Safe and Sterile: Unveiling the Key Packaging Solution For Parenteral Drugs
In pharmaceutical industries, the need to maintain the sterility of products is a key requirement. Sterile packaging systems eliminates the risks of microbial contamination of the product or packaging without compromising on the quality of the goods being packed or transported. The process of sterilisation involves the use of a sterile manufacturing vessel, a washing machine for bottles, vials, ampoules etc.., sterile blending vessels, and a depyrogenation tunnel, among others.
When it comes to packaging parenteral products, there are six primary sterile packaging systems in use today. Each of these systems offers unique advantages and is chosen based on various factors including the nature of the product and its intended use. Let’s explore these packaging systems in detail:
1. Vials (Glass and Plastic): Vials are a common choice for multi-dose applications. They are typically made of glass and are preferred for liquid and freeze-dried injectables. Glass vials are favoured due to their ease of sterilisation and transfer to aseptic environments. Plastic vials, while less common, are pre-sterilised and used when appropriate. Glass vials, however, remain the gold standard.
2. Prefilled Syringes (Glass and Plastic): Prefilled syringes have witnessed significant market growth, primarily due to their ease of use, dosage accuracy, and patient convenience. They are used for a wide range of injectable products, with many vaccines packaged and delivered in syringes. Ensuring the integrity of the syringe’s container-closure post-filling is crucial.
3. Ampoules (Glass): Ampoules, sealed glass vials, were once highly popular for small volume injectable products. Their advantage lies in using a single material (glass), reducing potential interactions with the drug. However, glass particles can enter the product upon opening, leading to a decline in their use in the U.S. They are still commonly used internationally.
4. Cartridges (Glass): Cartridges are similar to syringes but designed to fit into delivery pen devices. Initially used in dentistry, they gained popularity with insulin delivery. Cartridges offer dose accuracy and patient convenience, particularly for proteins like insulin and growth hormone.
5. Bottles (Glass and Plastic): Bottles are typically used for large volume injectable solutions or emulsions. They come in various sizes and materials, with blow-moulded glass and plastic being common. The container-closure interface depends on whether the bottles contain single or multiple doses.
6. Bags (Plastic): Bags are ideal for intravenous fluid administration. They come in various sizes and are convenient for transporting and delivering parenteral products. Barcoding is often used for product identification due to label readability challenges.
The packaging of parenteral drugs is a complex process; hence the packages are often run through a sterility testing isolator to meet the sterilisation requirements of the industry.
In summary, selecting the right packaging system for parenteral products depends on several factors, including product type, material compatibility, convenience, and sterility maintenance. Vials are the most common choice, followed by prefilled syringes, which are expected to grow in popularity. While ampoules were once favoured, their use has declined in the U.S. due to particle concerns. Cartridges, bottles, and bags cater to specific needs within the parenteral product market, offering versatility and choice.
The landscape of parenteral packaging is dynamic, driven by advancements in pharmaceuticals and the evolving needs of patients and healthcare providers.
F Plus Healthcare Technologies strives to meet these evolving needs, catering to several countries across the globe by providing state-of-the-art pharmaceutical equipment and more. Our range of equipment for sterile packaging is designed keeping accessibility and convenience paramount while also focusing on the changing needs and limitations. Finding out more about our range of sterile packaging is easier by speaking to our team to sharing your needs. You can reach out to us at [email protected] to know more.
