FDA commands different industries for validating environmental conditions in industries like pharmaceutical and biologics. Environmental conditions may directly impact the quality of the products. Temperature and Humidity mapping validation can be done by installation of different machines that can qualify the operationality. This includes an incubator, humidity chambers, deep freezer etc.
However, at some point, the manufacturer loses control over the situation. He can manage the conditions in the lab, manufacturing unit, his warehouse. But when it comes to retailer, transporter or end user, he cannot control things to such an extent. What he could do is, make his products withstand different conditions.
In the pharmaceutical industry, you cannot test the products as these are drugs but of course, you can test the packings. If they are sustainable in different conditions or not. Apart from packing, it is very important that labels also survive the environmental conditions.
Testing for Humid Environment
Humidity chambers are widely utilised in the pharmaceutical industry to assess the behaviour of products and their packings in extreme humidity. The testing is not done on every product. Instead, during research testing is an ongoing simultaneous process.
It is important to know that due to humidity if there is any composition disturbance, is it leading to some hazardous results or remain neutral or unaffected.
Second important thing to know is the behaviour of packing in humid conditions. Take the example of blister packing. The lower film is bonded with plastic cover using adhesion. If this adhesion is getting affected by humidity? The labels which are stick on packings and prints on the packings, should not get removed due to moisture in the air.
Testing for High-Temperature Environment
It is always advised to store the medicine in cool and dry place. The reason behind is the uncertain behaviour of the drugs and its packing due to exposure of high temperature. Some polymer packings tend to release particles due to rise in temperature. These are usually non-reactive packings but due to sensitive nature of drugs, such contamination cannot be tolerated. This may disturb the overall composition. This is why packings are tested for any change in properties due to a temperature of the surroundings. Hot air ovens are a common sight in pharmaceutical industries. Apart from testing of products, they are widely used in the dry sterilization process.
For more information about humidity chamber and hot air oven, contact our experts.