Packaging
manufacturing facilities they have – or have access to via a CDMO. “You have to make sure that you have a manufacturing option for the primary packaging that you’re choosing and that it’s not just wishful thinking,” he stresses. “I’ve come across innovators who have interesting approaches from a stability perspective but these containers would be very difficult to be filled. It’s great if you have a fantastic product but if you cannot produce it, you cannot industrialise it.”
In addition, all the components of the packaging need to be considered at the very beginning of the development process. “As an example, if you’re choosing a glass vial, it’s important to make the choice as a system. You need to choose a vial, rubber stopper and crimp cap in connection to your production process and your formulation considerations. It really comes back to integrated product design,” Mahler says. “It doesn’t help if you choose a vial and later choose a stopper then maybe the stopper doesn’t fit. The system won’t show sufficient closure integrity.”
Shelf-life and sterilisation
Shelf-life is another important point for manufacturers to consider. If glass precipitation occurs due to a reaction with an incompatible formulation, it could take 18 months after filling for this to be detected during stability testing. Similarly, an injector device could stall years down the line if the primary packaging includes too little silicone lubricant due to concerns about using too much. “You could observe stability issues, usability issues, manufacturing issues or container closure integrity issues, which would touch the heart and soul of a sterile product,” Mahler says. “Primary packaging choice must be made with the end in mind. If you’re targeting a product that should be used with an injector and you’re targeting a five year shelf life, that’s the design that you must have in mind and that's the trajectory of the product design you need to make.”
Sterilisation procedures can also have a significant impact on glass containers. “If there’s still some remaining water from the washing process in the glass and you heat it up to 250ºC, water can be a pretty nasty and aggressive solvent. So it’s very important to decide on what processing you have in your internal facility versus any ready- to-use primary packaging, paying close attention to particulates, endotoxins and any other contaminants,” Mahler says.
It always comes back to the fact that packaging should not be the choice of one department, whether that’s procurement, formulation or manufacturing. “You really have all these to take into account,” Mahler stresses. “Choice of primary packaging is not to be taken lightly. You can’t simply be inspired by a vendor and say, ‘That
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Expanding understanding Two of the most exciting areas of research in the primary packaging field are coatings and surface treatments, which are being developed to overcome some of the traditional downsides of plastic and polymer containers, and studies into new and improved methods of closing and sealing glass and plastic containers.
“As more complex primary packaging comes forward, the question of container closure integrity becomes a more difficult one to answer,” Mahler says. “System thinking is one of my favourite terms and again it goes back to thinking about the container closure system at the outset and how you want to qualify that on a container closure endpoint.”
“It could be a chicken and egg discussion – do we choose the container because of the formulation or the formulation because of the container.”
The scientific community’s understanding of newer and more sensitive biologic drugs and how they interact with various forms of packaging also continues to evolve, something Mahler is convinced will accelerate in the next ten years. “It’s difficult to say which areas will be the next level of where you want to dig deeper, but there are big questions to answer around novel containers and coatings, as well as a lot of opportunities for further studying the interaction with processing formulations and primary packaging,” he concludes. ●
31 Choosing the right type Type I Borosilicate Glass
This type of glass has a borosilicate structure. It is ideal for containing all injectable preparations with acid, neutral and alkaline pH. It has good
resistance to thermal shocks and can be sterilised before or after filling. Container of USP type I glass (Neutral borosilicate glass).
Soda-Lime-Silica Glass but with a suitable
Type II
treatment on the inner surface to increase the hydrolytic resistance
This type of glass is a soda-lime glass which, by means of a special treatment, reaches the
hydrolytic stability of type I glass on its surface layer of 0.1-0.2 um. It is suitable for acidic and neutral
parenteral preparations. Type II glass container can be sterilised before or after filling. Container of USP type II glass (Treated soda-lime glass).
Type III Soda-Lime-Silica Glass
This type of glass has average hydrolytic resistance. It is suitable for containing non-aqueous injectable preparations and those in powder form. It can also be used for non-parenteral preparations. Type III glass container should be sterilised by dry heat before filling. Container of USP type III glass (Soda-lime glass).
Source: Biomed
sounds great, I’m going to try it’. At the end of the day, you really have to make a wise choice because the failure modes are many.”
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