How do you enhance product stability and shelf life?

Enhancing product stability and extending shelf life is crucial for manufacturers and producers in various industries, such as food, pharmaceuticals, cosmetics, and more. The specific methods and techniques you should employ can vary depending on the type of product you are dealing with, but here are some general strategies that can help improve product stability and shelf life: Proper Packaging: Choose appropriate packaging materials that provide a barrier against moisture, oxygen, and light, which are common factors that can degrade products. Store products at the recommended temperature to slow down chemical reactions that can cause degradation. Refrigeration or freezing may be necessary for some items.

A good tool to find the right parameters is the European Pharmacopoeia. The monographs provided correspond to regulatory specifications, they represent the limit values of medicinal product at the end of their shelf life (except for those provisions referring to production)

The appropriate and limits of your parameters should be selected based on what will jeopardise your product stability and safety. What is the product, how do you want to store it, how long etc. Once you have established this, everything else can be played with to make it what you want within the framework you have established.

For any new products or new formulation,or Change in formulation requires Accelerated stability study for 6 months at higher temperatures ie 40 /75RH for cold storage it will be 25/60 and if there are any failures during the process, there will be intermediate testing. you have to carry out real time stability study for 1 year based on the stability zones. These are the minimum prerequisite for submitting to regulatory and to establish the minimum shelf life. Reports of Accelerated stability study and realtime stability study is key for Pharmaceutical Product. Other than this depending on formulation there will be stress testing, photostability also performed.

1️⃣ Formulation Optimization:   ● Choose ingredients with stability to prevent spoilage.  Antioxidants or natural preservatives can extend shelf life.   ● Adjust the pH of the product to inhibit microbial growth.    ● Manage water activity levels, as lower water activity inhibits microbial growth. 2️⃣ Packaging Optimization: ● Use packaging materials with properties against oxygen, moisture, light, & contaminants. ● Implement (MAP) modified atmosphere packaging to control the gas composition, extending shelf life by reducing oxidation & microbial growth. ● Vacum sealing removes oxygen from the package, slowing down oxidative reactions & microbial growth. ● Ensure proper sealing integrity to prevent leaks or the entry of contaminants.

Never underestimate the importance of having the proper container, closure and labeling system for your product. Contamination can come in a variety of forms, such as an off odor or bad taste caused by leaching of chemicals in the adhesive from the label into the product.

For Pharmaceutical products, review of stability data is a crucial practice to keep an eye on the shelf life of this product. It not only helps to build a confidence on the quality of the product through out the shelf life when stored in the proposed or established storage condition. Any 'Significant change' in the stability result may impact on the shelf life of the product. If it is found having any 'significant change' during the stability study, upon proper investigation and out come, it need to be notified to the regulatory authority. It may result in change in packaging material or it may result in formulation to get the expected stable product. But finally it need to be informed to the regulatory authority to implement the changes.

Have you applied HACCP principles? This is actually a proven method for predicting and mitigating risks. Try applying the Hazard to something other than Food Safety...

The FIFO philosophy always was a favourite, also, following the implemented SOPs and WIs, continuously reviewing their fit for purpose with SMEs and experienced team members. The real cherry on the top will lie on providing great training experiences to all staff involved in following this documentation and guidelines - creating a genuine positive impact through innovative and creative ways to deliver the required training and coaching does impact establishing a "do what's right" working culture. Leadership team members also need to be educated in the importance of regularly browsing shop floors and production areas to engage with everyone - not micromanaging, individual contributor empowerment in maintaining the highest quality standards.