Regulatory Requirements Of Pharmaceutical Packaging And Their Importance

The authenticity, quality and purity of medicines greatly depend on how they reach to the end users. Therefore, packaging has an enormous significance when it comes to pharmaceutical products. For medicine industry, packaging involves vigilance and risk, because it is the boxing of the medicine that determines their success.

Companies dealing with the packing of material are highly responsible for policy and regulation required while carrying out their work. It is vital for them to be aware of the regulatory requirements for packaging operations, which involves suitability, description, safety, protection, performance, compatibility, Quality Control, supplier and stability.

Each of the pharmaceutical packaging requirements has its significance. This article is not sufficient to cover entire features, hence only few of them are discussed below:
Protection:

Medicinal products are very sensitive to some of the external elements. In some extreme conditions they change the chemical structure of the formula. This can be hazardous for end users if he is unaware of the fact that the product he is using has not been packed appropriately or has leakage. Medicinal products must be protected from the below listed elements:

• Reactive gases (like oxygen)
• Exposure to light
• Solvent loss (liquid-based content)
• Moisture permeation (powder content)
• Sterility (closure/container integrity)
• Leakage

Each product must be sealed and ensured they avoid every external element that can influence the integrity of the content.

Compatibility:

A good pharmaceutical packaging company will always ensure that the material they are using is compatible with the product content. Chemical composition of material used, like elastomers, plastic, adhesives, etc. are most of the time are reactive. The company must know the regulations for the compatibility of pharma products. Composition of each product varies individually and if the workers are not aware of their sensitivity with the material they using to pack, this might result into fatal outcome.

Safety:

Where it is important to protect the pharma product from unwanted chemical reaction, it is also important to ensure that the products are reaching to the end user safely and without damage. To ensure it, pharmaceutical packaging company must be aware of the packaging technique for the protection from any sort of damage. This includes proper uses of

• The thickness of the carton boards,
• Partitions used to separate products and to avoid their collision during carriage
• Wide polystyrene foam
• Loose fill packing with polystyrene chips
• Polystyrene blocks or sheets
• Foam rubber
• Bubble wrap

They always must be aware with these safety things.