Flexible parenteral packaging from vials to pre-filled syringes

Körber can offer highly flexible and adaptable solutions to the challenges of pharma parenteral packing, including lines that can handle very rapid format changes in seamlessly adapting from vial packaging to prefilled syringes.

The modularity and scalability of Dividella NeoTOP toploading packaging lines, along with their ability to support 100% monomaterial cartoning, have made them ideal in responding to the recent challenges in producing vaccines and vial packaging at unprecedented speed and scale.

Looking further ahead, the same modularity and adaptability also make the Dividella Solution ideal for responding to calls for the supply of vaccines in pre-filled syringes to support global vaccine programs, as well as the more general trend towards parenteral administration in pens, autoinjectors, etc.

Vaccine packaging challenges

Vaccine manufacturers in North America, Europe, India, Russia, China, and elsewhere have so far concentrated their packaging on vial packing, typically of 2ml glass vials or 5ml glass vials, for shipping and distribution to injection sites.

Conventional responses to the COVID-19 vaccine challenge highlighted particular issues, including a lack of supply of sterile glass vials in general and empty sterile vials during the early stages of the vaccine rollout from November 2020.

The coronavirus emergency also placed a premium on toploading vial packaging that can be performed within highly controlled temperature and sterilized environments and at very high speeds to meet global demand for billions of doses. At the same time, this vial packaging has to be performed with very high precision in feeding, handling and cartoning.

The scale of the challenge, as well as increasing environmental imperatives with ever-lower consumer tolerance for plastic packaging, has also underlined the advantages of monomaterial card and paper based parenteral cartoning solutions that are inherently far more cost-effective and sustainable. A monomaterial parenteral carton formed on the Dividella NeoTOP toploading solution can out-perform polyvinyl chloride (PVC) or polyethylene terephthalate (PET) blister pack and attendant end-load carton.

Feeding and handling adaptability

The power of Dividella’s NeoTOP cartoning solutions is in vaccine vial and injection  vial packaging enhanced by modular feeding systems that allow packaging lines to be optimized and tailored for all packaging formats.

Dividella feeding modules can be selected to support Top Loading or side loading of sensitive parenterals, including small single use or large multi dose vials, prefilled syringes, pens, and auto injectors. In the case of the new NeoTRAY solution, both can be effected simultaneously.

Modular concepts

Modular design means for example that different feeding elements can be incorporated at will within the overall NeoTOP system to support any combination of needs, ranging from specific types of vial packaging formats to a wide range of different medicinal products and devices, parenterals, or solid forms.

All Dividella NeoTOP platforms feature smooth and quick format changes as standard, with all machines, designed to accommodate different packaging configurations on a single platform with short changeover times.

The modular concept also allows the Dividella NeoTOP x and NeoTOP 804 machines to adapt to handle syringes, mainly prefilled syringes or combipacks of injection vials plus syringes that will be required to support truly global vaccine administration programs.

Körber’s Dividella solutions will allow just that in allowing ‘plug and play’ scale up or retrofit of a machine installed for vial packaging : by swapping the vial feeding module for syringe feed or extending the machine to package user selection of vials (including amber vials, autosampler vials, chemistry vials, sample vials, or serum vials), along with syringes, pens, or autoinjectors, thanks to multipurpose feeding and loading modules and highly adaptable monomaterial packaging formats.

Dividella feeding technologies

One of the key challenges in parenteral packaging is to devise a feeding system that will apply gentle yet flexible handling for fragile items such as syringes, sterile glass vials, pens, soft blisters, etc. In this area Dividella is able to apply a very wide range of feeding technologies.

Feeding is a particular challenge for fragile items Here, Dividella is able to apply a very wide range of feeding technologies and customized solutions linked to upstream machines. New modular feeding systems based on Dividella’s great  experience in pharma object handling allow up to 500 objects per minute to be aligned, spread, and individually checked before insertion into the packaging line.

Prefilled syringes

Körber’s modular and highly flexible/adaptable monomaterial packaging platforms support are ideally suited to economical and efficient packaging of parenteral products, including the whole range of prefilled syringe types.

Dividella’s latest toploading solutions cater to pharmaceutical manufacturers looking to produce small batches – down to individual units – more efficiently with support for semi and fully automatic packaging of vaccine and injection vials, syringes, auto-injectors and other parenteral products, even down to applying product labels to syringes.

Over recent years, the pharmaceutical industry has increasingly embraced prefilled syringes as a more user-friendly delivery format for parenteral drugs and vaccines, simple to handle and with minimal risk of spillage, contamination, or crucial dosage errors.

This trend has been accelerated by the greater prevalence of biotech products with their greater therapeutic effect but whose active ingredients are frequently too unstable to be incorporated into solid-dose tablets or capsules. More than 90% of these products are therefore packaged as liquids in syringes, injection vials, or ampoules.

The most effective vial packing solutions therefore also need to support highly flexible packaging schemes that can handle a wide range of alternative formats such as prefilled syringes while at the same time providing sensitive handling and optimal product protection and delivering the flexibility for ‘on demand’ manufacturing that includes small, medium and large lot sizes.

Further functional advantages from the top-loading format include ease of access, immediate presentation of entire contents for the end user, better integration of patient literature or user labelling, superior integration of disparate elements such as additional needles and small vials, more evident tamper protection, and ease of reclosure.

Resources

Click on Toploading packaging solutions to find out more.
Click on Cartoners for the pharmaceutical and biotech industry for further information.