Freeze drying is a process that removes water from a product while modifying its structure and composition as little as possible. This is accomplished by freezing the product, causing the water it contains turns to ice, and then exposing it to a vacuum, so the ice is sublimed, passing directly from a solid state to a gas. This preservation and processing technique is commonly used in the food, pharmaceutical and cosmetic industries, because it offers countless advantages. Freeze-dried products:
The main benefit of freeze drying is its ability to preserve for long periods products that are unstable and heat-sensitive and could deteriorate rapidly. Freeze-dried products are increasingly being used in different sectors. In the food industry, freeze drying continues to grow in popularity: from instant coffee or tea to infant food, more and more freeze-dried products are available on the market. In the pharmaceutical industry, freeze drying is widely used to store an extensive range of injectable products such as vaccines, increasing their shelf life and guaranteeing high safety standards.
Freeze drying facilitates the storage and transport of pharmaceutical products. However, it is a complex process that must be studied in great depth from standpoint of product formulation and the packaging in which it is to be stored. There are many essential factors:
To meet these requirements, freeze-dried drugs are generally sold in vials, bottles and dual-chamber syringes or cartridges.
For products that need to be packaged in a sterile environment, it is essential to verify packaging integrity to prevent the risk of contamination that could have very serious consequences on the health of patients. As with all injectable products, 100% of freeze-dried injectable products must be inspected according to the USP <1207>. To protect patient safety, manufacturers must ensure that every specimen placed on the market meets the quality standard, since the use of even one contaminated or improperly stored product could seriously damage a patient’s health. Automated tests provide rapid results and guarantee high accuracy and can help ensure these standards are met in every case. A variety of test methods can be used, but great care must be paid to the handling of the product to guarantee the perfect integrity of the packaging.
Bonfiglioli Engineering provides varied solutions for leak detection and packaging integrity of freeze-dried packaging including Vacuum and Pressure Decay testing, Headspace Gas Analysis and Automatic Visual Inspection or even a mix of these, customized to fit client requirements.
Need to speak with an expert to understand the optimal leak detection method for your container and product type? Contact us now.