquid Chromatography with tandem mass spectrometry), GCMS (Gas Chromatography Mass Spectrometry), XRD (X-Ray Diffraction), and HPLC (High performance liquid chromatography) etc.

All these labs use high performance equipments which are very sensitive to moisture. High moisture is a threat to such equipments as condensation can take place and damage them. Equipments such as X ray Diffractometer, mass spectrometer, HPLC equipment etc need to be utilized in humidity controlled environment for maximum efficiency and to avoid errors.

High humidity can also cause deterioration in quality of the sample. To keep the air clean, mould and mildew free and the room free from musty odour a dehumidifier can be installed. It will serve the purpose of maintaining required RH levels and will reduce downtime and errors.

Adverse Effects of Humidity in Pharmaceutical Industry

Increased downtime and energy consumption

Damage to sensitive and expensive testing equipment

Condensation on the walls and ceilings in rooms

Increase in microbiological growth

Issues in product drying and mixing

Discomfort to people working in these areas

Poor accuracy

Agglomeration of powdered substances

Reduced productivity

Reduction in shelf life of products

Our Solution

Our compact and Industrial Dehumidifiers help in maintain ideal RH levels in Pharmaceutical Industries where sterility and hygiene are of utmost importance. Using dehumidifiers will ensure Goods Manufacturing Practices (GMP) compliance and also make sure that the product safety is quality is not compromised.

There are several areas in Pharmaceuticals where a Dehumidifier is required. Some of them can be stated as:

  • Storage
  • Clean rooms and R&D Labs 
  • Testing Labs such as LCMS, HPLC, and XRD etc.
  • Filling and Packaging areas
  • Manufacturing and Processing areas 
  • Drying Areas 

Dehumidifiers are easy to use devices and give prominent results. Advantage of using Dehumidifier over Air conditioner is that Dehumidifiers help us in controlling moisture levels without bringing significant drop in temperature whereas an Air conditioner will also help in controlling moisture levels but with a large drop in temperature. Thus using Dehumidifier is a better and feasible alternative as it also assists in cutting energy costs.

Advantages Dehumidifier offers in Healthcare Industry:

  • Increases production efficiency
  • Decreases downtime 
  • Maintenance of sensitive testing equipment 
  • Increase in shelf life of products 
  • Prevent damage of hygroscopic powders 
  • Reduced number of rejections 
  • Energy savings 
  • Reduces overall cost

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