PACKAGING COMPONENTS TESTING
Packaging is a very crucial aspect of any pharmaceutical product. Packaging components only influence the stability of a drug but also affect the quality and product identification. Drug containers remain in close contact with the products from the packaging to their consumption.
Packaging component testing in this industry is an assurance of the stability of the drugs for their intended use. Issues with thermodynamic stability or chemical inconsistencies can result in harmful contamination, leading to alteration in the therapeutic mechanism of the drugs. This testing plays a vital role in maintaining the efficacy, stability, and shelf-life of pharmaceutical products.
Some of the considerations in packaging components testing include:
- The assessment of container-closure systems, which include primary packaging materials and closures.
- Assessing the compatibility between the drug product and the packaging material with compatibility testing.
- Evaluating the physical and mechanical properties of the materials, such as tensile strength, elongation, puncture resistance, and others.
The United States Pharmacopeia (USP) parameters mentioned in the chapter <661.2> “Plastic Materials of Construction” outlines specific tests and acceptance criteria for various aspects, including extractable, leachable, heavy metals, and elemental impurities. The new parameters in the USP Chapter <1031> “Biological Reactivity Tests, In Vitro” states potential interaction between packaging materials and pharmaceutical products. The guidelines in these USP chapters ensure the safety and suitability of packaging products used in the pharmaceutical industry, helping to maintain the integrity and quality of the products.
Our packaging component testing is carried out to guarantee the suitability of each drug products
Packaging components testing is a vital part of quality control in our laboratories. We carry out a wide range of studies and testing procedures to ensure the packaging remains harmless with no contamination with the drug products.
Importance Of Packaging Components Testing
Packaging components testing holds significant importance in this industry for several many reasons:
- By conducting thorough testing, we can maintain the integrity of the products and ensure that the packaging components continue to serve as a crucial barrier between the drug product and its external environment.
- Testing packaging materials minimizes the risk of product contamination, tampering, or counterfeiting. This is particularly crucial for sterile products or drugs that are susceptible to degradation.
- Compatibility testing ensures that the packaging material does not interact with the drug product in a way that compromises its stability.
- Testing packaging components helps companies to ensure that the packaging materials are durable, aesthetically appealing, and contain accurate information.
Overall, by conducting comprehensive testing, pharmaceutical companies can mitigate risks, uphold the highest safety standards and maintain the integrity of drug products.