Körber’s solutions for prefilled syringe packaging

Modularity is essential to meet the technical parenteral packaging requirements of modern pharmaceutical products, including the growing diversity of prefilled syringes, vials and other types of injection device.

The Dividella NeoTOP Solution from Körber helps pharma & biotech manufacturers achieve operational and commercial viability through a quality-driven modular packaging platform approach that combines low to high speed packaging machines, compact and economical carton forms, thorough product protection with ease of use, quick set up and reduced total cost of ownership.

Körber’s modular packaging solutions offer safety combined with sustainability, efficiency, economy and user friendliness.

Dividella NeoTOP Solution from Körber

The Dividella NeoTOP Solution from Körber describes a range of highly modular and therefore flexible and adaptable toploading packaging machines that are combined with 100% monomaterial cardboard, which enables economical and efficient parenteral packaging of the whole range of pharma products, including  prefilled syringe formats.

The Dividella NeoTOP x can be adapted to the specific requirements of pharmaceutical product manufacturing, making it ideal for the production of small to medium batch sizes. Other Dividella NeoTOP machines, such as the Dividella NeoTOP 804 and the Dividella NeoTOP 1604, support higher speed production of mid to large size lots also being modular and expandable throughout.

Packaging of prefilled 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 filled syringes, syringe vial combinations, or ampoules.

Innovative carton packaging solutions for prefilled syringes are needed to enhance their marketability, which also means meeting increasingly stringent regulatory guidelines on product protection, security traceability and environmental sustainability.

The most effective packing solutions for prefilled syringes therefore need to support highly flexible packaging schemes that can handle a wide range of different containers and formats while  at the same time providing sensitive handling, optimal product protection and delivering the flexibility for ‘on demand’ manufacturing that includes small, medium and large lot sizes. The ideal modern packaging system must also support vision system automatic item and code checking, integrated labelling, printing and inserts, auto-checking of variable data, minimized machine setup and changeover times and GMP compliance.

A genuinely holistic approach to packaging must also consider the functional requirements of the parenteral package, which are not only to safeguard the product throughout its route from manufacture to final point of use but also to deliver patient information and tracking data to form an end-to-end metadata link between the pharma company and its consumers. In effect, the carton becomes an essential part of the prefilled syringe delivery system, delivering patient benefits like ease of access, reclosability clear instructions and peace of mind.

A monomaterial syringe carton formed on the Dividella NeoTOP delivers powerful advantages over PVC or PET blister packs and attendant end-load cartons. Not only does this avoid plastics use, now facing consumer resistance but there are also savings in material costs and logistics, with up to 40% reduction in the ratio between product and package volume for disposable filled syringes.

Other benefits include:

• Flat cardboard and partition blanks – printable on both sides
• Secure automated erecting and gluing
• Secure product insertion process (100% verification after insertion)

Over the entire manufacturing and logistics process, this results in concrete advantages for manufacturers in parenteral packaging as well as benefits in logistics for end users. This is particularly noticeable in cold chain logistics where packaging volume is priced at premium levels. The total effect is to reduce both Total Cost of Ownership (TCO) and Total Cost of Package (TCP).

A total prefilled syringe packaging solution

The latest Dividella NeoTOP x automatic packaging line represents an optimum solution for prefilled syringe packaging with an output of up to 45 ppm per minute and catering for carton sizes from (l x w x h in mm) 60 х 45 х 17 to 260 х 200 х 120. Like earlier models, Dividella NeoTOP x operates in a timed mode and includes interconnected modules, each performing specific production steps: carton and insert erection, product insertion, leaflet insertion, carton closure, labelling, etc.

Internal inserts can have up to 6 partitions glued in position while rotating 90^o to the transportation axis. The carton is erected in the first module and then transferred to the next module for product insertion. This module can have automatic feeders for parenteral packaging or a flexible manual insertion unit designed for two or more operators.

Prefilled syringe feeding

Feeding is a particular challenge for fragile items such as filled syringes, vials, pens and soft blisters. Here, Körber 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.

In recent years, Körber, on the basis of its particular expertise in this area, has already developed many different customized feeding systems.

Resources

Click on Toploading cartoners with Partition for more information.
Click on Dividella NeoTOP x: Flexibility at its best to download brochure.
Click on Small lots: How Sharp meets their challenge with Dividella NeoTOP to download case study.